Lexology April 14, 2023
On April 11, the U.S. Department of Health & Human Services (HHS) Office of the National Coordinator (ONC) posted a proposed rule entitled, “Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing.” The Notice of Proposed Rulemaking (NPRM) includes proposals to “promote greater trust in the predictive decision support interventions (DSIs) used in healthcare to…enable users to determine whether predictive DSI is fair, appropriate, valid, effective, and safe, and enable market competition and align with the U.S. Food & Drug Administration (FDA)’s recent guidance on clinical decision support (CDS).” HHS ONC also released a blog post and press release on the NPRM, and comments are due 60 days after the rule’s Federal Register publication on April...
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