How the FDA can improve regulation of mobile health, according to FDASIA workgroup

By MHN Staff

Brad2By Bradley Merrill Thompson

This seems like an appropriate time to talk about what can be done to improve FDA regulation so that mobile app development can flourish. First I’ll tackle current events that make this a good time to have this discussion, and then I’ll get into the recommendations that the so-called “FDASIA working group” made with regard to how to improve FDA regulation.

Current Events Concerning FDA Regulation of mobile health

From what I hear, last week at the HIMSS 2014 meeting in Orlando, Florida there was considerable discussion about the PROTECT Act, legislation recently introduced in the Senate that would remove much of HIT, including many mobile apps, from FDA regulation.

I’m also hearing many people asking questions about the anticipated report HHS will send to Congress as required by section 618 of FDASIA. This required report will outline what the FDA, in consultation with ONC and FCC, would propose as a strategy for addressing HIT, and specifically mobile health. Congress requested the report to get input on how to balance our need for innovation with our need to protect patient safety. At HIMSS, agency speakers explained that the goal is now to get the report out by the end of March. Unfortunately, I have no idea what it will say. At the meeting this week, FDA and ONC officials gave only a few hints, for example suggesting that they were looking more deeply into clinical decision support software.

Further making this topic timely, this week new data were released on the views doctors hold toward mobile apps. A Quantia poll of 250 doctors found that 42 percent won't prescribe apps because of the lack of regulatory oversight. On one level, the debate around the PROTECT Act is about the patient, and our core value of doing what's best for the patient. But on another level, it is also about the industry, and about what is needed for the mHealth industry to flourish. A lack of confidence in our industry helps no one.

FDASIA Working Group’s Recommended Reforms to FDA Regulation

As we debate the PROTECT Act and as we await the HHS report, let’s talk about what FDA can do better. This is a topic that the FDASIA working group discussed at great length last summer. As explained above, the Federal government convened this working group to advise the federal agencies on what they should consider as they develop a recommended approach to regulating (or not) HIT. Under section 618 of FDASIA, the sequence is that the working group makes recommendations to FDA, ONC and FCC, and then the three agencies are to make recommendations to Congress.

At the specific direction of Congress, the group was geographically diverse and included representatives of patients, consumers, health care providers, startup companies, health plans or other third-party payers, venture capital investors, information technology vendors, health information technology vendors, small businesses, purchasers, employers, and others. In all, it included 29 experts, plus me. Since Congress is the one that created this process through its 2012 legislation and even specified the types of people who were to be included in the working group and the scope of the report it wanted to receive, it seems to me that Congress should not ignore its own process.

In the final analysis of that group, the top regulatory improvement issues related to FDA revolved around FDA doing a better job of explaining the existing legal requirements. The problem isn’t the statute. The devil is in the details, and innovators need those details to be able to make business decisions. One of the biggest challenges that innovators have in this space is the presently opaque regulatory system.

Congress can't tackle the details. It’s not set up for that. Instead, with regard to FDA regulation, in its final PowerPoint presentation to the government the FDASIA working group recommended that FDA pursue three basic reforms: 

1. Slide 35. FDA needs to do a better job at a very granular level of explaining what types of software the agency regulates and what types it doesn't. The examples of topics given at the FDASIA workgroup where FDA needs to provide greater clarity as soon as possible include:

a. The difference between disease-related claims that FDA regulates and wellness related claims that the agency does not.

b. The circumstances under which software is considered to be an accessory to a medical device, and thus regulated.

c. The definition of clinical decision support software, and the types of such software that are high risk and thus merit regulation.

I can’t emphasize enough how important this was to the working group, because mobile app development requires investment, and the amount of the investment and associated timelines vary dramatically based on whether an app is going to be FDA regulated or not. Confusion around whether a particular app will be regulated is simply sand in the gears of commerce, keeping the software development machine from reaching its full potential. In September FDA did publish the MMA guidance document addressing mobile health broadly, but the specific questions above remain.

2. Slide 36. For those apps that FDA does regulate, the agency needs to do a better job at a detailed level of explaining how the following requirements apply to mobile apps:

a. The regulatory pathway for premarket review,

b. The quality system requirements and

c. Post-market obligations including adverse event reporting.

These questions are all on top of the questions that FDA has sought to answer to date regarding which apps get regulated. But like the question of which apps get regulated, these topics are not susceptible to being thoroughly explained through broad sweeping statements that you might find in congressional legislation. What we need are manuals that explain this stuff more specifically, and FDA is the one to write those manuals.

3. Slide 37. FDA needs to do a better job of interacting with entrepreneurs. They need to do a better job of answering questions reliably and quickly. They need to do a better job of proactive education. They need to do a better job of organizing the resources on their website and other available resources to make them easier to understand and follow for IT entrepreneurs. Quite bluntly they need to be more entrepreneur friendly.

This doesn’t mean FDA shouldn’t oversee entrepreneurs if they are developing novel, high risk technologies. That would not be good for the patient. It means FDA needs to enable entrepreneurs to develop and provide innovative and safe products so doctors, patients and investors have confidence in the mHealth industry.

If you want to read the PowerPoint presentation, you can find it here. It’s only a PowerPoint presentation, so what I’ve done in this post is provide you the background behind this portion of the presentation. I served as the cochair of the Regulations Subgroup, so this is the stuff my cochair and I were responsible for marshaling through the workgroup.


The experts who comprised the FDASIA working group (and I) reached consensus that those improvements would greatly help entrepreneurs bring new innovative products to market, while at the same time allowing the regulatory system to do its job protecting the health and safety of patients. None of these improvements are susceptible of statutory implementation. The problem is not with the statute, but with the written guidance and other materials that FDA issues. This requires people down in the trenches at the agency figuring all of this stuff out, not people in Congress legislating at a high level.

Having said that, personally I think it would be very productive for Congress and FDA to work together on these issues. There is a balancing of innovation and patient safety that needs to be achieved here, and that is not an exclusively technical issue. There are policy issues to be weighed, and Congress is closer to the people so to speak. I hate to sound like a silly idealist, but it would be really great if we could all work together on important topics like this. While the appropriate forum may be at FDA, I would welcome constructive congressional involvement in the process. To me this means meeting regularly with the agency and communicating congressional goals. Legislation is not the only tool Congress possesses, and I would hope that with regard to something this important we could all collaborate.