A new standard for health and wellness apps will be published in April, with the intent to ‘help ensure quality across the whole lifecycle’. The standard, or code of practice, was developed by the British Standards Institution (BSI), the national standards body for the UK, with the help of industry experts after a lengthy consultation.
The standard will focus on health and wellbeing apps with both professional and public-facing applications – and will cover how we decide an app is fit for purpose, how to provide evidence for its capabilities, how it addresses security and privacy issues and risk management.
“There are thousands of apps in existence that have some sort of health or wellbeing application, some used by healthcare professionals and others are for consumer use,” explained Rob Turpin, Market Development Manager for healthcare, at the BSI, in an address at UK eHealth Week on Tuesday (March 3rd).”
“I think it’s agreed that good quality mobile health apps can help improve healthcare delivery,” he continued, but more is needed to be done to ensure that they ‘do what they say on the tin’. “There are a number of ‘bad’ or bogus apps out there – some of them unintentionally so. Today’s app developer has a lot of things they need to consider when creating their apps – not just to meet their own needs but to suit those of the user. What we’re doing is giving them a steer from the outset as to what is relevant. ‘How are you going to build the evidence to show how it is effective?’ ‘What about the regulatory aspects?’”
But just as there are ‘bad apps’ out there, says Turpin, there are also examples of where it’s being done well. He cited the case of Mersey Burns, a free and multi-award winning clinical tool for calculating burn area percentages. Designed for physicians, it runs on an iPad or other handheld device and is the first phone app in the UK to have been regulated as a medical device by the Medicine and Healthcare products Regulatory Agency (MHRA).
“With European directives in this area themselves being revised over the next 12 months, there is going to be a lot of movement in the health and wellbeing apps space – and our standard will be the first piece in the jigsaw,” said Turpin. “And it’s really not something that the BSI can solve on its own – we need involvement from knowledgeable others within the industry.”
Is there a danger in too many regulations stifling innovation? “Yes, of course there is – and especially for the smaller businesses that may not have the resources to invest in all the extra work that they may involve,” commented Turpin. “And that’s why we’ve made sure we’ve invited in discussions those who see this as a concern before creating this standard.”
“And yes, having to meet the stipulations of a new standard may change your business model, but you’re building a more sustainable business and hence a more valuable product into the bargain – one that can differentiate your offering from others out there.” As products like Mersey Burns, no doubt have shown.
The standard will be available as a free download, to make the content available to as many people as possible.