We did the hard work so you don’t have to, and you can inherit a lot of the work that we’ve done in terms of audits. Our HIPAA-compliant online forms, and API service simplify compliance for you. In an effort to be transparent, we go into a good amount detail on this page. As a lead in, below is a high level summary of our major architecture, our guiding principles, and how it maximizes our security.
|Encryption||All data is encrypted in transit, end to end, and at rest. Log data is also encrypted to mitigate risk of ePHI stored in log files.|
|Minimum Necessary Access||Access controls are always defaults to no access unless overridden manually.|
|System Access Tracking||All access requests and changes of access, as well as approvals, are tracked and retained.|
|PHI Segmentation||All customer data is segmented. Additionally, all platform customers have a dedicated overlay network (subnet) for additional network segmentation.|
|Monitoring||All network requests, successful and unsuccessful, are logged, along with all system logs. API PHI requests (GET, POST, PUT, DELETE) log the requestor, location, and data changed/viewed. Additionally, alerts are proactively sent based on suspicious activity.|
|Auditing||All log data is unified, enabling secure access to full historical network activity records.|
|Minimum Risk to Architecture||Secure, encrypted access is the only form of public access enabled to servers. All API access must first pass through FormDr Aptible firewalls. To gain full access to FormDr systems, users must login via 2 factor authentication, authenticate to the specific system as a regular user, and upgrade privileges on the systems temporarily as needed.|
|Vulnerability Scanning||All customer and internal networks are scanned regularly for vulnerabilities.|
|Intrusion Detection||All production systems have intrusion detection software running to proactively detect anomalies.|
|Backup||All customer data is backed up every 24 hours. Seven (7) days of rolling backups are retained.|
|Disaster Recovery||FormDr has an audited and regularly tested disaster recovery plan. This plan also applies to customers, and they inherit this from us.|
|Documentation||All documentation (policies and procedures that make up our security and compliance program) is stored using Dropbox and Google Apps.|
|Risk Management||We proactively perform risk assessments to assure changes to our infrastructure do not expose new risks to ePHI. Risk mitigation is done before changes are pushed to production.|
|Workforce Training||Despite not having access to the ePHI of our customers, all FormDr workforce members undergo HIPAA and security training regularly.|
See the details of how we comply with HIPAA below. These are mapped to specific HIPAA rules. There’s a lot here but again, we are taking on this responsibility so that our customers don’t have to. Controls marked with an (Req) are Required. Controls marked with an (A) are Addressable. In our environment, controls outlined below are implemented on all infrastructure that processes, stores, transmits, or can otherwise gain access to ePHI (electronic protected health information).
Taken directly from the wording of the Security Rule, administrative safeguards are administrative actions, and policies and procedures, to manage the selection, development, implementation, and maintenance of security measures to protect electronic protected health information and to manage the conduct of the covered entity’s workforce in relation to the protection of that information. There aren’t specific security settings in this section, and the most important area covered is the risk assessment. The risk assessment is a fundamental process for any organization that wants to become compliant.
|Risk Analysis (Req)||Conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic PHI held by the covered entity.|
|Risk Management (Req)||Implement security measures sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level to comply with Sec. 164.306(a) [Security standards: General rules; (a) General requirements].|
|Sanction Policy (Req)||Apply appropriate sanctions against workforce members who fail to comply with the security policies and procedures of the covered entity.|
|Information System Activity Review (Req)||Implement procedures to regularly review records of information system activity, such as audit logs, access reports, and security incident tracking reports.|
FormDr has a risk management policy that defines the risk analysis and risk management process. This policy is operationalized with processes to conduct regularly risk assessments. FormDr uses the government standard, NIST800-30, for performing risk analysis. Our policy begins with an inventory of all FormDr systems, mapping of where ePHI is processed, transmitted, or stored, identification of threats, risks, and likelihood, and the mitigation of risks. Policies address risk inherent within the environment and mitigating the risk to an acceptable and reasonable level. FormDr has a Sanction Policy that has sanctions for employees not adhering to certain policies, and for specifically violating HIPAA rules. Policies and procedures address the requirements of monitoring and logging system level events and actions taken by individuals within the environment. All requests into and out of the FormDr network are logged, as well as all system events. FormDrhas implemented multiple logging and monitoring solutions to track events within their environment and to monitor for certain types of behavior. Log data is regularly reviewed. Additionally, proactive alerts are enabled and triggered based on certain suspicious activity.
|Assigned Security Responsibility (Req)||Identify the security official who is responsible for the development and implementation of the policies and procedures required by this subpart for the entity.|
FormDr has formally assigned and documented its security officer.
|Authorization and/or Supervision (A)||Implement procedures for the authorization and/or supervision of workforce members who work with electronic protected health information or in locations where it might be accessed.|
|Workforce Clearance Procedure (A)||Implement procedures to determine that the access of a workforce member to electronic protected health information is appropriate.|
|Termination Procedures (A)||Implement procedures for terminating access to electronic protected health information when the employment of a workforce member ends or as required by determinations made as specified in paragraph (a)(3)(ii)(B) [Workforce Clearance Procedures] of this section.|
FormDr has policies in place that require workforce members requesting access to ePHI to submit an authorization form that is signed and acknowledges their responsibility of safeguarding ePHI. The form must also be approved by the Security Officer. Once signed and approved, then the individual will be provisioned access to systems deemed business necessary. All Access to ePHI is based on minimum necessary requirements and least privilege. FormDr cannot access ePHI unless customers explicitly grant access. FormDr policies define the immediate removal of access once an employee has been terminated, with the Security Officer responsible for terminating the access. Once HR initiates the termination process the termination checklist is referenced to ensure necessary actions are taken to remove systems and facilities access.
|Isolating Health care Clearinghouse Function (Req)||If a health care clearinghouse is part of a larger organization, the clearinghouse must implement policies and procedures that protect the electronic protected health information of the clearinghouse from unauthorized access by the larger organization.|
|Access Authorization (A)||Implement policies and procedures for granting access to electronic protected health information, for example, through access to a workstation, transaction, program, process, or other mechanism.|
|Access Establishment and Modification (A)||Implement policies and procedures that, based upon the entity’s access authorization policies, establish, document, review, and modify a user’s right of access to a workstation, transaction, program, or process.|
FormDr does not perform the functions of a Healthcare Clearinghouse, so aspects of this section are not applicable. The Security Officer determines the roles necessary for each system and application. When access is needed to FormDr infrastructure, a request and acknowledgement form is signed and then approved by the Security Officer. FormDr has a formal process for requesting additional access to ePHI, and again FormDr customers must approve all requests concerning ePHI.
|Security Reminders (A)||Periodic security updates to all members of FormDr|
|Protection from Malicious Software (A)||Procedures for guarding against, detecting, and reporting malicious software.|
|Log-in Monitoring (A)||Procedures for monitoring login attempts and reporting discrepancies.|
|Password Management (A)||Procedures for creating, changing, and safeguarding passwords.|
FormDr has a Security Awareness training policy in place that requires new employees and current employees to conduct training upon hire and annually thereafter. Minimum training is done annually, with regular informal security and compliance training done every other week. FormDr proactively assesses and tests for malicious software within their environment, both infrastructure and workstations. Members of the FormDr team monitor bug and vulnerability lists to assure they remain up to date. FormDr is monitoring and logging successful and unsuccessful login attempts to the servers within its environment and policies are in place requiring audit logging, which include login attempts. Password configurations are set to require that passwords are a minimum of 8 characters in length, account lockout after 5 invalid attempts, and an account lockout after 15 minutes of inactivity.
|Response and Reporting (Req)||Identify and respond to suspected or known security incidents; mitigate, to the extent practicable, harmful effects of security incidents that are known to the covered entity; and document security incidents and their outcomes.|
FormDr has implemented a formal incident response plan (IRP), which discusses the procedures for identifying, responding to, and escalating suspected and confirmed security breaches. FormDr has implemented an incident response team for the purposes of dealing with potential security breaches. The IRP has specific types of incidents to look out for, as well as some common types of incidents that are monitored for within the environment.
|Data Backup Plan (Req)||Establish and implement procedures to create and maintain retrievable exact copies of electronic protected health information.|
|Disaster Recovery Plan (Req)||Establish (and implement as needed) procedures to restore any loss of data.|
|Emergency Mode Operation Plan (Req)||Establish (and implement as needed) procedures to enable continuation of critical business processes for protection of the security of electronic PHI while operating in emergency mode.|
|Testing and Revision Procedure (A)||Implement procedures for periodic testing and revision of contingency plans.|
|Applications and Data Criticality Analysis (A)||Assess the relative criticality of specific applications and data in support of other contingency plan components.|
FormDr has a formal Backup and Recovery Policy that defines the data backup strategy, including: schedule, associated responsibilities, and any risk-assessed exclusion to the backup schedule. FormDr has a formal Disaster Recovery plan to ensure the efficient recovery of critical business data and systems in the event of a disaster. The DR plan includes specific technical procedures necessary to reinstate the infrastructure and data to allow critical business functions to continue business operations after a disaster has occurred. Additionally, the FormDr DR plan includes requirements for performing annual testing of the DR plan to ensure its effectiveness. FormDr has a DR plan, or a Business Continuity Plan (BCP), to aid in the efficient recovery of critical business functions after a disaster has been declared. The BCP goes into effect after facility outage of 24 hours. The BCP identifies critical information necessary to resume business operations such as: Hardware/software requirements, recovery time objectives, forms, employee/vendor contact lists, alternate working procedures, emergency access procedures, and a data and application criticality analysis. The BCP includes an Emergency Mode Operations Plan that addresses the access and protection of ePHI while operating in emergency mode. The DR and BPC plans are reviewed and tested annually or whenever significant infrastructure changes occur. FormDr has a performed an applications and data criticality analysis that details what systems and application need be recovered and their specific order in the recovery process.
|Evaluation (Req)||Perform a periodic technical and non-technical evaluation, based initially upon the standards implemented under this rule and subsequently, in response to environmental or operational changes affecting the security of electronic PHI that establishes the extent to which an entity’s security policies and procedures meet the requirements of this subpart.|
FormDr has formal internal policies and procedures for conducting periodic technical and non-technical testing. These define procedures for performing quarterly internal and external vulnerability scanning, as well as annual penetration testing. Vulnerability scanning is performed regularly on a weekly basis and with any major changes in infrastructure. Additionally, non-technical evaluations occur on an annual basis to ensure that the security posture of FormDr is at the defined level, approved by management, and communicated down to FormDr employees.
|Written Contract or Other Arrangement (Req)||A covered entity, in accordance with Â§ 164.306 [Security Standards: General Rules], may permit a business associate to create, receive, maintain, or transmit electronic protected health information on the covered entity’s behalf only if the covered entity obtains satisfactory assurances, in accordance with Â§ 164.314(a) [Business Associate Contracts or Other Arrangements] that the business associate will appropriately safeguard the information. Document the satisfactory assurances required by paragraph (b)(1) [Business Associate Contracts and Other Arrangements] of this section through a written contract or other arrangement with the business associate that meets the applicable requirements of Â§ 164.314(a) [Business Associate Contracts or Other Arrangements].|
FormDr has a formalized template, as well as policies in place regarding Business Associate Agreements (BAA) and written contracts. FormDr has engaged a third-party provider for hosting responsibilities and has written attestations of safeguarding its data. Additionally, FormDr performs due diligence in assuring that third-party providers they select go through their due diligence process and provide services consistent with FormDr’s security and compliance posture.
This one is pretty straight forward – physical measures, policies, and procedures to protect a covered entity’s electronic information systems and related buildings and equipment, from natural and environmental hazards, and unauthorized intrusion. Data center security is typically easier to address than office security, though at FormDr we address both.
|Contingency Operations (A)||Establish (and implement as needed) procedures that allow facility access in support of restoration of lost data under the disaster recovery plan and emergency mode operations plan in the event of an emergency.|
|Facility Security Plan (A)||Implement policies and procedures to safeguard the facility and the equipment therein from unauthorized physical access, tampering, and theft.|
|Access Control and Validation Procedures (A)||Implement procedures to control and validate a person’s access to facilities based on their role or function, including visitor control, and control of access to software programs for testing and revision.|
|Maintenance Records (A)||Implement policies and procedures to document repairs and modifications to the physical components of a facility which are related to security (for example, hardware, walls, doors, and locks).|
FormDr infrastructure supporting its environments is hosted at Aptible which provides hosting and recovery compliant services for the infrastructure. The FormDr headquarters also has written policies and procedures for safeguarding the corporate location, which include workstations with access to the environment protected from unauthorized physical access. The FormDr environment is entirely hosted and built on hardware components provided by Aptible and AWS which FormDr would never have access into.
|Workstation Use (Req)||Implement policies and procedures that specify the proper functions to be performed, the manner in which those functions are to be performed, and the physical attributes of the surroundings of a specific workstation or class of workstation that can access ePHI.|
FormDr has policies in place that define the acceptable uses in place for workstations within the environment. These policies define the acceptable and unauthorized uses of personnel that provide workstations with access to systems potentially interacting with ePHI. These policies are enforced on all workstations. All internal email uses HIPAA-compliant vendors.
|Workstation Security (Req)||Implement physical safeguards for all workstations that access ePHI, to restrict access to authorized users.|
FormDr has a formal Workstation and Portable Media Security Policy that identifies the specific requirements of each device. The policies define the requirements for using and/or restricted specific actions while engaged with any ePHI. Additionally, workstations are secured appropriately to limit exposure to breaches. Actions and events are monitored and controlled, with user restrictions on downloading or copying any ePHI without documented approval and business justification. Additionally, all file storage internally at FormDr utilizes HIPAA-compliant cloud-based vendors (currently AWS S3 and Google Apps).
|Disposal (Req)||Implement policies and procedures to address the final disposition of ePHI, and/or the hardware or electronic media on which it is stored.|
|Media Re-use (Req)||Implement procedures for removal of ePHI from electronic media before the media are made available for re-use.|
|Accountability (A)||Maintain a record of the movements of hardware and electronic media and any person responsible therefore.|
|Data Backup and Storage (A)||Create a retrievable, exact copy of electronic protected health information, when needed, before movement of equipment.|
FormDr has policies and procedures for all workstations that interact with and may potentially become exposed to ePHI. These policies have requirements for secure media disposal so that ePHI cannot be recovered from these systems. FormDr has Media re-use requirements for the workstations, despite the fact that these workstations do not have access to and interaction with ePHI.
This section of HIPAA outlines the technology and the policy and procedures for its use that protect electronic protected health information and control access to it. It is important to note that these requirements are not prescriptive, and there is flexibility in implementation. The key is that measures that are reasonable and appropriate are implemented to safeguard ePHI.
|Unique User Identification (Req)||Assign a unique name and/or number for identifying and tracking user identity.|
|Emergency Access Procedure (Req)||Establish (and implement as needed) procedures for obtaining necessary electronic protected health information during an emergency.|
|Automatic Logoff (A)||Implement electronic procedures that terminate an electronic session after a predetermined time of inactivity.|
|Encryption and Decryption (A)||Implement a method to encrypt and decrypt electronic protected health information.|
All users within the FormDr environment are issued a unique username and password. All accounts are local and unique. General/shared accounts are not in place and root access is restricted and monitored. FormDr has a process for obtaining access to ePHI should an emergency or disaster occur. FormDr systems settings on all of its servers have session timeout features enabled and configured to terminate sessions after 30 minutes. FormDr encrypts all stored data in its environment using 256-bit AES encryption. Additionally, all data in transit is encrypted end to end (more below).
|Audit Controls (Req)||Implement hardware, software, and/or procedural mechanisms that record and examine activity in information systems that contain or use ePHI.|
FormDr has policies in place addressing audit trail requirements. Systems within the its environment are logged to a centralized logging solution, Aptible, which monitors system level events and contains a user ID, timestamp, event, origination, and type of event. These logs are constantly monitored for suspicious events and alerts are generated for any type of behavior that is suspicious.
|Mechanism to Authenticate Electronic Protected (A)||Implement electronic mechanisms to corroborate that electronic protected health information has not been altered or destroyed in an unauthorized manner.|
FormDr has employed a centralized access control system for authenticating and accessing internal systems where ePHI resides. Accounts on the internal database are restricted to a limited number of personnel, with logging in place to track all transactions.
|Person or Entity Authentication (Req)||Implement procedures to verify that a person or entity seeking access to ePHI is the one claimed.|
FormDr has a formal policy that describes the process of verifying a person’s identity before unlocking their account, resetting their password, and/or providing access to ePHI.
|Integrity Controls (A)||Implement security measures to ensure that electronically transmitted ePHI is not improperly modified without detection.|
|Encryption (A)||Implement a mechanism to encrypt ePHI in transit.|
All data in transit with FormDr is sent over internet connections through an TLS1.1/TLS1.2 encrypted mechanism. Load balancers segment the traffic and send transmissions of the data to the application servers via an encrypted connection using the TLS protocol. Additionally, none of the internal application servers, database servers, and log and monitoring servers are accessible via public internet.
These requirements simply outline the need for a business associate agreement (BAA) between covered entities and business associates. This requirement has recently been extended to require a BAA between business associates and all subcontractors. That linking, chaining together of a BAA, has created for new and interesting legal and business questions. Basically, each layer in the chain of BAA takes on certain responsibilities and certain risks as part of HIPAA, and there needs to be consistency. We’ve taken a proactive approach to BAA to mitigate risk for our customers and assure consistency along the chain of BAA.
|Business Associate Contracts (Req)||The Implementation Specifications for the HIPAA Security Rule Organizational Requirements “Business Associate Contracts or Other Arrangements” standard were evaluated under section 164.308(b)(1) above.|
|Other Arrangements (Req)||Rules to engaging with additional 3rd parties, like subcontractors.|
FormDr has a formalized policy and process is in place concerning the BAA. A BAA templates is in place and BAA contracts are reviewed for consistency. FormDr has a formal policy and process in place for performing due diligence with any third party or vendor before engaging them. Additionally, contracts are retained that detail the responsibility of safeguarding any information to which the provider may have access, as well as creating consistency for FormDr and FormDr customers.
|Policies and Procedure s (Req)||Implement reasonable and appropriate policies and procedures to comply with the standards, implementation specifications, or other requirements of this subpart, taking into account those factors specified in Â§ 164.306(b)(2)(i), (ii), (iii), and (iv). This standard is not to be construed to permit or excuse an action that violates any other standard, implementation specification, or other requirements of this subpart.|
FormDr has a formalized Policy Management program that ensures that policies are developed, implemented, and updated according to best practice and organization requirements. In the words of our auditors, this is a policy about our policies.
|Time Limit (Req)||Retain the documentation required by paragraph (b)(1) of this section for 6 years from the date of its creation or the date when it last was in effect, whichever is later.|
|Availability (Req)||Make documentation available to those persons responsible for implementing the procedures to which the documentation pertains.|
|Updates (Req)||Review documentation periodically, and update as needed, in response to environmental or operational changes affecting the security of the electronic protected health information.|
FormDr retains the necessary policies and documentation for a minimum of 6 years. All policies and procedures are available and distributed to personnel on the company’s shared drive (currently Dropbox and Google Apps). FormDr has an update and review process for reviewing all policies and procedures and updating them as necessary. Additionally, FormDr tracks and maintains revision history, approval signature, and timestamps to ensure policies are reviewed and updated according to organization requirements.
These were updates made to strengthen the Privacy, Security, and Breach Notifications rules within HIPAA.
|In General||A covered entity that accesses, maintains, retains, modifies, records, stores, destroys, or otherwise holds, uses, or discloses unsecured protected health information (as defined in subsection (h)(1)) shall, in the case of a breach of such information that is discovered by the covered entity, notify each individual whose unsecured protected health information has been, or is reasonably believed by the covered entity to have been, accessed, acquired, or disclosed as a result of such breach.|
|Notification of Covered Entity by Business Associate||The requirements for the HITECH Act Notification in the Case of Breach – Notification of Covered Entity by Business Associate – Uses and Disclosures: Organizational Requirements “Business Associate Contracts” standard are located in the “BA Requirements” worksheet.|
FormDr has a formal breach notification policy that addresses the requirements of notifying affected individuals and customers of a suspected breach of ePHI. These policies outline the relevant and responsible parties in case of a breach, forensics work to discover extent of breach, reason for breach, correction of infrastructure to prevent any future breach, and requirements for notifying customers of a breach within 24 hours. FormDr is a defined Business Associate or subcontractor according to HIPAA regulations and the specific customer relationship.
|In General||Subject to subsection (g), all notifications required under this section shall be made without unreasonable delay and in no case later than 60 calendar days after the discovery of a breach by the covered entity involved (or business associate involved in the case of a notification required under subsection (b)).|
FormDr has a breach notification policy that addresses the requirements of notifying the affected individuals or customers within 24 hours of a breach.
|Description of Breach||Regardless of the method by which notice is provided to individuals under this section, notice of a breach shall include, to the extent possible, the following: (1) A brief description of what happened, including the date of the breach and the date of the discovery of the breach, if known.|
|Description of EPHI Involved||(2) 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, or disability code).|
|Actions by Individuals||3) The steps individuals should take to protect themselves from potential harm resulting from the breach.|
|Contact Procedures||(5) Contact procedures for individuals to ask questions or learn additional information, which shall include a toll-free telephone number, an e-mail address, Web site, or postal address.|
FormDr has Breach Notification policies in place and they include a brief description of the breach, including the date of the breach and the date of the discovery of the breach, if known. FormDr breach notification policies include 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 personally identifiable information were involved) and what the source of the breach was. Our breach notification policies include steps the individual should take to protect themselves from potential harm resulting from the breach. Our policies also provide the contact procedures for individuals to ask questions or learn additional information, which includes a toll-free telephone number, an e-mail address, website, or postal address.