FDA + Mobile Health Post = Ambiguity

Do you ever get the sense that this whole “FDA regulating mobile health” is a bit of a circus? I’ve spent time trying to read up on what happened last week at the FDA meetings in Washington and I’m still confused about the whole thing. I understand it became — or maybe it always was — a political debate pitting those that supposedly support business and innovation against those that supposedly support safety, using regulation as the vehicle.

As an aside, I recently got into a debate with friends about mobile devices and apps for young child education. The parallels to healthcare were eerie. Both healthcare and education have lots of technology money, products, and policies being thrown at them by people that don’t really understand the problems because they aren’t clinicians, teachers, patients, caregivers, parents, or students (actually, it seems hard not be any of those roles.)

I don’t think innovation has to come from within the industry, but some understanding of the key stakeholders is required. In healthcare, having a deep understanding of patients and their social structure and motivations is required if we’re going to enable patients to lead us.

Back to mobile health regulation and the FDA. I’m really confused about why this is taking so long. Either regulate or don’t regulate. Make rules and let’s start interpreting them. Or was the draft FDA guidance meant to generate discussion and ultimately a decision on whether to really regulate or not? See, I’m confused.

I wrote a while back after the initial draft guidance about regulating mobile health apps and devices. I believe now, as I did then, that certain apps and devices should be regulated.

  • Devices that integrate with mobile apps to measure biometric data (mobile health accessories). Good examples of devices in this category are connected glucometers like Glooko and iBGStar, pulse oximeters, and blood pressure cuffs. But even this gets a bit blurry to me when I start thinking about wireless scales. If scales are going to really be used in health and remote monitoring — and the use case I’m thinking of is a heart failure patient discharged from the hospital with a wireless scale (Withings or Fitbit let’s say) — then those scales need to be FDA cleared. The reason is that changes in weight would be a part of identifying and targeting interventions to avoid a readmission or an acute decompensation (I’m not sure you can use "decompensation" in place of "decompensated," but I am anyway).
  • Clinical decision support apps for providers. I did some reading and remember something to the effect of having a learned intermediary (clinician) between the app and the actual decision — dosing a med, for example — means that FDA clearance is not necessarily required. I’m not really sure if this was ever the case, or if it is still the case today. The app also needs to provide the intermediary with access to the algorithm that reached the decision. If this really is the case, I think this is ludicrous. Anything that advises a clinician about a treatment for a specific patient needs should be regulated. Doctors are some of the most learned intermediaries out there but 1) they can’t keep up with all the science, and 2) they don’t have the time to review and assess app algorithms for accuracy. They will catch ludicrous suggestions, but hopefully so will other systems like pharmacies and dispensing machines. This is a category that definitely might be stifled by innovation, but I’m not sure how you can avoid regulating in this area. It’s easy to create simple apps that help providers with calculations, like certain risk assessment or treatment apps, but there really needs to be some way to verify the accuracy of the apps themselves. Who else is going to take on the liability of "approving" these apps?
  • Clinical decision support for consumers. This is gray because wellness and disease care are gray. Apps that take an image of a skin lesion and tell whether it is cancerous should be regulated, but this is the obvious one. Legally, is it permissible for an app developer to say "for entertainment purposes only" and get around regulation? I think this area is going to be the hardest category of apps to regulate. I’m not sure we’re any closer today than we were two years ago to understanding what apps need to go through the FDA and which do not. I’m also not sure more Congressional meetings are going to help us along.

One other thing about all of this that really baffles me. Speaking specifically about mobile apps and software, I’m not sure why there is a distinction between mobile and everything else, especially as it all converges, both in terms of hardware (big phones and small tablets) and software (responsive web, hybrid apps). What about health accessories that connected desktop computers for data display?

I’m curious what you would do if you were an app developer creating apps for healthcare. If you were new, low on cash, and needing to get to market as fast as possible, would you err on the side of caution and go through the FDA or would you go to market and wait for final rules to decide? Or follow both paths concurrently, which is what I’d do at this point I think? The problem is that even the final rules are going to leave a good amount to interpretation, something that will make for a nice environment for consulting and legal gigs.

Travis Good is an MD/MBA involved with health IT startups. More about me.

  • I wonder if a better way to clarify this is to consider if there are good analogies to what is approved now? For example, OTC blood pressure machines and glucometers get FDA approval (although scales do not- even though CHF patients certainly will use them to judge their weight)… so does making them mobile change things?

    And how about text books or websites which provide algorhithms that docs may use- did the FDA ever regulate Harrison’s Textbook of Medicine? Or did they ever regulate an order set that a doctor used on paper, or the word document program that created it, or the printer which printed it? So should they now start truly regulating a software system which automates the process? It seems that if we go down that slippery slope, then any EMR system will need full FDA regulation – between orders, CDS, documentation, etc… which will slow things down considerably.

    And I am torn on this – on one hand, I could see the argument about having firmer regulations around clinical IT systems… on the other hand, it would create immense bureaucracy and red tape and expense that it would stifle things quickly. Perhaps a compromise (which already exists in some part) is to make sure that there is reporting to a standardized body when known errors or problems are found… and that there is documentation they are fixed…. this ongoing conversation will be interesting – hope you stay on top of it!

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