The Royal College of Physicians of London, the professional organization that sets the standards of medical training in the UK, has published a set of guidelines about how doctors there should use medical apps. The two-page guidance document places a heavy emphasis on the CE Mark, but also places the onus on doctors to use their own judgment in using apps in clinical practice. The guidance lays out which apps are classed as medical devices and would require a CE Mark, and the language is very similar to the parameters the FDA has laid out here in the US. “Briefly, apps that diagnose, support diagnosis or clinical decisions, make calculations to determine diagnosis or treatment, or are used for any medical purpose are classed as ‘medical devices’,” the RCP writes. “For example, users of the Mersey Burns app (a CE Marked app) can input the parts of a patient’s body that have been burned and it calculates the percentage of skin damage and their fluid balance requirements. A medical app does not need to link to the patient’s records or capture the patient’s name or NHS number; if it uses patient-specific information, it is a medical app and it needs a CE Mark.” By contrast, apps that don’t require a CE Mark include “apps that have only administrative functions”, “apps that give general guidance or support training”, and “apps that do not provide personalized advice”. In addition, a general purpose calculator wouldn’t suddenly become a medical app, even if it was used by a doctor in the treatment of a patient. The RCP recommends that doctors try out medical apps in airplane mode to make sure they’re not using WiFi in the background in a way that could compromise patient data security, and recommends that doctors double check that all data in the app applies to the current patient, and wasn’t stored from a previous use. In the document, the RCP also makes it clear that they have no plans to validate individual medical apps. “The medical app market is evolving rapidly, and the Royal College of Physicians (RCP) is monitoring it closely,” they write. “The RCP has no plans to endorse particular medical apps (in the same way that it would not endorse a particular drug), although it is centrally involved with other organizations in establishing quality criteria for apps.” One such document is actually due out later this month. The British Standards Institute promised that the document, called PS277, would create a “standard for health and wellbeing apps” at e-Health Week in London in March. According to a report from DigitalHealth.net, the guidance will provide a set of quality standards for both patient and physician-facing apps. Source
