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H&S VIP Roundtable: FDA regulation of digital health tools

VIP This event is for VIPs only.


4:00 pm — 5:00 pm
Wednesday, February 28, 2018

Harvard Innovation Labs - 102

Innovators in the digital health space should be aware of the complex legal and regulatory framework that governs digital technologies today, including FDA regulation of mobile devices and privacy and security requirements.  This session, led by Melissa Bianchi and Jenn Henderson of Hogan Lovells, will provide an overview of FDA and data issues to consider, such as:

  • Recent developments and FDA guidance clarifying the scope of regulation of digital health and software
  • Factors FDA uses to determine which digital health products are subject to active regulation, and which ones are not
  • Digital health products that FDA has recently approved/cleared
  • What data protection laws apply to digital health tools
  • Obtaining appropriate patient consents to collect and use data collected from digital health tools

Melissa and Jenn will provide a brief overview of these topics, and then you’ll have an opportunity to ask your questions.

For a bio on Jennifer Henderson, please see here.


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