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July 24/31, 2018

FDA Regulation of Mobile Medical Apps

Author Affiliations
  • 1US Food and Drug Administration, Silver Spring, Maryland
JAMA. 2018;320(4):337-338. doi:10.1001/jama.2018.8832

Mobile apps are increasingly used in health care to promote wellness, treat and diagnose disease, aid clinical decision-making, and manage patient care in hospitals and homes.

Historically, health care has been slow to implement disruptive technology tools that have transformed other areas of commerce and daily life. One factor that has been cited is uncertainty surrounding regulation that accompanies medical products, and how US Food and Drug Administration (FDA) regulations may apply to software platforms. There also are questions in the marketplace about the clinical validity and utility of certain mobile tools.

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