Important: DHACA’s response to the RCP advice on medical apps

The Royal College of Physicians has just published app guidance that, according to EHI “doctors should only use medical apps with an official CE mark”. EHI goes on to clarify that the guidance “applies to medical apps that can be classed as medical devices, which are bound by EU law to carry the mark.”

The Digital Health & Care Alliance (DHACA), of which this reviewer is Managing Director, is extremely concerned that this advice may seriously impact on the beneficial use of medical apps in the UK as it places the onus of deciding whether an app is a medical device on individual clinicians, a decision that at times even experienced MHRA personnel can equivocate on.

As the original research done by this editor on the topic of medical app take-up demonstrated, clinicians (more…)