mHealth: the Latest App-date from the MHRA

Given the likelihood in the next few years of significant cuts in the funding of health and social care and the current financial state of many public bodies it is essential that any opportunity to reduce the cost of health and social care provision is given the attention it deserves.

There are now a wide variety of different health and social care apps that could assist the NHS and local authorities in reducing the cost of care provision. For example, there are apps that allow blood pressure and even blood testing to take place at home without medical professionals being present. If these apps could link in with GP and pharmacists then potentially this could reduce the number of GP visits and hospital attendances.

Already on the private health market are mHealth apps which use artificial intelligence to assist in reaching a diagnosis.  This goes well beyond the standard flowchart used by NHS 111 to analyse the answers given in order to reach a diagnosis.  Given the problems faced by NHS 111, could the 111 system be replaced by an initial app based assessment with the ability to use a video consultation where appropriate rather than directing individuals directly to emergency services or their GP?  Again, what if these apps were made available at the entry to GP surgeries and A&E so that individuals are directed at an earlier stage to the most appropriate service?

As with many potential innovations the key is going to be to change the culture of care provision and behaviour.  No change will be truly effective without upfront investment to get the people to whom this would really make a difference using the technology.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published updated guidance which helps to identify the health apps which are medical devices in order to make sure they comply with regulations and are acceptably safe.  Importantly, the new guidance considers when decision support software may be considered a medical device.  The standard position is that it may be a medical device when it applies automated reasoning.  However, this may not be the case if its purpose is only to provide information to enable a healthcare professional to make a clinical decision as they rely on their own knowledge. Whether or not it is a medical device appears to depend on whether it is likely that the raw data can or will be reviewed by the professional.

The EU has also published first draft guidance on how to assess mHealth apps.  Whether or not the UK remains in the EU this would also be worth considering when considering where and how to invest.

When considering investing in mHealth there are a number of factors that should be considered:

• The mechanism for any savings to be identified.
• How the app facilitates integration with primary and secondary care as well as social care
• How the app assists identification and implementation of efficient and effective patient management.
• App quality – what are the risks associated with the app and what post market surveillance does the developer have in place to identify and address any glitches.
• Does an app support clinical decision and if so, is it registered as a medical device?
• Does the app store personal information? How secure it this?
• Does the app share personal information with primary/secondary providers? How is consent sought for this data sharing?

If you have any questions about this article or you are looking to develop a Health App and you need legal support please get in touch with me or your usual Bevan Brittan contact.