Should the FDA regulate medical apps?

by Chad Hyett

There’s a storm brewing around the regulation of medical apps. The FDA has been skirting the issue for too long and it’s having detrimental effects on the potential for such apps. Recent FDA hearings have revealed that the agency is watching the apps stores for potential alarms and that they are drafting guidance. Whatever that means.

The FDA needs to make a decision quickly if they are to regulate medical apps. There’s three ways they can go (and many more I suppose but these are the main ones):

  • To get approval, manufacturers would be responsible for reporting any problems to the FDA and correcting safety issues. There’d be some differences in the level of monitoring based on the potential risk of the app, for sure.
  • Apps would need to adhere to some standard FDA guidelines on quality, safety and consistency.
  • The apps would need premarket safety and efficacy data for approval. This is the harshest (and longest… and most expensive) route.

Or this whole thing could unfold like the dietary supplement industry where it’s up to the FDA to prove that an app is unsafe or ineffective.

I truly believe in this industry’s potential to improve health and save money, so I think there should be some standard guidance to keep apps that don’t have real potential off the market (or marginalized). If the FDA is to get involved, it has to be in cooperation with industry. There’s got to be a balance between the FDA making regulations as to what an effective app should contain and manufacturers proving the value of their apps.

Both sides need to move quickly and here’s why: Reimbursement is hindering the adoption of mobile health. This is a well-documented problem – just check out PricewaterhouseCooper’s latest report on mobile health.

If the FDA were to provide regulation, this could help with reimbursement. By providing clear guidance on what a good health app is, and more importantly what it’s not, the agency would also be providing some direction on what insurers should reimburse – because those are the apps that have potential to improve health and reduce costs.

However, since reimbursement is the real underlying issue, I think it probably makes sense to move in a third direction just as the EHR world has found itself in with meaningful use. CMS could provide some very clear guidance on the criteria that apps need to meet in order to get reimbursed by Medicare/Medicaid. There should even be tiers of reimbursement. Hopefully private insurers would follow suit. If an app becomes qualified as reimbursable, then physicians would likely adopt it. There’s even evidence that suggests physicians will embrace new technology if it’s reimbursable, even though there may be no solid evidence that it improves outcomes.

Regardless, the FDA should make a decision about what they are going to do with apps quickly. I say let CMS define what they will reimburse; it’s working for EHRs and the FDA has enough to worry about.

Chad Hyett is member of the Board, Zibbel, Inc., and blogs at Mobile Health 360.

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