Mobile Application Development and connected devices specifically for health and medical use has become one of the most rapidly-growing product marketplaces. The unregulated, Wild-West days of app development for use in the medical industry are quickly coming to an end … or at least, that appears to be the plan. The US Food and Drug Administration (FDA) has the task of shaping guidelines for mobile health devices and the applications that run them. They monitor and report adverse events or other problems with medical devices but because they aren’t mobile app experts, personnel at the FDA can’t possibly keep up with Apple when it comes to approving new medical apps.
The FDA, fueled by several medical standards committees is investigating the rather large (and still growing) backlog of apps deployed into medical environments; apps ranging from physician practice management aides to remote control of a prosthetic leg. How large of a backlog? According to USA Today, this time last year, there were nearly 40,000 medical applications available for mobile devices (indeed a lot), but in a recent Research2Guidance report, that number has more than doubled to over 97,000 medical applications (if you count general health and fitness apps in with their medical counterparts). This huge influx of new product development participants in an otherwise well-documented and regulated industry has paralyzed the medical community as a whole and, understandably, grabbed the attention of the FDA, as they scramble to find the best way to establish parameters with which to validate and/or define the efficacy of the claims these apps make.
In all fairness, a good number of applications that could be considered a part of the medical app category actually target other relatively-benign support services (such as patient scheduling), not laying claim to any medical treatment value in their programming… and this is largely how these apps have continued to fly under the radar of the FDA’s jurisdiction. as pure-of-intent as these apps may be, there are other considerations that the FDA is expected to address as they begin to review their potentially-expanded role in the area of mobile app regulation. For example, a schedule app for a Physician’s practice may at first glance seem innocent-enough to push through without too much oversight, however established traceability practices such as medical records privacy handling is a very necessary programming and development consideration that many first-time developers might simply overlook in their pre-development planning. This has serious implications if handled incorrectly and it represents just one of the many concerns expressed by industry safety experts.
Regulating medical applications is just the tip of the regulatory iceberg. Medical device developers must also understand the importance of safety testing new instruments and how to navigate UL standards testing relating to safety research, scientific expertise and uncompromising emphasis on quality. Electronic device developers must see that the instrument itself also complies with CE Mark certifications to insure that the instrument is not only safe but meets with all relevant essential requirements such as health and safety or environmental requirements indicating its compliance with EU legislation.
The regulatory gap doesn’t just affect current medical treatment policy; it also affects the medical application development community as a whole. In fact, it is widely viewed that this lack of regulation on the claims made by medical app developers is the very thing that is holding back an otherwise strong, industry-wide push to integrate mobile applications in physicians’ daily practices … and that is where the medical community is paralyzed. Until the FDA establishes a more comprehensive role in the matter of mobile application authorization for use in the health industry, and until some standard of regulatory approval is put into effect for apps deployed into the medical marketplace, there exists a vacuum of potential liability that, with all of the attention the FDA is corralling, may further halt the progress of product proliferation and the potential for genuine ingenuity in an industry that desperately needs to keep moving forward in order to meet the demands of its tech-savvy users.
Patients are demanding from their Practitioners, the sort of rapid, no-waiting-room response that can only be delivered by technology. Developers are anxious to supply the patient care providers with the technology. However soon, regulation is expected to bring about stricter standards of app deployment and for some, this may come as an unexpected surprise. If you’re targeting the medical industry for your next app or hardware “app-cessory” (hardware controlled by a mobile device), then it will be important to partner with someone that has genuine medical app deployment experience, otherwise, you may find that your app doesn’t make the grade when the new regulation comes into effect … you don’t want to be stuck with a medical app that doesn’t see the light of a Physician’s work area.