The British Standards Institution has published a set of standards to support developers creating health and wellness apps.
PAS 277 outlines a set of principles that app developers should follow, to make sure that their products and services can be trusted by healthcare professionals and the public.
Its main aim is to define the quality criteria for registries and repositories of healthcare apps, so that they meet the needs of users. However, the BSI suggested that it may also help doctors to select apps to recommend to patients or for organisations to commission bespoke apps.
The guidance was developed as a response to the growing environment for health and wellness apps, driven by increasing use of mobile devices such as smartphones and tablets, although it also applies to apps that run on desktop computers.
Available as a free download on the BSI website, PAS 277 brings together good practices in app development and healthcare information management. It also draws on existing standards for software life-cycle processes in medical devices and software development.
It applies to any health and wellness app, which the BSI describes as an “app that contributes to any aspect of the physical, mental or social wellbeing of the user or any other subject of care or wellbeing”.
Significantly, the BSI said that PAS 277 does not provide guidance on whether an app should be classed a medical device and would be subject to further regulatory control.
This issue was brought to light by the Royal College of Physicians in guidance published last month, which recommends that members only use medical apps with a CE mark, an indicator that medical devices must carry to shows they comply with EU safety, health and environmental requirements.
The RCP guidance was challenged by Charles Lowe, who said that this approach may discourage doctors from using useful apps as they would be unwilling to make a decision on whether an app is a medical device or not.
PAS 277 is designed with developers in mind rather than healthcare professionals and covers the complete life-cycle of an app – including those associated with wearable devices – from planning to testing and updating once it reaches market.
It outlines several quality criteria app developers should bear in mind when looking to have its product available via a repository such as the Health Apps Library on NHS Choices.
These criteria include regulatory and legal compliance, with the onus on app developers to research current compliance regulations and if they apply to their product.
Apps should also have their functionality determined using case studies and user stories, while accessibility requirements should also be considered, with usability described as a “critical property”.
Other recommendations suggest developers should take into account the impact on an app when it is used on a device that has intermittent network connectivity, as well as what mechanisms are needed to inform the user that an upgrade is available.
Security and privacy issues also feature in the standards, with the BSI stating that personal data used or collected by the app be described in the privacy statement document.
Developers should also state how the anonymity of anonymised data can be maintained as well as what happens to personal data when the user choses to delete the app.
The guidance was sponsored by UK tech body Innovate UK and was developed with the involvement of several UK healthcare organisations, including NHS England, BUPA, RCP, Digital Health and Care Alliance and the Health and Social Care Information Centre.
It marks a significant step forward in fast-growing area where standards are struggling to keep pace, although further guidelines and standards are expected to be produced.
Speaking at the e-Health Week event in London in March 2015 Robert Turpin, healthcare market development manager for BSI, told the audience that PAS 277 was just the “first piece in the jigsaw” in healthcare app standards.
The issue is addressed in the Department of Health’s ‘Personalised Health and Care 2020’ framework, which proposes an endorsement system for apps endorsed by the NHS. Proposals on how this will be done are due to be published next month.