A draft proposal of the FDA guidelines for regulating mobile medical applications was released in July, 2011 (http://www.regulations.gov/#!documentDetail;D=FDA-2011-D-0530-0001). In response, the mHealth Regulatory Coalition sent detailed comments on the proposal (http://mhealthregulatorycoalition.org/wp-content/uploads/2010/06/MRC-Comments-on-FDA-Draft-MMA-Guidance.pdf). There was a recent piece in the Washington Times “The FDA’s Assault on Mobile Technologies” (http://p.washingtontimes.com/news/2012/feb/7/fdas-assault-on-mobile-technologies/) which, in my opinion, was misguided. No one in the healthcare industry (pharmaceutical, medical device, or technology) is enamored with the FDA. They recently drastically raised review fees for device companies and slow down approval processes more year after year. Between 2005 and 2008, the FDA clearance process time increased 30%, and has continually increased, notwithstanding increased funding and staffing levels. Regardless of its procedural faults, I will attempt to lay out my reasons why this regulatory body needs to oversee digital health technologies. This article should not be seen as a blanket endorsement of the FDA’s specific operational processes and policies, but as a rebuttal to the claim that it is assaulting the mobile health industry.
1. The FDA is responsible for protecting and promoting public health via regulation and supervision of medical devices. The FDA will not regulate all mobile medical apps. They will regulate apps which have the potential for patient harm. Heretofore, most apps which have been sold are wellness and fitness apps which are not targeted at diagnosing or treating specific diseases. Apps which furnish medical information and/or guidance to providers and patients, by definition have the potential for harm.
2. FDA oversight will encourage quality clinical trials. When one buys something of any worth, especially in the medical space, a reasonable question to ask is “Does it work?” The word ‘work’ may refer to furnishing reliable information, reproducibly making a diagnosis, performing a task, and/or offering deduced medical advice. Regulatory agencies like the FDA and CMS rightfully ask for clinical trial data to approve a device for use and reimbursement. Having been a member of a Medicare Carrier Advisory Board, I can attest that this criterion constitutes one of the first pass litmus tests for approval. I will leave the reimbursement issue aside, since business models of apps might vary even more than traditional technologies. However, contrary to popular mHealth industry’s wishful thinking, healthcare providers themselves as well as these agencies make decisions based on objective evidence, sometimes comparative, whether a technology is useful, asking “where’s the beef?” Few mHealth apps have been through clinical trials. The ones which have been, with the exception of a handful, are woefully underpowered. One recently publicized trial involving monitoring vital signs in heart failure patients and touted as a big success involved 22 patients. Trials cost money, to be sure. However, technology company developers and executives fail to see the benefit and commercial capital that a positive well-done clinical trial may result in. Do they not have enough faith in their product to do the studies? Do they need more clinical perspective in the developmental process? Not only will trials substantiate efficacy, but hopefully cost-effectiveness and superiority to currently accepted practice. Clinical trials are not needed for all apps. And they are not irrefutable. But they do provide credibility and marketing power, which benefit purchasers and companies respectively.
3. The FDA’s mandate is not covered by other entities which may have other jurisdictions over mHealth apps. Referring to agencies like the ONC and FCC which oversee EHRs and broadband access respectively, Mr. White in the Washington Times’ piece says “This piecemeal and oftentimes conflicting structure raises another concern with how the FDA’s proposed framework will coexist with the rules established by these other agencies and how these agencies will achieve the shared goals of protecting health while promoting innovation.” I do not see any obvious conflicting structure of this oversight. Would it be ideal to have one agency regulate all these aspects of mobile health apps? Sure. But just as the Institute of Medicine recommended that the FDA, in its opinion, should not, because of lack of expertise and other reasons, regulate electronic health records, there are obvious reasons why regulation of this industry requires multiple players. The Department of Transportation doesn’t enforce traffic laws which take place on interstate highways.
4. FDA regulation of mobile health apps will promote corporate responsibility. The recalls of foods and medical devices in recent years have revealed many unscrupulous practices. It is an agency accused of acting too slowly, inefficiently, and even being beholden to the companies it is overseeing. However, without any oversight, there would be potential for both ethically less responsible manufacturing and surveillance practices and significantly more public mistrust of the industry. Huge fines have not eliminated prohibited practices of some FDA regulated companies, but they do deter most others.
5. Mobile health apps will revolutionize and become a substantial part of healthcare. Mobile health apps are not a passing fad, curiosity, or game. They will constitute a significant sector of healthcare in the future. Establishing regulatory standards early on in its development and adoption will serve to pave the way for issues which may arise down the line.
Mr. White’s states that “Constraints on speed to market and increased regulatory costs combined with tax-driven price increases may cause developers to move on to other, less burdensome endeavors.” There are still pharmaceutical companies and medical device companies who think there is money to be made in the marketplace. Sure, mobile health apps and other digital health technologies will be cheaper with perhaps smaller profit margins, but the size of the market itself is such that entrepreneurs will still see the worth of doing business. He goes on to say, “We need smart regulation for health information technology, not the same old, same old. We can and must do better.” I wholeheartedly agree with this. However, a new regulation does not mean a lack of regulation. The issues and specific recommendations raised by the mHealth Regulatory Commission, if addressed, will be a great framework of responsible regulation of a rapidly growing important sector of healthcare.