Mobile Health Technologies Face a Changing Regulatory and Patent Landscape

Electronic health and mobile health technologies represent important and rapidly growing segments of the medical device industry, with pointof-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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