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 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. HB Ad Slot HB Mobile Ad Slot Current Legal Analysis Viking River Who? Another Cautionary Tale About Arbitration Agreement Drafting by: Jonathan P. Slowik , Michelle L. Lappen Expecting the Unexpected by: Jennifer B. Rubin Cancer Drugs: Strategies For Patenting Antibody-Drug Conjugate Inventions by: Oyvind Dahle Key Second Circuit Decision Defines AKS Willfulness Standard by: Conor O. Duffy , Leslie J. Levinson DOJ’s First Intervention in Cybersecurity FCA Qui Tam Case Signals Continued Cyber Enforcement by: Eleanor M. Ross , Jeffery M. Chiow HB Ad Slot HB Mobile Ad Slot More from Mintz Expecting the Unexpected by: Jennifer B. Rubin Telephone and Texting Compliance News: Regulatory Update — Federal Communications Commission Kicks Off “Spring Cleaning” Initiative by Shutting Down Two Scam-Calling Campaigns by: Russell H. Fox , Jonathan P. Garvin Energy & Sustainability Washington Update — May 2024 by: R. Neal Martin HIPAA Privacy Protections for PHI related to Reproductive Health Care: The Final Rule and what Covered Entities and Business Associates need to Know by: Cassandra L. Paolillo DOL Releases Final Rule Substantially Increasing Minimum Salary Thresholds for Most Exempt Employees by: H. Andrew Matzkin , Evan M. Piercey Federal Circuit Affirms Obviousness of Rifaximin Polymorph Patents and Denial of Motion to Modify Judgment After Post-Trial Patented Indication Carve Out by: Joseph D. Rutkowski , Peter J. Cuomo In Split Vote, FTC Approves Controversial Final Rule Banning Most Post-Employment Non-Competes; Rule Already Subject to Challenge in Court by: Talia R. Weseley , Danielle M. Bereznay EU Imposes ESG Compliance Requirements for Companies' Supply Chains by: Jacob H. Hupart DOJ’s Criminal Division Announces Pilot Program on Voluntary Self-Disclosure for Individuals by: Eoin P. Beirne , Nick A. LaPalme CMS Publishes Final Rules Implementing Part C and Part D Program Changes by: Tara E. Dwyer , Bridgette A. Keller Upcoming Legal Education Events Jun 4 2024 FinTech and Securities Trading Platforms May 22 2024 California Labor and Employment Laws: Essential Insights | Union Rules For Non-Union Workforces May 17 2024 Upon Further Review: A Look Back at the Last Year in the Third, Fourth, and D.C. Circuits May 15 2024 Capital Connect: Finance & Funding in Life Sciences HB Ad Slot HB Mobile Ad Slot Print