Application access – patient selection

Clarifications:

• While no standard is required for this criterion, we intend to adopt a standards-based approach for certification in a future rulemaking. We encourage the use of the Fast Healthcare Interoperability Resources (FHIR®) specification.
• Security:
  • For the purposes of certification there is no conformance requirement related to the registration of third party applications that use the APIs. If a Health IT Module requires registration as a pre-condition for accessing the APIs, then, the process must be clearly specified in the API documentation as required by the criterion. ONC strongly believes that registration should not be used as a means to block information sharing via APIs. [see also 80 FR 62676]
  • This criterion does not currently include any security requirements beyond the privacy and security approach detailed above, but we encourage organizations to follow security best practices and implement security controls, such as penetration testing, encryption, audits, and monitoring as appropriate. ONC expects health IT developers to include information on how to securely use their APIs in the public documentation required by the certification criteria and follow industry best practices. [see also 80 FR 62676]
  • ONC strongly encourages developers to build security into their APIs following industry best practices. [see also 80 FR 62677]
  • A “trusted connection” means the link is encrypted/integrity protected according to § 170.210(a)(2) or (c)(2). As such, ONC does not believe it is necessary to specifically name HTTPS and/or SSL/TLS as this standard already covers encryption and integrity protection for data in motion. [see also 80 FR 6267]
  • APIs could be used when consent or authorization by an individual is required. In circumstances where there is a requirement to document a patient’s request or particular preferences, APIs can enable compliance with documentation requirements. The HIPAA Privacy Rule (45 CFR Part 160 and Part 164, Subparts A and E) permits the use of electronic documents to qualify as writings for the purpose of proving signature (e.g., electronic signatures). [see also 80 FR 62677]
• By requiring that documentation and terms of use be open and transparent to the public by requiring a hyperlink to such documentation to be published with the product on the ONC Certified Health IT Product List (CHPL), ONC hopes to encourage an open ecosystem of diverse and innovative applications that can successfully and easily interact with different Health IT Modules’ APIs. [see also 80 FR 62679]
• A health IT developer must demonstrate that its API functionality properly performs consistent with this certification criterion’s requirements. How this is done is up to the health IT developer. Doing so could include, but is not limited to, the health IT developer using existing tools or creating its own app or “client” to interact with the API as well as using a third-party application.
• Health IT developers are able to update/upgrade/improve functionality that’s within the scope of certification, provided that certain rules and conditions are followed. The “API criteria” § 170.315(g)(7), § 170.315(g)(9), and § 170.315(g)(10) are treated no different under this regulatory structure. If a developer seeks to update their API functionality post-certification a developer will need to consider the following:
  • If their ONC-ACB requires notification or updated documentation associated with the functionality they changed. This procedure is at the discretion of the ONC-ACB and may result in an additional CHPL listing.
  • Pursuant to the certification criteria, there is a documentation portion in each, which would include (publicly available) technical specifications, configuration requirements, and terms of use. Insofar as a developer updates their API post-certification, they are expected to keep all of this documentation up-to-date. Similarly, ONC-ACBs are expected to oversee/enforce/surveil that this action is taken and could find a non-conformity if those updates are not made.
  • If any of their changes would require updates to the developer’s 170.523(k)(1) disclosures (the broader product transparency disclosures).

Technical outcome – The health IT can receive a request with sufficient information to uniquely identify a patient and return an ID or other token that can be used by an application to subsequently execute requests for that patient’s data.

Clarifications:

• The developer can determine the method and the amount of data by which the health IT uniquely identifies a patient. [see also 80 FR 62678]
• The term “token” is not to be interpreted as the token in the OAuth2 workflow, but simply as an identifier for something that would uniquely identify a patient.

Technical outcome – The API must include accompanying documentation, which contains API syntax, function names, required and optional parameters and their data types, return variables and their types/structures, exceptions, and exception handling methods and their returns.

Clarifications:

• No additional clarifications.

Technical outcome – The API must include accompanying documentation, which contains software components and configurations that would be necessary for an application to implement in order to be able to successfully interact with the API and process its response(s).

Clarifications:

• No additional clarifications.

Technical outcome – The documentation used to meet the provisions in (g)(7)(ii)(A)(1)-(3) must be available through a publicly accessible hyperlink.

Clarifications:

• The hyperlink provided for all of the documentation referenced by provision (g)(7)(ii)(A) must reflect the most current version of the Health IT developer’s documentation.
• All of the documentation referenced by provision (g)(7)(ii)(A) must be accessible to the public via a hyperlink without additional access requirements, including, without limitation, any form of registration, account creation, “click-through” agreements, or requirement to provide contact details or other information prior to accessing the documentation.