This series of posts covers some work I have been doing over the past three months: attempting to answer the question of how best to improve the perception by clinicians and patients of the efficacy of health-related apps. This work has been done for the i-Focus project, part of the Technology Strategy Board’s dallas programme.
Part I attempted to summarise the EU regulations covering health-related apps. The point was made that any health-related app must comply with data protection and consumer protection requirements, irrespective of whether the risk level is sufficient for it to be classified as a ‘medical device’. Where an app is classified as a ‘medical device’ it also has to be classified so that the appropriate adjudication work can be determined for it to receive a CE mark (Class I, lowest risk, requires least investigation; Class III, highest risk, requires greatest investigation).
This post summarises the principal findings from discussions with a very wide range of potential stakeholders, (more…)