Do we need to rethink regulation for health apps?

Tom Finnegan

23 September 2015

A recent article by Stephen Armstrong in the British Medical Journal provides an interesting discussion about the increasing use of ‘health apps’ and what can be done to improve their regulation. 

Health apps have proliferated greatly in the last couple of years and are an element of the quantified-self and personalised-health movements, in the sense that they can help people track and understand elements of their health and thus take more responsibility for it. The UK Government, for example, says of health apps that: “We need to continue to encourage patients and citizens to use new technologies to better manage their health, care and treatment. And they need to feel confident in doing so.

This made me think about what is really meant by ‘health apps’, the implications of trying to regulate them, why one might wish to do so, and whether we are focusing on the right things.

What is a health app anyway?

The term ‘health app’ is ambiguous – an ‘application’ certainly isn’t restricted to one type of computer system or an easily categorised type of software. A health app might be software used by doctors to support their decisions, an application on tablet computers to help consumers make health choices, or an application on smartphones linked to wearable sensors that track movement and heart rate. There is also a blurred line between health apps and ‘wearable tech’ – sensors like the FitBit – because while the wearable element may not constitute a health app, many of these products come with the apps that make them useful to consumers, and so might be caught by the meaning of the term given that they are packaged together.

Relevant regulation

The BMJ article notes the main regulatory areas applicable to health apps: data protection, medical devices, and advertising. Consumer protection regulation goes unmentioned but is important, especially where implementing the EU product liability Directive. But, as Armstrong notes, “there is little regulation or guidance available for doctors or patients on quality, safety, or efficacy”, which is the main point of that article.

The medical devices regulatory framework provides some structure, but is a well-known grey area in terms of definitions: what actually constitutes a medical device is difficult to determine. 

Maureen Baker is quoted in the article. She notes: “If it isn’t a medical device there is no reliable framework or standard beyond the NHS Choices library guidelines, which were created two years ago and haven’t been reviewed since”. 

However, this may change in the near future: amendments to the forthcoming EU in vitro diagnostic medical devices Regulation would expand the definition to include devices intended to be used for “direct or indirect medical purposes” including “providing information concerning direct or indirect impacts on health”, which would appear to include health and lifestyle apps.

So what regulation in the UK does try to provide for quality, safety, or efficacy? Armstrong lays out a number of approaches: NHS England maintains the NHS Choices Health Apps Library the British Standards Institution has voluntary best practice guidance, and the National Information Board is consulting on stronger endorsement processes, which will be led by the National Institute for Health and Care Excellence, Public Health England and the Health & Social Care Information Centre. 

Although the “quality, safety, or efficacy” of health apps are vital to determine and regulate, there is another side to the control of these apps that the BMJ article does not expand on: the impact they might have on the delivery of healthcare more generally, and how that might need to be managed. 

The future of health apps

A recent Forbes article made some eye-opening observations about the future use of wearable sensors and health apps in corporate ‘wellness’ programmes and the interest of health insurers in accessing the resultant data. Kelly Barnes, who tracks healthcare for PricewaterhouseCoopers and acts as a consultant for insurers argued: “If you can take this wearable and I can see a constant level of activity and constant parameters on fitness activities, I’ll take points off your premium… I can set rates on a daily basis as opposed to just once a year” .

The eventual popularity of these technologies, and the influence they have, remains unknown. Where they do have an effect, it might be in a specific, relatively easily quantifiable sense (such as affecting one’s health insurance premiums) or it might be more ephemeral (such as encouraging individuals to take responsibility for their health or challenging solidaristic notions of healthcare.) 

To me, this is a major challenge, although it is difficult with publicly available information to know the real extent of corporate and insurer interest in using the data derived from wearables and health apps, and what effect it might have. Uptake and impact are especially difficult to predict in the EU, because the trend seems strongest in the USA, which has a very different health and legal system.  

Any potential effects would be mediated through regulatory frameworks, which are already present. My point is not that there is some kind of insoluble crisis on the horizon but that quality, safety, or efficacy of health apps are not the only important thing to consider. Depending on how things develop, health apps and wearable technology may have a significant impact not just on the information doctors, patients, and customers receive day-to-day, but on the overall approach to healthcare.

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