Three key questions for FDA mHealth regulation

By Brian Dolan
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Bradley Merrill ThompsonBy Bradley Merrill Thompson, Partner, Epstein Becker & Green, P.C.

The mHealth Regulatory Coalition (MRC) recently released “A Call for Clarity: Open Questions on the Scope of FDA Regulation of mHealth," which is a 60-page paper that focuses on two fundamental questions: (1) what mHealth hardware and software will FDA regulate and (2) if a product is regulated, to what degree? The Coalition tackles these questions because, quite simply, the answers are fundamental to the business planning process. Companies as well as investors need answers as soon as possible to continue innovation.

MRC is comprised of organizations representing most of the stakeholder categories in mHealth. The group includes for-profit companies in the medical device, IT infrastructure, telecommunication carrier, mHealth app developer, and mobile phone industries. Beyond those categories, the membership includes nonprofit representatives of the hospital and medical provider segment, as well as professional societies and trade associations with broad memberships impacted by mHealth regulation.

The coalition wrote the paper after spending nearly five months meeting internally and with others, including entrepreneurs and established companies alike, to learn about the future of mHealth and the challenges developers are facing. Through that process, the coalition identified the specific open questions needed to determine whether FDA would regulate a company’s products. MRC wanted to drive the analysis to a level of specificity that would be meaningful to FDA.

Many of the questions arise because certain FDA policies were written decades ago at a time when our understanding of the connections between lifestyle and disease were not well-understood. This is not the first time the FDA has confronted such a challenge. In the early 1990s when scientists began to understand better the connections between dietary supplements and health, initially the FDA tried to regulate those supplements as drugs. At the time, the FDA’s policies required that any health claims associated with ingested products triggered drug status. Fortunately, Congress and the FDA came up with a more nuanced regulatory solution that allowed dietary supplements to be brought to market without filing a new drug application.

A very significant number of mHealth products appear designed to help consumers make better choices in their lifestyles, thereby promoting healthy living. mHealth creates a connection that gives people better access to useful information when they need it wherever they are—where they live, where they work and where they play. That access to information allows consumers to take more control of their lives and make better decisions on such things as diet, exercise and avoiding conditions that stress their health. Just as with dietary supplements, it must be recognized that this new knowledge of connections between lifestyle and health should not cause innovative, low risk products to become over-regulated.

At a high-level, the Coalition’s whitepaper focuses on questions that arise in three areas:

1.To what extent can mHealth-related products be excluded from FDA regulation by focusing their marketing campaigns on general improvements to consumer wellness, as opposed to focusing on the management or treatment of diseases such as diabetes and hypertension? For example, would the hardware and software associated with a system promoted for periodic transmission of a consumer’s weight to his physician be a regulated medical claim or an unregulated wellness claim? What if the data are instead merely transmitted to a personal health record not associated with any particular physician? The Coalition generated a set of similar questions that all require clarification of the fine line between treatment of disease and promotion of wellness that defines FDA jurisdiction.

2.To what extent do mobile phones and other generic communication hardware become FDA regulated medical devices simply because they are promoted for connection to a medical device? Would a mobile phone manufacturer that does nothing more than passively sell through its online store a third-party app designed to connect the mobile phone to a blood glucose meter cause the mobile phone to become a regulated medical device? Would a mobile phone intended to be used to download data from a pacemaker become itself a Class III medical device and regulated to the highest degree? The FDA's so-called accessory policy that for decades has held that any product intended to be connected to a medical device is regulated to the same degree as the medical device produces some illogical scenarios if applied literally in today's connected health environment.

3.To what extent does the FDA regulate software apps that are intended to reside on mobile phones, ordinary PCs, servers or perhaps in the cloud if they function to provide connections between communication hardware and medical devices or as repositories for health data? For example, does the FDA intend to regulate personal health records? Is a software app stored on a mobile phone regulated as a medical device if it asks the patient questions and transmits the patient's answers to a health care provider? Does the FDA plan to regulate decision support software residing on a physician's mobile phone that offers a preliminary analysis of data received from the patient? Would software that sends a doctor an alert based on changes in a consumer’s weight require prior clearance from the FDA? To what extent would software that the FDA intends to regulate require premarket notification? It has been years since the FDA clarified its stance on the regulation of software and today’s mHealth systems heavily rely on software for a wide variety of functionality that requires clarity from the FDA on the appropriate level of regulation.

The whitepaper explains existing FDA policy in these three areas, answers at least at a high level the few questions that can be answered, and most importantly identifies the remaining open questions. In doing so, the paper lays the foundation for the development of a guidance document that MRC plans to propose to the FDA, addressing the open questions. Essentially, the Coalition first had to agree on the scope and nature of the problems to be solved, so that it could then suggest solutions.

The path forward includes developing the proposed guidance document. In the process, the coalition will reach out to other stakeholders to get input. The goal is to complete the proposal and deliver it to FDA by the end of the first quarter. We believe FDA will probably want to hold a public meeting to gain additional input. We're hoping that with advanced planning, that public meeting could occur perhaps next spring.

Everyone—including the FDA—wants to see innovation in mHealth. To see 1,000 ideas blossom, however, industry needs some clarity regarding the scope of the FDA’s requirements going forward in each of these areas. Business people simply have to know whether compliance with the FDA regulations needs to be part of their plan. Clarity and predictability are crucial to continued innovation in mHealth.

FDA has previously announced that it is working on its own guidance document to offer some general advice on how mHealth apps are regulated, including what needs to be in a premarket submission. It is difficult to predict when any new policy will emerge from the Agency. As anyone who has followed the proposed medical device data system rule knows, it can take years. The Coalition’s hope is that the FDA will find this whitepaper useful in moving that process along.

FDA's Jeff Shuren, the top device regulator at the agency, offered several encouraging comments at the November 10 mHealth Summit sponsored by the NIH Foundation. He pragmatically focused on risk, and noted that the agency would likely choose to let low-risk technologies blossom without stringent regulation. At the same time, we must recognize that we do not all assess risk in the same way, so the task now is to get clarity on where exactly that dividing line falls. We are hopeful we can arrive at that result soon.

For more, read the 60-page MRC white paper over at the Coalition site (PDF)