A legal and practical guide to developing mobile medical applications (“apps”): navigating a potential minefield

Abstract

Apple opened its App Store in July 2008. In the intervening years over 30 billion applications, or ‘‘apps’’, have been downloaded. Other manufacturers also have their App Store equivalents though Apple commands by far the biggest share of the market. Whilst the overall percentage of medical apps available for download from these app stores is relatively small, they are, due to the sheer size of the market, quite high in number. There are more than 30,000 ‘‘Medical and Healthcare & Fitness’’ apps on Apple’s App Store alone. The nature of these varies immensely, ranging from those which are purely fitness and exercise related to those which are tantamount to medical devices. It can be hard for healthcare professionals to identify which apps are appropriate for clinical use since they tend to be assigned an app store category dependent on the suggestion of the developer. This means that categorisation is at best superficial and at worst misleading. In addition, relatively little information about safety, quality control and regulatory compliance is provided. Until these systems catch up with technology, healthcare professionals should be wary of apps that make claims of medical or quasi-medical functionality but then seek to disclaim liability for such functionality in the small print of their user conditions. Allied to the phenomenal increase in the numberof medical apps available for use by healthcare professionals has been the use by them of mobile devices for the purposes of their work. In addition to the rate of increase in the use of medical apps’doctors and other healthcare professionals are designing their own apps for in-house and wider circulation. This innovation gives rise to a number of practical, legal and regulatory issues of which potential app developers ought to be aware. The aim of this article is to provide an accurate yet accessible account of the law and regulatory provisions relating to these issues for those without any formal legal training. Specifically, the following are considered in detail: