Navigating Health Tech: Regulations for AI/ML in Medical Devices and Software

By Benjamin M. Zegarelli, Pat G. Ouellette

Of Counsel Benjamin Zegarelli and Associate 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.

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Benjamin M. Zegarelli

Of Counsel

Benjamin advises pharmaceutical, medical device and biotech companies on the FDA regulatory process to identify the correct regulatory pathway, assisting with FDA communications and strategy.

Pat G. Ouellette

Associate

Pat focuses his practice on advising health care organizations on regulatory, compliance, data privacy, and transactional matters. He is also a Certified Information Privacy Professional–US (CIPP–US).