Medical Apps. Are they regulated?


August 24, 2015

With the huge increase in the number of medical apps to hit the app stores over the last few years how can we be confident these apps are credible for recommendation by healthcare professionals and for use by patients?

Broadly speaking when considering regulation in this area medical apps can be split into two categories; those that are considered medical devices and require regulation by the Medicines and Healthcare products Regulatory Agency (MHRA) and those that are not.

There is some good guidance from the MHRA highlighting which apps are more likely to require regulation and CE marked as medical devices:

In general any app that plays a role in dose calculations, symptom tracking or provides clinical guidance which helps making a diagnosis or decision in healthcare are likely to fall within the scope of the medical devices directive.

Examples of medical apps requiring CE marking include:

  • apps acting as accessories to medical devices such as in the measurement of temperature, heart rate, blood pressure and blood sugars could be a medical device as are programmes for prosthetics could be classed as medical devices
  • apps with software that monitors a patient and collects information entered by the user, measured automatically by the app or collected by a point of care device may qualify as a medical device if the output affects the treatment of an individual

For those apps that don’t require this regulation the British Standard Industry (BSI) has produced a very helpful standard which gives recommendations for quality criteria of health and wellness apps, intended to meet the needs of healthcare professionals, patients, carers and the wider public.

It provides advice throughout the full app project life cycle, including development, testing, releasing and updating of an app, including clinical, native, hybrid and web-based apps. It also addresses fitness for purpose and the monitoring of usage and informs the development of health and wellness apps intended for internal use as well as those that are placed in the market, including those free of charge.

Examples of medical apps which may not require CE marking include:

  • apps with software that provides general information but does not provide personalised advice, although it may be targeted to a particular user group, is unlikely to be considered a medical device
  • apps with software that is used to book an appointment, request a prescription or have a virtual consultation is also unlikely to be considered a medical device if it only has an administrative function

Regulation in this area is very important and although still in early days progress, as with the BSI standard, has certainly been made. Here at Technical Health we are focused on ensuring the success of our digital health solutions and see assistance with this regulation and MHRA CE marking as a vital part of our service.

Contact George at Technical Health for more information.