Health care providers and consumers are increasingly using mobile technology to exchange information. Many health IT providers readily acknowledge that some level of oversight is required to ensure patient safety and privacy protections, but many providers question whether the FDA is the right agency for the job and want to see the FDASIA recommendations.
Can the FDA, with its already limited resources and lengthy review cycles, regulate the fast-moving health IT industry? Should it? Health IT is fundamentally different from a medical device in many ways. For oversight purposes, the key differentiator between the two is the opportunity for clinical intervention in the use of health IT. Many medical devices interact directly with the patient (such as an infusion pump or pacemaker). Most health IT, on the other hand, merely provides information to clinicians, who ultimately make independent, experienced care decisions. Physicians are informed, but not controlled, by the information. This leads to a vast difference in the patient risk proposition and rigid regulatory oversight is not appropriate.
Advocates of a broad health IT oversight framework – which encompasses mobile health IT – are urging the FDA to delay release of its final guidance, particularly in light of a July 2012 Congressional mandate for the creation of a comprehensive oversight framework that avoids regulatory duplication.
But some mobile medical application developers are pressing the FDA to move forward immediately, believing its guidance will reduce the regulatory uncertainty that they believe is stifling innovation and investment in some aspects of mHealth.
The Draft Mobile Guidance states that the FDA does not presently intend to regulate electronic medical textbooks, apps that automate general office operations, and EHR apps…yet. That implied “yet” has given many in the health IT industry a pause. Contrary to the hopes of those who expect the Mobile Guidance, once finalized, to provide regulatory certainty to the mHealth industry, that “yet” underscores the fundamental uncertainty inherent in reliance on regulatory guidance – guidance is not binding and can be revised by the issuing agency at any time.
Recent FDA hearings have provided some clarity regarding specific categories of apps that will or will not be regulated, at least in the immediate term (see http://www.eweek.com/mobile/fda-clarifies-plans-for-mobile-health-app-regulation/). But gray areas remain depending on how the FDA ends up interpreting its own obligations, and a staggering number of apps could easily fall within the FDA’s regulatory purview.
For example, if the FDA regulates apps acting as clinical decision support tools (apps that essentially collect information, convert it using algorithms and provide a patient-specific result), reference tools like prescription reference apps, drug interaction checkers, and even arguably, EHRs, could become subject to FDA regulation. This would result in the regulation of technology merely because it automates a calculation that could be done by a physician less efficiently and with much greater possibility of human error. The Draft Guidance could result in the regulation of information delivered to physicians via mobile technology—essentially regulating technology by supposed category (“mobile”) rather than by true function. Such an outcome would stifle progress and innovation in the burgeoning mobile health IT industry, to the detriment of patients, care providers and the health care system.
Overbroad, heavy-handed regulation can and does stifle innovation. As the mHealth Regulatory Coalition has correctly pointed out, regulatory uncertainty can have no less an innovation-stifling effect. Congress’s FDASIA mandate is correct: any permanent oversight framework should be risk-based, appropriately taking into account the vastly different risk profiles of health IT compared to traditional medical devices. It should protect patients, while promoting innovation and avoiding regulatory duplication (both of which also protect patients, by allowing innovation to flourish).
The FDASIA Workgroup is working at a rapid pace not often seen in Washington. Final Mobile Guidance is unnecessary, would create rather than alleviate regulatory uncertainty, and would arguably be counter to Congress’s express mandate to avoid regulatory duplication.