What’s the FDA Regulating? – 1/10/12

Last July, the FDA issued draft guidance for mobile medical applications, hoping to solicit comments before finalizing rules. Many groups, including HIMSS, AMIA, and the ATA responded with comments and recommendations. Only time will tell what rules are actually put in place for mobile medical apps.

For now, I’ve been curious what mobile app developers are thinking about regulation and if proactive steps are being taken. Until the rules are official and mobile apps are regulated, getting FDA clearance is more about marketing than safety. Several vendors have proactively earned approval. It always makes for a good PR splash and I’m sure helps, especially with a clinical product.

I reported on the new guidance last July, summing up my thoughts based on the FDA documents. I recently had reason to go back and dig a little deeper into the guidance, as I’m working on IRB (institutional review board) approval for a study of the efficacy and usability of a mobile app for mental health patients.

The app is used by the patient at different intervals — including immediately prior to an appointment — to collect specific subjective information. This information is then used to help the patient with targeted topics to discuss with a PCP, including treatment options. The questions and all the education and treatment options are evidence-based, using well established guidelines. The PCP can see the algorithm used, with references, within the app. No treatments or recommendations are made to the patient, just topics to discuss with their PCP.

I thought we were in the clear in terms of FDA regulation, but the IRB wanted confirmation from the FDA. The initial FDA contact hedged, saying it sounded like it would be a regulated app, but that he couldn’t actually confirm or deny. I’m now waiting to hear back from a supposedly authoritative FDA official.

This is the section of the draft guidance that most closely applies:

Mobile apps that allow the user to input patient-specific information and – using formulae or processing algorithms – output a patient-specific result, diagnosis, or treatment recommendation to be used in clinical practice or to assist in making clinical decisions. Examples include mobile apps that provide a questionnaire for collecting patient-specific lab results and compute the prognosis of a particular condition or disease, perform calculations that result in an index or score, calculate dosage for a specific medication or radiation treatment, or provide recommendations that aid a clinician in making a diagnosis or selecting a specific treatment for a patient.

Interestingly, I think our app is going to be addressed more closely by the FDA’s guidance on clinical decision support systems. We intend to offer the same app on the web, so it will be more of a mental health service and less of a mobile app for mental health.

For now, my opinion is that our tool is low risk, especially considering that it presents evidence-based options of care to the PCP and does not make any specific treatment or even lifestyle recommendations to patients. It also provides transparency into the algorithm and evidence behind the algorithm.

What I’m worried about is that we could get stuck in IRB and won’t be be able to study the app. We’ve already gotten several PCP groups signed on to participate and have the app developed and ready to go. With a little bit of positive data, I think we can approach payers and health systems.

The FDA does not want to be perceived as impeding innovation. In a rapidly changing industry, high risk apps should be targeted and regulated, but small players should not be subjected to unnecessary hoops for low-risk apps. Maybe the specific IRB we’re working with is being overly careful in requiring us to have a statement from the FDA that our app does not need FDA approval. We could always shift things around, as we have a partner at another institution with a different IRB.

I’m curious to get thoughts from readers because I’m a little torn on the whole thing. After recently watching my wife download and test three drug dosing apps on her iPhone, each calculating different does for the same pediatric patient, I’m a believer that FDA regulation is necessary. What do you think?

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

  • chris wasden

    I met with senior leadership of the FDA last week on this topic and was quite impressed by their attitude and approach. They will be providing some guidance in the future that makes things more clear, but in general their view is that they want to only regulate a small subset of the mhealth world. We got on the topic of algorithms and intelligence in apps and they said if all you are doing is making electronic a paper based system or tool that has already been vetted over time, then they don’t need to regulate that. If you are providing fairly low levels of intelligence in the app, that won’t require their review either. They want to be focused on those are of new application and meaningful risk.

    You may recall the recent event with Melofind, where Suren had to step in himself and correct the errant decision of his staff when they didn’t not initially approve an app that was more accurate than physicians.


    So overall, I think that things are moving in the right direction, although I am sure we all want them to move there faster.

    I think the bigger problem is NOT the FDA, but the risk averse nature of the IRBs and their unwillingness to have an opinion or take any risk in areas that are inherently unrisky.

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