HHS finalizes AI transparency rule
By Hayley Desilva / December 13, 2023
The Health and Human Services Department finalized a rule on Wednesday that sets transparency standards for the development of artificial intelligence in health IT software.
In a release, HHS' Office of the National Coordinator for Health Information Technology said the "Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing" rule sets technical transparency and risk-management requirements for some healthcare software systems that use AI and other predictive algorithms.
Developers that want to certify their AI-enabled health IT products through ONC are required to describe how their algorithm was designed, developed and trained. They also must inform ONC whether patient demographic, social determinants of health or other equity-related data was used in training the AI model.
Developers must provide information for clinical users about how to assess them for fairness, appropriateness, validity, effectiveness and safety, ONC said in the release.
"One of the thing the rule does is it creates transparency, first and foremost, because I think we have to start with transparency," said Micky Tripathi, national coordinator for health IT, at a hearing held by the House Committee on Energy and Commerce on Wednesday.
The proposed rule, released in April, had originally included a wider scope of companies that would be affected by the standards, including third-party digital health companies that interface AI and machine learning applications with electronic health record systems. But the final rule limits the standards to the just the EHR developers themselves. In public letters to ONC sent in June, EHR vendors Epic and Oracle Health said the proposed rules could place them and other EHR companies in a role that may oversee third-party developers of predictive AI models
ONC also updated its interoperability standards for its certification program, which is set go into effect by Jan. 1, 2026. The latest standards have more accurate patient characteristics data related to health equity, disparities and public health interoperability, ONC said in the release.
The rule also revises certain information blocking definitions and exceptions to support information sharing and adhere to other practices of electronic healthcare information outlined under the Trusted Exchange Framework and Common Agreement. On Tuesday, ONC said that TEFCA was operational with Epic and other organizations leading the way in creating a "network of networks."
The rule be submitted to the Office of the Federal Register in the coming days, ONC said.