Building trust In health apps
In the UK, NHS Digital has launched a national app assessment programme to help patients and health professionals understand which apps can be trusted to lead to better outcomes. So what turns a regular app into a “trusted” app which can then enter the NHS Apps Library? Could the programme be an archetype for other European countries?
The aim of the app assessment programme is to provide reassurance for patients, healthcare professionals and local commissioners that digital tools meet NHS standards for clinical safety and effectiveness. It was set up to provide guidance for developers to ensure they have the right information to develop healthcare tools. The idea is that if developers want to publish an app on the NHS Apps Library, which lists trusted apps, it must be subjected to rigorous assessment first.
Mark Salmon, Programme Director at the National Institute for Health and Care Excellence (NICE), which was involved with the assessment programme from the start, said the NHS is currently underutilising health apps: “We’re not commissioning them or utilising them as much as we could within the health system. There are lots of reasons why that is. It’s about building clinicians’ trust in using digital technologies when dealing with the care of patients, trusting the technical platform on which they’re built, the consent models around the use of the information they hold and understanding the business models that app developers employ.”
A need for robust regulation with health apps
The assessment process is a series of steps which have been designed to take these considerations into account. The first step is to check whether the app meets the assessment criteria, if it does, the app can be submitted to NHS Digital through the Health Developer Network. If the app is considered suitable, the developers can then answer a set of Digital Assessment Questions (DAQs). Their answers will be reviewed by experts and, if they are satisfied, the app will be added to the library.
Salmon said the DAQs covered a range of areas and were taken from legislation, from best practice, from codes of practice and existing standards such as ISO standards and BSA standards: “They’re quite tough; they’re not easy to meet. Work has been ongoing with developers over the past few years to pilot their use of the standards and we know it’s a high bar to reach, which is what you want. You want a high standard if the NHS is thinking about commissioning and using apps in healthcare.”
‘If your taxi app screws up, it can ruin your whole evening, if your health app screws up it can ruin your whole life’.
He said it was hard to explain exactly what kind of clinical evidence was needed for app validation at this stage: “You’d have to look at whether they were patient facing or professional facing, whether they were information only, or part of a clinical decision making system. You’d treat the riskier ones more comprehensively, for example, where there’s potential for patient harm, or where there are sensitivities around the context in which the app is being used.”
Approved assessors have now been appointed to help with the evaluation process. Our Mobile Health was appointed in February and its Chief Operations Officer is Charles Lowe. He said health apps require strict regulation: “My principle advice to developers is that health apps are different from everything else. A lot of people get themselves very upset that there is so much regulation in this area. And to repeat a comment someone once made a long time ago, ‘If your taxi app screws up, it can ruin your whole evening, if your health app screws up it can ruin your whole life’.”
Developers will be rewarded in due course
Obviously the assessment process requires patience but Lowe thinks that developers will be rewarded eventually: “Some apps on the Apps Library are free and some aren’t. In due course, developers will get paid by someone. If they have been asked to develop something specifically, they will get paid, for example, people that have done development work for Public Health England. When Public Health England put apps on that page, their purpose was not to make money out of it, but to spread the smoking cessation app”. According to Salmon there is no specific NICE criteria for reimbursing apps because they are just focusing on evidence at the moment and looking at how to evaluate the evidence.
It’s early days yet so it’s hard to tell exactly who will pay for what, but it seems likely that developers will stand to gain if their app makes it through the assessment process and onto the NHS Apps Library.