Last week, on 29 June, the Digital Health and Care Alliance (“DHACA”) held its ninth “DHACA Day” conference on digital health in London. Speakers addressed, among other things, the draft EU guidance on the assessment of mobile health apps, and how patients may be able to access apps on the NHS in the UK.
DHACA is a non-profit, sector-led organisation that promotes collaboration between the public sector, industry and charities to expedite the development of digital and care systems in the UK and Europe. Its membership consists of statutory and private service providers, manufacturers, software developers, consumer representative bodies, regulatory bodies and trade bodies.
Charles Lowe, from the European Commission’s DG Connect responsible for preparing the EU guidance, gave an update on the proposed guidelines for mHealth app developers, which are intended to accompany the Code of Conduct on Privacy. We have previously set out a summary of the structure of the guidance and the number of technical and regulatory policy issues that have not yet been adequately addressed. In particular, the guidelines, which will be voluntary, will contain a scoring system for risk assessment against which developers will self-certify. There are nine criteria that must be considered when developing an app. The Commission believes the core criteria relate to the quality of the app: reliability, transparency, credibility, safety, and security. DHACA is currently engaging the Working Party to discuss whether the additional criteria relating to the functionality of the app (including stability, effectiveness, usability and desirability) should also be considered. Each of the criteria will be assessed against a detailed question set and given a numerical score. It is yet to be decided whether there will be a “pass mark” for acceptable apps or whether, given the varied risk profiles of apps (e.g., a lower risk “lifestyle” app, such as a step counter vs. a higher risk “medical” app, such as to monitor diabetes), there should be a range of acceptable marks, or how this should be structured.
Julie Bretland of Our Mobile Health (a private company that provides consultancy services to the mobile health technology market) also gave an overview of the UK National Information Board’s (“NIB”) Workstream 1.2: “providing citizens with access to an assessed set of NHS and social care ‘apps’”. The market for health apps is currently unregulated in the UK. The purpose of Workstream 1.2 is to produce an assessment framework that enables the UK’s National Institute of Health and Care Excellence (“NICE”) to identify and promote the most effective health apps and to provide a benchmark for quality so that apps can be made available to patients on the NHS. Workstream 1.2 represents an evolution of NHS England’s 2013 policy to develop a library of NHS-reviewed health apps that would help people manage their health and wellness. The “Health Apps Library” was previously made available to patients via the NHS Choices website. However, it was shut down in October 2015 after concerns raised about the data security of the apps on offer were substantiated in a study conducted by Imperial College London. The assessment process under Workstream 1.2 is intended to address the privacy risks associated with health apps, as well as to set standards of safety, accessibility, usability, technical stability and interoperability.
The proposed assessment framework for apps to be made available on the NHS consists of four stages:
- Stage 1: Self-assessment against defined criteria
- Stage 2: “Community” evaluation (or peer review)
- Stage 3: Preparing a benefit case
- Stage 4: Independent impact evaluation
Stages 1 and 2 will be overseen by Public Health England, which is concerned with preparing the business case for an app. Completing stages 1 and 2 will allow the developer to offer its app via the NHS Choices website. Stages 3 and 4 are to be overseen by NICE, which is concerned with evaluating the business case for an app and, ultimately, determining which apps should be recommended by healthcare professionals. It remains to be seen whether the UK procedure will take into account any assessment undertaken under the EU guidance.
