Healthcare apps present unprecedented opportunities to transform the way healthcare is delivered, but these new media for delivering healthcare bring with them novel risks and challenges. The speed at which this area of healthcare is growing points to future claims for harm caused to patients and issues of risk and responsibility that are already intricate in clinical negligence litigation, and which are potentially made more complicated when traditional healthcare is shifted into the digital arena.
Dan Morris, Partner at Bevan Brittan LLP, in this article discusses the evolving lines of responsibility relating to health apps when an end user suffers harm, and that whilst app developers might primarily be concerned with trying to shoehorn an app into a particular regulatory category, they should not assume that a particular designation will protect them from ultimate responsibility for fault where harm arises. Dan also shares his reaction to the US Food and Drug Administration’s (‘FDA’) determination that Matis’s My Baby’s Beat app is a non-medical device.
A recent report estimates that the number of mobile health apps available on the UK market has nearly doubled in two years and now exceeds 318,000, with approximately 200 new apps being added every day . Faced with oversubscribed GP surgeries, lengthy waiting times and inconvenient appointments, patients - particularly younger, tech-savvy but time-poor patients - are turning to their smartphones to stay on top of their health and wellness, whether that is by arranging a remote GP consultation which can be set up in under 10 minutes, online management of repeat prescriptions, or obtaining a referral to a specialist consultant at a tertiary care centre. Technology is radically altering the way that people are engaging with healthcare and there are clearly many positives to these developments. But the delivery of remote healthcare via such technology also raises urgent questions about risk, responsibility and cost in the event that an end user suffers harm as a result of remotely delivered care.
[1.] IQVIA, The Growing Value of Digital Health: Evidence and Impact on Human Health and the Healthcare System, November 2017.
This article was originally published in Digital Health Legal Magazine in April 2018.