Inside the ONC’s Plans to Regulate Health AI: Proposal on Predictive Decision Support Interventions

By on June 14, 2023

The Department of Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) published a notice of proposed rulemaking on April 18, 2023, titled “Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing,” or HTI-1.

HTI-1 includes proposals that would create new transparency and risk management expectations for artificial intelligence (AI) and machine learning (ML) technology that aid decision-making in healthcare. Importantly, ONC’s proposal includes requirements for a broad set of technologies based on algorithms or models that could be used by many types of users, for any purpose, irrespective of the technology’s risk profile and regardless of who developed the algorithm or model. If finalized, ONC’s HTI-1 proposal for AI/ML technologies they define as “Predictive Decision Support Interventions” will significantly impact the development, deployment and use of AI/ML tools in healthcare. As of June 14, 2023, comments on the HTI-1 proposed rule are due on June 20, 2023.

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Alya Sulaiman
Alya Sulaiman helps clients navigate complex regulatory, privacy and transactional matters, with a focus on artificial intelligence, machine learning and data strategy in digital health. Alya has substantial experience with product counseling and provides guidance during the conception, development, launch and support of new digital health products and services. She regularly advises organizations on developing artificial intelligence governance and compliance frameworks, including guiding artificial intelligence risk assessments and mitigation plans, vendor oversight and training of key stakeholders.




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