This series of posts covers some work I have been doing over the past three months: attempting to answer the question of how best to improve the perception by clinicians and patients of the efficacy of health-related apps. This work has been done for the i-Focus project, part of the Technology Strategy Board’s dallas programme.
Part I briefly summarised the EU regulations covering health-related apps. The point was made that any health-related app must comply with data protection and consumer protection requirements, irrespective of whether the risk level is sufficient for it to be classified as a ‘medical device’. Where an app is classified as a ‘medical device’ it also has to be classified so that the appropriate adjudication work can be determined for it to receive a CE mark (Class I, lowest risk, requires least investigation; Class III, highest risk, requires greatest investigation).
Part II summarised the principal findings from discussions with a very wide range of potential stakeholders, from patients to consultants, and from individual app developers to chief executives of app curation companies. The key findings were:
- There is currently little academically-endorsed evidence of medical app efficacy, though much anecdotal evidence;
- There are too many bogus apps around;
- There are safety worries – for example where clinicians are using unregulated apps to manage medication dosage;
- The process for obtaining certification is unclear;
- Some app developers are ignoring data privacy legislation;
- The business model for achieving sales via the NHS is not well understood.
In addition, a theme running through both posts is that there is an international dimension to this issue, with some countries, notably the US, well advanced in certain aspects.
From these findings, four key conclusions emerge:
- The most important segment of the market is ‘medical apps’ – those that can provide substantial benefits to both patients and clinicians, whilst potentially exposing users also to significant risk if not properly regulated (many health-related apps hold little health risk as they are purely associated with wellness or sports/fitness; the principle of proportionality needs to apply as the pace of development and change is very rapid.)
- There is a powerful need for a clarification of the process centred around the MHRA by which apps with a medical/wellbeing improvement purpose are classified as medical apps, and, where they meet the definition of a medical device, how best to determine their Class.
- Some means of determining the cost effectiveness of medical apps is necessary, to enhance the perception of their efficacy and, where access needs to be restricted, to unblock processes such as how best to manage the prescription nationally.
- The relevance of international regulation needs to be taken into account. This will require any new measures to consider EU and US regulation as many devices may be sold as European devices, with associated (US based) app stores.
For the first two of these, there is strong support across all stakeholders for a group to come together to agree an appropriate process centred on the MHRA for wide dissemination. An organisation established under the auspices of the Technology Strategy Board’s dallas programme called the Digital Health And Care Alliance (“DHACA” – temporary website here) is happy to coordinate this dissemination and has already had significant expressions of support and interest.
For the third and fourth of these, the overwhelming view of those consulted was that NICE will be the best organisation in the UK both to develop the best way to evaluate the efficacy of medical apps, including advising on appropriate means of evidence gathering, and to perform a similar function to that it already does for drugs and medical hardware. Any NICE approach will of course need to be recognised in an international context, given the international nature of the supply and growing significance of mobile internet-based distribution and emerging international regulation in this space; much indeed as is the case already with pharmaceuticals. Preparatory to NICE taking on the role, there will of course be a need to research the topic, as has been done for previous tasks taken on by the organisation. Perhaps including medical apps in subsequent Medtech Information Briefings might help spread the word too.
At this point, it is perhaps also worth addressing the piece posted on TTA by my Editor colleague Donna Cusano after the second part of this series had been published that posed the question Certifying health apps: is it at all possible? This is also a more general objection that many have expressed, the basic argument being that there are so many apps, and they change so fast, that no public body will have the capability adequately to monitor them. Perhaps the clearest response to this is that, as explained in Part II, unless this matter is taken in hand, it will be only a matter of time before the risks of not certifying apps become all too clear. The better question therefore is how to make it possible to certify medical apps. The response, suggested by NICE is that, working with the MHRA, they have for other products developed a system for certifying internal individual certification processes within companies. Thus responsibility for the certification work would fall mainly on the app developer/sales organisation. This would also cover the key point mentioned in Part II of the need to keep monitoring the safety and efficacy of apps as changes are made to reflect operating system changes, and enhancements. Clearly curating organisations have a key role here too. It’s also worth mentioning that this proposal has been discussed with the NHS Apps Library, with whom I am told it fits well.
Currently, I am engaged, via DHACA, in discussions with all the key players to try to make this happen (many of whom will be presenting at the Playing games, using apps, promoting wellbeing event at the RSM on 10th April) – all comments & suggestions, and assistance, would be gratefully received either by comment to this post or, preferably, directly to email@example.com.
Finally a big thank-you to everyone that has helped me with this work – the list is long!