Apple Inc. announced the release of ResearchKit, an open-source software framework that is expected to enhance medical research. Apple claims its product enables everyone to take part in research that will advance medical knowledge and that it is “taking research out of the lab and into the real world.”
Mobile health technology, including wearable sensors and mobile applications, has been available for some time. Companies have been developing mobile medical applications (MMAs) for so long that the U.S. Food and Drug Administration (FDA) has already established their classifications and safety-monitoring rules and the Federal Communications Commission (FCC) has established rules and the frequency band for use with wireless body sensors. While it appears that Apple actually was lagging behind, it is encouraging that it finally joined the trend.
What Are MMAs?
The FDA defines mobile applications (apps) as “software programs that run on smartphones and other mobile communication devices. They can also be accessories that attach to a smartphone or other mobile communication devices, or a combination of accessories and software.” Some apps help users manage their health information and wellness or learn more about health issues. MMAs are apps intended for data collection, health-related decision making or interventions that may affect health management, health outcomes or body functions. MMAs, which can be designed for health-care providers or for patients, fit the definition of medical devices and undergo the same scrutiny. The FDA is responsible for monitoring their safety and functionality.
How Does the FDA Regulate MMAs?
For mobile apps that pose a low risk to user safety, the FDA intends to exercise enforcement discretion. However, the FDA requires a review of MMAs that may pose a higher safety risk if they do not function as intended. To appreciate the possible risks involved, note these examples of MMAs for which the FDA will exercise enforcement discretion.
The spectrum of intended use listed indicates how apparently simple functions may have a significant health impact, and it’s understandable why the FDA maintains its right to regulate them.
For examples of MMAs the FDA will regulate, go here.
Reviewing that list can change one’s awareness of the possible impacts of MMAs. Users are already reporting problems such as the accuracy of measurements for some applications, so the need for regulation and oversight is obvious.
From a research perspective, the possibilities are enormously increased, but the usual study-design problems such as sample bias, verification of data and compliance must still be addressed. While the widespread availability of smartphones may increase access to health care through MMAs, a prescription may still be needed for some apps.
What is Good About Apple’s Announcement?
The availability of MMAs has dramatically increased in the past few years, with many independent manufacturers involved in their creation. Apple is neither the first nor the only manufacturer of mobile computing devices that claims it is revolutionizing mobile technology and its application in medical research and health care. Manufacturers using the Android operating system, such as Samsung, have similar products and claims.
What is most attractive to researchers who have experience with acquiring data from thousands of users using electronic devices is the open-source framework. Large-scale studies using self-enrollment and consumer electronic devices cannot depend on just one brand of required device. An open platform enables compatibility of various brands; however, if “open” is limited to one operating system, any research attempted with MMAs will exclude at least half of the population at the outset.
It is clear that there are limitations in how applications based on two different operating systems may interact, but progress will be slowed even more if intentional barriers are introduced. We hope the philosophy of openness goes a bit further this time than it has in the past.
How Can MMAs Help Divers?
The market for mobile apps geared toward divers is in its early stages. Apps already exist for logging, planning and calculating dives. Dive planners and dive computers, however, are not considered medical devices. A dive computer is a kind of wearable sensor intended to provide information necessary to protect the health of divers, but it does not measure body functions or provide assistance with diagnosis or treatment.
Wearable technology suitable for underwater use could help physiological studies of divers in their underwater environment. Currently we can measure a limited number of parameters such as heart rate, heart electrical activity, body temperature, brain electrical activity and breathing rate using customized, unreliable and costly equipment. Some promising new technologies are available, and we hope the use of MMAs may speed the development of new wearable sensors for underwater use.
True MMAs that meet FDA guidelines and assist in the diagnosis and treatment of divers are not yet available, but we may not have to wait long for their appearance. These may be the first line of products for divers that will be regulated by the FDA.
Mobile application technology is promising. While we should remain hopeful about the possibilities, we also must acknowledge that more work is necessary before divers can reap the benefits of these new apps.