Many startup healthcare entrepreneurs have big-time angst about the FDA regulation. Some say, “I am only going to make consumer-facing products.” Or, “I am only going to market in Europe” – forgetting that European countries and the UK have their own versions of regulation. Or, they say they will find other strategies that they think could get them out from under the onus of the dreaded regulations. Of note, although there are somewhere between 50-100,000 mHealth apps, only about 100 have been cleared by the FDA so far.
So, when Nathan Cortez, JD Associate Dean of Research at SMU Dedman School of Law, and his co-authors Glenn Cohen, JD (Harvard Law School) and Aaron Kesselheim, MD, JD, MPH (Harvard Medical School) published their review of the issues in the July 24, 2014 issue of The New England Journal of Medicine, I knew I wanted to interview him on TDWI Radio. Luckily, he agreed – you can listen to the interview here or you can download as a podcast on iTunes:
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?
It was a fun and informative half-hour with a leading expert in his field. Enjoy.
Professor Nathan 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.
Professor Cortez has presented his research around the country to diverse audiences, including to professional societies, at industry conferences, to regulators, and at several law schools, including Harvard, North Carolina, Wisconsin, Texas, and Yale. He also provides frequent legal commentary to the media, including the Associated Press, Chicago Tribune, CNN, the Huffington Post, the Los Angeles Times, NPR, and Slate.com (including his recent essay for Slate, The FDA Needs to Regulate Digital Snake Oil).
Before joining the SMU faculty, Professor Cortez practiced with the Washington D.C. law firm Arnold & Porter, as part of its pharmaceutical, health care, and biotech practice. He represented clients in health care regulatory matters, with a special emphasis on health care fraud and abuse, FDA enforcement, privacy, and the Medicare and Medicaid programs. He represented clients during litigation, in corporate transactions, during agency enforcement actions, and during congressional investigations and hearings. While at Arnold & Porter, Professor Cortez litigated pro bono cases with the Mexican American Legal Defense and Educational Fund (MALDEF), and was a Board Member of the D.C. Hispanic Bar Foundation. In 2006, he was a Visiting Assistant Professor at Rutgers-Camden Law School.
In 2013, Professor Cortez and Glenn Cohen received a grant from the Radcliffe Institute for Advanced Study at Harvard University to host an Exploratory Seminar on Mobile Health.