BSI to publish apps standards

The British Standards Institution is set to publish guidelines on the development of healthcare apps in April this year.

Speaking at the e-Health Week event in London this week Robert Turpin, healthcare market development manager for BSI, said the PAS 277 guidance would be a “standard for health and wellbeing apps” to support developers hoping to gain wide uptake for software for tablets and smartphone devices.

The primary focus of the set of standards is on “commodity” apps that can downloaded from platforms such as the Apple store or Google Play, said Turpin, and will cover apps intended for both healthcare professionals and the general public.

PAS 277, which will be free to download, is based on existing medical device and software principles and provides a set of quality standards covering the full life-cycle of the app, including advice on maintenance and risk management standards.

As the UK national standards body the BSI has experience in healthcare providing quality management reviews and product certifications for medical device manufacturers.

The rise of health and well-being apps – Turpin said there are over 100,000 available – has led to calls from the healthcare community for greater regulation to ensure that the public and healthcare professionals only have access to ones that are safe and effective.

The issue is addressed in the Department of Health’s ‘Personalised Health and Care 2020’ framework, which proposes a kitemarking system for apps endorsed by the NHS.

Proposals for this system are scheduled to be published by June 2015 with the kitemarking of apps to begin by the end of 2015.

Turpin said the BSI’s guidance was relevant to the plans described in the framework but was just the “first piece in the jigsaw” for further standards to be developed.

The regulation of healthcare apps has been the subject of prolonged debate, with some developers fearing that excessive regulation could stifle the market.

NHS England has, to date, taken a relatively informal approach, asking the Health and Social Care Information Centre to take a risk management approach to asessing the apps in the NHS Choices health apps library.

The US has moved to regulate apps that go beyond advice and can be considered a medical device. The UK's Medicines and Healthcare Products Regulatory Authority has indicated that it may move int he same direction.

Individual developers have actively sought accreditation.The Mersey Burns App, which calculates how much fluid a burns victim needs, and which won an EHI Award in 2013, was the first to win a CE mark from the MHRA.

The app was accredited after clinical trials demonstrated it was more accurate and quicker at calculating the result than doctors working out the figure by hand.

Going forward it’s the area of efficacy and reimbursement that needs the most attention to encourage innovation in the field, said Turpin.

“To really revolutionise this area we need to develop the efficacy models and the reimbursement models; so we need to have NICE evaluations, we need to have evidence around using apps, we need to have proper procurement models in the NHS so that patients can access them, the public can access them, but also so that developers can be properly reimbursed.”

The NHS is investing in the development of several healthcare apps, and several were recently awarded funding as part of the NHS Innovation Challenge Prizes.

Successful projects included the MicroGuide App, which serves a library of microbiological information for doctors who want information on antibiotics and infections; Relax Anaesthetics, which provides games and music to distract children before surgery; and the NeoMate App to help junior doctors and nurses with decision-making.