In September 2013, the FDA published the final guidance on mHealth regulation. They classified the range of mobile apps into 3 categories. At one end are apps that essentially look and act like traditional medical devices. These will be actively regulated by the FDA and require pre-market clearance. At the other end are apps that could be considered non-medical use and will not be regulated. However, the vast majority of interesting mHealth apps fall somewhere in between. This category will be subject to “enforcement discretion”. In other words, the FDA will probably not actively regulate this kind of app, but it reserves the right to do so. An interesting consideration for this category is how to provide the maximum patient benefit without getting on the FDA’s radar. Alternately, there might be some benefits in embracing regulation for strategic reasons. This panel will discuss the issues with navigating the regulatory landscape in this space.
Moderator: Geetha Rao, PhD
Geetha Rao, CEO of Springborne Life Sciences is an experienced entrepreneur, executive, and strategic advisor at Health Tech Forum (HTF) as well as others. Currently, she also serves as Vice President of Corporate Development at Triple Ring Technologies, an innovator in medical, aerospace, and security technologies, as well as several start-up and non-profit advisory boards. Previously, she was Chief Corporate Development Officer at Molecular Image, Inc., a personalized medicine diagnostic company and President and CEO of Norgren Systems, a biotechnology/drug discovery automation company. Dr. Rao is active with several entrepreneur-support organizations, including Astia (formerly Women’s Technology Cluster), MIT/Stanford Venture Lab. Previously she has been guest faculty on Stanford University’s Biodesign Innovation Program and on the Advisory Committee for UCSC Extension’s Medical Device Certificate Program. Dr. Rao is a graduate of the Indian Institute of Technology, Madras, holds a doctorate from Massachusetts Institute of Technology, and a master’s degree from Stanford University’s Graduate School of Business, where she was a Sloan Fellow.
Gerry Hinkley, JD
Gerry is a partner with the Pillsbury law firm in San Francisco and Chair of the firm’s Health Care Industry Team and a strategic advisor at Health Tech Forum (HTF).
Gerry is also chair of the HIMSS Legal Task Force and a member of the Leadership Council of the eHealthInitiative. Gerry’s practice is focused on health care services and patient privacy compliance and enforcement as well as entrepreneurial startups in the health care space. Gerry is a frequent speaker at Health 2.0 and HIMSS programs.
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