How Big a Loophole is “Wellness”?

How Big a Loophole is “Wellness”?

The medical app and regulatory pot is being stirred as products continue to appear, including those with questionable FDA credentials, or lack of credentials.

As discussed in our earlier posts on apps regulation (here and here), an app is a medical device if its meets the congressionally mandated and FDA enforced definition of a medical device as something whose intended use “is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man”.  As stated in the FDA’s Draft Guidance, omitted from this definition, and therefore not medical devices, are apps “that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness.”

Some manufacturers have identified this health and wellness exception as fertile ground for asserting that their product falls within this exception, and therefore is free of FDA before-market scrutiny. In some cases this ground is plowed in the form of an express disclaimer, even though such a disclaimer may not be particularly credible. For example Brad Thompson, in a post for MD&DI cites the example of a urinalysis phone app and hardware system that includes the disclaimer that the device “is intended to be used for health and wellness information purposes and as a demonstration of technology. It is not intended to be used for diagnosis of disease or other conditions, or the cure, mitigation, treatment or prevention of disease and should not be used as a medical device.” In other words, the manufacturer expressly disclaims the very definition of a medical device. (And, no, you do not urinate directly on the phone.)

This disclaimer might be fine if it made sense that you would do self urinalysis just for wellness purposes, and if the company did not also make assertions on its website that appear to be to the contrary, e.g. ”can help you analyse, interpret and trend your urinalysis data to help you understand and manage diseases like diabetes and its, urinary tract infections and pre-eclampsia.” If the device is being used to manage disease it pretty much sounds like a medical device, despite the disclaimer. We, and presumably the FDA,  then have the issue of whether claims can be offset by disclaimers, i.e. is it a balancing act in which the greater weight prevails, or do claims establish intended use regardless of disclaimers.

An interesting thing about an express disclaimer based on the very definition of a medical device is that it demonstrates that the manufacturer was fully aware of FDA requirements and was actively trying to avoid falling within the regulatory framework. This is different from those app developers who remain ignorant of FDA regulation (or so they may claim). Avoidance and or ignorance of FDA regulation is not limited to the app arena. I recently attended a talk by a company that aggregated and moved around medical data over the hospital network and that appeared to me to be in the MDDS space, if not of an even higher classification. When asked about their FDA status (and not even by me), the response was a shrug and general denial that they were covered.

If disclaimers actually are enough to free oneself from engaging with the FDA, there is no reason why their efficacy would be limited to mobile apps. For example we have discussed the disclaimer that a VoIP hospital phone system was not intended for primary communication, and that Clinical Decision Support (CDS) systems might carry a disclaimer to the effect that the advice provided by the CDS should not be relied on. This leads to one form of the ultimate disclaimer: “This product may or may not do what we have claimed it can do. Therefore it should only be used for personal entertainment, or as an adjunct to the use of other devices that can confirm that this device actually works.” Or going one step further: “Do not use this product.”

In this more general regard  I recently had occasion to review a device’s direct-to-patient brochure where it was alleged that the information in the brochure was misleading if not not outright false. Part of the manufacture’s defense of this allegation was the asserted expectation that the patient’s discussion with their physician would offset the lack of being forthcoming in the brochure.  One might characterize this as asserting that it was OK to be misleading in one document if you told the truth elsewhere. i.e. you had to add up (and maybe weight) the misinformation and the correct information across multiple platforms and assess the net weight to determine net truth or falsity.

By the way, medical apps are/were the subject of House hearings on 3/19-21 following a March 1 letter to the FDA by house Republicans asking about both regulation and taxation under the Medical Device Tax. In part the letter asked what I thought the FDA had already answered, e.g. does running a medical app on an off-the-shelf general purpose platform make that platform a medical device? Answer: No. More on these hearings to come.

William Hyman is Professor Emeritus of the Department of Biomedical Engineering at Texas A&M University. He recently retired and has moved to New York City where he continues his professional activities.

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8 comments

  1. William Hyman

    Today’s House hearing on apps is available as a replay.
    http://energycommerce.house.gov/hearing/health-information-technologies-harnessing-wireless-innovation

    Basically everyone agreed that the FDA should finalize the apps guidance, that medical devices needed to be regulated at the appropriate level, and that uncertainty was a bad thing. It was also noted that if uncertainty is a bad thing, then creating new unfounded uncertainties (for political purposes?) is bad as well. The applicability of the Medical Device Tax was also discussed. In summary, those that hate the tax hate it here too. If you don’t hate the tax then you might recognize that the current retail exemption covers most direct to consumer medical apps, and that the platform is not subject to the tax in any case.

  2. William Hyman

    Today’s 2 hour hearing generated a consensus that good apps are good, but bad apps are bad; appropriate regulation is good but inappropriate regulation is bad. the FDA is sometimes too slow; and garage medical app developers (why would you develop an app in the garage?) may develop a game instead if faced with regulation. Part of the hearing also segued into Heath IT and EHRs which is quite a different topic. No one mentioned that when the FDA issues an apps Final Guidance to replace the Draft Guidance, it will still just be a Guidance, i.e. non-binding. Some speakers, including representatives and panelists, continued to invoke hypothetical government actions as fact, including that even if the FDA said they weren’t going to do something, they might do it anyway. On the tax front, there was the strange assertion that an app that was free would become subject to the 2.3% retail price tax, seemingly overlooking that 2.3% of zero is zero.

    http://energycommerce.house.gov/hearing/health-information-technologies-how-innovation-benefits-patients#video

  3. William Hyman

    Day three of the hearings featured Ms. Christy Foreman,
    Director, Office of Device Evaluation, Center for Devices and Radiological Health FDA, and Dr. Farzad Mostashari,National Coordinator,Health Information Technology, DHHS.

    Ms. Foreman reiterated the FDAs position on what they will and will not regulate. This should now be clear, except among those who prefer to sow confusion. She further said that the final guidance will be out…soon.

    Dr. Mostashari, of course, spoke to EHR/Health IT issues, and offered no surprises to anyone actually following what has been going on in that arena.

    The replay is at http://energycommerce.house.gov/hearing/health-information-technologies-administration-perspectives-innovation-and-regulation

  4. Great post! I agree with you that medical apps should be taxed if they are considered by FDA to be medical devices (and there is even a guidance for it).

    Your example about the pamphlet sounds dangerously like fraud.

    Thanks for the great read, Bill.

  5. William Hyman

    The FDA discovered the urinalysis app mentioned in this post and issued a warning letter to the manufacturer that was posted on 5/21/13.
    http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm353513.htm?source=govdelivery

    It basically ignores the issue of urinalysis not being a medical device, and simply states that they apparently do not have clearance.

  6. William Hyman

    MD&DI picked up on another twist in this company’s App vs FDA game.
    http://www.mddionline.com/blog/devicetalk/uchek%E2%80%99s-bizarre-response-fda-letter-unfolding-saga

    UChek completed FDA Registration and Listing, self declaring that their device was Class 1 despite its claims, and then referenced R&L as proof of compliance, not withstanding that R&L is no such thing.

  7. William Hyman

    See update here on release of final mobile app guidance:
    http://medicalconnectivity.com/2013/09/23/fda-issues-final-guidance-on-mobile-medical-apps/
    The final guidance was announced and was available on 9/23/13. The guidance itself is dated 9/25/13.
    There is another interesting overview at the FDALaw Blog:
    http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2013/09/mobile-medical-applications-a-thoughtful-guidance-is-finalized.html
    (I am not related to my namesake at FDALaw Blog’s law firm.)

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