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In Washington, a New Wrangle Over Digital Health Rules

Recent moves by the U.S Congress to curtail the Food and Drug Administration’s oversight of medical apps and other digital health products and loosen regulation of the sector is meeting surprising resistance from some entrepreneurs and health startups, who argue that a sound and consistent regulatory regime will be good for the industry.

The FDA has come under fire from some quarters as an impediment to innovation in the sector. The agency curtailed the genetic testing service of the high-profile startup 23 and Me, for example, and Congressional advocates of deregulation say that certain “low risk” technologies like clinical software shouldn’t be subject to an FDA approval process that can be expensive and time-consuming.

A letter sent last month to the FDA by six Senators pushes the agency to clarify how it will regulate the medical app space without hampering innovation. Meanwhile legislation has been introduced in both chambers of Congress to restrict the FDA’s authority over medical software, with one bill proposing that the National Institute of Standards and Technology set some of the rules.

But medical entrepreneurs say that regulatory certainty is the most important thing, and that wrangling between Congress and the FDA will only confuse matters and delay the establishment of clear rules. A much-anticipated FDA report on regulatory strategies for healthcare IT was supposed to be released by the end of March, but has not yet appeared.

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Whether the Congressional efforts to limit the FDA’s authority move ahead could depend on how the agency proceeds from here in further detailing its policies and how they will be implemented. “What really matters is how the FDA puts its guidance into effect," says Morgan Reed.  

This story has been updated with a comment from the FDA.

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“Companies have invested up to a million dollars into developing an app that they believe is worth more than a 99 cent download. FDA approval and an assurance of higher quality is a mark that elevates their products. The implied higher quality is a defining difference between them and the competition.”