The Royal College of Physicians (RCP) recently released a new factsheet providing guidance to doctors who use software applications in clinical practice. The new resource was developed after a consultation with the Medicines and Healthcare Products Regulatory Agency (MHPRA) and the General Medical Council, and specifically addresses medical apps that could be classified as medical devices in their own right, highlighting that, according to EU law, such apps are required to have the CE mark in order to be usable by physicians in practice.
When is a Medical App Considered a Medical Device?
According to the RCP’s recent statements, a software app can be considered a medical device if it is used in the diagnosis or clinical decision-making process. Furthermore, if an application contains features that assist in processes related to treatment or diagnosis, or is otherwise used by physicians for any medical purpose, it could be considered a medical device under EU legislation. In summary, any kind of software that is used by physicians to aid in clinical practice, could be considered a medical device, and should therefore contain the CE mark.
The RCP clarified that it is not against the use of apps in medical practice, and that there are numerous health and wellbeing apps used by doctors and patients that would not be classified as medical devices, such as apps that assist in booking appointments, providing general healthcare guidance, or apps that are not specifically intended for medical use but can find use in clinical practice (i.e. – calculators or scheduling apps).
Are There Consequences for Using Apps that Aren’t CE-Marked?
The RCP warned physicians to be wary about using any non CE-marked apps that meet the above criteria, as doing so could leave the physician and their practice open to litigation and legal repercussions that could affect their career.
While it is still unclear what kind of penalties doctors could face for using software applications that aren’t CE marked during clinical practice, it’s safe to assume that going against the RCP’s guidance would only be inviting trouble. As such, doctors throughout Europe are being urged to reconsider the apps they use to diagnose and treat patients, placing a stronger importance on the CE mark requirement.
Which Apps Already Have the CE Mark?
Ironically, when you consider the total number of medical apps available, there are relatively few that have the CE mark. In fact, when Jeremy Watt of RCP was asked a couple of years ago he stated that he was only personally aware of one app that had the CE mark at the time – Mersey Burns, an app that calculates the fluid needs of burn victims according to how much skin damage they’ve incurred.
The Mersey Burns app got its CE mark way back in 2011 and received an award in 2013 after establishing itself as one of the most renowned medical apps in the UK. However, since then a few other apps have received the CE mark, including iBG Star from Sanofi, the AliveCor app, and the suite of monitoring apps from AirStrip Technology.
Will This Be Counterproductive for the Med-Tech Community?
Despite recent comments from GP Des Spence, stating that most medical apps are “unscientific and untested,” rebuttals from the tech community have pointed out that healthcare professionals run the risk of “running behind the times” technologically if physicians are forced to wait for apps to receive a CE mark before using them.
Still, regulatory bodies in Europe and the UK have already begun taking steps to make it easier for developers to get their apps CE marked, with the Department of Health planning to address the issue in the upcoming Personalised Health and Care Framework, and the British Standards Institution planning to release guidelines on healthcare app development later this month.