JAMA Network October 11, 2018
Health care in the United States is the most expensive in the world, yet health care quality is highly variable.1 Health apps have the potential to improve efficiency and value while lowering costs. More than 325 000 health apps have been developed, with increasing investment during the past decade. If health apps are to be successful and broadly adopted, patients and clinicians must have confidence that they are safe and effective.
The US Food and Drug Administration (FDA) recently announced a “precertification” program for mobile apps because the regulatory framework put in place by Congress in 1976 was intended primarily for hardware and is not suited to software, which regulators refer to as “software as a medical device.”2 This new program...
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