United States of America: Closed consultation on ONC proposed rule on “Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing”

On 20 June 2023, the Office of the National Coordinator for Health Information Technology (ONC) of the Department of Health and Human Services (HHS) closed its consultation on a proposed rule entitled “Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing”. The proposed rule focuses on advancing interoperability, enhancing transparency, and supporting the access, exchange, and use of electronic health data. In particular, the rule includes provisions implementing the Electronic Health Record Reporting Program, modifying information blocking regulations, revising Certification Program criteria, updating the USCDI baseline version, and adopting new standards for interoperability. The rule also involves collaboration with federal partners to promote greater trust in predictive decision-support interventions used in healthcare, ensuring fairness, appropriateness, validity, effectiveness, and safety, while encouraging market competition and aligning with FDA guidance on clinical decision-support.