As intimated in our review of last year’s predictions, we feel little need to change course significantly, however some are now done & dusted, whereas others have a way to go. The latter include a concern about doctors, especially those in hospitals, continuing to use high-risk uncertified apps where the chance of injury or death of a patient is high if there is an error in them. Uncertified dosage calculators are considered particularly concerning.
Of necessity this is an area where clinicians are unwilling to be quoted, and meetings impose Chatham House rules. Suffice to say therefore that the point has now been well taken, and the MHRA are well aware of general concerns. Our first prediction therefore is that:
One or more Royal College/College will advise or instruct its members only to use CE-certified or otherwise risk-assessed medical apps.
The challenge here of course is that a restriction to CE-certified apps-only would be a disaster as many, if not most, apps used by clinicians do not meet the definition of a Medical Device and so could not justifiably be CE-certified. And apps are now a major source of efficiencies in hospitals – (more…)