The MHRA issued updated guidance that aims to identify a healthcare app that fulfils medical device regulations, confirming its safety. Users are able to check if their health app is a medical device, and what to look for to make sure the app is safe and works. The guidance is useful for software developers who create such apps.
With the increasing use of technology, both healthcare professionals and patients have become dependent on the use of healthcare apps. These apps aim to provide a diagnosis or suggest a treatment by collecting and analysing patient data, such as heartbeat or blood pressure. It is therefore important that these apps meet regulations as they are categorised as medical devices. If the app is not working as expected, incorrect information can be given to patients resulting in serious consequences.