There are well over 150 000 health apps available in Europe¹—from those designed to improve general wellness to apps that monitor medical conditions, apps for clinicians, and apps that function as medical devices. There have been more than 102 billion down-loads of health apps worldwide yet there is little regulation or guidance available for doctors or patients on quality, safety, or efficacy.

What is the problem?

Since the UK government founded the Cochrane Centre in 1992, evidence based medicine has been at the heart of healthcare.² With the burgeoning apps market, however, things are different.

“There's a huge and growing number of health apps out there, and with that comes a wide variation in quality, testing, and evaluation,” says Sarah Williams, senior health information officer at Cancer Research UK. “As with any new technology there's a lot we still need to understand about whether they can be effective, especially in the long term, and, perhaps more importantly, whether they're helping the people who really need it.”

Technically any app that makes efficacy claims needs to be able to produce some evidence to support its claims under the European Directive on Misleading Advertising. This may, however, not include the high quality evidence from randomised controlled trials that clinicians have come to expect.

“People are increasingly using apps to monitor, manage, and even treat conditions but have no information on whether or how the apps have been calibrated, and it's hard to find any information on the research used in development,” explains Patricia Wilkie, chair of the National Association for Patient Participation. “It's a very murky area.”

Risks of uninformed choice

“People choose health apps the same way as they choose any apps—quality of design and how easy they are to use,” explains Satish Misra, cardiology fellow at the Johns Hopkins Hospital in Baltimore and managing editor …