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

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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Introducing McDermott’s AI in Healthcare Resource Center

Stay up-to-date and in-the-know on the surge of developments impacting AI in healthcare.

Our global, cross-practice team has curated links to key AI-related resources from legislative and executive bodies, government agencies and industry stakeholders in one easy-access location to help you stay current and engage in the AI conversation. We will continuously update this page as new developments emerge.
You will find:

  • Opportunities for public comment from lawmakers and government agencies to help you shape AI policy
  • Healthcare-specific policy and regulatory initiatives and legislative activity to watch
  • Frameworks, playbooks, whitepapers, blogs and more from key stakeholders
  • Insights and analysis from McDermott’s global healthcare, privacy and health policy leaders

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