Thompson said that industry groups have been calling for years for the FDA to define how it plans to regulate a category of software called clinical decision support. This broadly refers to tools to help doctors with diagnoses and treatment decisions.
In addition to health IT start-ups, many of the largest technology companies are entering this area with machine learning applications to detect signs of disease from mounds of medical data and images. IBM has made a huge bet on its Watson technology for hospitals, while Alphabet could bring its DeepMind technology to the U.S.
The FDA first announced plans to publish a guidance document in 2011. The 21st Century Cures Act said that software, if intended to help maintain a healthy lifestyle, is generally outside the scope of regulation. Gottlieb promised that the FDA will provide more specific guidelines.
Gottlieb also said the FDA is looking at supporting developers of lower risk digital health products in order to “reduce the time and cost of market entry.”
If the agency gets it right, start-ups will really benefit, said Thompson.
“We have been waiting for this for a long, long time,” he said.
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