“Apps” that harm patients will be hunted down, says regulatorBMJ 2015; 350 doi: https://doi.org/10.1136/bmj.h1579 (Published 23 March 2015) Cite this as: BMJ 2015;350:h1579
A UK health regulator has issued a warning to makers of mobile medical “apps” that may harm patients.
Neil McGuire, clinical director of devices at the Medicines and Healthcare Products Regulatory Agency (MHRA) said, “Be under no illusion—if you have a medical device and it’s software or an app and patients come to grief, we’re coming looking.”
McGuire spoke at a health technologies seminar in London on 18 March attended by NHS and private sector representatives including device developers and designers. He was asked whether the United Kingdom and Europe would follow the US Food and Drug Administration’s lead in taking a supposedly “softer” line on certain classes of devices in guidance issued last month.1
McGuire said he understood that the FDA was going to “take very seriously the most risky software and apps and look at them in detail and . . . ignore the minor ones that make very little in the way of medical claims. They’ll also largely ignore all the other ones in the middle, but they’ll reserve the right to jump all over your face if something goes wrong.”
He added, “We don’t know if that’s the right approach to take in Europe. We are considering this very carefully. But there is no way we are going to be able to regulate millions and millions and millions of apps and all the software that goes into high risk devices, so we’re going to have to come to a sensible conclusion about how we deal with this.”
The seminar, held by Westminster Health Forum, heard claims that developing technologies were “outpacing” the ability of organisations and institutions to respond effectively. For example, concerns were raised over some devices, such as a mobile phone app said to estimate cancer risk from images of skin moles.
Matthew Khoory, managing director of MediWise, a British company working on a medical device to help people manage their diabetes, said that he saw regulation not as a burden but as a means of “differentiation” between types of devices. He said that wearable technologies encompassed wellness and fitness trackers that may help to promote healthy lifestyles, as well as approved medical devices that took longer and cost far more to bring to market.
Khoory said, “There is a place for both. It is all about the claims, understanding the quality of those devices, the quality of the data, and how that will be used.
“We’re almost saturated now with technologies; it’s very fragmented. The main question now is, how do we start to integrate it into healthcare systems, into health data, what piece of technology do we trust, and how do we pull that into electronic health records and start to influence clinical decision making?”
John Pugh, seminar co-chair and Liberal Democrat MP who chairs the all party parliamentary group on “telehealth,” said that technology could help in dealing with the increasing burden of chronic diseases. He said that “apps were not very high on the list” of what patients wanted. Instead, patients wanted help from peers—someone they could refer to for advice about their condition, he said.
Pugh added, “We are very interested in the concept of self management. The question is, where do apps and low tech fit into that? There are a lot of apps around at the moment, [and] a lot of them are being intensively used by the ‘worried well.’”
Cite this as: BMJ 2015;350:h1579