FDA Regulation of Mobile Health

Mobile health is widely hyped and poorly understood concept.  It generally relates to the ability to execute health and health-care related software applications on devices carried around by providers or consumers, usually a smartphone or tablet.   The proliferation of these technologies has caused regulatory uncertainty, principally in regard to the stance of the Food & Drug Administration, the main regulator for medical devices.  (NEJM Article)   One obvious source of confusion has been the extent to which mobile health falls under the notion of a “medical device”, which is related to long-standing uncertainty about how the FDA view health information technology more broadly.  The article points out that the stakes are high; a burdensome regulatory environment may hinder development and deployment of useful applications, but one that is lax or non-existent can put patients at risk for serious adverse events.  One value of effective regulation is that it heightens patient and provider confidence in the technologies they may be interested in using.  The authors identify three primary benefits of mobile health–gathering more data more frequently and using it effectively; reducing spending by avoiding visits or duplicative services; and broadening access to care; but also note there is already evidence of the risks of these technologies, primarily apps that give inaccurate information or guidance.  A couple of frightening examples are given, including an app that miscalculated insulin doses and one that generated wrong joint status scores in arthritis patients.  The current FDA guidance on mobile health suggests that many apps will not be regulated at all and those that are will generally be class II devices, which are approved through the 510(k) pathway with limited review.  While the FDA seems to be generally accommodating to industry, there are proposals in Congress which would limit the FDA’s ability to regulate mobile health.  As the authors point out, these seem very misguided.  If these apps are to be relied upon by patients and clinicians, there needs to be some independent check on their accuracy before they go on the market and some ongoing review that they are not causing adverse events.  As noted above, one issue is the FDA’s failure to yet comprehensively set out a rational policy on health and medical software review and approvals.  Certainly any software that is going to be used for clinical decision supports needs some testing and review of its functionality and output.  This is too critical to patient safety to ignore.  As the authors suggest, perhaps third-party validation could be one approach for review before marketing, and the FDA should mandate ongoing post-market surveillance by the vendor.  If the mobile health industry wants to be taken seriously, it should support a regulatory approach that creates market confidence in the industry’s products.