Congressional Quarterly reports that the Food and Drug Administration has yet to give final guidance on which of the growing number of mobile health apps it will regulate. Draft guidance indicates “enforcement discretion” will be taken toward consumer-oriented mobile apps, especially ones that are more high risk. The draft guidance also notes that clinical apps could “present a potential risk to patients if they do not work as intended.” Many health industry groups would like to see a wider regulatory framework on IT in place before the FDA issues specific mobile app guidance.
That sounds familiar.
For a more detailed look at this issue – with particular emphasis on the issue of enforcement discretion see, “A Regulatory App-ening.”