FDA Regulation of Mobile Apps

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The Doctor Weighs In

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Nathan Cortez, JD co-wrote an article on FDA regulation of mobile apps published in the July 24, 2014 issue of NEJM. Luckily, we snagged an opportunity to interview him - you can listen here.

We covered a wide variety of topics including:

  • Why regulate mHealth anyway?
  • The new FDA guidance — what needs to be regulated and what does not?
  • How does the FDA handle at continual updates of mobile health products – so different from the pharmaceuticals that they regulate?  How do they decide whether an update constitutes a major change, requiring re-review and one that is minor and does not?
  • What is “substantially equivalence” and how is it being used in mHealth
  • How does the FDA handle mHealth products that provide consumer decision support (CDS)?  What is the difference between low risk and high risk CDS?
  • Does the FDA have the right people/processes in place to provide oversight of mHealth?

Professor Cortez teaches and writes in the areas of health law, administrative law, and FDA law.  His research focuses on emerging markets in health care and biotechnology. Prof. Cortez has become one of the world’s leading legal scholars on medical tourism, patient mobility, and cross-border health insurance, and has published several articles and book chapters on the legal and ethical implications of these phenomena. His research also addresses mobile health technologies, how to regulate innovations that disrupt static regulatory regimes, the First Amendment restraints on FDA regulation (including FDA's graphic tobacco warnings), immigration federalism, and alternative modes of regulation.

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