1. Introduction

Smylen, Inc ("Smylen") is committed to ensuring the confidentiality, privacy, integrity, and availability of all electronic protected health information (ePHI) it receives, maintains, processes and/or transmits on behalf of its Customers. As providers of compliant, hosted software used by health technology vendors, developers, designers, agencies, custom development shops, and enterprises, Smylen strives to maintain compliance, proactively address information security, mitigate risk for its Customers, and assure known breaches are completely and effectively communicated in a timely manner. The following documents address core policies used by Smylen to maintain compliance and assure the proper protections of infrastructure used to store, process, and transmit ePHI for Smylen Customers.

Smylen provides a technology enabled, mobile web based marketplace ("platform") for consumers to book dental treatments, and a membersip rewards program sponsored by organizations and offered to groups. These Categories are cited throughout policies as Customers in each category inherit different policies, procedures, and obligations from Smylen.

The platform stores dental treatment information and medical history to provide a seamless consumer experience going to the dentist. Smylen makes every effort to reduce the risk of unauthorized disclosure, access, and/or breach of Smylen customer data through the use of secure cloud technologies. Our platorm is locked down at all levels including the network (firewalls, dedicated VPC, etc), server (encryption at rest and in transit, strict of use containers, etc) and application layer. Access is limited to those who need it for their jobs, and any changes or exceptions are documented so such that these claims are verifable by audit.

1.2 Compliance Inheritance

Smylen provides compliant hosted software for its Customers. Smylen is a new company and has not completed a HIPAA/HITRUST compliance audit by a national third-party compliance firm to validate and map organizational policies and technical controls to HIPAA rules. Smylen's CTO has built the company policies, procedures, and technology with HIPAA/HITRUST in mind and is seeking a firm to conduct an audit to verify this claim. Notewistanding, Smylen's platform was built by security and privacy experts, runs entirely on AWS using its highest grade of security tooling; current production systems on AWS will be included in Smylen's third-party audits and HITRUST certification.

Smylen signs business associate agreements (BAAs) with its Customers who are dentists and the covered entitiy. These BAAs outline Smylen obligations and dentist obligations, as well as liability in the case of a breach. Smylen does not manage aspects of compliance for Customers. Certain aspects of compliance cannot be inherited. Because of this, Smylen Customers, in order to achieve full compliance or HITRUST Certification, must implement certain organizational policies. These policies and aspects of compliance fall outside of the services and obligations of Smylen.

Smylen does not act as a covered entity. When Smylen does operate as a business associate (not a subcontractor), Smylen provides access to ePHI in the platform only to those delivering or recieving treatment.

Smylen signed a BAA with AWS as they manage the security of our infrastructure from datacenter, network up to but not including the application and data. The network, servers, container management, databases and storage are secured by AWS and covered by their BAA. In addition, we use AWS SecurityHub, GuardDuty and CloudTrail for continuous monitoring, remediation and compliance.

1.3 Smylen Organizational Concepts

The entire infrastructure environment is hosted at Amazon Tech (AWS). Smylen does not have physical access into the network or server components. The Smylen environment consists of nginx load balancers and web servers; scalable Node.JS application servers; MySQL and Redis database servers; S3 encrypted file storage; Cloudwatch logging and monitoring; Docker containers; and replicated dev/staging environments in seperate AWS account.

Within the Smylen environment on AWS, all data transmission is encrypted and all hard drives are encrypted so data at rest is also encrypted; this applies to all servers - those hosting Docker containers, databases, APIs, log servers, etc. Smylen assumes all data may contain ePHI, even though our Risk Assessment does not indicate this is the case, and provides appropriate protections based on that assumption.

In the case of Smylen Customers, it is the responsibility of the Customer to restrict, secure, and assure the privacy of all ePHI data on their end of the wire, as this is not under the control or purview of Smylen.

1.4 Requesting Audit and Compliance Reports

Smylen, at its sole discretion, shares audit reports, including its HITRUST reports and Corrective Action Plans (CAPs), with customers on a case by case basis. All audit reports are shared under explicit NDA in Smylen format between Smylen and party to receive materials. Audit reports can be requested by Smylen workforce members for Customers or directly by Smylen Customers.

The following process is used to request audit reports:

1. Email is sent to compliance-reports@smylen.com. In the email, please specify the type of report being requested and any required timelines for the report.
2. Smylen staff will log an issue with the details of the request into the Smylen Task Management System. The Smylen Task Management System is used to track requests' status and outcomes.
3. Smylen will confirm if a current NDA is in place with the party requesting the audit report. If there is no NDA in place, Smylen will send one for execution.
4. Once it has been confirmed that an NDA is executed, Smylen staff will move the issue to "Under Review".
5. The Smylen Security Officer or Privacy Officer must Approve or Reject the Issue. If the Issue is rejected, Smylen will notify the requesting party that we cannot share the requested report.
6. If the issue has been Approved, Smylen will send the customer the requested audit report and complete the Task Management System issue for the request.

1.5 Version Control

Refer to the GitHub repository at https://github.com/danhorowitznyc/policies/ for the full version history of these policies.

2. HIPAA Inheritance

2.1 HIPAA Inheritance for Smylen Customers

2.2 HIPAA Inheritance for Platform Add-on Customers

3. Policy Management Policy

Smylen implements policies and procedures to maintain compliance and integrity of data. The Security Officer and Privacy Officer are responsible for maintaining policies and procedures and assuring all Smylen workforce members, business associates, customers, and partners are adherent to all applicable policies. Previous versions of policies are retained to assure ease of finding policies at specific historic dates in time.

3.1 Applicable Standards

3.1.1 Applicable Standards from the HITRUST Common Security Framework

• 12.c - Developing and Implementing Continuity Plans Including Information Security

3.1.2 Applicable Standards from the HIPAA Security Rule

• 164.316(a) - Policies and Procedures
• 164.316(b)(1)(i) - Documentation

3.2 Maintenance of Policies

1. All policies are stored and updated to maintain Smylen compliance with HIPAA, HITRUST, NIST, and other relevant standards. Updates and version control are done similarly to source code control.
2. Policy update requests can be made by any workforce member at any time. Furthermore, all policies are reviewed annually by both the Security and Privacy Officer to assure they are accurate and up-to-date.
3. Smylen employees may request changes to policies using the following process:
4. The Smylen employee initiates a policy change request by creating an Issue in the Smylen Task Management System. The change request may optionally include a GitHub pull request from a separate branch or repository containing the desired changes.
5. The Security Officer or the Privacy Officer is assigned to review the policy change request.
6. Once the review is completed, the Security Officer or Privacy Officer approves or rejects the Issue. If the Issue is rejected, it goes back for further review and documentation.
7. If the review is approved, the Security Officer or Privacy Officer then marks the Issue as Done, adding any pertinent notes required.
8. If the policy change requires technical modifications to production systems, those changes are carried out by authorized personnel using Smylen's change management process (§9.4).
9. All policies are made accessible to all Smylen workforce members. The current master policies are published at https://policy.smylen.com.
   • Changes are automatically communicated to all Smylen team members through integrations between GitHub and Slack that log all GitHub policy channels to a dedicated Smylen Slack Channel.
   • The Security Officer also communicates policy changes to all employees via email. These emails include a high-level description of the policy change using terminology appropriate for the target audience.
10. All policies, and associated documentation, are retained for 6 years from the date of its creation or the date when it last was in effect, whichever is later
    1. Version history of all Smylen policies is done via GitHub.
    2. Backup storage of all policies is done with Box.
11. The policies and information security policies are reviewed and audited annually, or after significant changes occur to Smylen's organizational environment. Issues that come up as part of this process are reviewed by Smylen management to assure all risks and potential gaps are mitigated and/or fully addressed. The process for reviewing polices is outlined below:
12. The Security Officer initiates the policy review by creating an Issue in the Smylen Task Management System.
13. The Security Officer or the Privacy Officer is assigned to review the current Smylen policies (https://policy.smylen.com/).
14. If changes are made, the above process is used. All changes are documented in the Issue.
15. Once the review is completed, the Security Officer or Privacy Officer approves or rejects the Issue. If the Issue is rejected, it goes back for further review and documentation.
16. If the review is approved, the Security Officer or Privacy Officer then marks the Issue as Done, adding any pertinent notes required.
17. Policy review is monitored on a quarterly basis using the Task Management System reporting to assess compliance with above policy.
18. Smylen utilizes the HITRUST MyCSF framework to track compliance with the HITRUST CSF on an annual basis. Smylen also tracks compliance with HIPAA and publishes results at https://hipaa.smylen.com. In order to track and measure adherence on an annual basis, Smylen uses the following process to track HITRUST audits, both full and interim:
19. The Security Officer initiates the HITRUST audit activity by creating an Issue in the Smylen Task Management System.
20. The Security Officer or the Privacy Officer is assigned to own and manage the HITRUST activity.
21. Once the HITRUST activity is completed, the Security Officer approves or rejects the Issue.
22. If the review is approved, the Security Officer then marks the Issue as Done, adding any pertinent notes required.
23. Compliance with annual compliance assessments, utilizing the HITRUST CSF as a framework, is monitored on a quarterly basis using the Task Management System reporting to assess compliance with above policy.

Additional documentation related to maintenance of policies is outlined in §5.3.1.

4. Risk Management Policy

This policy establishes the scope, objectives, and procedures of Smylen's information security risk management process. The risk management process is intended to support and protect the organization and its ability to fulfill its mission.

4.1 Applicable Standards

4.1.1 Applicable Standards from the HITRUST Common Security Framework

• 03.a - Risk Management Program Development
• 03.b - Performing Risk Assessments
• 03.c - Risk Mitigation

4.1.2 Applicable Standards from the HIPAA Security Rule

• 164.308(a)(1)(ii)(A) - HIPAA Security Rule Risk Analysis
• 164.308(a)(1)(ii)(B) - HIPAA Security Rule Risk Management
• 164.308(a)(8) - HIPAA Security Rule Evaluation

4.2 Risk Management Policies

1. It is the policy of Smylen to conduct thorough and timely risk assessments of the potential threats and vulnerabilities to the confidentiality, integrity, and availability of electronic protected health information (ePHI) (and other confidential and proprietary electronic information) it stores, transmits, and/or processes for its Customers and to develop strategies to efficiently and effectively mitigate the risks identified in the assessment process as an integral part of the Smylen's information security program.
2. Risk analysis and risk management are recognized as important components of Smylen's corporate compliance program and information security program in accordance with the Risk Analysis and Risk Management implementation specifications within the Security Management standard and the evaluation standards set forth in the HIPAA Security Rule, 45 CFR 164.308(a)(1)(ii)(A), 164.308(a)(1)(ii)(B), 164.308(a)(1)(i), and 164.308(a)(8).
   1. Risk assessments are done throughout product life cycles;
   2. Before the integration of new system technologies and before changes are made to Smylen physical safeguards; and
      • These changes do not include routine updates to existing systems, deployments of new systems created based on previously configured systems, deployments of new Customers, or new code developed for operations and management of the Smylen Platform.
   3. While making changes to Smylen physical equipment and facilities that introduce new, untested configurations.
   4. Smylen performs periodic technical and non-technical assessments of the security rule requirements as well as in response to environmental or operational changes affecting the security of ePHI.
3. Smylen implements security measures sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level to:
   1. Ensure the confidentiality, integrity, and availability of all ePHI Smylen receives, maintains, processes, and/or transmits for its Customers;
   2. Protect against any reasonably anticipated threats or hazards to the security or integrity of Customer ePHI;
   3. Protect against any reasonably anticipated uses or disclosures of Customer ePHI that are not permitted or required; and
   4. Ensure compliance by all workforce members.
4. Any risk remaining (residual) after other risk controls have been applied, requires sign off by the senior management and Smylen's Security Officer.
5. All Smylen workforce members are expected to fully cooperate with all persons charged with doing risk management work, including contractors and audit personnel. Any workforce member that violates this policy will be subject to disciplinary action based on the severity of the violation, as outlined in the Smylen Roles Policy.
6. The implementation, execution, and maintenance of the information security risk analysis and risk management process is the responsibility of Smylen's Security Officer (or other designated employee), and the identified Risk Management Team.
7. All risk management efforts, including decisions made on what controls to put in place as well as those to not put into place, are documented and the documentation is maintained for six years.
8. The details of the Risk Management Process, including risk assessment, discovery, and mitigation, are outlined in detail below. The process is tracked, measured, and monitored using the following procedures:
9. The Security Officer or the Privacy Officer initiates the Risk Management Procedures by creating an Issue in the Smylen Task Management System.
10. The Security Officer or the Privacy Officer is assigned to carry out the Risk Management Procedures.
11. All findings are documented in an approved spreadsheet that is linked to the Issue.
12. Once the Risk Management Procedures are complete, along with corresponding documentation, the Security Officer approves or rejects the Issue. If the Issue is rejected, it goes back for further review and documentation.
13. If the review is approved, the Security Officer then marks the Issue as Done, adding any pertinent notes required.
14. The Risk Management Procedure is monitored on a quarterly basis using the Task Management System reporting to assess compliance with above policy.

4.3 Risk Management Procedures

4.3.1 Risk Assessment

The intent of completing a risk assessment is to determine potential threats and vulnerabilities and the likelihood and impact should they occur. The output of this process helps to identify appropriate controls for reducing or eliminating risk.

• Step 1. System Characterization

  • The first step in assessing risk is to define the scope of the effort. To do this, identify where ePHI is received, maintained, processed, or transmitted. Using information-gathering techniques, the Smylen Platform boundaries are identified.
  • Output - Characterization of the Smylen Platform system assessed, a good picture of the Platform environment, and delineation of Platform boundaries.

• Step 2. Threat Identification

  • Potential threats (the potential for threat-sources to successfully exercise a particular vulnerability) are identified and documented. All potential threat-sources from historical incidents and data from intelligence agencies, the government, etc., are reviewed to help generate a list of potential threats.
  • Output - A threat list containing a list of threat-sources that could exploit Platform vulnerabilities.

• Step 3. Vulnerability Identification

  • Develop a list of technical and non-technical Platform vulnerabilities that could be exploited or triggered by potential threat-sources. Vulnerabilities can range from incomplete or conflicting policies that govern an organization's computer usage to insufficient safeguards to protect facilities that house computer equipment to any number of software, hardware, or other deficiencies that comprise an organization's computer network.
  • Output - A list of the Platform vulnerabilities (observations) that could be exercised by potential threat-sources.

• Step 4. Control Analysis

  • Document and assess the effectiveness of technical and non-technical controls that have been or will be implemented by Smylen to minimize or eliminate the likelihood / probability of a threat-source exploiting a Platform vulnerability.
  • Output - List of current or planned controls (policies, procedures, training, technical mechanisms, insurance, etc.) used for the Platform to mitigate the likelihood of a vulnerability being exercised and reduce the impact of such an adverse event.

• Step 5. Likelihood Determination

  • Determine the overall likelihood rating that indicates the probability that a vulnerability could be exploited by a threat-source given the existing or planned security controls.
  • Output - Likelihood rating of low (.1), medium (.5), or high (1). Refer to the NIST SP 800-30 definitions of low, medium, and high.

• Step 6. Impact Analysis

  • Determine the level of adverse impact that would result from a threat successfully exploiting a vulnerability. Factors of the data and systems to consider should include the importance to Smylen's mission; sensitivity and criticality (value or importance); costs associated; loss of confidentiality, integrity, and availability of systems and data.
  • Output - Magnitude of impact rating of low (10), medium (50), or high (100). Refer to the NIST SP 800-30 definitions of low, medium, and high.

• Step 7. Risk Determination

  • Establish a risk level. By multiplying the ratings from the likelihood determination and impact analysis, a risk level is determined. This represents the degree or level of risk to which an IT system, facility, or procedure might be exposed if a given vulnerability were exercised. The risk rating also presents actions that senior management must take for each risk level.
  • Output - Risk level of low (1-10), medium (>10-50) or high (>50-100). Refer to the NIST SP 800-30 definitions of low, medium, and high.

• Step 8. Control Recommendations

  • Identify controls that could reduce or eliminate the identified risks, as appropriate to the organization's operations to an acceptable level. Factors to consider when developing controls may include effectiveness of recommended options (i.e., system compatibility), legislation and regulation, organizational policy, operational impact, and safety and reliability. Control recommendations provide input to the risk mitigation process, during which the recommended procedural and technical security controls are evaluated, prioritized, and implemented.
  • Output - Recommendation of control(s) and alternative solutions to mitigate risk.

• Step 9. Results Documentation

  • Results of the risk assessment are documented in an official report, spreadsheet, or briefing and provided to senior management to make decisions on policy, procedure, budget, and Platform operational and management changes.
  • Output - A risk assessment report that describes the threats and vulnerabilities, measures the risk, and provides recommendations for control implementation.

4.3.2 Risk Mitigation

Risk mitigation involves prioritizing, evaluating, and implementing the appropriate risk-reducing controls recommended from the Risk Assessment process to ensure the confidentiality, integrity and availability of Smylen Platform ePHI. Determination of appropriate controls to reduce risk is dependent upon the risk tolerance of the organization consistent with its goals and mission.

• Step 1. Prioritize Actions

  • Using results from Step 7 of the Risk Assessment, sort the threat and vulnerability pairs according to their risk-levels in descending order. This establishes a prioritized list of actions needing to be taken, with the pairs at the top of the list getting/requiring the most immediate attention and top priority in allocating resources
  • Output - Actions ranked from high to low

• Step 2. Evaluate Recommended Control Options

  • Although possible controls for each threat and vulnerability pair are arrived at in Step 8 of the Risk Assessment, review the recommended control(s) and alternative solutions for reasonableness and appropriateness. The feasibility (e.g., compatibility, user acceptance, etc.) and effectiveness (e.g., degree of protection and level of risk mitigation) of the recommended controls should be analyzed. In the end, select a "most appropriate" control option for each threat and vulnerability pair.
  • Output - list of feasible controls

• Step 3. Conduct Cost-Benefit Analysis

  • Determine the extent to which a control is cost-effective. Compare the benefit (e.g., risk reduction) of applying a control with its subsequent cost of application. Controls that are not cost-effective are also identified during this step. Analyzing each control or set of controls in this manner, and prioritizing across all controls being considered, can greatly aid in the decision-making process.
  • Output - Documented cost-benefit analysis of either implementing or not implementing each specific control

• Step 4. Select Control(s)

  • Taking into account the information and results from previous steps, Smylen's mission, and other important criteria, the Risk Management Team determines the best control(s) for reducing risks to the information systems and to the confidentiality, integrity, and availability of ePHI. These controls may consist of a mix of administrative, physical, and/or technical safeguards.
  • Output - Selected control(s)

• Step 5. Assign Responsibility

  • Identify the workforce members with the skills necessary to implement each of the specific controls outlined in the previous step, and assign their responsibilities. Also identify the equipment, training, and other resources needed for the successful implementation of controls. Resources may include time, money, equipment, etc.
  • Output - List of resources, responsible persons and their assignments

• Step 6. Develop Safeguard Implementation Plan

  • Develop an overall implementation or action plan and individual project plans needed to implement the safeguards and controls identified. The Implementation Plan should contain the following information:
    • Each risk or vulnerability/threat pair and risk level;
    • Prioritized actions;
    • The recommended feasible control(s) for each identified risk;
    • Required resources for implementation of selected controls;
    • Team member responsible for implementation of each control;
    • Start date for implementation;
    • Target date for completion of implementation;
    • Maintenance requirements.
  • The overall implementation plan provides a broad overview of the safeguard implementation, identifying important milestones and timeframes, resource requirements (staff and other individuals' time, budget, etc.), interrelationships between projects, and any other relevant information. Regular status reporting of the plan, along with key metrics and success indicators should be reported to Smylen Senior Management.
  • Individual project plans for safeguard implementation may be developed and contain detailed steps that assigned resources carry out to meet implementation timeframes and expectations. Additionally, consider including items in individual project plans such as a project scope, a list deliverables, key assumptions, objectives, task completion dates and project requirements.
  • Output - Safeguard Implementation Plan

• Step 7. Implement Selected Controls

  • As controls are implemented, monitor the affected system(s) to verify that the implemented controls continue to meet expectations. Elimination of all risk is not practical. Depending on individual situations, implemented controls may lower a risk level but not completely eliminate the risk.
  • Continually and consistently communicate expectations to all Risk Management Team members, as well as senior management and other key people throughout the risk mitigation process. Identify when new risks are identified and when controls lower or offset risk rather than eliminate it.
  • Additional monitoring is especially crucial during times of major environmental changes, organizational or process changes, or major facilities changes.
  • If risk reduction expectations are not met, then repeat all or a part of the risk management process so that additional controls needed to lower risk to an acceptable level can be identified.
  • Output - Residual Risk documentation

4.3.3 Risk Management Schedule

The two principle components of the risk management process - risk assessment and risk mitigation - will be carried out according to the following schedule to ensure the continued adequacy and continuous improvement of Smylen's information security program:

• Scheduled Basis - an overall risk assessment of Smylen's information system infrastructure will be conducted annually. The assessment process should be completed in a timely fashion so that risk mitigation strategies can be determined and included in the corporate budgeting process.
• Throughout a System's Development Life Cycle - from the time that a need for a new, untested information system configuration and/or application is identified through the time it is disposed of, ongoing assessments of the potential threats to a system and its vulnerabilities should be undertaken as a part of the maintenance of the system.
• As Needed - the Security Officer (or other designated employee) or Risk Management Team may call for a full or partial risk assessment in response to changes in business strategies, information technology, information sensitivity, threats, legal liabilities, or other significant factors that affect Smylen's Platform.

4.4 Process Documentation

Maintain documentation of all risk assessment, risk management, and risk mitigation efforts for a minimum of six years.

5. Roles Policy

Smylen has a Security Officer [164.308(a)(2)] and Privacy Officer [164.308(a)(2)] appointed to assist in maintaining and enforcing safeguards towards compliance. The responsibilities associated with these roles are outlined below.

5.1 Applicable Standards

5.1.1 Applicable Standards from the HITRUST Common Security Framework

• 02.f - Disciplinary Process
• 06.d - Data Protection and Privacy of Covered Information
• 06.f - Prevention of Misuse of Information Assets
• 06.g - Compliance with Security Policies and Standards

5.1.2 Applicable Standards from the HIPAA Security Rule

• 164.308(a)(2) - Assigned Security Responsibility
• 164.308(a)(5)(i) - Security Awareness and Training

5.2 Privacy Officer

The Privacy Officer is responsible for assisting with compliance and security training for workforce members, assuring the organization remains in compliance with evolving compliance rules, and helping the Security Officer in his responsibilities.

1. Provides annual training to all workforce members of established policies and procedures as necessary and appropriate to carry out their job functions, and documents the training provided.
2. Assists in the administration and oversight of business associate agreements.
3. Manage relationships with customers and partners as those relationships affect security and compliance of ePHI.
4. Assist Security Officer as needed.

The current Smylen Privacy Officer is Derek Giddon (travis@smylen.com).

5.2.1 Workforce Training Responsibilities

1. The Privacy Officer facilitates the training of all workforce members as follows:
   1. New workforce members within their first month of employment;
   2. Existing workforce members annually;
   3. Existing workforce members whose functions are affected by a material change in the policies and procedures, within a month after the material change becomes effective;
   4. Existing workforce members as needed due to changes in security and risk posture of Smylen.
2. The Security Officer or designee maintains documentation of the training session materials and attendees for a minimum of six years.
3. The training session focuses on, but is not limited to, the following subjects defined in Smylen's security policies and procedures:
   1. HIPAA Privacy, Security, and Breach notification rules;
   2. HITRUST Common Security Framework;
   3. NIST Security Rules;
   4. Risk Management procedures and documentation;
   5. Auditing - Smylen may monitor access and activities of all users;
   6. Workstations may only be used to perform assigned job responsibilities;
   7. Users may not download software onto Smylen's workstations and/or systems without prior approval from the Security Officer;
   8. Users are required to report malicious software to the Security Officer immediately;
   9. Users are required to report unauthorized attempts, uses of, and theft of Smylen's systems and/or workstations;
   10. Users are required to report unauthorized access to facilities
   11. Users are required to report noted log-in discrepancies (i.e. application states user's last log-in was on a date user was on vacation);
   12. Users may not alter ePHI maintained in a database, unless authorized to do so by a Smylen Customer;
   13. Users are required to understand their role in Smylen's contingency plan;
   14. Users may not share their user names nor passwords with anyone;
   15. Requirements for users to create and change passwords;
   16. Users must set all applications that contain or transmit ePHI to automatically log off after 15 minutes of inactivity;
   17. Supervisors are required to report terminations of workforce members and other outside users;
   18. Supervisors are required to report a change in a user's title, role, department, and/or location;
   19. Procedures to backup ePHI;
   20. Procedures to move and record movement of hardware and electronic media containing ePHI;
   21. Procedures to dispose of discs, CDs, hard drives, and other media containing ePHI;
   22. Procedures to re-use electronic media containing ePHI;
   23. SSH key and sensitive document encryption procedures.

5.3 Security Officer

The Security Officer is responsible for facilitating the training and supervision of all workforce members [164.308(a)(3)(ii)(A) and 164.308(a)(5)(ii)(A)], investigation and sanctioning of any workforce member that is in violation of Smylen security policies and non-compliance with the security regulations [164.308(a)(1)(ii)(c)], and writing, implementing, and maintaining all polices, procedures, and documentation related to efforts toward security and compliance [164.316(a-b)].

The current Smylen Security Officer is Dan Horowitz (ryan@smylen.com).

5.3.1 Organizational Responsibilities

The Security Officer, in collaboration with the Privacy Officer, is responsible for facilitating the development, testing, implementation, training, and oversight of all activities pertaining to Smylen's efforts to be compliant with the HIPAA Security Regulations, HITRUST CSF, and any other security and compliance frameworks. The intent of the Security Officer Responsibilities is to maintain the confidentiality, integrity, and availability of ePHI. The Security Officer is appointed by and reports to the Board of Directors and the CEO.

These organizational responsibilities include, but are not limited to the following:

1. Oversees and enforces all activities necessary to maintain compliance and verifies the activities are in alignment with the requirements.
2. Helps to establish and maintain written policies and procedures to comply with the Security rule and maintains them for six years from the date of creation or date it was last in effect, whichever is later.
3. Reviews and updates policies and procedures as necessary and appropriate to maintain compliance and maintains changes made for six years from the date of creation or date it was last in effect, whichever is later.
4. Facilitates audits to validate compliance efforts throughout the organization.
5. Documents all activities and assessments completed to maintain compliance and maintains documentation for six years from the date of creation or date it was last in effect, whichever is later.
6. Provides copies of the policies and procedures to management, customers, and partners, and has them available to review by all other workforce members to which they apply.
7. Annually, and as necessary, reviews and updates documentation to respond to environmental or operational changes affecting the security and risk posture of ePHI stored, transmitted, or processed within Smylen infrastructure.
8. Develops and provides periodic security updates and reminder communications for all workforce members.
9. Implements procedures for the authorization and/or supervision of workforce members who work with ePHI or in locations where it may be accessed.
10. Maintains a program promoting workforce members to report non-compliance with policies and procedures.
    • Promptly, properly, and consistently investigates and addresses reported violations and takes steps to prevent recurrence.
    • Applies consistent and appropriate sanctions against workforce members who fail to comply with the security policies and procedures of Smylen.
    • Mitigates, to the extent practicable, any harmful effect known to Smylen of a use or disclosure of ePHI in violation of Smylen's policies and procedures, even if effect is the result of actions of Smylen business associates, customers, and/or partners.
11. Reports security efforts and incidents to administration immediately upon discovery. Responsibilities in the case of a known ePHI breach are documented in the Smylen Breach Policy.
12. The Security Officer facilitates the communication of security updates and reminders to all workforce members to which it pertains. Examples of security updates and reminders include, but are not limited to:
    • Latest malicious software or virus alerts;
    • Smylen's requirement to report unauthorized attempts to access ePHI;
    • Changes in creating or changing passwords;
    • Additional security-focused training is provided to all workforce members by the Security Officer. This training includes, but is not limited to:
    • Data backup plans;
    • System auditing procedures;
    • Redundancy procedures;
    • Contingency plans;
    • Virus protection;
    • Patch management;
    • Media Disposal and/or Re-use;
    • Documentation requirements.
13. The Security Officer works with the COO to ensure that any security objectives have appropriate consideration during the budgeting process.
    • In general, security and compliance are core to Smylen's technology and service offerings; in most cases this means security-related objectives cannot be split out to separate budget line items.
    • For cases that can be split out into discrete items, such as licenses for commercial tooling, the Security Officer follows Smylen's standard corporate budgeting process.
      • At the beginning of every fiscal year, the COO contacts the Security Officer to plan for the upcoming year's expenses.
      • The Security Officer works with the COO to forecast spending needs based on the previous year's level, along with changes for the upcoming year such as additional staff hires.
      • During the year, if an unforeseen security-related expense arises that was not in the budget forecast, the Security Officer works with the COO to reallocate any resources as necessary to cover this expense.

5.3.2 Supervision of Workforce Responsibilities

Although the Security Officer is responsible for implementing and overseeing all activities related to maintaining compliance, it is the responsibility of all workforce members (i.e. team leaders, supervisors, managers, directors, co-workers, etc.) to supervise all workforce members and any other user of Smylen's systems, applications, servers, workstations, etc. that contain ePHI.

1. Monitor workstations and applications for unauthorized use, tampering, and theft and report non-compliance according to the Security Incident Response policy.
2. Assist the Security and Privacy Officers to ensure appropriate role-based access is provided to all users.
3. Take all reasonable steps to hire, retain, and promote workforce members and provide access to users who comply with the Security regulations and Smylen's security policies and procedures.

5.3.3 Sanctions of Workforce Responsibilities

All workforce members report non-compliance of Smylen's policies and procedures to the Security Officer or other individual as assigned by the Security Officer. Individuals that report violations in good faith may not be subjected to intimidation, threats, coercion, discrimination against, or any other retaliatory action as a consequence.

1. The Security Officer promptly facilitates a thorough investigation of all reported violations of Smylen's security policies and procedures. The Security Officer may request assistance from others.
   • Complete an audit trail/log to identify and verify the violation and sequence of events.
   • Interview any individual that may be aware of or involved in the incident.
   • All individuals are required to cooperate with the investigation process and provide factual information to those conducting the investigation.
   • Provide individuals suspected of non-compliance of the Security rule and/or Smylen's policies and procedures the opportunity to explain their actions.
   • The investigator thoroughly documents the investigation as the investigation occurs. This documentation must include a list of all employees involved in the violation.
2. Violation of any security policy or procedure by workforce members may result in corrective disciplinary action, up to and including termination of employment. Violation of this policy and procedures by others, including business associates, customers, and partners may result in termination of the relationship and/or associated privileges. Violation may also result in civil and criminal penalties as determined by federal and state laws and regulations.
   • A violation resulting in a breach of confidentiality (i.e. release of PHI to an unauthorized individual), change of the integrity of any ePHI, or inability to access any ePHI by other users, requires immediate termination of the workforce member from Smylen.
3. The Security Officer facilitates taking appropriate steps to prevent recurrence of the violation (when possible and feasible).
4. In the case of an insider threat, the Security Officer and Privacy Officer are to set up a team to investigate and mitigate the risk of insider malicious activity. Smylen workforce members are encouraged to come forward with information about insider threats, and can do so anonymously.
5. The Security Officer maintains all documentation of the investigation, sanctions provided, and actions taken to prevent reoccurrence for a minimum of six years after the conclusion of the investigation.

6. Data Management Policy

Smylen has procedures to create and maintain retrievable exact copies of electronic protected health information (ePHI) stored in its systems. The policy and procedures will assure that complete, accurate, retrievable, and tested backups are available for all systems used by Smylen.

Data backup is an important part of the day-to-day operations of Smylen. To protect the confidentiality, integrity, and availability of ePHI, both for Smylen and Smylen Customers, complete backups are done daily to assure that data remains available when needed and in case of a disaster.

Violation of this policy and its procedures by workforce members may result in corrective disciplinary action, up to and including termination of employment.

6.1 Applicable Standards

6.1.1 Applicable Standards from the HITRUST Common Security Framework

• 01.v - Information Access Restriction

6.1.2 Applicable Standards from the HIPAA Security Rule

• 164.308(a)(7)(ii)(A) - Data Backup Plan
• 164.310(d)(2)(iii) - Accountability
• 164.310(d)(2)(iv) - Data Backup and Storage

6.2 Backup Policy and Procedures

1. Perform daily snapshot backups of all systems that process, store, or transmit ePHI for Smylen Customers.
2. The Smylen Tech Team is designated to be in charge of backups.
3. Tech Team members are trained and assigned to complete backups and manage the backup media.
4. Document backups
   • Name of the system
   • Date & time of backup
   • Where backup stored (or to whom it was provided)
5. Securely encrypt stored backups in a manner that protects them from loss or environmental damage.
6. Test backups annually and document that files have been completely and accurately restored from the backup media.

7. System Access Policy

Access to Smylen systems and applications is limited for all users, including but not limited to workforce members, volunteers, business associates, contracted providers, and consultants. Access by any other entity is allowable only on a minimum necessary basis. All users are responsible for reporting an incident of unauthorized use or access of the organization's information systems. These safeguards have been established to address the HIPAA Security regulations including the following:

7.1 Applicable Standards

7.1.1 Applicable Standards from the HITRUST Common Security Framework

• 01.d - User Password Management
• 01.f - Password Use
• 01.r - Password Management System
• 01.a - Access Control Policy
• 01.b - User Registration
• 01.h - Clear Desk and Clear Screen Policy
• 01.j - User Authentication for External Connections
• 01.q - User Identification and Authentication
• 01.v - Information Access Restriction
• 02.i - Removal of Access Rights
• 06.e - Prevention of Misuse of Information Assets

7.1.2 Applicable Standards from the HIPAA Security Rule

• 164.308(a)(4)(ii)(C) Access Establishment and Modification
• 164.308(a)(3)(ii)(B) Workforce Clearance Procedures
• 164.308(a)(4)(ii)(B) Access Authorization
• 164.312(d) Person or Entity Authentication
• 164.312(a)(2)(i) Unique User Identification
• 164.308(a)(5)(ii)(D) Password Management
• 164.312(a)(2)(iii) Automatic Logoff
• 164.310(b) Workstation Use
• 164.310(c) Workstation Security
• 164.308(a)(3)(ii)(C) Termination Procedures

7.2 Access Establishment and Modification

1. Requests for access to Smylen Platform systems and applications are made formally using the following process:
2. A Smylen workforce member initiates the access request by creating an Issue in the Smylen Task Management System.
   • User identities must be verified prior to granting access to new accounts.
   • Identity verification must be done in person where possible; for remote employees, identities must be verified over the phone.
   • For new accounts, the method used to verify the user's identity must be recorded on the Issue.
3. The Security Officer or Privacy Officer will grant access to systems as dictated by the employee's job title. If additional access is required outside of the minimum necessary to perform job functions, the requester must include a description of why the additional access is required as part of the access request.
4. Once the review is completed, the Security Officer or Privacy Officer approves or rejects the Issue. If the Issue is rejected, it goes back for further review and documentation.
5. If the review is approved, the Security Officer or Privacy Officer then marks the Issue as Done, adding any pertinent notes required. The Security Officer or Privacy Officer then grants requested access.
   • New accounts will be created with a temporary secure password that meets all requirements from §7.12, which must be changed on the initial login.
   • All password exchanges must occur over an authenticated channel.
   • For production systems, access grants are accomplished by adding the appropriate user account to the corresponding LDAP group.
   • For non-production systems, access grants are accomplished by leveraging the access control mechanisms built into those systems. Account management for non-production systems may be delegated to a Smylen employee at the discretion of the Security Officer or Privacy Officer .
6. Access is not granted until receipt, review, and approval by the Smylen Security Officer or Privacy Officer.
7. The request for access is retained for future reference.
8. All access to Smylen systems and services is reviewed and updated on a bi-annual basis to ensure proper authorizations are in place commensurate with job functions. The process for conducting reviews is outlined below:
   1. The Security Officer initiates the review of user access by creating an Issue in the Smylen Task Management System.
   2. The Security Officer is assigned to review levels of access for each Smylen workforce member.
   3. If user access is found during review that is not in line with the least privilege principle, the process below is used to modify user access and notify the user of access changes. Once those steps are completed, the Issue is then reviewed again.
   4. Once the review is completed, the Security Officer approves or rejects the Issue. If the Issue is rejected, it goes back for further review and documentation.
   5. If the review is approved, the Security Officer then marks the Issue as Done, adding any pertinent notes required.
   6. Review of user access is monitored on a quarterly basis using the Task Management System reporting to assess compliance with above policy.
9. Any Smylen workforce member can request change of access using the process outlined in §7.2 paragraph 1.
10. Access to production systems is controlled using centralized user management and authentication.
11. Temporary accounts are not used unless absolutely necessary for business purposes.
    • Accounts are reviewed every 90 days to ensure temporary accounts are not left unnecessarily.
    • Accounts that are inactive for over 90 days are removed.
12. In the case of non-personal information, such as generic educational content, identification and authentication may not be required. This is the responsibility of Smylen Customers to define, and not Smylen.
13. Privileged users must first access systems using standard, unique user accounts before switching to privileged users and performing privileged tasks.
    • For production systems, this is enforced by creating non-privileged user accounts that must invoke sudo to perform privileged tasks.
    • Rights for privileged accounts are granted by the Security Officer or Privacy Officer using the process outlined in §7.2 paragraph 1.
14. All application to application communication using service accounts is restricted and not permitted unless absolutely needed. Automated tools are used to limit account access across applications and systems.
15. Generic accounts are not allowed on Smylen systems.
16. Access is granted through encrypted, VPN tunnels that utilize two-factor authentication.
    • Two-factor authentication is accomplished using a Time-based One-Time Password (TOTP) as the second factor.
    • VPN connections use 256-bit AES 256 encryption, or equivalent.
    • VPN sessions are automatically disconnected after 30 minutes of inactivity.
17. In cases of increased risk or known attempted unauthorized access, immediate steps are taken by the Security and Privacy Officer to limit access and reduce risk of unauthorized access.
18. Direct system to system, system to application, and application to application authentication and authorization are limited and controlled to restrict access.

7.3 Workforce Clearance

1. The level of security assigned to a user to the organization's information systems is based on the minimum necessary amount of data access required to carry out legitimate job responsibilities assigned to a user's job classification and/or to a user needing access to carry out treatment, payment, or healthcare operations.
2. All access requests are treated on a "least-access principle."
3. Smylen maintains a minimum necessary approach to access to Customer data. As such, Smylen, including all workforce members, does not readily have access to any ePHI.

7.4 Access Authorization

1. Role based access categories for each Smylen system and application are pre-approved by the Security Officer, or an authorized delegate of the Security Officer.
2. Smylen utilizes hardware and software firewalls to segment data, prevent unauthorized access, and monitor traffic for denial of service attacks.

7.5 Person or Entity Authentication

1. Each workforce member has and uses a unique user ID and password that identifies him/her as the user of the information system.
2. Each Customer and Partner has and uses a unique user ID and password that identifies him/her as the user of the information system.
3. All Customer support desk interactions must be verified before Smylen support personnel will satisfy any request having information security implications.
   • Smylen's current support desk software, Zendesk, requires users to authenticate before submitting support tickets.
   • Support issues submitted via Smylen's dashboard require that users authenticate with their Smylen account before submitting support tickets.
   • Support issues submitted by email must be verified by Smylen personnel using a phone number that has been registered with the corresponding account.

7.6 Unique User Identification

1. Access to the Smylen Platform systems and applications is controlled by requiring unique User Login IDs and passwords for each individual user and developer.
2. Passwords requirements mandate strong password controls (see below).
3. Passwords are not displayed at any time and are not transmitted or stored in plain text.
4. Default accounts on all production systems, including root, are disabled.
5. Shared accounts are not allowed within Smylen systems or networks.
6. Automated log-on configurations that store user passwords or bypass password entry are not permitted for use with Smylen workstations or production systems.

7.7 Automatic Logoff

1. Users are required to make information systems inaccessible by any other individual when unattended by the users (ex. by using a password protected screen saver or logging off the system).
2. Information systems automatically log users off the systems after 15 minutes of inactivity.
3. The Security Officer pre-approves exceptions to automatic log off requirements.

7.8 Employee Workstation Use

All workstations at Smylen are company owned, and all are laptop Apple products running Mac OSX or Linux.

1. Workstations may not be used to engage in any activity that is illegal or is in violation of organization's policies.
2. Access may not be used for transmitting, retrieving, or storage of any communications of a discriminatory or harassing nature or materials that are obscene or "X-rated". Harassment of any kind is prohibited. No messages with derogatory or inflammatory remarks about an individual's race, age, disability, religion, national origin, physical attributes, sexual preference, or health condition shall be transmitted or maintained. No abusive, hostile, profane, or offensive language is to be transmitted through the organization's system.
3. Information systems/applications also may not be used for any other purpose that is illegal, unethical, or against company policies or contrary to organization's best interests. Messages containing information related to a lawsuit or investigation may not be sent without prior approval.
4. Solicitation of non-company business, or any use of organization's information systems/applications for personal gain is prohibited.
5. Transmitted messages may not contain material that criticizes the organization, its providers, its employees, or others.
6. Users may not misrepresent, obscure, suppress, or replace another user's identity in transmitted or stored messages.
7. Workstation hard drives will be encrypted using FileVault 2.0 or equivalent.
8. All workstations have firewalls enabled to prevent unauthorized access unless explicitly granted.
9. All workstations are to have the following messages added to the lock screen and login screen: This computer is owned by Smylen, Inc. By logging in, unlocking, and/or using this computer you acknowledge you have seen, and follow, these policies (https://policy.smylen.com) and have completed this training (https://training.smylen.com/). Please contact us if you have problems with this - privacy@smylen.com.

7.9 Wireless Access Use

1. Smylen production systems are not accessible directly over wireless channels.
2. Wireless access is disabled on all production systems.
3. When accessing production systems via remote wireless connections, the same system access policies and procedures apply to wireless as all other connections, including wired.
4. Wireless networks managed within Smylen non-production facilities (offices, etc.) are secured with the following configurations:
   • All data in transit over wireless is encrypted using WPA2 encryption;
   • Passwords are rotated on a regular basis, presently quarterly. This process is managed by the Smylen Security Officer.

7.10 Employee Termination Procedures

1. The Human Resources Department (or other designated department), users, and their supervisors are required to notify the Security Officer upon completion and/or termination of access needs and facilitating completion of the "Termination Checklist".
2. The Human Resources Department, users, and supervisors are required to notify the Security Officer to terminate a user's access rights if there is evidence or reason to believe the following (these incidents are also reported on an incident report and is filed with the Privacy Officer):
   • The user has been using their access rights inappropriately;
   • A user's password has been compromised (a new password may be provided to the user if the user is not identified as the individual compromising the original password);
   • An unauthorized individual is utilizing a user's User Login ID and password (a new password may be provided to the user if the user is not identified as providing the unauthorized individual with the User Login ID and password).
3. The Security Officer will terminate users' access rights immediately upon notification, and will coordinate with the appropriate Smylen employees to terminate access to any non-production systems managed by those employees.
4. The Security Officer audits and may terminate access of users that have not logged into organization's information systems/applications for an extended period of time.

7.11 Paper Records

Smylen does not use paper records for any sensitive information. Use of paper for recording and storing sensitive data is against Smylen policies.

7.12 Password Management

1. User IDs and passwords are used to control access to Smylen systems and may not be disclosed to anyone for any reason.
2. Users may not allow anyone, for any reason, to have access to any information system using another user's unique user ID and password.
3. On all production systems and applications in the Smylen environment, password configurations are set to require:
   • a minimum length of 12 characters;
   • a mix of upper case characters, lower case characters, and numbers or special characters;
   • a yearly password expiration for administrative accounts;
   • prevention of password reuse using a history of the last 6 passwords;
   • where supported, modifying at least 4 characters when changing passwords;
   • account lockout after 5 invalid attempts.
4. All system and application passwords must be stored and transmitted securely.
   • Where possible, passwords should be stored in a hashed format using a salted cryptographic hash function (SHA-256 or equivalent).
   • Passwords that must be stored in non-hashed format must be encrypted at rest pursuant to the requirements in §17.8.
   • Transmitted passwords must be encrypted in flight pursuant to the requirements in §17.9.
5. Each information system automatically requires users to change passwords at a pre-determined interval as determined by the organization, based on the criticality and sensitivity of the ePHI contained within the network, system, application, and/or database.
6. Passwords are inactivated immediately upon an employee's termination (refer to the Employee Termination Procedures in §7.10).
7. All default system, application, and Partner passwords are changed before deployment to production.
8. Upon initial login, users must change any passwords that were automatically generated for them.
9. Password change methods must use a confirmation method to correct for user input errors.
10. All passwords used in configuration scripts are secured and encrypted.
11. If a user believes their user ID has been compromised, they are required to immediately report the incident to the Security Office.
12. In cases where a user has forgotten their password, the following procedure is used to reset the password.
    • The user submits a password reset request to password-reset@smylen.com. The request should include the system to which the user has lost access and needs the password reset.
    • An administrator with password reset privileges is notified and connects directly with the user requesting the password reset.
    • The administrator verifies the identity of the user either in-person or through a separate communication channel such as phone or Slack.
    • Once verified, the administrator resets the password.

The password-reset email inbox is used to track and store password reset requests. The Security Officer is the owner of this group and modifies membership as needed.

7.13 Access to ePHI

1. Employees may not download ePHI to any workstations used to connect to production systems.
2. Disallowing transfer of ePHI to workstations is enforced through technical measures.
   • All production access to systems is performed through a bastion/jump host accessed through a VPN. Direct access to production systems is disallowed by Smylen's VPN configuration.
   • On production Linux bastions, all file transfer services are disabled including file-transfer functionality of SSH services (SCP/SFTP).
   • On production Windows bastions, local drive mappings are disabled by Group Policy settings.
   • Configuration settings for enforcing these technical controls are managed by Smylen's configuration management tooling.

7.14 Smylen Customer Access to Systems

Smylen grants Smylen customer secure system access via VPN connections. This access is only to Customer-specific systems, no other systems in the environment. These connections are setup at customer deployment. These connections are secured and encrypted and the only method for customers to connect to Smylen hosted systems.

In the case of data migration, Smylen does, on a case by case basis, support customers in importing data. In these cases Smylen requires that all data is secured and encrypted in transit, such as by using SFTP or SCP for transferring files.

In the case of an investigation, Smylen will assist customers, at Smylen's discretion, and law enforcement in forensics.

8. Auditing Policy

Smylen shall audit access and activity of electronic protected health information (ePHI) applications and systems in order to ensure compliance. The Security Rule requires healthcare organizations to implement reasonable hardware, software, and/or procedural mechanisms that record and examine activity in information systems that contain or use ePHI. Audit activities may be limited by application, system, and/or network auditing capabilities and resources. Smylen shall make reasonable and good-faith efforts to safeguard information privacy and security through a well-thought-out approach to auditing that is consistent with available resources.

It is the policy of Smylen to safeguard the confidentiality, integrity, and availability of applications, systems, and networks. To ensure that appropriate safeguards are in place and effective, Smylen shall audit access and activity to detect, report, and guard against:

• Network vulnerabilities and intrusions;
• Breaches in confidentiality and security of patient protected health information;
• Performance problems and flaws in applications;
• Improper alteration or destruction of ePHI;
• Out of date software and/or software known to have vulnerabilities.

This policy applies to all Smylen Add-on systems that store, transmit, or process ePHI.

8.1 Applicable Standards

8.1.1 Applicable Standards from the HITRUST Common Security Framework

• 0.a Information Security Management Program
• 01.a Access Control Policy
• 01.b User Registration
• 01.c Privilege Management
• 09.aa Audit Logging
• 09.ac Protection of Log Information
• 09.ab - Monitoring System Use
• 06.e - Prevention of Misuse of Information

8.1.2 Applicable Standards from the HIPAA Security Rule

• 45 CFR §164.308(a)(1)(ii)(D) - Information System Activity Review
• 45 CFR §164.308(a)(5)(ii)(B) & (C) - Protection from Malicious Software & Log-in Monitoring
• 45 CFR §164.308(a)(8) - HIPAA Security Rule Periodic Evaluation
• 45 CFR §164.312(b) - Audit Controls
• 45 CFR §164.312(c)(2) - Mechanism to Authenticate ePHI
• 45 CFR §164.312(e)(2)(i) - Integrity Controls

8.2 Auditing Policies

1. Responsibility for auditing information system access and activity is assigned to Smylen's Security Officer. The Security Officer shall:
   • Assign the task of generating reports for audit activities to the workforce member responsible for the application, system, or network;
   • Assign the task of reviewing the audit reports to the workforce member responsible for the application, system, or network, the Privacy Officer, or any other individual determined to be appropriate for the task;
   • Organize and provide oversight to a team structure charged with audit compliance activities (e.g., parameters, frequency, sample sizes, report formats, evaluation, follow-up, etc.).
   • All connections to Smylen are monitored. Access is limited to certain services, ports, and destinations. Exceptions to these rules, if created, are reviewed on an annual basis.
2. Smylen's auditing processes shall address access and activity at the following levels listed below. In the case of Smylen Customers, Application and User level auditing is the responsibility of the Customer; Smylen provides software to aggregate and view User and Application logs, but the log data collected is the responsibility of the Smylen Customer. Auditing processes may address date and time of each log-on attempt, date and time of each log-off attempt, devices used, functions performed, etc.
   • User: User level audit trails generally monitor and log all commands directly initiated by the user, all identification and authentication attempts, and data and services accessed.
   • Application: Application level audit trails generally monitor and log all user activities, including data accessed and modified and specific actions.
   • Cloud: Cloud level audit trails generally monitor and log user activities, applications accessed, and other system defined specific actions. Smylen utilizes AWS CloudTrail to assure the integrity of file system data.
   • Network: Network level audit trails generally monitor information on what is operating, penetrations, and vulnerabilities.
3. Smylen shall log all incoming and outgoing traffic to into and out of its environment. This includes all successful and failed attempts at data access and editing. Data associated with this data will include origin, destination, time, and other relevant details that are available to Smylen.
4. Smylen relies on AWS to scan their systems for malicious and unauthorized software every hour and at reboot of systems.
5. Smylen leverages process monitoring tools throughout its environment.
6. Smylen treats its Dashboard as a Platform Add-on and, as such, it logs all activity associated with Dashboard Access.
7. Smylen uses AWS GuardDuty to monitor the integrity of all the cloud infrastructure and GitHub notifications to monitor the code in repository and 3rd party packages for vulnerabilities.
8. Smylen shall identify "trigger events" or criteria that raise awareness of questionable conditions of viewing of confidential information. The "events" may be applied to the entire Smylen Platform or may be specific to a Customer, partner, business associate, Platform Add-on or application (See Listing of Potential Trigger Events below).
9. In addition to trigger events, Smylen utilizes AWS GuardDuty log correlation functionality to proactively identify and enable alerts based on log data.
10. Logs are reviewed weekly by the Security Officer.
11. Smylen's Security Officer and Privacy Officer are authorized to select and use auditing tools that are designed to detect network vulnerabilities and intrusions. Such tools are explicitly prohibited by others, including Customers and Partners, without the explicit authorization of the Security Officer. These tools may include, but are not limited to:
    • Scanning tools and devices;
    • Password cracking utilities;
    • Network "sniffers."
    • Passive and active intrusion detection systems.
12. The process for review of audit logs, trails, and reports shall include:
    • Description of the activity as well as rationale for performing the audit.
    • Identification of which Smylen workforce members will be responsible for review (workforce members shall not review audit logs that pertain to their own system activity).
    • Frequency of the auditing process.
    • Determination of significant events requiring further review and follow-up.
    • Identification of appropriate reporting channels for audit results and required follow-up.
13. Vulnerability testing software may be used to probe the network to identify what is running (e.g., operating system or product versions in place), whether publicly-known vulnerabilities have been corrected, and evaluate whether the system can withstand attacks aimed at circumventing security controls.
    • Testing may be carried out internally or provided through an external third-party vendor. Whenever possible, a third party auditing vendor should not be providing the organization IT oversight services (e.g., vendors providing IT services should not be auditing their own services - separation of duties).
    • Testing shall be done on a routine basis, currently monthly.
14. Software patches and updates will be applied to all systems in a timely manner.

8.3 Audit Requests

1. A request may be made for an audit for a specific cause. The request may come from a variety of sources including, but not limited to, Privacy Officer, Security Officer, Customer, Partner, or an Application owner or application user.
2. A request for an audit for specific cause must include time frame, frequency, and nature of the request. The request must be reviewed and approved by Smylen's Privacy or Security Officer.
3. A request for an audit must be approved by Smylen's Privacy Officer and/or Security Officer before proceeding. Under no circumstances shall detailed audit information be shared with parties without proper permissions and access to see such data.
   • Should the audit disclose that a workforce member has accessed ePHI inappropriately, the minimum necessary/least privileged information shall be shared with Smylen's Security Officer to determine appropriate sanction/corrective disciplinary action.
   • Only de-identified information shall be shared with Customer or Partner regarding the results of the investigative audit process. This information will be communicated to the appropriate personnel by Smylen's Privacy Officer or designee. Prior to communicating with customers and partners regarding an audit, it is recommended that Smylen consider seeking risk management and/or legal counsel.

8.4 Review and Reporting of Audit Findings

1. Audit information that is routinely gathered must be reviewed in a timely manner, currently monthly, by the responsible workforce member(s). On a quarterly basis, logs are reviewed to assure the proper data is being captured and retained. The following process details how log reviews are done at Smylen:
2. The Security Officer initiates the log review by creating an Issue in the Smylen Task Management System.
3. The Security Officer, or a Smylen Security Engineer assigned by the Security Officer, is assigned to review the logs.
4. Relevant audit log findings are added to the Issue; these findings are investigated in a later step. Once those steps are completed, the Issue is then reviewed again.
5. Once the review is completed, the Security Officer approves or rejects the Issue. Relevant findings are reviewed at this stage. If the Issue is rejected, it goes back for further review and documentation. The communications protocol around specific findings are outlined below.
6. If the Issue is approved, the Security Officer then marks the Issue as Done, adding any pertinent notes required.
7. The reporting process shall allow for meaningful communication of the audit findings to those workforce members, Customers, or Partners requesting the audit.
   • Significant findings shall be reported immediately in a written format. Smylen's security incident response form may be utilized to report a single event.
   • Routine findings shall be reported to the sponsoring leadership structure in a written report format.
8. Reports of audit results shall be limited to internal use on a minimum necessary/need-to-know basis. Audit results shall not be disclosed externally without administrative and/or legal counsel approval.
9. Security audits constitute an internal, confidential monitoring practice that may be included in Smylen's performance improvement activities and reporting. Care shall be taken to ensure that the results of the audits are disclosed to administrative level oversight structures only and that information which may further expose organizational risk is shared with extreme caution. Generic security audit information may be included in organizational reports (individually-identifiable ePHI shall not be included in the reports).
10. Whenever indicated through evaluation and reporting, appropriate corrective actions must be undertaken. These actions shall be documented and shared with the responsible workforce members, Customers, and/or Partners.
11. Log review activity is monitored on a quarterly basis using the Task Management System reporting to assess compliance with above policy.

8.5 Auditing Customer and Partner Activity

1. Periodic monitoring of Customer and Partner activity shall be carried out to ensure that access and activity is appropriate for privileges granted and necessary to the arrangement between Smylen and the 3rd party. Smylen will make every effort to assure Customers and Partners do not gain access to data outside of their own Environments.
2. If it is determined that the Customer or Partner has exceeded the scope of access privileges, Smylen's leadership must remedy the problem immediately.
3. If it is determined that a Customer or Partner has violated the terms of the HIPAA business associate agreement or any terms within the HIPAA regulations, Smylen must take immediate action to remediate the situation. Continued violations may result in discontinuation of the business relationship.

8.6 Audit Log Security Controls and Backup

1. Audit logs shall be protected from unauthorized access or modification, so the information they contain will be made available only if needed to evaluate a security incident or for routine audit activities as outlined in this policy.
2. All audit logs are protected in transit and encrypted at rest to control access to the content of the logs.
3. Audit logs shall be stored on a separate system to minimize the impact auditing may have on the privacy system and to prevent access to audit trails by those with system administrator privileges.
   • Separate systems are used to apply the security principle of "separation of duties" to protect audit trails from hackers.
   • Smylen logging servers include Elasticsearch, Logstash, and Kibana (ELK) as part of their baseline configuration to ease reviewing of audit log data. The ELK toolkit provides message summarization, reduction, and reporting functionality.
4. For Smylen Customers choosing to use Smylen logging services, log data will be separated from the log data of other Smylen Customers.

8.7 Workforce Training, Education, Awareness and Responsibilities

1. Smylen workforce members are provided training, education, and awareness on safeguarding the privacy and security of business and ePHI. Smylen's commitment to auditing access and activity of the information applications, systems, and networks is communicated through new employee orientation, ongoing training opportunities and events, and applicable policies. Smylen workforce members are made aware of responsibilities with regard to privacy and security of information as well as applicable sanctions/corrective disciplinary actions should the auditing process detect a workforce member's failure to comply with organizational policies.
2. Smylen Customers are provided with necessary information to understand Smylen auditing capabilities, and Smylen Customers can choose the level of logging and auditing that Smylen will implement on their behalf.

8.8 External Audits of Information Access and Activity

1. Prior to contracting with an external audit firm, Smylen shall:
   • Outline the audit responsibility, authority, and accountability;
   • Choose an audit firm that is independent of other organizational operations;
   • Ensure technical competence of the audit firm staff;
   • Require the audit firm's adherence to applicable codes of professional ethics;
   • Obtain a signed HIPAA business associate agreement;
   • Assign organizational responsibility for supervision of the external audit firm.

8.9 Retention of Audit Data

1. Audit logs shall be maintained based on organizational needs. There is no standard or law addressing the retention of audit log/trail information. Retention of this information shall be based on:
   • Organizational history and experience.
   • Available storage space.
2. Reports summarizing audit activities shall be retained for a period of six years.
3. Audit log data is retained locally on the audit log server for a one-month period. Beyond that, log data is encrypted and moved to warm storage (currently S3) using automated scripts, and is retained for a minimum of one year.
4. For Smylen Customers, they choose the length of backup retention and availability that Smylen will implement and enforce.

8.10 Potential Trigger Events

• High risk or problem prone incidents or events.
• Business associate, customer, or partner complaints.
• Known security vulnerabilities.
• Atypical patterns of activity.
• Failed authentication attempts.
• Remote access use and activity.
• Activity post termination.
• Random audits.

9. Configuration Management Policy

Smylen standardizes and automates configuration management through the use of Terraform scripts as well as documentation of all changes to production systems and networks. Terraform automatically configures all Smylen systems according to established and tested policies, and are used as part of our Disaster Recovery plan and process.

9.1 Applicable Standards

9.1.1 Applicable Standards from the HITRUST Common Security Framework

• 06 - Configuration Management

9.1.2 Applicable Standards from the HIPAA Security Rule

• 164.310(a)(2)(iii) Access Control & Validation Procedures

9.2 Configuration Management Policies

1. Terraform and containers are used to standardize and automate configuration management.
2. No systems are deployed into Smylen environments without approval of the Smylen CTO.
3. All changes to production systems, network devices, and firewalls are approved by the Smylen CTO before they are implemented to assure they comply with business and security requirements.
4. All changes to production systems are tested before they are implemented in production.
5. Implementation of approved changes are only performed by authorized personnel.
6. Tooling to generate an up-to-date inventory of systems, including corresponding architecture diagrams for related products and services, is hosted on GitHub.
   • All systems are categorized as production and utility to differentiate based on criticality.
   • The Security Officer maintains scripts to generate inventory lists on demand using APIs provided by each cloud provider.
   • These scripts are used to generate the diagrams and asset lists required by the Risk Assessment phase of Smylen's Risk Management procedures (§4.3.1).
   • After every use of these scripts, the Security Officer will verify their accuracy by reconciling their output with recent changes to production systems. The Security Officer will address any discrepancies immediately with changes to the scripts.
7. All frontend functionality (developer dashboards and portals) is separated from backend (database and app servers) systems by being deployed on separate servers or containers.
8. All software and systems are tested using unit tests and end to end tests.
9. All committed code is reviewed using pull requests to assure software code quality and proactively detect potential security issues in development.
10. Smylen utilizes development and staging environments that mirror production to assure proper function.
11. Smylen also deploys environments locally to assure functionality before moving to staging or production.
12. All formal change requests require unique ID and authentication.
13. Smylen does not provision servers to host applications rather all applications run in containers on ECS/EKS so systems are ephemeral and immutable.
14. Clocks are continuously synchronized to an authoritative source across all systems using NTP or a platform-specific equivalent. Modifying time data on systems is restricted.
15. Secrets are stored in HSM or equivilant API, seperate from non-sensitive configuration data.

9.3 Provisioning Production Systems

1. Before provisioning any systems, ops team members must file a request in the Smylen Task Management System.
   • Task Management System access requires authenticated users.
   • The CTO grants access to the Task Management System following the procedures covered in the Access Establishment and Modification section.
2. The CTO, or an authorized delegate of the CTO, must approve the provisioning request before any new system can be provisioned.
3. Once provisioning has been approved, the ops team member must configure the new system according to the standard baseline chosen for the system's role.
4. If the system will be used to house production data (ePHI), the ops team member must add an encrypted data volume during provisioning.
5. Once the system has been provisioned, the ops team member must contact the security team to inspect the new system. A member of the security team will verify that the secure baseline has been applied to the new system, including (but not limited to) verifying the following items:
   • Removal of default users used during provisioning.
   • Network configuration for system.
   • Data volume encryption settings.
   • Security settings that cover intrusion and malware detection.
   • All items listed below in the operating system-specific subsections below.
6. Once the security team member has verified the new system is correctly configured, the team member must add that system to the SecurityHub scanner configuration.
7. The new system may be rotated into production once the CTO verifies all the provisioning steps listed above have been correctly followed and has marked the Issue with the Approved state.

9.3.1 Provisioning Linux Containers

1. Linux containers have their baseline security configuration applied via docker configuration. These cover:
   • Ensuring that the stack is up-to-date with security patches and is configured to apply patches in accordance with our policies.
   • Stopping and disabling any unnecessary services and features.
   • Configuring volumes for providers that do not have native support for encrypted data volumes, including ensuring that encryption keys are protected from unauthorized access.
   • Configuring any authentication to require MFA.
   • Configuring audit logging as described in the Auditing Policy section.
2. Any additional configuration applied to the stack must be clearly documented by the ops team member in the DT request by specifying the purpose of the new container.

9.3.2 Provisioning Management Systems

1. Provisioning management systems such as Gateways, Authentication, or VPN follows the same procedure as provisioning a production system.
2. Critical infrastructure services such as logging, monitoring, authentication servers, or dns must be configured with security, backup and high-availability.
   • These are approved by the CTO, or an authorized delegate of the CTO, to be in accordance with all Smylen policies, including setting appropriate:
     • Audit logging requirements.
     • Password size, strength, and expiration requirements.
     • Transmission encryption requirements.
     • Network connectivity timeouts.
3. Critical infrastruture roles applied to new systems must be clearly documented by the ops team member in the DT request.

9.4 Changing Existing Systems

1. Subsequent changes to already-provisioned systems are unconditionally handled by one of the following methods:
   • Changes to Terraform or CloudFormation scripts.
   • Changes to Docker configuration.
   • For configuration changes that cannot be handled by Terraform, Cloudformation and Docker configuration, a runbook describing exactly what changes will be made and by whom.
2. Configuration changes to Docker or Terraform/CloudFormation must be initiated by creating a Merge Request in GitHub.
   • The ops team member will create a feature branch and make their changes on that branch.
   • The ops team member must test their configuration change locally when possible, or on a development and/or staging sandbox otherwise.
   • At least one other ops team member must review the change before merging the change into the main branch.
3. In all cases, before rolling out the change to production, the ops team member must file an Issue in the DT project describing the change. This Issue must link to the reviewed Merge Request and/or include a link to the runbook.
4. Once the request has been approved by the CTO, the ops team member may roll out the change into production environments.

9.5 Patch Management Procedures

1. Smylen uses automated tooling to ensure systems are up-to-date with the latest security patches.

9.6 Software Development Procedures

1. All development uses feature branches based on the main branch used for the current release. Any changes required for a new feature or defect fix are committed to that feature branch.
   • These changes must be covered under 1) a unit test where possible, or 2) integration tests.
   • Integration tests are required if unit tests cannot reliably exercise all facets of the change.
2. Developers are strongly encouraged to follow the commit message conventions suggested by GitHub.
   • Commit messages should be wrapped to 72 characters.
   • Commit messages should be written in the present tense. This convention matches up with commit messages generated by commands like git merge and git revert.
3. Once the feature and corresponding tests are complete, a pull request will be created using the GitHub web interface. The pull request should indicate which feature or defect is being addressed and should provide a high-level description of the changes made.
4. Code reviews are performed as part of the pull request procedure. Once a change is ready for review, the author(s) will notify other engineers using an appropriate mechanism, typically via an @channel message in Slack.
   • Other engineers will review the changes, using the guidelines above.
   • Engineers should note all potential issues with the code; it is the responsibility of the author(s) to address those issues or explain why they are not applicable.
5. If the feature or defect interacts with ePHI, or controls access to data potentially containing ePHI, the code changes must be reviewed by two members of Smylen's Blue Team (software security team) before the feature is marked as complete.
   • The Blue Team members will provide a security analysis of features to ensure they satisfy Smylen's compliance and security commitments.
   • This review must include a security analysis for potential vulnerabilities such as those listed in the OWASP Top 10 or the CWE top 25.
   • This review must also verify that any actions performed by authenticated users will generate appropriate audit log entries.
   • Blue Team members are required to undergo annual training on identifying the most common software vulnerabilities and will receive ongoing training on Smylen's compliance and security requirements.
6. Once the review process finishes, each reviewer should leave a comment on the pull request saying "looks good to me" (often abbreviated as "LGTM"), at which point the original author(s) may merge their change into the release branch.

9.7 Software Release Procedures

1. Software releases are treated as changes to existing systems and thus follow the procedure described in §9.4.

10. Facility Access Policy

Smylen works with Subcontractors to assure restriction of physical access to systems used as part of the Smylen Platform. Smylen and its Subcontractors control access to the physical buildings/facilities that house these systems/applications, or in which Smylen workforce members operate, in accordance to the HIPAA Security Rule 164.310 and its implementation specifications. Physical Access to all of Smylen facilities is limited to only those authorized in this policy. In an effort to safeguard ePHI from unauthorized access, tampering, and theft, access is allowed to areas only to those persons authorized to be in them and with escorts for unauthorized persons. All workforce members are responsible for reporting an incident of unauthorized visitor and/or unauthorized access to Smylen's facility.

Of note, Smylen does not have ready access to ePHI, it provides cloud-based, compliant infrastructure to covered entities and business associates. Smylen does not physically house any systems used by its Platform in Smylen facilities. Physical security of our Platform servers is outlined in §1.4.

10.1 Applicable Standards

10.1.1 Applicable Standards from the HITRUST Common Security Framework

• 08.b - Physical Entry Controls
• 08.d - Protecting Against External and Environmental Threats
• 08.j - Equipment Maintenance
• 08.l - Secure Disposal or Re-Use of Equipment
• 09.p - Disposal of Media

10.1.2 Applicable Standards from the HIPAA Security Rule

• 164.310(a)(2)(ii) Facility Security Plan
• 164.310(a)(2)(iii) Access Control & Validation Procedures
• 164.310(b-c) Workstation Use & Security

10.2 Smylen-controlled Facility Access Policies

1. Visitor and third party support access is recorded and supervised. All visitors are escorted.
2. Repairs are documented and the documentation is retained.
3. Fire extinguishers and detectors are installed according to applicable laws and regulations.
4. Maintenance is controlled and conducted by authorized personnel in accordance with supplier-recommended intervals, insurance policies and the organization's maintenance program.
5. Electronic and physical media containing covered information is securely destroyed (or the information securely removed) prior to disposal.
6. The organization securely disposes media with sensitive information.
7. Physical access is restricted using smart locks that track all access.
   • Restricted areas and facilities are locked when unattended (where feasible).
   • Only authorized workforce members receive access to restricted areas (as determined by the Security Officer).
   • Access and keys are revoked upon termination of workforce members.
   • Workforce members must report a lost and/or stolen key(s) to the Security Officer.
   • The Security Officer facilitates the changing of the lock(s) within 7 days of a key being reported lost/stolen
8. Enforcement of Facility Access Policies
   • Report violations of this policy to the restricted area's department team leader, supervisor, manager, or director, or the Privacy Officer.
   • Workforce members in violation of this policy are subject to disciplinary action, up to and including termination.
   • Visitors in violation of this policy are subject to loss of vendor privileges and/or termination of services from Smylen.
9. Workstation Security
   • Workstations may only be accessed and utilized by authorized workforce members to complete assigned job/contract responsibilities.
   • All workforce members are required to monitor workstations and report unauthorized users and/or unauthorized attempts to access systems/applications as per the System Access Policy.
   • All workstations purchased by Smylen are the property of Smylen and are distributed to users by the company.

11. Incident Response Policy

Smylen implements an information security incident response process to consistently detect, respond to, and report incidents, minimize loss and destruction, mitigate the weaknesses that were exploited, and restore information system functionality and business continuity as soon as possible.

The incident response process addresses:

• Continuous monitoring of threats through intrusion detection systems (IDS) and other monitoring applications;
• Establishment of an information security incident response team;
• Establishment of procedures to respond to media inquiries;
• Establishment of clear procedures for identifying, responding, assessing, analyzing, and follow-up of information security incidents;
• Workforce training, education, and awareness on information security incidents and required responses; and
• Facilitation of clear communication of information security incidents with internal, as well as external, stakeholders.

Note: These policies were adapted from work by the HIPAA Collaborative of Wisconsin Security Networking Group. Refer to the linked document for additional copyright information.

11.1 Applicable Standards

11.1.1 Applicable Standards from the HITRUST Common Security Framework

• 11.a - Reporting Information Security Events
• 11.c - Responsibilities and Procedures

11.1.2 Applicable Standards from the HIPAA Security Rule

• 164.308(a)(5)(i) - Security Awareness and Training
• 164.308(a)(6) - Security Incident Procedures

11.2 Incident Management Policies

The Smylen incident response process follows the process recommended by SANS, an industry leader in security. Process flows are a direct representation of the SANS process which can be found in this document.

Smylen's incident response classifies security-related events into the following categories:

• Events - Any observable computer security-related occurrence in a system or network with a negative consequence. Examples:
  • Hardware component failing causing service outages.
  • Software error causing service outages.
  • General network or system instability.
• Precursors - A sign that an incident may occur in the future. Examples:
  • Monitoring system showing unusual behavior.
  • Audit log alerts indicated several failed login attempts.
  • Suspicious emails targeting specific Smylen staff members with administrative access to production systems.
• Indications - A sign that an incident may have occurred or may be occurring at the present time. Examples:
  • IDS alerts for modified system files or unusual system accesses.
  • Antivirus alerts for infected files.
  • Excessive network traffic directed at unexpected geographic locations.
• Incidents - A violation of computer security policies or acceptable use policies, often resulting in data breaches. Examples:
  • Unauthorized disclosure of ePHI.
  • Unauthorized change or destruction of ePHI.
  • A data breach accomplished by an internal or external entity.
  • A Denial-of-Service (DoS) attack causing a critical service to become unreachable.

Smylen employees must report any unauthorized or suspicious activity seen on production systems or associated with related communication systems (such as email or Slack). In practice this means keeping an eye out for security events, and letting the Security Officer know about any observed precursors or indications as soon as they are discovered.

11.2.1 Identification Phase

1. Immediately upon observation Smylen members report suspected and known Events, Precursors, Indications, and Incidents in one of the following ways:
   1. Direct report to management, the Security Officer, Privacy Officer, or other;
   2. Email;
   3. Phone call;
   4. Online incident response form located here;
   5. Secure Chat;
   6. Anonymously through workforce member's desired channels.
2. The individual receiving the report facilitates completion of an Incident Identification form and notifies the Security Officer (if not already done).
3. The Security Officer determines if the issue is an Event, Precursor, Indication, or Incident.
   1. If the issue is an event, indication, or precursor the Security Officer forwards it to the appropriate resource for resolution.
      1. Non-Technical Event (minor infringement): the Security Officer completes a SIR Form and investigates the incident.
      2. Technical Event: Assign the issue to an IT resource for resolution. This resource may also be a contractor or outsourced technical resource, in the event of a small office or lack of expertise in the area.
   2. If the issue is a security incident the Security Officer activates the Security Incident Response Team (SIRT) and notifies senior management.
      1. If a non-technical security incident is discovered the SIRT completes the investigation, implements preventative measures, and resolves the security incident.
      2. Once the investigation is completed, progress to Phase V, Follow-up.
      3. If the issue is a technical security incident, commence to Phase II: Containment.
      4. The Containment, Eradication, and Recovery Phases are highly technical. It is important to have them completed by a highly qualified technical security resource with oversight by the SIRT team.
      5. Each individual on the SIRT and the technical security resource document all measures taken during each phase, including the start and end times of all efforts.
      6. The lead member of the SIRT team facilitates initiation of a SIR Form or an Incident Survey Form. The intent of the SIR form is to provide a summary of all events, efforts, and conclusions of each Phase of this policy and procedures.
4. The Security Officer, Privacy Officer, or Smylen representative appointed notifies any affected Customers and Partners. If no Customers and Partners are affected, notification is at the discretion of the Security and Privacy Officer.
5. In the case of a threat identified, the Security Officer is to form a team to investigate and involve necessary resources, both internal to Smylen and potentially external.

11.2.2 Containment Phase (Technical)

In this Phase, Smylen's IT department attempts to contain the security incident. It is extremely important to take detailed notes during the security incident response process. This provides that the evidence gathered during the security incident can be used successfully during prosecution, if appropriate.

1. The SIRT reviews any information that has been collected by the Security Officer or any other individual investigating the security incident.
2. The SIRT secures the network perimeter.
3. The IT department performs the following:
   1. Securely connect to the affected system over a trusted connection.
   2. Retrieve any volatile data from the affected system.
   3. Determine the relative integrity and the appropriateness of backing the system up.
   4. If appropriate, back up the system.
   5. Change the password(s) to the affected system(s).
   6. Determine whether it is safe to continue operations with the affected system(s).
   7. If it is safe, allow the system to continue to function;
      1. Complete any documentation relative to the security incident on the SIR Form.
      2. Move to Phase V, Follow-up.
   8. If it is NOT safe to allow the system to continue operations, discontinue the system(s) operation and move to Phase III, Eradication.
   9. The individual completing this phase provides written communication to the SIRT.
4. Continuously apprise Senior Management of progress.
5. Continue to notify affected Customers and Partners with relevant updates as needed

11.2.3 Eradication Phase (Technical)

The Eradication Phase represents the SIRT's effort to remove the cause, and the resulting security exposures, that are now on the affected system(s).

1. Determine symptoms and cause related to the affected system(s).
2. Strengthen the defenses surrounding the affected system(s), where possible (a risk assessment may be needed and can be determined by the Security Officer). This may include the following:
   1. An increase in network perimeter defenses.
   2. An increase in system monitoring defenses.
   3. Remediation ("fixing") any security issues within the affected system, such as removing unused services/general host hardening techniques.
3. Conduct a detailed vulnerability assessment to verify all the holes/gaps that can be exploited have been addressed.
   1. If additional issues or symptoms are identified, take appropriate preventative measures to eliminate or minimize potential future compromises.
4. Complete the Eradication Form.
5. Update the documentation with the information learned from the vulnerability assessment, including the cause, symptoms, and the method used to fix the problem with the affected system(s).
6. Apprise Senior Management of the progress.
7. Continue to notify affected Customers and Partners with relevant updates as needed.
8. Move to Phase IV, Recovery.

11.2.4 Recovery Phase (Technical)

The Recovery Phase represents the SIRT's effort to restore the affected system(s) back to operation after the resulting security exposures, if any, have been corrected.

1. The technical team determines if the affected system(s) have been changed in any way.
   1. If they have, the technical team restores the system to its proper, intended functioning ("last known good").
   2. Once restored, the team validates that the system functions the way it was intended/had functioned in the past. This may require the involvement of the business unit that owns the affected system(s).
   3. If operation of the system(s) had been interrupted (i.e., the system(s) had been taken offline or dropped from the network while triaged), restart the restored and validated system(s) and monitor for behavior.
   4. If the system had not been changed in any way, but was taken offline (i.e., operations had been interrupted), restart the system and monitor for proper behavior.
   5. Update the documentation with the detail that was determined during this phase.
   6. Apprise Senior Management of progress.
   7. Continue to notify affected Customers and Partners with relevant updates as needed.
   8. Move to Phase V, Follow-up.

11.2.5 Follow-up Phase (Technical and Non-Technical)

The Follow-up Phase represents the review of the security incident to look for "lessons learned" and to determine whether the process that was taken could have been improved in any way. It is recommended all security incidents be reviewed shortly after resolution to determine where response could be improved. Timeframes may extend to one to two weeks post-incident.

1. Responders to the security incident (SIRT Team and technical security resource) meet to review the documentation collected during the security incident.
2. Create a "lessons learned" document and attach it to the completed SIR Form.
   1. Evaluate the cost and impact of the security incident to Smylen using the documents provided by the SIRT and the technical security resource.
   2. Determine what could be improved.
   3. Communicate these findings to Senior Management for approval and for implementation of any recommendations made post-review of the security incident.
   4. Carry out recommendations approved by Senior Management; sufficient budget, time and resources should be committed to this activity.
   5. Close the security incident.

11.2.6 Periodic Evaluation

It is important to note that the processes surrounding security incident response should be periodically reviewed and evaluated for effectiveness. This also involves appropriate training of resources expected to respond to security incidents, as well as the training of the general population regarding Smylen's expectation for them, relative to security responsibilities. The incident response plan is tested annually.

11.3 Security Incident Response Team (SIRT)

Current members of the Smylen SIRT:

• Security Officer
• Privacy Officer

12. Breach Policy

To provide guidance for breach notification when impressive or unauthorized access, acquisition, use and/or disclosure of the ePHI occurs. Breach notification will be carried out in compliance with the American Recovery and Reinvestment Act (ARRA)/Health Information Technology for Economic and Clinical Health Act (HITECH) as well as any other federal or state notification law.

The Federal Trade Commission (FTC) has published breach notification rules for vendors of personal health records as required by ARRA/HITECH. The FTC rule applies to entities not covered by HIPAA, primarily vendors of personal health records. The rule is effective September 24, 2009 with full compliance required by February 22, 2010.

The American Recovery and Reinvestment Act of 2009 (ARRA) was signed into law on February 17, 2009. Title XIII of ARRA is the Health Information Technology for Economic and Clinical Health Act (HITECH). HITECH significantly impacts the Health Insurance Portability and Accountability (HIPAA) Privacy and Security Rules. While HIPAA did not require notification when patient protected health information (PHI) was inappropriately disclosed, covered entities and business associates may have chosen to include notification as part of the mitigation process. HITECH does require notification of certain breaches of unsecured PHI to the following: individuals, Department of Health and Human Services (HHS), and the media. The effective implementation for this provision is September 23, 2009 (pending publication HHS regulations).

In the case of a breach, Smylen shall notify all affected Customers. It is the responsibility of the Customers to notify affected individuals.

12.1 Applicable Standards

12.1.1 Applicable Standards from the HITRUST Common Security Framework

• 11.a Reporting Information Security Events
• 11.c Responsibilities and Procedures

12.1.2 Applicable Standards from the HIPAA Security Rule

• 164.308(a)(6)(i) - Security Incident Procedures
• HITECH Notification in the Case of Breach - 13402(a) and 13402(b)
• HITECH Timeliness of Notification - 13402(d)(1)
• HITECH Content of Notification - 13402(f)(1)

12.2 Smylen Breach Policy

1. Discovery of Breach: A breach of ePHI shall be treated as "discovered" as of the first day on which such breach is known to the organization, or, by exercising reasonable diligence would have been known to Smylen (includes breaches by the organization's Customers, Partners, or subcontractors). Smylen shall be deemed to have knowledge of a breach if such breach is known or by exercising reasonable diligence would have been known, to any person, other than the person committing the breach, who is a workforce member or Partner of the organization. Following the discovery of a potential breach, the organization shall begin an investigation (see organizational policies for security incident response and/or risk management incident response) immediately, conduct a risk assessment, and based on the results of the risk assessment, begin the process to notify each Customer affected by the breach. Smylen shall also begin the process of determining what external notifications are required or should be made (e.g., Secretary of Department of Health & Human Services (HHS), media outlets, law enforcement officials, etc.)
2. Breach Investigation: The Smylen Security Officer shall name an individual to act as the investigator of the breach (e.g., privacy officer, security officer, risk manager, etc.). The investigator shall be responsible for the management of the breach investigation, completion of a risk assessment, and coordinating with others in the organization as appropriate (e.g., administration, security incident response team, human resources, risk management, public relations, legal counsel, etc.) The investigator shall be the key facilitator for all breach notification processes to the appropriate entities (e.g., HHS, media, law enforcement officials, etc.). All documentation related to the breach investigation, including the risk assessment, shall be retained for a minimum of six years. A template breach log is located here.
3. Risk Assessment: For an acquisition, access, use or disclosure of ePHI to constitute a breach, it must constitute a violation of the HIPAA Privacy Rule. A use or disclosure of ePHI that is incident to an otherwise permissible use or disclosure and occurs despite reasonable safeguards and proper minimum necessary procedures would not be a violation of the Privacy Rule and would not qualify as a potential breach. To determine if an impermissible use or disclosure of ePHI constitutes a breach and requires further notification, the organization will need to perform a risk assessment to determine if there is significant risk of harm to the individual as a result of the impermissible use or disclosure. The organization shall document the risk assessment as part of the investigation in the incident report form noting the outcome of the risk assessment process. The organization has the burden of proof for demonstrating that all notifications to appropriate Customers or that the use or disclosure did not constitute a breach. Based on the outcome of the risk assessment, the organization will determine the need to move forward with breach notification. The risk assessment and the supporting documentation shall be fact specific and address:
   • Consideration of who impermissibly used or to whom the information was impermissibly disclosed;
   • The type and amount of ePHI involved;
   • The cause of the breach, and the entity responsible for the breach, either Customer, Smylen, or Partner;
   • The potential for significant risk of financial, reputational, or other harm.
4. Timeliness of Notification: Upon discovery of a breach, notice shall be made to the affected Smylen Customers no later than 4 hours after the discovery of the breach. It is the responsibility of the organization to demonstrate that all notifications were made as required, including evidence demonstrating the necessity of delay.
5. Delay of Notification Authorized for Law Enforcement Purposes: If a law enforcement official states to the organization that a notification, notice, or posting would impede a criminal investigation or cause damage to national security, the organization shall:
   • If the statement is in writing and specifies the time for which a delay is required, delay such notification, notice, or posting of the timer period specified by the official; or
   • If the statement is made orally, document the statement, including the identify of the official making the statement, and delay the notification, notice, or posting temporarily and no longer than 30 days from the date of the oral statement, unless a written statement as described above is submitted during that time.
6. Content of the Notice: The notice shall be written in plain language and must contain the following information:
   • A brief description of what happened, including the date of the breach and the date of the discovery of the breach, if known;
   • A description of the types of unsecured protected health information that were involved in the breach (such as whether full name, Social Security number, date of birth, home address, account number, diagnosis, disability code or other types of information were involved), if known;
   • Any steps the Customer should take to protect Customer data from potential harm resulting from the breach;
   • A brief description of what Smylen is doing to investigate the breach, to mitigate harm to individuals and Customers, and to protect against further breaches;
   • Contact procedures for individuals to ask questions or learn additional information, which may include a toll-free telephone number, an e-mail address, a web site, or postal address.
7. Methods of Notification: Smylen Customers will be notified via email and phone within the timeframe for reporting breaches, as outlined above.
8. Maintenance of Breach Information/Log: As described above and in addition to the reports created for each incident, Smylen shall maintain a process to record or log all breaches of unsecured ePHI regardless of the number of records and Customers affected. The following information should be collected/logged for each breach (see sample Breach Notification Log):
   • A description of what happened, including the date of the breach, the date of the discovery of the breach, and the number of records and Customers affected, if known.
   • A description of the types of unsecured protected health information that were involved in the breach (such as full name, Social Security number, date of birth, home address, account number, etc.), if known.
   • A description of the action taken with regard to notification of patients regarding the breach.
   • Resolution steps taken to mitigate the breach and prevent future occurrences.
9. Workforce Training: Smylen shall train all members of its workforce on the policies and procedures with respect to ePHI as necessary and appropriate for the members to carry out their job responsibilities. Workforce members shall also be trained as to how to identify and report breaches within the organization.
10. Complaints: Smylen must provide a process for individuals to make complaints concerning the organization's patient privacy policies and procedures or its compliance with such policies and procedures.
11. Sanctions: The organization shall have in place and apply appropriate sanctions against members of its workforce, Customers, and Partners who fail to comply with privacy policies and procedures.
12. Retaliation/Waiver: Smylen may not intimidate, threaten, coerce, discriminate against, or take other retaliatory action against any individual for the exercise by the individual of any privacy right. The organization may not require individuals to waive their privacy rights under as a condition of the provision of treatment, payment, enrollment in a health plan, or eligibility for benefits.

12.3 Smylen Platform Customer Responsibilities

1. The Smylen Customer that accesses, maintains, retains, modifies, records, stores, destroys, or otherwise holds, uses, or discloses unsecured ePHI shall, without unreasonable delay and in no case later than 60 calendar days after discovery of a breach, notify Smylen of such breach. The Customer shall provide Smylen with the following information:
   • A description of what happened, including the date of the breach, the date of the discovery of the breach, and the number of records and Customers affected, if known.
   • A description of the types of unsecured protected health information that were involved in the breach (such as full name, Social Security number, date of birth, home address, account number, etc.), if known.
   • A description of the action taken with regard to notification of patients regarding the breach.
   • Resolution steps taken to mitigate the breach and prevent future occurrences.
2. Notice to Media: Smylen Customers are responsible for providing notice to prominent media outlets at the Customer's discretion.
3. Notice to Secretary of HHS: Smylen Customers are responsible for providing notice to the Secretary of HHS at the Customer's discretion.

12.4 Sample Letter to Customers in Case of Breach

[Date]

[Name] [Name of Customer] [Address 1] [Address 2] [City, State Zip Code]

Dear [Name of Customer]:

I am writing to you from Smylen, Inc., with important information about a recent breach that affects your account with us. We became aware of this breach on [Insert Date] which occurred on or about [Insert Date]. The breach occurred as follows:

Describe event and include the following information:

• A brief description of what happened, including the date of the breach and the date of the discovery of the breach, if known.
• A description of the types of unsecured protected health information that were involved in the breach (such as whether full name, Social Security number, date of birth, home address, account number, diagnosis, disability code or other types of information were involved), if known.
• Any steps the Customer should take to protect themselves from potential harm resulting from the breach.
• A brief description of what Smylen is doing to investigate the breach, to mitigate harm to individuals, and to protect against further breaches.
• Contact procedures for individuals to ask questions or learn additional information, which includes a toll-free telephone number, an e-mail address, web site, or postal address.

Other Optional Considerations:

• Recommendations to assist customer in remedying the breach.

We will assist you in remedying the situation.

Sincerely,

Derek Giddon, MD
Co-founder - Smylen, Inc.
travis@smylen.com
303-351-2640

13. Disaster Recovery Policy

The Smylen Contingency Plan establishes procedures to recover Smylen following a disruption resulting from a disaster. This Disaster Recovery Policy is maintained by the Smylen Security Officer and Privacy Officer.

The following objectives have been established for this plan:

1. Maximize the effectiveness of contingency operations through an established plan that consists of the following phases:
   • Notification/Activation phase to detect and assess damage and to activate the plan;
   • Recovery phase to restore temporary IT operations and recover damage done to the original system;
   • Reconstitution phase to restore IT system processing capabilities to normal operations.
2. Identify the activities, resources, and procedures needed to carry out Smylen processing requirements during prolonged interruptions to normal operations.
3. Identify and define the impact of interruptions to Smylen systems.
4. Assign responsibilities to designated personnel and provide guidance for recovering Smylen systems during prolonged periods of interruption to normal operations.
5. Ensure coordination with other Smylen staff who will participate in the contingency planning strategies.
6. Ensure coordination with external points of contact and vendors who will participate in the contingency planning strategies.

This Smylen Contingency Plan has been developed as required under the Office of Management and Budget (OMB) Circular A-130, Management of Federal Information Resources, Appendix III, November 2000, and the Health Insurance Portability and Accountability Act (HIPAA) Final Security Rule, Section §164.308(a)(7), which requires the establishment and implementation of procedures for responding to events that damage systems containing electronic protected health information.

This Smylen Contingency Plan is created under the legislative requirements set forth in the Federal Information Security Management Act (FISMA) of 2002 and the guidelines established by the National Institute of Standards and Technology (NIST) Special Publication (SP) 800-34, titled "Contingency Planning Guide for Information Technology Systems" dated June 2002.

The Smylen Contingency Plan also complies with the following federal and departmental policies:

• The Computer Security Act of 1987;
• OMB Circular A-130, Management of Federal Information Resources, Appendix III, November 2000;
• Federal Preparedness Circular (FPC) 65, Federal Executive Branch Continuity of Operations, July 1999;
• Presidential Decision Directive (PDD) 67, Enduring Constitutional Government and Continuity of Government Operations, October 1998;
• PDD 63, Critical Infrastructure Protection, May 1998;
• Federal Emergency Management Agency (FEMA), The Federal Response Plan (FRP), April 1999;
• Defense Authorization Act (Public Law 106-398), Title X, Subtitle G, "Government Information Security Reform," October 30, 2000

Example of the types of disasters that would initiate this plan are natural disaster, political disturbances, man made disaster, external human threats, internal malicious activities.

Smylen defines two categories of systems from a disaster recovery perspective.

1. Critical Systems. These systems host application servers and database servers or are required for functioning of systems that host application servers and database servers. These systems, if unavailable, affect the integrity of data and must be restored, or have a process begun to restore them, immediately upon becoming unavailable.
2. Non-critical Systems. These are all systems not considered critical by definition above. These systems, while they may affect the performance and overall security of critical systems, do not prevent Critical systems from functioning and being accessed appropriately. These systems are restored at a lower priority than critical systems.

13.1 Applicable Standards

13.1.1 Applicable Standards from the HITRUST Common Security Framework

• 12.c - Developing and Implementing Continuity Plans Including Information Security

13.1.2 Applicable Standards from the HIPAA Security Rule

• 164.308(a)(7)(i) - Contingency Plan

13.2 Line of Succession

The following order of succession to ensure that decision-making authority for the Smylen Contingency Plan is uninterrupted. The Chief Technology Officer (CTO) is responsible for ensuring the safety of personnel and the execution of procedures documented within this Smylen Contingency Plan. If the CTO is unable to function as the overall authority or chooses to delegate this responsibility to a successor, the CEO or COO shall function as that authority. To provide contact initiation should the contingency plan need to be initiated, please use the contact list below.

• Dan Horowitz, CTO/Security Officer: 631-664-4028, dan@smylen.com
• Derek Giddon, CEO/Privacy Officer: 516-633-9016, derek@smylen.com

13.3 Responsibilities

The following teams have been developed and trained to respond to a contingency event affecting the IT system.

1. The Tech Team is responsible for recovery of the Smylen hosted environment, network devices, and all servers. Members of the team include personnel who are also responsible for the daily operations and maintenance of Smylen.
2. The Tech Team is responsible for assuring all application servers, web services, and platform add-ons are working. It is also responsible for testing redeployments and assessing damage to the environment.

The team leader is the CTO and directs the Tech Team.

Members of the Tech team must maintain local copies of the contact information from §13.2. Additionally, the CTO must maintain a local copy of this policy in the event Internet access is not available during a disaster scenario.

13.4 Testing and Maintenance

The CTO shall establish criteria for validation/testing of a Contingency Plan, an annual test schedule, and ensure implementation of the test. This process will also serve as training for personnel involved in the plan's execution. At a minimum the Contingency Plan shall be tested annually (within 365 days). The types of validation/testing exercises include tabletop and technical testing. Contingency Plans for all application systems must be tested at a minimum using the tabletop testing process. However, if the application system Contingency Plan is included in the technical testing of their respective support systems that technical test will satisfy the annual requirement.

13.4.1 Tabletop Testing

Tabletop Testing is conducted in accordance with the the CMS Risk Management Handbook, Volume 2. The primary objective of the tabletop test is to ensure designated personnel are knowledgeable and capable of performing the notification/activation requirements and procedures as outlined in the CP, in a timely manner. The exercises include, but are not limited to:

• Testing to validate the ability to respond to a crisis in a coordinated, timely, and effective manner, by simulating the occurrence of a specific crisis.

13.4.2 Technical Testing

The primary objective of the technical test is to ensure the communication processes and data storage and recovery processes can function at an alternate site to perform the functions and capabilities of the system within the designated requirements. Technical testing shall include, but is not limited to:

• Process from backup system at the alternate site;
• Restore system using backups; and
• Switch compute and storage resources to alternate processing site.

13.5 Disaster Recovery Procedures

13.5.1 Notification and Activation Phase

This phase addresses the initial actions taken to detect and assess damage inflicted by a disruption to Smylen. Based on the assessment of the Event, sometimes according to the Smylen Incident Response Policy, the Contingency Plan may be activated by the CTO.

The notification sequence is listed below:

• The first responder is to notify the CTO. All known information must be relayed to the CTO.
• The CTO is to contact the Tech Team and inform them of the event. The CTO is to to begin assessment procedures.
• The CTO is to notify team members and direct them to complete the assessment procedures outlined below to determine the extent of damage and estimated recovery time. If damage assessment cannot be performed locally because of unsafe conditions, the CTO is to follow the steps below.
  • Damage Assessment Procedures:
    • The CTO is to logically assess damage, gain insight into whether the infrastructure is salvageable, and begin to formulate a plan for recovery.
  • Alternate Assessment Procedures:
    • Upon notification, the CTO is to follow the procedures for damage assessment with combined Tech and Tech Teams.
• The Smylen Contingency Plan is to be activated if one or more of the following criteria are met:
  • Smylen systems will be unavailable for more than 48 hours.
  • Hosting facility is damaged and will be unavailable for more than 24 hours.
  • Other criteria, as appropriate and as defined by Smylen.
• If the plan is to be activated, the CTO is to notify and inform team members of the details of the event and if relocation is required.
• Upon notification from the CTO, group leaders and managers are to notify their respective teams. Team members are to be informed of all applicable information and prepared to respond and relocate if necessary.
• The CTO is to notify the hosting facility partners that a contingency event has been declared and to ship the necessary materials (as determined by damage assessment) to the alternate site.
• The CTO is to notify remaining personnel and executive leadership on the general status of the incident.
• Notification can be message, email, or phone.

13.5.2 Recovery Phase

This section provides procedures for recovering the application at an alternate site, whereas other efforts are directed to repair damage to the original system and capabilities.

The following procedures are for recovering the Smylen infrastructure at the alternate site. Procedures are outlined per team required. Each procedure should be executed in the sequence it is presented to maintain efficient operations.

Recovery Goal: The goal is to rebuild Smylen infrastructure to a production state.

The tasks outlines below are not sequential and some can be run in parallel.

1. Contact Partners and Customers affected - Tech
2. Assess damage to the environment - Tech
3. Begin replication of new environment using automated and tested scripts. At this point it is determined whether to recover in Rackspace, AWS, Azure, or SoftLayer. - Tech
4. Test new environment using pre-written tests - Tech
5. Test logging, security, and alerting functionality - Tech
6. Assure systems are appropriately patched and up to date. - Tech
7. Deploy environment to production - Tech
8. Update DNS to new environment. - Tech

13.5.3 Reconstitution Phase

This section discusses activities necessary for restoring Smylen operations at the original or new site. The goal is to restore full operations within 24 hours of a disaster or outage. When the hosted data center at the original or new site has been restored, Smylen operations at the alternate site may be transitioned back. The goal is to provide a seamless transition of operations from the alternate site to the computer center.

1. Original or New Site Restoration
   • Begin replication of new environment using automated and tested scripts - Tech
   • Test new environment using pre-written tests. - Tech
   • Test logging, security, and alerting functionality. - Tech
   • Deploy environment to production - Tech
   • Assure systems are appropriately patched and up to date. - Tech
   • Update DNS to new environment. - Tech
2. Plan Deactivation
   • If the Smylen environment is moved back to the original site from the alternative site, all hardware used at the alternate site should be handled and disposed of according to the Smylen Media Disposal Policy.

14. Disposable Media Policy

Smylen recognizes that media containing ePHI may be reused when appropriate steps are taken to ensure that all stored ePHI has been effectively rendered inaccessible. Destruction/disposal of ePHI shall be carried out in accordance with federal and state law. The schedule for destruction/disposal shall be suspended for ePHI involved in any open investigation, audit, or litigation.

ePHI is only stored in our hosted environment using encrypted storage. Smylen does not use, own, or manage any mobile devices, SD cards, or tapes that have access to ePHI.

14.1 Applicable Standards

14.1.1 Applicable Standards from the HITRUST Common Security Framework

• 0.9o - Management of Removable Media

14.1.2 Applicable Standards from the HIPAA Security Rule

• 164.310(d)(1) - Device and Media Controls

14.2 Disposable Media Policy

1. All removable media is restricted, audited, and is encrypted.
2. Smylen assumes all disposable media in its Platform may contain ePHI, so it treats all disposable media with the same protections and disposal policies.
3. All destruction/disposal of ePHI media will be done in accordance with federal and state laws and regulations and pursuant to the Smylen's written retention policy/schedule. Records that have satisfied the period of retention will be destroyed/disposed of in an appropriate manner.
4. Records involved in any open investigation, audit or litigation should not be destroyed/disposed of. If notification is received that any of the above situations have occurred or there is the potential for such, the record retention schedule shall be suspended for these records until such time as the situation has been resolved. If the records have been requested in the course of a judicial or administrative hearing, a qualified protective order will be obtained to ensure that the records are returned to the organization or properly destroyed/disposed of by the requesting party.
5. Before reuse of any media, for example, all ePHI is rendered inaccessible, cleaned, or scrubbed. All media is formatted to restrict future access.
6. All Smylen Subcontractors provide that, upon termination of the contract, they will return or destroy/dispose of all patient health information. In cases where the return or destruction/disposal is not feasible, the contract limits the use and disclosure of the information to the purposes that prevent its return or destruction/disposal.
7. Any media containing ePHI is disposed using a method that ensures the ePHI could not be readily recovered or reconstructed.
8. The methods of destruction, disposal, and reuse are reassessed periodically, based on current technology, accepted practices, and availability of timely and cost-effective destruction, disposal, and reuse technologies and services.
9. In the case of a Smylen Customer terminating a contract with Smylen and no longer utilizing Smylen Services, the following actions will be taken depending on the Smylen Services in use. In all cases it is solely the responsibility of the Smylen Customer to maintain the safeguards required of HIPAA once the data is transmitted out of Smylen Systems.
   • In the case of Smylen Customer termination, Smylen will provide the customer with 30 days from the date of termination to export data.

15. IDS Policy

In order to preserve the integrity of data that Smylen stores, processes, or transmits for Customers, Smylen implements strong intrusion detection tools and policies to proactively track and retroactively investigate unauthorized access. Smylen currently utilizes AWS Guardduty to track integrity, monitor log data, and detect unauthorized access.

15.1 Applicable Standards

15.1.1 Applicable Standards from the HITRUST Common Security Framework

• 09.ab - Monitoring System Use
• 06.e - Prevention of Misuse of Information
• 10.h - Control of Operational Software

15.1.2 Applicable Standards from the HIPAA Security Rule

• 164.312(b) - Audit Controls

15.2 Intrusion Detection Policy

1. AWS Guardduty is used to monitor and correlate log data from different systems on an ongoing basis. Reports generated by AWS Guardduty are reviewed by the Security Officer on a monthly basis.
2. AWS Guardduty generates alerts to analyze and investigate suspicious activity or suspected violations.
3. AWS Guardduty monitors cloud integrity and sends real time alerts when suspicious changes are made to its configuration.
4. Automatic monitoring is done to identify patterns that might signify the lack of availability of certain services and systems (DoS attacks).
5. Smylen firewalls monitor all incoming traffic to detect potential denial-of-service attacks. Suspected attack sources are blocked automatically. Additionally, our hosting provider actively monitors its network to detect denial-of-service attacks.
6. All new firewall rules and configuration changes are tested before being pushed into production. All firewall and router rules are reviewed every quarter.
7. Smylen utilizes redundant firewall on network perimeters.

16. Vulnerability Scanning Policy

Smylen is proactive about information security and understands that vulnerabilities need to be monitored on an ongoing basis. Smylen utilizes AWS Inspector and GitHub to consistently scan, identify, and address vulnerabilities. We also utilize AWS GuardDuty for integrity checking and intrusion detection.

16.1 Applicable Standards

16.1.1 Applicable Standards from the HITRUST Common Security Framework

• 10.m - Control of Technical Vulnerabilities

16.1.2 Applicable Standards from the HIPAA Security Rule

• 164.308(a)(8) - HIPAA Security Rule Evaluation

16.2 Vulnerability Scanning Policy

1. AWS Inspector management is performed by the Smylen Security Officer, or an authorized delegate of the Security Officer.
2. AWS Inspector is used to monitor all internal IP addresses (servers, VMs, etc) on Smylen networks.
3. Frequency of scanning is as follows:
4. on a weekly basis;
5. after every production deployment.
6. Reviewing AWS Inspector reports and findings, as well as any further investigation into discovered vulnerabilities, is the responsibility of the Smylen Security Officer. The process for reviewing AWS Inspector reports is outlined below:
7. The Security Officer initiates the review of a AWS Inspector Report by creating an Issue in the Smylen Task Management System.
8. The Security Officer, or a Smylen Security Engineer assigned by the Security Officer, is assigned to review the AWS Inspector Report.
9. If new vulnerabilities are found during review, the process outlined below is used to test those vulnerabilities. Once those steps are completed, the Issue is then reviewed again.
10. Once the review is completed, the Security Officer approves or rejects the Issue. If the Issue is rejected, it goes back for further review.
11. If the review is approved, the Security Officer then marks the Issue as Done, adding any pertinent notes required.
12. In the case of new vulnerabilities, the following steps are taken:

• All new vulnerabilities are verified manually to assure they are repeatable. Those not found to be repeatable are manually tested after the next vulnerability scan, regardless of if the specific vulnerability is discovered again.
• Vulnerabilities that are repeatable manually are documented and reviewed by the Security Officer and Privacy Officer to see if they are part of the current risk assessment performed by Smylen.
  • Those that are a part of the current risk assessment are checked for mitigations.
  • Those that are not part of the current risk assessment trigger a new risk assessment, and this process is outlined in detail in the Smylen Risk Assessment Policy.

6. All vulnerability scanning reports are retained for 6 years by Smylen. Vulnerability report review is monitored on a quarterly basis using the Task Management System reporting to assess compliance with above policy.
7. Penetration testing is performed regularly as part of the Smylen vulnerability management policy.

• External penetration testing is performed annually by a third party.
• Internal penetration testing is performed quarterly. Below is the process used to conduct internal penetration tests.
  1. The Security Officer initiates the penetration test by creating an Issue in the Smylen Task Management System.
  2. The Security Officer, or a Smylen Security Engineer assigned by the Security Officer, is assigned to conduct the penetration test.
  3. Gaps and vulnerabilities identified during penetration testing are reviewed, with plans for correction and/or mitigation, by the Smylen Security Officer before the Issue can move to be approved.
  4. Once the testing is completed, the Security Officer approves or rejects the Issue. If the Issue is rejected, it goes back for further testing and review.
  5. If the Issue is approved, the Security Officer then marks the Issue as Done, adding any pertinent notes required.
• Penetration tests results are retained for 6 years by Smylen.
• Internal penetration testing is monitored on an annual basis using the Task Management System reporting to assess compliance with above policy.

8. This vulnerability policy is reviewed on a quarterly basis by the Security Officer and Privacy Officer.

17. Data Integrity Policy

Smylen takes data integrity very seriously. As stewards and partners of Smylen Customers, we strive to assure data is protected from unauthorized access and that it is available when needed. The following policies drive many of our procedures and technical settings in support of the Smylen mission of data protection.

Production systems that create, receive, store, or transmit Customer data (hereafter "Production Systems") must follow the guidelines described in this section.

17.1 Applicable Standards

17.1.1 Applicable Standards from the HITRUST Common Security Framework

• 10.b - Input Data Validation

17.1.2 Applicable Standards from the HIPAA Security Rule

• 164.308(a)(8) - HIPAA Security Rule Evaluation

17.2 Disabling Non-Essential Services

1. All Production Systems must disable services that are not required to achieve the business purpose or function of the system.

17.3 Monitoring Log-in Attempts

1. All access to Production Systems must be logged. This is done following the Smylen Auditing Policy.

17.4 Prevention of Malware on Production Systems

1. All Production Systems must run in container, on ECS/EKS to assure no malware is present. Detected malware is evaluated and removed.
2. All Production Systems are to only be used for Smylen business needs.

17.5 Patch Management

1. Software patches and updates will be applied to all systems in a timely manner. In the case of routine updates, they will be applied after thorough testing. In the case of updates to correct known vulnerabilities, priority will be given to testing to speed the time to production. Critical security patches are applied within 30 days from testing and all security patches are applied within 90 days after testing.
2. Administrators subscribe to mailing lists to ensure that they are using current versions of all Smylen-managed software on Production Systems.

17.6 Intrusion Detection and Vulnerability Scanning

1. Production systems are monitored using AWS GuardDuty and SecurityHub systems. Suspicious activity is logged and alerts are generated.
2. Vulnerability scanning of Production Systems must occur on a predetermined, regular basis, no less than annually. Currently it is weekly. Scans are reviewed by Security Officer, with defined steps for risk mitigation, and retained for future reference.

17.7 Production System Security

1. System, network, and server security is managed and maintained by the Security Officer in conjunction with the Tech team.
2. Up-to-date system lists and architecture diagrams are kept for all production environments.
3. Access to Production Systems is controlled using centralized tools and two-factor authentication.

17.8 Production Data Security

1. Reduce the risk of compromise of Production Data with daily backups, encryption, secure storage of secrets, and dual factor authentication for administrators.
2. Implement and/or review controls designed to protect Production Data from improper alteration or destruction.
3. Ensure that confidential data is stored in a manner that supports user access logs and automated monitoring for potential security incidents.
4. Ensure Smylen Customer Production Data is segmented and only accessible to Customers authorized to access data.
5. All Production Data at rest is stored on encrypted volumes using encryption keys managed by Smylen. Encryption at rest is ensured through the use of automated deployment scripts referenced in the Configuration Management Policy.
6. Volume encryption keys and machines that generate volume encryption keys are protected from unauthorized access. Volume encryption key material is protected with access controls such that the key material is only accessible by privileged accounts.
7. Encrypted volumes use AES encryption with a minimum of 256-bit keys, or keys and ciphers of equivalent or higher cryptographic strength.

17.9 Transmission Security

1. All data transmission is encrypted end to end using encryption keys managed by Smylen. Encryption is not terminated at the network end point, and is carried through to the application.
2. Transmission encryption keys and machines that generate keys are protected from unauthorized access. Transmission encryption key material is protected with access controls such that the key material is only accessible by privileged accounts.
3. Transmission encryption keys use a minimum of 4096-bit RSA keys, or keys and ciphers of equivalent or higher cryptographic strength (e.g., 256-bit AES session keys in the case of IPsec encryption).
4. Transmission encryption keys are limited to use for one year and then must be regenerated.
5. In the case of Smylen provided APIs, provide mechanisms to assure person sending or receiving data is authorized to send and save data.
6. System logs of all transmissions of Production Data access. These logs must be available for audit.

18. Data Retention Policy

Data retention is not a requirement within HIPAA, however Smylen understands and appreciates the importance of health data retention and will remove data upon request.

18.1 State Medical Record Laws

• Listing of state requirements for medical record retention

18.2 Data Retention Policy

Acting as a business associate, Smylen is not directly responsible for health and medical records retention as set forth by each state.

• Current Smylen Customers have data stored by Smylen as a part of the Smylen Service.
• Customers can email us to remove their accounts and ePHI

19. Employees Policy

Smylen is committed to ensuring all workforce members actively address security and compliance in their roles at Smylen. As such, training is imperative to assuring an understanding of current best practices, the different types and sensitivities of data, and the sanctions associated with non-compliance.

19.1 Applicable Standards

19.1.1 Applicable Standards from the HITRUST Common Security Framework

• 02.e - Information Security Awareness, Education, and Training
• 06.e - Prevention of Misuse of Information Assets
• 07.c - Acceptable Use of Assets
• 09.j - Controls Against Malicious Code
• 01.y - Teleworking

19.1.2 Applicable Standards from the HIPAA Security Rule

• 164.308(a)(5)(i) - Security Awareness and Training

19.2 Employment Policies

1. All new workforce members, including contractors, are given training on security policies and procedures, including operations security, within 30 days of employment.
   • Records of training are kept for all workforce members.
   • Upon completion of training, workforce members complete this form.
   • Current Smylen training is hosted at training.smylen.com.
   • Employees must complete this training before accessing production systems containing ePHI.
2. All workforce members are granted access to formal organizational policies, which include the sanction policy for security violations.
3. The Smylen Employee Handbook clearly states the responsibilities and acceptable behavior regarding information system usage, including rules for email, Internet, mobile devices, and social media usage.
   • Workforce members are required to sign an agreement stating that they have read and will abide by all terms outlined in the Smylen Employee Handbook, along with all policies and processes described in this document.
   • A Human Resources representative will provide the agreement to new employees during their onboarding process.
4. Smylen does not allow mobile devices to connect to any of its production networks.
5. All workforce members are educated about the approved set of tools to be installed on workstations.
6. All new workforce members are given HIPAA training within 30 days of beginning employment. Training includes HIPAA reporting requirements, including the ability to anonymously report security incidents, and the levels of compliance and obligations for Smylen and its Customers and Partners.
   • Current Smylen training is hosted at training.smylen.com.
7. All remote (teleworking) workforce members are trained on the risks, the controls implemented, their responsibilities, and sanctions associated with violation of policies. Additionally, remote security is maintained through the use of VPN tunnels for all access to production systems with access to ePHI data.
8. All Smylen-purchased and -owned computers are to display this message at login and when the computer is unlocked: This computer is owned by Smylen, Inc. By logging in, unlocking, and/or using this computer you acknowledge you have seen, and follow, these policies (https://policy.smylen.com) and have completed this training (https://training.smylen.com). Please contact us if you have problems with this - privacy@smylen.com.
9. Employees may only use Smylen-purchased and -owned workstations for accessing production systems with access to ePHI data.
   • Any workstations used to access production systems must be configured as prescribed in §7.8.
   • Any workstations used to access production systems must have virus protection software installed, configured, and enabled.
   • Smylen may monitor access and activities of all users on workstations and production systems in order to meet auditing policy requirements (§8).
10. Access to internal Smylen systems can be requested using the procedures outlined in §7.2. All requests for access must be granted by the Smylen Security Officer.
11. Request for modifications of access for any Smylen employee can be made using the procedures outlined in §7.2.
12. Smylen employees are strictly forbidden from downloading any ePHI to their workstations.
    • Restricting transfers of ePHI is enforced through technical controls as described in §7.13.
    • Employees found to be in violation of this policy will be subject to sanctions as described in §5.3.3.
13. Employees are required to cooperate with federal and state investigations.
    • Employees must not interfere with investigations through willful misrepresentation, omission of facts, or by the use of threats against any person.
    • Employees found to be in violation of this policy will be subject to sanctions as described in §5.3.3.

19.3 Issue Escalation

Smylen workforce members are to escalate issues using the procedures outlined in the Employee Handbook. Issues that are brought to the Escalation Team are assigned an owner. The membership of the Escalation Team is maintained by the Chief Executive Officer.

Security incidents, particularly those involving ePHI, are handled using the process described in §11.2. If the incident involves a breach of ePHI, the Security Officer will manage the incident using the process described in §12.2. Refer to §11.2 for a list of sample items that can trigger Smylen's incident response procedures; if you are unsure whether the issue is a security incident, contact the Security Officer immediately.

It is the duty of that owner to follow the process outlined below:

1. Create an Issue in the Smylen Task Management System.
2. The Issue is investigated, documented, and, when a conclusion or remediation is reached, it is moved to Review.
3. The Issue is reviewed by another member of the Escalation Team. If the Issue is rejected, it goes back for further evaluation and review.
4. If the Issue is approved, it is marked as Done, adding any pertinent notes required.
5. The workforce member that initiated the process is notified of the outcome via email.

20. Approved Tools Policy

Smylen utilizes a suite of approved software tools for internal use by workforce members. These software tools are either self-hosted, with security managed by Smylen, or they are hosted by a Subcontractor with appropriate business associate agreements in place to preserve data integrity. Use of other tools requires approval from Smylen leadership.

20.1 List of Approved Tools

• GitHub. GitHub is hosted Git, the version control system.
• Google Apps. Google Apps is used for email and document collaboration.
• Trello. Trello is used for Task management and to generate artifacts for compliance procedures.

21. 3rd Party Policy

Smylen makes every effort to assure all 3rd party organizations are compliant and do not compromise the integrity, security, and privacy of Smylen or Smylen Customer data. 3rd Parties include Customers, Partners, Subcontractors, and Contracted Developers.

21.1 Applicable Standards

21.1.1 Applicable Standards from the HITRUST Common Security Framework

• 05.i - Identification of Risks Related to External Parties
• 05.k - Addressing Security in Third Party Agreements
• 09.e - Service Delivery
• 09.f - Monitoring and Review of Third Party Services
• 09.g - Managing Changes to Third Party Services
• 10.1 - Outsourced Software Development

21.1.2 Applicable Standards from the HIPAA Security Rule

• 164.314(a)(1)(i) - Business Associate Contracts or Other Arrangements

21.2 Policies to Assure 3rd Parties Support Smylen Compliance

1. Smylen does not allow 3rd party access to production systems containing ePHI.
2. All connections and data in transit between the Smylen Platform and 3rd parties are encrypted end to end.
3. A standard business associate agreement with Customers and Partners is defined and includes the required security controls in accordance with the organization's security policies. Additionally, responsibility is assigned in these agreements.
4. Smylen has Service Level Agreements (SLAs) with Subcontractors with an agreed service arrangement addressing liability, service definitions, security controls, and aspects of services management.
   • Subcontractors must coordinate, manage, and communicate any changes to services provided to Smylen.
   • Changes to 3rd party services are classified as configuration management changes and thus are subject to the policies and procedures described in §9; substantial changes to services provided by 3rd parties will invoke a Risk Assessment as described in §4.2.
   • Smylen utilizes monitoring tools to regularly evaluate Subcontractors against relevant SLAs.
5. No Smylen Customers or Partners have access outside of their own environment, meaning they cannot access, modify, or delete anything related to other 3rd parties.
6. Smylen does not outsource software development.
7. Smylen maintains and annually reviews a list all current Partners and Subcontractors.
   • The list of current Partners and Subcontractors is maintained by the Smylen Privacy Officer, includes details on all provided services (along with contact information), and is recorded in §1.4.
   • The annual review of Partners and Subcontractors is conducted as a part of the security, compliance, and SLA review referenced below.
8. Smylen assesses security, compliance, and SLA requirements and considerations with all Partners and Subcontractors. This includes annual assessment of SOC2 reports for all Smylen infrastructure partners.
   • Smylen leverages recurring calendar invites to assure reviews of all 3rd party services are performed annually. These reviews are performed by the Smylen Security Officer and Privacy Officer. The process for reviewing 3rd party services is outlined below:
     1. The Security Officer initiates the SLA review by creating an Issue in the Smylen Task Management System.
     2. The Security Officer, or Privacy Officer, is assigned to review the SLA and performance of 3rd parties. The list of current 3rd parties, including contact information, is also reviewed to assure it is up to date and complete.
     3. SLA, security, and compliance performance is documented in the Issue.
     4. Once the review is completed and documented, the Security Officer approves or rejects the Issue. If the Issue is rejected, it goes back for further review and documentation.
9. Regular review is conducted as required by SLAs to assure security and compliance. These reviews include reports, audit trails, security events, operational issues, failures and disruptions, and identified issues are investigated and resolved in a reasonable and timely manner.
10. Any changes to Partner and Subcontractor services and systems are reviewed before implementation.
11. For all partners, Smylen reviews activity annually to assure partners are in line with SLAs in contracts with Smylen.
12. SLA review is monitored on a quarterly basis using the Task Management System reporting to assess compliance with above policy.
13. The 3rd Party Assurance process is reviewed annually and updated to include any necessary changes.
14. Changes to the 3rd Party Assurance process will also be made on an ad-hoc basis in cases where operational changes require it or if the process is found lacking.

22. Key Definitions

• Application: An application hosted by Smylen, either maintained and created by Smylen, or maintained and created by a Customer or Partner.

• Application Level: Controls and security associated with an Application. In the case of Smylen Customers, Smylen does not have access to and cannot assure compliance with security standards and policies at the Application Level.

• Audit: Internal process of reviewing information system access and activity (e.g., log-ins, file accesses, and security incidents). An audit may be done as a periodic event, as a result of a patient complaint, or suspicion of employee wrongdoing.

• Audit Controls: Technical mechanisms that track and record computer/system activities.

• Audit Logs: Encrypted records of activity maintained by the system which provide: 1) date and time of activity; 2) origin of activity (app); 3) identification of user doing activity; and 4) data accessed as part of activity.

• Access: Means the ability or the means necessary to read, write, modify, or communicate data/ information or otherwise use any system resource.

• Backup: The process of making an electronic copy of data stored in a computer system. This can either be complete, meaning all data and programs, or incremental, including just the data that changed from the previous backup.

• Backup Service: A logging service for unifying system and application logs, encrypting them, and providing a dashboard for them. Offered with all Smylen Add-ons and as an option for Smylen Customers.

• Breach: Means the acquisition, access, use, or disclosure of protected health information (PHI) in a manner not permitted under the Privacy Rule which compromises the security or privacy of the PHI. For purpose of this definition, "compromises the security or privacy of the PHI" means poses a significant risk of financial, reputational, or other harm to the individual. A use or disclosure of PHI that does not include the identifiers listed at §164.514(e)(2), limited data set, date of birth, and zip code does not compromise the security or privacy of the PHI. Breach excludes:

  1. Any unintentional acquisition, access or use of PHI by a workforce member or person acting under the authority of a Covered Entity (CE) or Business Associate (BA) if such acquisition, access, or use was made in good faith and within the scope of authority and does not result in further use or disclosure in a manner not permitted under the Privacy Rule.
  2. Any inadvertent disclosure by a person who is authorized to access PHI at a CE or BA to another person authorized to access PHI at the same CE or BA, or organized health care arrangement in which the CE participates, and the information received as a result of such disclosure is not further used or disclosed in a manner not permitted under the Privacy Rule.
  3. A disclosure of PHI where a CE or BA has a good faith belief that an unauthorized person to whom the disclosure was made would not reasonably have been able to retain such information.

• Business Associate: A person or entity that performs certain functions or activities that involve the use or disclosure of protected health information on behalf of, or provides services to, a covered entity.

• Covered Entity: A health plan, health care clearinghouse, or a healthcare provider who transmits any health information in electronic form.

• De-identification: The process of removing identifiable information so that data is rendered to not be PHI.

• Disaster Recovery: The ability to recover a system and data after being made unavailable.

• Disaster Recovery Service: A disaster recovery service for disaster recovery in the case of system unavailability. This includes both the technical and the non-technical (process) required to effectively stand up an application after an outage. Offered with all Smylen Add-ons and as an option for Smylen Customers.

• Disclosure: Disclosure means the release, transfer, provision of, access to, or divulging in any other manner of information outside the entity holding the information.

• Customers: Contractually bound users of Smylen Platform.

• Electronic Protected Health Information (ePHI): Any individually identifiable health information protected by HIPAA that is transmitted by, processed in some way, or stored in electronic media.

• Environment: The overall technical environment, including all servers, network devices, and applications.

• Event: An event is defined as an occurrence that does not constitute a serious adverse effect on Smylen, its operations, or its Customers, though it may be less than optimal. Examples of events include, but are not limited to:

  • A hard drive malfunction that requires replacement;
  • Systems become unavailable due to power outage that is non-hostile in nature, with redundancy to assure ongoing availability of data;
  • Accidental lockout of an account due to incorrectly entering a password multiple times.

• Hardware (or hard drive): Any computing device able to create and store ePHI.

• Health and Human Services (HHS): The government body that maintains HIPAA.

• Individually Identifiable Health Information: That information that is a subset of health information, including demographic information collected from an individual, and is created or received by a health care provider, health plan, employer, or health care clearinghouse; and relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual; and identifies the individual; or with respect to which there is a reasonable basis to believe the information can be used to identify the individual.

• Indication: A sign that an Incident may have occurred or may be occurring at the present time. Examples of indications include:

  • The network intrusion detection sensor alerts when a known exploit occurs against an FTP server. Intrusion detection is generally reactive, looking only for footprints of known attacks. It is important to note that many IDS "hits" are also false positives and are neither an event nor an incident;
  • The antivirus software alerts when it detects that a host is infected with a worm;
  • Users complain of slow access to hosts on the Internet;
  • The system administrator sees a filename with unusual characteristics;
  • Automated alerts of activity from log monitors like AWS GuardDuty;
  • An alert from GuardDuty about integrity issues.

• Intrusion Detection System (IDS): A software tool use to automatically detect and notify in the event of possible unauthorized network and/or system access.

• IDS Service: An Intrusion Detection Service for providing IDS notification to customers in the case of suspicious activity. Offered with all Smylen Add-ons and as an option for Smylen Customers.

• Law Enforcement Official: Any officer or employee of an agency or authority of the United States, a State, a territory, a political subdivision of a State or territory, or an Indian tribe, who is empowered by law to investigate or conduct an official inquiry into a potential violation of law; or prosecute or otherwise conduct a criminal, civil, or administrative proceeding arising from an alleged violation of law.

• Logging Service: A logging service for unifying system and application logs, encrypting them, and providing a dashboard for them. Offered with all Smylen Add-ons and as an option for Smylen Customers.

• Messaging: API-based services to deliver and receive SMS messages.

• Minimum Necessary Information: Protected health information that is the minimum necessary to accomplish the intended purpose of the use, disclosure, or request. The "minimum necessary" standard applies to all protected health information in any form.

• Off-Site: For the purpose of storage of Backup media, off-site is defined as any location separate from the building in which the backup was created. It must be physically separate from the creating site.

• Organization: For the purposes of this policy, the term "organization" shall mean Smylen.

• Partner: Contractual bound 3rd party vendor with integration with the Smylen Platform. May offer Add-on services.

• Platform: The overall technical environment of Smylen.

• Protected Health Information (PHI): Individually identifiable health information that is created by or received by the organization, including demographic information, that identifies an individual, or provides a reasonable basis to believe the information can be used to identify an individual, and relates to:

  • Past, present or future physical or mental health or condition of an individual.
  • The provision of health care to an individual.
  • The past, present, or future payment for the provision of health care to an individual.

• Role: The category or class of person or persons doing a type of job, defined by a set of similar or identical responsibilities.

• Sanitization: Removal or the act of overwriting data to a point of preventing the recovery of the data on the device or media that is being sanitized. Sanitization is typically done before re-issuing a device or media, donating equipment that contained sensitive information or returning leased equipment to the lending company.

• Trigger Event: Activities that may be indicative of a security breach that require further investigation (See Appendix).

• Restricted Area: Those areas of the building(s) where protected health information and/or sensitive organizational information is stored, utilized, or accessible at any time.

• Role: The category or class of person or persons doing a type of job, defined by a set of similar or identical responsibilities.

• Precursor: A sign that an Incident may occur in the future. Examples of precursors include:

  • Suspicious network and host-based IDS events/attacks;
  • Alerts as a result of detecting malicious code at the network and host levels;
  • Alerts from file integrity checking software;
  • Audit log alerts.

• Risk: The likelihood that a threat will exploit a vulnerability, and the impact of that event on the confidentiality, availability, and integrity of ePHI, other confidential or proprietary electronic information, and other system assets.

• Risk Management Team: Individuals who are knowledgeable about the Organization's HIPAA Privacy, Security and HITECH policies, procedures, training program, computer system set up, and technical security controls, and who are responsible for the risk management process and procedures outlined below.

• Risk Assessment: (Referred to as Risk Analysis in the HIPAA Security Rule); the process:

  • Identifies the risks to information system security and determines the probability of occurrence and the resulting impact for each threat/vulnerability pair identified given the security controls in place;
  • Prioritizes risks; and
  • Results in recommended possible actions/controls that could reduce or offset the determined risk.

• Risk Management: Within this policy, it refers to two major process components: risk assessment and risk mitigation. This differs from the HIPAA Security Rule, which defines it as a risk mitigation process only. The definition used in this policy is consistent with the one used in documents published by the National Institute of Standards and Technology (NIST).

• Risk Mitigation: Referred to as Risk Management in the HIPAA Security Rule, and is a process that prioritizes, evaluates, and implements security controls that will reduce or offset the risks determined in the risk assessment process to satisfactory levels within an organization given its mission and available resources.

• Security Incident (or just Incident): A security incident is an occurrence that exercises a significant adverse effect on people, process, technology, or data. Security incidents include, but are not limited to:

  • A system or network breach accomplished by an internal or external entity; this breach can be inadvertent or malicious;
  • Unauthorized disclosure;
  • Unauthorized change or destruction of ePHI (i.e. delete dictation, data alterations not following Smylen's procedures);
  • Denial of service not attributable to identifiable physical, environmental, human or technology causes;
  • Disaster or enacted threat to business continuity;
  • Information Security Incident: A violation or imminent threat of violation of information security policies, acceptable use policies, or standard security practices. Examples of information security incidents may include, but are not limited to, the following:
  • Denial of Service: An attack that prevents or impairs the authorized use of networks, systems, or applications by exhausting resources;
  • Malicious Code: A virus, worm, Trojan horse, or other code-based malicious entity that infects a host;
  • Unauthorized Access/System Hijacking: A person gains logical or physical access without permission to a network, system, application, data, or other resource. Hijacking occurs when an attacker takes control of network devices or workstations;
  • Inappropriate Usage: A person violates acceptable computing use policies;
  • Other examples of observable information security incidents may include, but are not limited to:
    • Use of another person's individual password and/or account to login to a system;
    • Failure to protect passwords and/or access codes (e.g., posting passwords on equipment);
    • Installation of unauthorized software;
    • Terminated workforce member accessing applications, systems, or network.

• Threat: The potential for a particular threat-source to successfully exercise a particular vulnerability. Threats are commonly categorized as:

  • Environmental - external fires, HVAC failure/temperature inadequacy, water pipe burst, power failure/fluctuation, etc.
  • Human - hackers, data entry, workforce/ex-workforce members, impersonation, insertion of malicious code, theft, viruses, SPAM, vandalism, etc.
  • Natural - fires, floods, electrical storms, tornados, etc.
  • Technological - server failure, software failure, ancillary equipment failure, etc. and environmental threats, such as power outages, hazardous material spills.
  • Other - explosions, medical emergencies, misuse or resources, etc.

• Threat Source: Any circumstance or event with the potential to cause harm (intentional or unintentional) to an IT system. Common threat sources can be natural, human or environmental which can impact the organization's ability to protect ePHI.

• Threat Action: The method by which an attack might be carried out (e.g., hacking, system intrusion, etc.).

• Unrestricted Area: Those areas of the building(s) where protected health information and/or sensitive organizational information is not stored or is not utilized or is not accessible there on a regular basis.

• Unsecured Protected Health Information: Protected health information (PHI) that is not rendered unusable, unreadable, or indecipherable to unauthorized individuals through the use of technology or methodology specified by the Secretary in the guidance issued under section 13402(h)(2) of Pub. L.111-5 on the HHS website.

  1. Electronic PHI has been encrypted as specified in the HIPAA Security rule by the use of an algorithmic process to transform data into a form in which there is a low probability of assigning meaning without the use of a confidential process or key and such confidential process or key that might enable decryption has not been breached. To avoid a breach of the confidential process or key, these decryption tools should be stored on a device or at a location separate from the data they are used to encrypt or decrypt. The following encryption processes meet this standard.
  2. Valid encryption processes for data at rest (i.e. data that resides in databases, file systems and other structured storage systems) are consistent with NIST Special Publication 800-111, Guide to Storage Encryption Technologies for End User Devices.
  3. Valid encryption processes for data in motion (i.e. data that is moving through a network, including wireless transmission) are those that comply, as appropriate, with NIST Special Publications 800-52, Guidelines for the Selection and Use of Transport Layer Security (TLS) Implementations; 800-77, Guide to IPSec VPNs; or 800-113, Guide to SSL VPNs, and may include others which are Federal Information Processing Standards FIPS 140-2 validated.
  4. The media on which the PHI is stored or recorded has been destroyed in the following ways:
  5. Paper, film, or other hard copy media have been shredded or destroyed such that the PHI cannot be read or otherwise cannot be reconstructed. Redaction is specifically excluded as a means of data destruction.
  6. Electronic media have been cleared, purged, or destroyed consistent with NIST Special Publications 800-88, Guidelines for Media Sanitization, such that the PHI cannot be retrieved.

• Vendors: Persons from other organizations marketing or selling products or services, or providing services to Smylen.

• Vulnerability: A weakness or flaw in an information system that can be accidentally triggered or intentionally exploited by a threat and lead to a compromise in the integrity of that system, i.e., resulting in a security breach or violation of policy.

• Workstation: An electronic computing device, such as a laptop or desktop computer, or any other device that performs similar functions, used to create, receive, maintain, or transmit ePHI. Workstation devices may include, but are not limited to: laptop or desktop computers, personal digital assistants (PDAs), tablet PCs, and other handheld devices. For the purposes of this policy, "workstation" also includes the combination of hardware, operating system, application software, and network connection.

• Workforce: Means employees, volunteers, trainees, and other persons whose conduct, in the performance of work for a covered entity, is under the direct control of such entity, whether or not they are paid by the covered entity.

23. Smylen HIPAA Business Associate Agreement ("BAA")

This HIPAA Business Associate Agreement (this "BAA") defines the rights and responsibilities of Provider and Customer with respect to Protected Health Information ("PHI") as defined in the Health Insurance Portability and Accountability Act of 1996 and the regulations promulgated thereunder, including the HITECH Act and Omnibus Rule, as each may be amended from time to time (collectively, "HIPAA"). This BAA shall be applicable only in the event and to the extent Provider meets, with respect to Customer, the definition of a Business Associate set forth at 45 C.F.R. §160.103, or applicable successor provisions. This BAA shall only be applicable to Customer's Hosting Services or Services to the extent that Customer uses the Hosting Services for Customer's Applications and as specified in the Platform as a Service Agreement of which this Exhibit C is attached and fully referenced and incorporated herein (the "Smylen Agreement"). This BAA is intended to ensure that Business Associate and Customer will establish and implement appropriate safeguards where Business Associate may receive, create, maintain, use or disclose in connection with the functions, activities and services that Business Associate performs on behalf of Customer solely to perform its duties and responsibilities under the Smylen Agreement.

1. Applicability and Definitions. This BAA applies only where:
   1. Customer uses the Hosting Services to store or transmit any PHI as defined in 45 C.F.R. §160.103
   2. Customer has applied the required security configurations, as specified in Section 5.2 of this BAA to Customer's Applications. Customer acknowledges that this BAA does not apply to any other accounts it may have now or in the future. Unless otherwise expressly defined in this BAA, all capitalized terms in this BAA will have the meanings set forth in the Smylen Agreement or in HIPAA.
2. Additional Meanings.
   • "Business Associate" shall mean Provider, or Smylen, Inc.
   • "HITECH ACT" shall mean the Health Information Technology for Economic and Clinical Health Act.
   • "Individual" shall have the same meaning as the term "individual" in 45 CFR § 160.103 and shall include a person who qualifies as a personal representative in accordance with 45 CFR § 164.502(g).
   • "Privacy Rule" shall mean the Standards for Privacy of Individually Identifiable Health Information at 45 CFR part 160 and part 164, subparts A and E.
   • "Protected Health Information" or "PHI" shall have the same meaning as the term "protected health information" in 45 CFR § 160.103, limited to the information received by Business Associate from or on behalf of Customer.
   • "Required By Law" shall have the same meaning as the term "required by law" in 45 CFR § 164.103.
   • "Security Rule" shall mean the Security Standards for the Protection of Electronic Protected Health Information, located at 45 CFR Part 160 and Subparts A and C of Part 164.
3. Permitted and Required Uses and Disclosures.
   1. Service Offerings. Business Associate may use or disclose PHI for or on behalf of Customer as defined in the Smylen Agreement.
   2. Administration and Management of Services. Business Associate may Use and Disclose PHI as necessary for the sole purpose of the proper management and administration of Hosting Services. Any disclosures under this section will be made only if Business Associate obtains reasonable assurances from the recipient of the PHI that (i) the recipient will hold the PHI confidentially and will use or disclose the PHI only as required by law or for the purpose for which it was disclosed to the recipient, and (ii) the recipient will notify Business Associate of any instances of which it is aware in which the confidentiality of the information has been breached.
4. Obligations of Business Associate.
   1. Limit on Uses and Disclosures. Business Associate will use or disclose PHI only as permitted by this BAA or as required by law, provided that any such use or disclosure would not violate HIPAA if done by a Covered Entity, unless permitted for a Business Associate under HIPAA.
   2. Safeguards. Business Associate will use reasonable and appropriate safeguards to prevent Use or Disclosure of PHI other than as provided for by this BAA, consistent with the requirements of Subpart C of 45 C.F.R. Part 164 (with respect to Electronic PHI) as determined by Business Associate and as reflected in the Smylen Agreement, which includes Disk Encryption and Encryption In-Transit services.
   3. Reporting. For all reporting obligations under this BAA, the parties acknowledge that, because Business Associate does not know the details of PHI contained in any of Customer Applications, there will be no obligation on the Business Associate to provide information about the identities of the Individuals who may have been affected, or a description of the type of information that may have been subject to a Security Incident, Impermissible Use or Disclosure, or Breach. Business Associate will ensure Customer access to Audit Logging to help Customer in addressing Customer's obligations for reporting under this BAA. Customer acknowledges Business Associate is under no obligation to provide additional support for Customer's BAA reporting obligations but may choose to provide such additional services at its sole discretion or at Customer expense.
   4. Reporting of Impermissible Uses and Disclosures. Business Associate will report to Customer any Use or Disclosure of PHI not permitted or required by this BAA of which Business Associate becomes aware.
   5. Reporting of Security Incidents. Business Associate will report to Customer on no less than fourteen business (14) days from the date any Security Incidents involving PHI of which Business Associate becomes aware in which there is a successful unauthorized access, use, disclosure, modification, or destruction of information or interference with system operations in an Information System in a manner that risks the confidentiality, integrity, or availability of such information. Notice is hereby deemed provided, and no further notice will be provided, for unsuccessful attempts at such unauthorized access, use, disclosure, modification, or destruction, such as pings and other broadcast attacks on a firewall, denial of service attacks, port scans, unsuccessful login attempts, or interception of encrypted information where the key is not compromised, or any combination of the above.
   6. Reporting of Breaches. Business Associate will report to Customer any Breach of Customer's Unsecured PHI that Business Associate may discover to the extent required by 45 C.F.R. § 164.410. Business Associate will make such report without unreasonable delay, and in no case later than four (4) hours after discovery of such Breach. Business Associate undertakes no obligation to report network security related incidents which occur on its managed network but does not directly involve Customer's use of Hosting Services.
   7. Subcontractors. Business Associate will ensure that any subcontractors that create, receive, maintain, or transmit PHI on behalf of Business Associate agree to restrictions and conditions at least as stringent as those found in this BAA, and agree to implement reasonable and appropriate safeguards to protect PHI.
   8. Access to PHI. Customer acknowledges that Business Associate is not required by this BAA to make disclosures of PHI to Individuals or any person other than Customer, and that Business Associate does not, therefore, expect to maintain documentation of such disclosure as described in 45 CFR § 164.528. In the event that Business Associate does make such disclosure, it shall document the disclosure as would be required for Customer to respond to a request by an Individual for an accounting of disclosures in accordance with 45 CFR §164.504(e)(2)(ii)(G) and §164.528, and shall provide such documentation to Customer promptly on Customer's request. In the event that a request for an accounting is made directly to Business Associate shall, within 5 Business Days, forward such request to Customer.
   9. Accounting of Disclosures. Business Associate will make available to Customer the information required to provide an accounting of Disclosures in accordance with 45 C.F.R. § 164.528 of which Business Associate is aware, if requested by Customer. Because Business Associate cannot readily identify which Individuals are identified or what types of PHI are included in Customer Content, Customer will be solely responsible for identifying which Individuals, if any, may have been included in Customer Content that Provider has disclosed and for providing a brief description of the PHI disclosed.
   10. Internal Records. Provider will make its internal practices, books, and records relating to the Use and Disclosure of PHI available to the Secretary of the U.S. Department of Health and Human Services ("HHS") for purposes of determining Customer compliance with HIPAA. Nothing in this section will waive any applicable privilege or protection, including with respect to trade secrets and confidential commercial information.
5. Customer's Obligations:
   1. Appropriate Use of HIPAA Accounts. Customer is responsible for implementing appropriate privacy and security safeguards in order to protect PHI in compliance with HIPAA and this BAA. Without limitation, Customer shall: (i) not include protected health information (as defined in 45 CFR 160.103) in any Services that are not or cannot be HIPAA compliant, (ii) utilize the highest level of audit logging in connection with its use of all Customer Applications, and (iii) maintain the maximum retention of logs in connection with its use of all Services.
   2. HIPAA Account Appropriate Configurations: Customer is solely responsible for configuring, and will configure, all Customer Applications as follows:
   3. Encryption. Customer shall encrypt all PHI stored or transmitted outside the Services in accordance with the Secretary of HHS's Guidance to Render Unsecured Protected Health Information Unusable, Unreadable, or Indecipherable to Unauthorized Individuals, available at http://www.hhs.gov/ocr/privacy/hipaa/administrative/breachnotificationrule/brguidance.html, as it may be updated from time to time, and as may be made available on any successor or related site designated by HHS.
   4. TLS Termination: All services must be served via TLS. Customer is responsible for providing, maintaining and updating a valid TLS certificate for use with the Service. TLS certificates must be a minimum of 4096 bit key size. Customer agrees to comply with Business Associate's requirements regarding TLS termination.
   5. Necessary Consents. Customer warrants that it has obtained any necessary authorizations, consents, and other permissions that may be required under applicable law prior to placing Customer Content, including without limitation PHI, on the Services.
   6. Restrictions on Disclosures. Customer shall not agree to any restriction requests or place any restrictions in any notice of privacy practices that would cause Business Associate to violate this BAA or any applicable law.
   7. Compliance with HIPAA. Customer shall not request or cause Business Associate to make a Use or Disclosure of PHI in a manner that does not comply with HIPAA or this BAA.
6. Term and Termination
   1. Term. The term of this BAA will commence on the Smylen Agreement Effective Date and will remain in effect until the earlier of the termination of the Smylen Agreement or notification by Customer that an account is no longer subject to this BAA.
   2. Effect of Termination. At termination of this BAA, Business Associate, if feasible, will return or destroy all PHI that Business Associate still maintains, if any. If return or destruction is not feasible, Business Associate will extend the protections of this Agreement to the PHI, limit further uses and disclosures to those purposes that make the return of the PHI infeasible, and make not further use or disclosure of PHI.
   3. If Customer requests contemporaneously with any termination event or notice, Business Associate will allow Customer to have access to Customer's account for a reasonable period of time following termination as necessary for Customer to retrieve or delete any PHI at its then current monthly recurring rate; provided, however, that if the security of Customer's servers has been compromised, or the Agreement was terminated by Customer's failure to use reasonable security precautions, Business Associate may: (i) provide Customer with restricted access via a dedicated or private link or tunnel to Customer account or (ii) refuse to allow Customer to have access to Customer's account but will use reasonable efforts to copy Customer data on to media Customer provides to Business Associate, and will ship the media to Customer at Customer expense. Business Associate's efforts to copy Customer data onto Customer media shall be billable as an Additional Service at Business Associate's then current hourly rates.
7. No Agency Relationship. As set forth in the Agreement, nothing in this BAA is intended to make either party an agent of the other. Nothing in this BAA is intended to confer upon Customer the right or authority to control Business Associate's conduct in the course of Business Associate complying with the Agreement and BAA.
8. Nondisclosure. Customer agrees that the terms of this BAA are not publicly known and constitute Business Associate Confidential Information under the Agreement.
9. Entire Agreement; Conflict. Except as amended by this BAA, the Agreement will remain in full force and effect. This BAA, together with the Agreement as amended by this BAA: (a) is intended by the parties as a final, complete and exclusive expression of the terms of their agreement; and (b) supersedes all prior agreements and understandings (whether oral or written) between the parties with respect to the subject matter hereof. If there is a conflict between the Agreement, this BAA or any other amendment or BAA to the Agreement or this BAA, the document later in time will prevail.
10. Miscellaneous.
    1. Amendment. Customer and Business Associate agrees to take such action as is reasonably necessary to amend this HIPAA BAA from time to time as is necessary for either party to comply with the requirements of the Privacy Rule and related laws and regulations.
    2. Survival. Customer and Business Associate's respective rights and obligations under this HIPAA BAA shall survive the termination of the Agreement.
    3. Interpretation. Any ambiguity in the Smylen Agreement shall be resolved to permit Customer to comply with HIPAA and the Privacy Rule.

SIGNATURE FOLLOWS

24. HIPAA Mappings to Smylen Controls

Below is a list of HIPAA Safeguards and Requirements and the Smylen controls in place to meet those.