HB Ad Slot HB Mobile Ad Slot Benjamin M. ZegarelliEmail212-692-6261Bio and Articles Pat G. OuelletteEmail617-348-4759Bio and Articles HB Ad Slot Navigating Health Tech: Regulations for AI/ML in Medical Devices and Software [Video] by: Benjamin M. Zegarelli, Pat G. Ouellette of Mintz - Viewpoints Tuesday, April 16, 2024 Related Practices & Jurisdictions Health Law & Managed CareBiotech, Food, DrugCommunications, Media & InternetAdministrative & Regulatory All Federal Print Mail Download i Facebook Twitter Linkedin Pinterest Reddit Facebook Messenger Email Digg Print Mastodon X Buffer Flipboard Benjamin Zegarelli and Pat Ouellete discussed the health care regulations governing medical devices and software and shared how to stay informed and navigate the evolving landscape of health care regulations. This session explored: FDA’s current approach to regulating AI/ML devices, including recent marketing authorization decisions and enforcement actions Other health care applications of AI/ML and the accompanying regulatory landscape Potential pitfalls and emerging regulations New regulations for EMR developers Proposed non-discrimination requirements in connection with health care provider use of AI by the Office for Civil Rights The recent White House AI Executive Order and the sections relevant to use of AI in health care Recent proposed legislation at the state and federal levels Click here to see the slides from this presentation. ©1994-2024 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved. Facebook Twitter Linkedin Pinterest Reddit Facebook Messenger Email Digg Print Mastodon X Buffer Flipboard HB Ad Slot HB Ad Slot HB Mobile Ad Slot Current Legal Analysis Was Your Confidential Information Leaked from the IRS? by: Timothy L. Jacobs LDT Final Rule Series: Part 1 – Rule Overview by: Scott S. Liebman , Dominick DiSabatino LDT Final Rule Series: Part 2 – Response to the Rule by: Scott S. Liebman , Dominick DiSabatino Senators Advance Three Election-Related AI Bills Out of Committee — AI: The Washington Report by: Bruce D. Sokler , Alexander Hecht SB 1524 Would Permit California Restaurants to Continue to Use Separate Mandatory Fees/Charges by: Alan R. Greenfield , Alice L. Kessler HB Ad Slot HB Mobile Ad Slot More from Mintz Senators Advance Three Election-Related AI Bills Out of Committee — AI: The Washington Report by: Bruce D. Sokler , Alexander Hecht Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program by: Tara E. Dwyer , Samantha Hawkins Eleventh Circuit Rules Corporate Grant Contest for Black Women Is Racially Discriminatory and Violates U.S. Constitution by: Jacob H. Hupart Legal Challenge to New York City's Local Law 97 Reinstated by Appellate Court by: Jacob H. Hupart Another Major European Bank Withdraws from Fossil Fuel Financing by: Jacob H. Hupart Acting U.S. Attorney Levy Forecasts False Claims Act COVID Cases Targeting Private Lenders Of CARES Act Loans That Failed In Their Obligation To Safeguard Government Funds by: Eoin P. Beirne , Jane Haviland Environmental Groups Drop Challenge to SEC Climate Disclosure Rule by: Jacob H. Hupart What’s New in Wireless - June 2024 by: Angela Y. Kung , Christen B'anca Glenn Energy & Sustainability M&A Activity — June 2024 by: Thomas R. Burton, III , Sahir Surmeli A Louisiana Judge May Strike Down Another EPA Clean Water Act Regulation and the Supreme Court Would Likely See it the Same Way. by: Jeffrey R. Porter Upcoming Legal Education Events Oct 9 2024 Government Contracts Annual Update 2024 Jun 26 2024 Navigating the First-in-the-nation Artificial Intelligence Act Jun 26 2024 TSCA Reform — Eight Years Later Jun 18 2024 There Is More to TSCA Reporting Than CDR: TSCA Sections 8(a), (c), (d), and (e) HB Ad Slot HB Mobile Ad Slot Print