FDA Clarifies mHealth Regulation Plans and Timeline

3-24-2013 10-29-30 PM

Representatives from the FDA appeared before the House Subcommittee on Oversight and Investigations to address concerns that over regulation would have a dampening effect on innovation within the budding mHealth industry.

During the hearing, FDA representative Christy Foreman clarified the administration’s regulatory intentions and associated timelines.

"[The] FDA seeks to strike the right balance by providing a risk-based, focused approach to the oversight of a small subset of mobile medical apps that present a potential risk to patients if they do not work as intended." – Christy L. Foreman, director of the FDA’s Office of Device Evaluation.

The takeaways from the hearing from a regulatory standpoint were as follows:

  • Apps that connect to medical devices, such as CT scanners or glucometers, will be regulated.
  • Apps that attempt to diagnose a condition, such as apps that claim to diagnose skin cancer, will be regulated.
  • Apps that provide access to EHRs will not be regulated.
  • Wellness, fitness, and medical resource apps will not be regulated.

This balanced approach to regulation should provide a general sign of relief for most mHealth entrepreneurs as it leaves most mobile apps unregulated.

In response to criticism that final guidelines have taken too long to publish and that the uncertainty is causing instability in the market, an FDA spokesperson assured Congress that guidance would be finalized in the coming weeks, and guaranteed that they would be published no later than September 30.

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