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55 Jurimetrics 477 (2014-2015)
Medical Device Regulation in the Information Age: A Mobile Health Perspective

handle is hein.journals/juraba55 and id is 524 raw text is: 0OMET MEDICAL DEVICE REGULATION IN THE INFORMATION AGE: A MOBILE HEALTH PERSPECTIVE Kevin Khachatryan* ABSTRACT: In September 2013, after two years of deliberation, the Food and Drug Administration (FDA) released its Final Guidance-nonbinding recommendations for mobile medical application (MMA) manufacturers. This revised guidance answered questions that plagued the health information technology (IT) industry. The agency explained its jurisdictional intent and limited its own authority to regulating higher risk mobile health apps. However, the guidance did not sufficiently address clinical decision support software or describe a classification mechanism. Instead of clear definitions, the Final Guidance relied on rigid examples. In the same time period and at the bequest of Congress, the FDA released the Food and Drug Administration Safety and Innova- tion Act (FDASIA) Health IT Report in 2014 proposing goals for health IT regulation and a risk-based classification system. Although the report was a step in the right di- rection and painted a picture of agency goals, the FDA's deregulatory tone was worri- some. It left adverse event reporting to an outside private-public agency and described a regulatory universe where the FDA's only jurisdiction would be over high-risk med- ical device IT. The report would leave the regulation of health IT functionality software to the Office of the National Coordinator for Health Information Technology (ONC) and other agencies. This comment proposes a more flexible, FDA-centric, mobile health (mHealth) regulatory pathway that pools the agency's past experience in regu- lating medical devices. I also propose a less cumbersome method of obtaining clear- ances for frequently updated software, a more technology-friendly approval pathway, and an interagency certification model. CITATION: Kevin Khachatryan, Comment, Medical Device Regulation in the Information Age: A Mobile Health Perspective, 55 Jurimetrics J. 477 507 (2015). A concerned parent checks her iPhone at a hospital. She taps open an app that synchronizes her child's treatment plan with the phone, updating her with vital information while she waits for a physician. She then checks a box to see what medications the child is receiving and why. The Phoenix Children's *J.D. Candidate, Sandra Day O'Connor College of Law, Arizona State University; Doctor of Pharmacy, 2013, Midwestern University-Glendale; B.S., 2009, Biochemistry, University of California-Los Angeles. The author would like to acknowledge Professor Gary Marchant, Andrew Sniegowski, alumni advisor, and Susan Russo, J.D., 2015, for their assistance during the writing of this comment. SUMMER 2015

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