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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  • Smart Doc

    I can think of no better way to destroy the nascent medical apps industry than to have corrupt federal political hacks and third rate bureaucrats hyper-regulating.

  • Rajesh

    The very premise of improvement in health is based on innovation in apps that contribute to improve the efficiency and knowledge of medical professionals and good health of consuners.

    I do not think FDA should regulate mobile apps in development. Instead FDA should keep a tab on popular apps related to health and based on the user feedback should take call on whether to allow an app to be in use.

  • doc99

    “Should the FDA regulate medical apps?”


  • Rob Fahrni

    I agree with Smart Doc. Let the market decide. Medical professionals should drive the marketplace for software, not federal regulators. It would only serve to kill off the little guys and open the doors to corruption.

  • IVF-MD

    Emphatically, no!

    We should REDUCE the harm done by bureaucracy, not increase it.

    Can you imagine if the FTC would have taken over the internet before all these free-market sites and innovations were created? We’d be back in the days of dialup and Compuserve.

  • Marc Gorayeb, MD

    Regulate medical apps? What’s a medical app? A pill or device that a patient puts into their body?
    Logical extension: regulate my computer, my pocket medical treatment guide, my Harrison’s Principles of Internal Medicine, the medical journals I read, the food I eat, the clothes I wear, the thoughts that come into my head.

  • Margalit Gur-Arie

    “Regulate medical apps? What’s a medical app? A pill or device that a patient puts into their body?”

    Good question and it does not have a clear cut answer.
    There are medical apps that are just apps that allow you to collect information and communicate (patient to physician, physician to physician, etc.). Those need no more regulation than their paper-phone-fax counterparts.

    However, there are, and soon there will be more, “apps” that diagnose and provide therapy. For example, an app that monitors pain and adjusts meds accordingly, on its own. Should such app have freedom to do whatever, or should it operate within “safe” parameters? Who decides and how is it enforced? Should there be a mechanism to validate that the “app” works as designed and does not malfunction frequently and causes adverse events, or just caveat emptor?

    At what point does an “app” become a “device”? Or is there such point? Even if you don’t put the “app” in your body, what happens when the “app” instructs you to put something in your body?

    I somehow don’t think there is one answer for all “apps”.

  • imdoc

    I am struggling with how, exactly, the regulators are going to keep it from happening. If someone in a foreign country which doesn’t respect our laws uploads something which does these things, what is to prevent someone in the U.S. from getting it and even paying? I can imagine telemedicine occurring from outside the country. What is the mechanism of enforcement?

    • Margalit Gur-Arie

      They can’t probably stop you from paying for a telemedicine consult from outside the country any more than they can prevent you from hopping on a plane and seeing a doctor in another country, but they can decide not to reimburse for such consult under any U.S. regulated insurance plan, and they can decide not to dispense any prescriptions originated from outside the U.S.. They can even regulate what “apps” a U.S. licensed physician can connect to their own EHR which will severely reduce the ability of non-regulated “apps” to operate. If they get around to “certifying” PHRs, they can impose the same limitations on personal records. That would pretty much limit the non-regulated app market to lifestyle applications, unless I’m missing something.

  • Drashish

    Absolutely not. We do not let the FDA even regulate supplements. What’s would happen if Harrisons Intenal Medicine need FDa approval in order to be published. Come on Americans, get real and stop asking the government to protect you craddle to grave. And lawyers, resist the temptation to create A new malpractice niche.

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