Welcome to the July edition of Akin Intelligence. In this month’s AI news, the U.S. Senate receives member-only briefings on AI, U.S. states continue to debate and legislate on AI issues, the U.S. prepares new AI-related...more
Welcome back to Akin Intelligence!
May featured major congressional hearings and state action in the United States, calls from industry and lawmakers for artificial intelligence (AI) regulation, and significant...more
On April 18, 2023, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) published a far-reaching proposed rule, Health Data, Technology, and...more
Multiple policy documents relating to software and digital health have been issued by the U.S. Food and Drug Administration (FDA). The documents offer: a framework for the use of digital health tools in the context of drug...more
Issued by the White House Office of Science and Technology Policy (OSTP) on October 4, 2022, the “Blueprint for an AI Bill of Rights” is the Biden-Harris administration’s seminal work on its vision for the future of...more
FDA Also Issues Report on Software Pre-Cert Pilot, Leaving Unanswered Questions on Future of Software Regulation -
Key Points -
The Final Guidance does not address the FDA’s risk-based enforcement discretion policy...more
Key Points
- FDA will publish draft guidance on its Predetermined Change Control Plan in 2021 and host a public workshop on transparency requirements around AI/ML-based devices.
- FDA plans to pilot Real-World Performance...more
Medical device and diagnostics companies and laboratories should anticipate significant legal, regulatory and market changes in 2020 that will have a lasting impact on the industry. From revisions to how the government...more
1/8/2020
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• FDA has released a white paper outlining a potential regulatory framework for software as a medical device (SaMD) that leverages artificial intelligence (AI) or machine learning (ML).
• The white paper distinguishes three...more