FDA Registration for Digital Health – AI

Webinar (ET)

Bradley Merrill Thompson, Member of the Firm, will present "FDA Registration for Digital Health – AI," a webinar hosted by the Israel Export Institute and the Economic and Trade Mission at the Embassy of Israel to the United States. 

In response to the coronavirus crisis, the FDA has loosened restrictions on remote patient monitoring devices and clinical decision support software to allow doctors to better combat the pandemic. Will these loosened restrictions remain in place once the crisis is over?

Medical device & digital health companies are also increasingly incorporating AI into their products. It is easy to see why, as AI and offers the potential to revolutionize medicine in areas such as drug discovery and the early detection and prevention of high-burden diseases and chronic conditions such as cancer, diabetes etc.

However, while Israel is a world leader in digital health and the application of AI to medicine, Israeli firms wishing to bring new technology to the US healthcare market must understand FDA regulations. Mr. Thompson is well-versed on the FDA's regulatory structure for digital health, and possesses a particularly deep knowledge regarding the agency's evolving approach to AI. He will address the FDA's response to the coronavirus, as well as his analysis of the agency's current trajectory on AI.

Topics include: 

  • New FDA guidance and policy positions on digital health, in response to the coronavirus pandemic
  • Recent FDA clearances and approvals in the area of digital health and AI
  • The scope of FDA's regulation of clinical decision support that employs AI, and broad changes that the FDA is contemplating in its approach to AI
  • The FDA's approach to regulating AI employed in telemedicine

For more information, visit Export.Gov.Il