By Kelly Mae Ross, CQ Roll Call
August 15, 2013 -- The number of mobile health applications available for smartphones and other mobile communication devices is exploding, but the Food and Drug Administration has yet to offer final guidance about which of these apps it will regulate.
Mobile health apps mainly fall into two broad categories: those that consumers use to manage their own health and apps that health care professionals use to help deliver care.
The consumer apps include such services as calorie counters; apps that organize and display personal health data, such as lab results; and apps that provide information about over-the-counter drugs.
Under the draft guidance the FDA issued in July 2011, the agency said while it would exercise "enforcement discretion" toward such consumer-oriented mobile apps, it plans to focus its efforts on regulating more high-risk applications.
Most of the 29-page FDA draft guidance document focuses on apps used for clinical purposes. The FDA said such apps could "present a potential risk to patients if they do not work as intended." Specifically, the draft guidance says that the regulatory line will be drawn at apps that are used as an accessory to an already-regulated FDA medical device or that transform a mobile platform into a regulated medical device. Examples of apps that fall under this category include those that turn mobile platforms into electronic stethoscopes, allow doctors to view x-rays on their phones, assist with the calculation of drug dosages for patients, and more.
A number of health industry groups have collectively said they would like the FDA to wait to issue specific guidance on mobile apps until a broader regulatory framework regarding health information technology has been completed. But a mobile health-focused coalition said current regulatory uncertainty may be causing some businesses interested in developing these types of apps to hesitate.
The FDA had already reviewed about 100 mobile medical apps as of March. One of those applications allows doctors to use smartphone-based EKG machines. Others create smartphone-based glucose monitors and remote blood pressure monitors, according to Christy Foreman, director of the Office of Device Evaluation in the Center for Devices and Radiological Health at the FDA, who testified at one of a series of House Energy and Commerce hearings in March on health apps.
Bradley Merrill Thompson, general counsel for the mHealth Regulatory Coalition, said in an email that scientists are working on apps that would be connected to sensors that would measure different patient health statuses. One example he gave is a "smart pill" app. Patients would ingest pills with sensors. Information from the sensors in the pills would be displayed on a mobile phone so that patients could keep track of such things as exactly when they took their medicine. This pill-tracking app could help doctors too because they would have an exact record of which medicine a patient took and when.
Mobile medical apps have the potential to make it easier for health care providers to do their jobs, but flaws in the construction of these apps could result in harmful consequences for both doctor and patient by providing inaccurate information that could delay diagnoses or treatments, experts say.
Mobile health technology is advancing at a rapid pace and federal regulators are trying to keep up.
"We believe that focusing FDA oversight on a narrow subset of mobile apps will encourage the development of new products while providing appropriate patient protections," Foreman said at one of the congressional hearings.
When to Regulate
There is a continuing debate over when the FDA should release its finalized guidance. The FDA said it has so far reviewed more than 130 public comments on its draft guidance that came out more than two years ago.
The 2012 Food and Drug Administration Safety and Innovation Act (PL 112-144) requires the secretary of Health and Human Services to work with the FDA, the Federal Communications Commission and the Office of the National Coordinator for Health Information Technology to recommend a framework for the regulation of health IT. The report is required to contain a proposed strategy and recommendations on an "appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication."
A working group was created to provide input on the development of this framework to the ONC. The group began holding meetings earlier this year and is supposed to issue a report to ONC's Health IT Policy Committee on Sept. 4. There is some speculation that the group could finish its work earlier than that.
In May, a notice was posted on the Federal Register website requesting public comment on the workgroup's report. The comment period is open until the end of August, but commenters were encouraged to submit their remarks before June 30.
A coalition of more than 100 organizations with an interest in mobile health, including consumer groups, medical societies and health IT startups, signed a letter sent to HHS requesting that all federal agencies wait to offer health IT-related guidance or regulations until the working group issues its report and HHS has made its regulatory framework recommendations. That includes FDA's final guidance on mobile apps.
Dan Haley, vice president of government and regulatory affairs at athenahealth, one of the organizations that signed the letter, said if any regulatory guidance involving a specific component of health IT was issued before the broader regulatory framework was finalized it would "muddy the waters" and create confusion among investors and potential stakeholders.
Not everyone agrees with this view. The mHealth Regulatory Coalition said in a position paper published in June and sent to HHS that the FDA does not need to wait for the broader framework to come out before it issues its final guidance because the guidance "does not overlap" with and has different objectives than the efforts of the working group and the HHS secretary.
According to the letter, "The FDA's guidance ... covers largely uncontroversial topics in that it simply explains what the existing FDA statutory authority means."
Thompson, a member of the working group, said that further delay of the final FDA guidance would be "industry unfriendly" because it could prevent IT startups and larger companies from investing in mobile health app technologies. In an email, Thompson said FDA guidance, written in more layman's terms would, "help entrepreneurs who just want to understand what [the] existing rules are."
An FDA official said issuing finalized regulatory guidance is a priority for the agency for 2013, but didn't provide a specific publication date.
