By Bradley Merrill Thompson, Member of the Firm at Epstein Becker & Green
My wife complains I live in the future, and I suppose that’s true. But on the heels of three days of hearings last week by two subcommittees of the House Energy and Commerce Committee, all focused on mHealth, I feel the urge to plan for the regulatory world after FDA publishes its final guidance. FDA testified the guidance should be out by October 1 of this year, but I would guess actually it will probably be out by mid-summer. I’m just basing that on the belief that FDA is now highly motivated to get the darn thing out.
So what happens then? What are the regulatory issues we in the mobile health arena will need to address after FDA’s guidance finally sees the light of day?
Brad’s Top Regulatory Issues for mHealth
After FDA publishes its final guidance, I believe the most important mHealth regulatory issues will include, in no particular order:
1.Congressional action on mHealth. Congress is getting very interested in how mHealth is regulated. Holding three days of hearings on a single topic is highly unusual. That suggests some within Congress are serious about moving legislation impacting mHealth. Indeed, one member of Congress has promised to introduce legislation to remove mHealth regulation from FDA, to do something as of yet unspecified with it. I suspect we will see some legislative fireworks.
2.The line between unregulated wellness and regulated disease claims. In 2009, FDA sent a letter to the Chairman of the Board and CEO of General Mills, alleging that General Mills had turned Cheerios into a drug by talking about the ability of the breakfast cereal to help manage cholesterol. FDA has always struggled to define with any precision the line between unregulated claims related to health and wellness, and regulated disease-type claims. Unfortunately, the letter to General Mills was not unique; this topic is one of FDA’s most common enforcement actions. This ambiguity is particularly threatening to mobile apps that operate in the area between traditional disease management and health and wellness. While the legal dividing line between disease and wellness is one predicated on the interpretation of marketing words, we desperately need to graft onto that analysis a risk-based approach so that simple apps that relate to disease in an innocuous fashion don’t get over-regulated.
3.The accessory rule. FDA has a long-standing rule saying that what you sell to connect to a medical device becomes a medical device itself by acting as an accessory. That rule creates enormous problems for mHealth where frankly everything is connected to everything else.
4.Regulation of software modules. The future of software development is characterized by modules, yet FDA has absolutely no policy for accommodating the fact that much software is simply connected modules, many of them pre-existing. As a result, it’s possible that FDA’s regulatory reach would extend to modules that have really no medical device functionality, simply because they have been added in some way to modules that perform medical device functionality. FDA must modernize its thinking in the area of software.
5.Quality system requirements for mobile apps. For mobile apps FDA regulates, the quality system requires that manufacturers use rigorous design controls to document and organize the software development process. But that’s not how app developers have traditionally operated, and this requirement potentially slows down development to a snail’s crawl. We need a new approach that will ensure quality on the one hand, but not impede what is so beautiful about app development -- its creativity and innovation. Further, the FDA’s definition of manufacturer was written with widgets in mind, not software. The applicability of the rules to software developers is anything but clear in an environment where developers collaborate deeply and constantly.
6.FDA’s clearance pathway for apps. Also for mobile apps that FDA regulates, we need to figure out what the path through FDA looks like -- what sort of data they expect before clearing a device.
7.FDA’s transition plan. Given all the confusion that has existed around which apps need to be cleared, some would argue FDA needs to give certain current app developers time to become compliant. That will be a difficult issues to address, because FDA takes the position that these items have been regulated for many years, and their new guidance is actually deregulatory. Yet some software companies not traditionally in the health business would say they had no idea FDA regulated these apps.
8.Software updates and regulatory oversight. Software application development is characterized by repeated and frequent improvement. We need to figure out how those improvements can be done within the context of an FDA premarket requirement and the quality system.
9.Global regulation of mHealth. These regulatory issues are not unique to the US – regulators globally are starting to focus on mobile health. The EU seems very interested in moving quickly into this area, both at the European Union level and the member state level. Northern member states in particular, such as Sweden, are developing their own approaches to software that differ from state to state. While the accessory issue is big in the US, it is potentially bigger in the EU where the definition of an accessory seems almost all-encompassing.
10.Pharmaceutical apps. Apps produced by pharmaceutical manufacturers add particular complexity. On the one hand, they would seem to be merely an extension of drug labeling, but on the other hand many of them are starting to add functionality that makes them look more like a device. In its draft guidance, FDA did little to clarify the wide-ranging area of pharmaceutical applications, and we are not optimistic that the final guidance will be much more specific in this area.
11.Broadening the discussion to ensure common sense prevails. Key stakeholders are not engaged in the regulatory debate. Patient and professional groups that have perhaps most at stake, as well as the enormous community of mobile app developers, have not been integrated into the dialogue around the appropriate balance between safety and innovation. Right now politicians and policymakers are trying to figure this stuff out largely for themselves, and on the advice of relatively narrow special interests.
12.FDA enforcement for mobile apps. Last week I testified before a House subcommittee about the need for balanced enforcement of the FDA requirements. Almost every day we see new apps being sold that should by all rights be FDA regulated, but where there’s no evidence the company has tried to comply. That’s a public health issue, because many of these apps focus on high-risk diseases and if they don’t work, someone could get hurt. Further, numerous companies are trying to do the right thing and comply, but finding themselves at a competitive disadvantage against those who don’t. To be sure, FDA faces a huge challenge in enforcement. We are awash in a sea of these apps, and developing a carefully constructed factual case to support enforcement is quite resource intensive. Indeed honestly, I don't have the answer. But we have to come up with a fair and efficient enforcement process that protects the public health and levels the playing field.
As FDA said at the hearing, in addition to understanding what FDA will regulate, it is equally important to understand what the issues will not be this year. According to FDA’s Christy Foreman, and as I testified on the first day of the hearings, FDA "would not consider mobile platform manufacturers to be medical device manufacturers just because their mobile platform could be used to run a mobile medical app regulated by FDA." Further, the medical device tax will not be an issue for mobile medical apps aimed at consumers.
The dozen issues outlined above, I predict, will dominate the regulatory policy discussions around mHealth for the balance of 2013 and beyond. These are not easy issues to resolve. The dichotomy between disease-related claims and wellness claims has plagued FDA for decades, in many ways being a defining difference between food and drugs. The accessory issue impacts far more than mobile medical apps, so FDA will need to involve many other stakeholders. Making matters worse, just as soon as FDA feels it has a handle on present technology and intended uses, those things change. So, I guess we live in interesting times.
