With a new president, the Food and Drug Administration may well reconsider whether mobile apps that deliver healthcare information to patients should be regulated. Scott Gottlieb, MD, the new FDA Commissioner, has used software as an example of where a new approach is needed.
In a 2015 article for Forbes, Dr. Gottlieb wrote, “Regulatory pathways should distinguish between digital tools that are trying to function like an existing medical device, versus those that are performing patient-specific analyses and provide patient-specific information based on data that can be accessed already, albeit far less efficiently. For the latter, we can take a page from the setup with EMRs, where the feds certify standards and an independent nonprofit ensures that software platforms meet those requirements.”
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