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


Date: April 11, 2024

Time: 1:00PM (EST)

Join us for an insightful webinar on health care regulations governing medical devices and software. Don't miss this opportunity to stay informed and navigate the evolving landscape of health care regulations.

In this session we will explore:

  • 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

Keep an eye out for our next session in this AI webinar series—an employment-focused webinar scheduled for May 23rd.

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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 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).