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 were already concerned at potential liability as, unlike the drugs and medical hardware they prescribe, medical apps do not yet have NICE endorsement.
Apps are used across the NHS to improve efficiency and patient outcomes. Whilst there are a few bad eggs, as Richard Brady has told successive Royal Society of Medicine medical apps events, the vast majority of these apps fulfill a useful purpose. It would therefore be a disaster if this advice resulted in the wholesale abandonment of their use – that would undoubtedly contribute to a significant worsening of the current NHS crisis.
Following extensive consultation with members on many aspects of medical apps, DHACA has proposed an alternative approach that a date should be set when all apps used in the NHS should be safety checked using the ISB0129 standard which would then also identify those requiring CE certification. After that date – set at a sensible time in the future – only ISB0129-approved, and where appropriate CE certified apps, should be allowed to be used.
As a result, DHACA is working actively with NHS England, HSCIC and other colleagues to develop an approval system both to reassure clinicians of the safety & privacy of apps and to estimate the benefit that such apps can deliver, under the aegis of the Personalised Health & Care to 2020 paper (now shortened by the cognoscenti to PHaC20).
DHACA, membership of which remains free at present, is also now a part of the small team pulling together the voluntary European Code on safety and privacy of medical apps – DHACA members’s views on what this should cover, in advance of a more formal consultation process, are greatly welcome.
For information, there is no central registration required for CE certifications of medical apps so listing is dependent on hearsay; the only CE certified apps this reviewer is aware of are Airstrip, Medopad, Mersey Burns, Mersey Micro, & Oncoassist, plus of course the accessory apps to devices like the Alivecor ECG peripheral and Sanofi’s iBGStar.
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