Mobile Health Technologies Face a Changing Regulatory and Patent Landscape

Vol. 10 No. 3

By

David J. Dykeman is the founding co-chair of the ABA Medical Devices Committee and co-chair of the Global Life Sciences & Medical Technology Group of international law firm Greenberg Traurig LLP. A registered patent attorney with more than 17 years of experience in patents, intellectual property, and licensing, David’s practice focuses on securing strategic worldwide intellectual property protection and related business strategy for high-tech clients, with particular expertise in medical devices, life sciences, biotechnology, and health care IT. David can be reached at 617-310-6009 or dykemand@gtlaw.com. Nancy E. Taylor is co-chair of Greenberg Traurig’s Health and FDA Business Practice. As an attorney she has advised clients on health care matters for more than two decades. Prior to joining Greenberg Traurig, Nancy served 10 years as Health Policy Director for the Senate Committee on Labor and Human Resources. She also served as CEO of a start-up medical device company, where she obtained eight product clearances, including securing reimbursement coverage for each product. Nancy can be reached at 202-331-3133 or taylorn@gtlaw.com. Jessica A. von Reyn is the editor of the weekly hot topic email newsletter of the ABA Medical Devices Committee. Jessica researches health care policy and reform at Northeastern University and is a recent graduate of the University of Wisconsin Law School. Jessica can be reached at javonreyn@gmail.com.

Electronic health and mobile health technologies represent important and rapidly growing segments of the medical device industry, with point-of-care diagnostics and personalized mobile applications becoming increasingly more common in clinical settings. As the technologies expand, the challenge of navigating the US Food and Drug Administration (FDA) regulatory environment becomes a necessary task for mobile health innovators looking to break into the market. Mobile medical technologies that perform functions such as diagnosing medical conditions, prescribing drugs, or ordering laboratory tests fall within the FDA regulatory framework and require FDA clearance prior to marketing. Developers of mobile health products must also establish a competitive edge with a strategic patent portfolio that protects core technology while exploring new patent areas and securing worldwide patent protection. Mobile health technology innovations will revolutionize the health care system, but companies hoping to capitalize on this boom must carefully navigate the changing regulatory and patent landscape.

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