There are all manner of medical and healthcare applications, or apps, available for mobile devices, with various capabilities and functions. While some are purely designed to allow easy access to medical information for healthcare workers or patients, others are more interactive.

A report released in late 2015 by the IMS Institute for Healthcare Informatics found that there were over 165,000 such apps available, with this number likely set to increase as interest in the potential health benefits of such technology grows.

It's easy to see how patients having ready access to information about their medical condition, or an effective way to monitor their health, could lead to patients who are more informed, better motivated and increasingly invested in managing their health.

Some apps simply offer a sleeker alternative to keeping a food, body weight or exercise diary, or provide advice on exercise and diet which could just as easily be found online or in a book.

Apps that allow users to input parameters such as blood pressure measurements are a modern replacement for a notebook and pen, although with the possible additional benefits of this data being processed to some extent - by displaying it in a graph or identifying trends, for example. At best they can encourage the user to engage with their health more; at worst they may just be ineffective and fail to deliver on their promise.

Of greater concern are those apps that have the potential to be detrimental to patients' health.

Regulation and reliability

One major problem relates to the reliability and regulation of health apps. The development and release of healthcare apps doesn't currently appear to require any medical input or rigorous accuracy checks of the information they provide.

Apps that meet the definition of a medical device must comply with the requirements of the relevant medical device directive and will fall under the regulatory responsibility of the Medicines and Healthcare product Regulatory Agency (MHRA). The MHRA has published guidance on when an app may be considered to be a medical device, but due to the sheer volume and diversity of health apps available, regulation is difficult.

The MHRA Devices Division has a small dedicated Software team dealing with these challenges, working to ensure consistency in their approach to regulating medical apps as devices when appropriate; this involves the cooperation and collaboration of all those interested in patient safety.

An obvious concern with inaccurate or misleading information given via health apps is the potential to raise patients' anxieties unnecessarily, which can put doctors in an awkward position. Alternatively, it could falsely reassure patients leading to them not seeking medical advice when they really need it.

An obvious concern with inaccurate or misleading information given via health apps is the potential to raise patients' anxieties unnecessarily

By way of example, a 2013 study published in JAMA Dermatology reviewed the accuracy of apps that claimed to diagnose skin cancer using photographs of lesions. The study concluded that even the most accurate of these apps failed to identify 18 of the 60 lesions which had previously been identified as melanomas. MHRA looked at this data and worked with relevant parties to address this or remove apps that were not CE marked from the marketplace.

As well as the potential for missed or delayed diagnoses, data security is another area of concern. A study published last year in BMC Medicine reviewed 79 health apps that had been deemed clinically safe and trustworthy by the NHS Health Apps Library. These were found to have variable adherence with Data Protection Principles, including some which transmitted personal and health data to allied online services without first encrypting it.

Applied knowledge

It's understandable therefore that clinicians may be reluctant to recommend health apps to patients or to be influenced by patient information provided by them. So how can doctors protect themselves in the face of health apps being more commonly used by patients, as well as becoming increasingly complex?

  1. Information gathered during the pilot of the NHS Health Apps Library is being used by the National Information Board (NIB) to develop a model for how to provide NHS endorsed health and care apps. The aim is to enable healthcare professionals to recommend safe and effective apps which patients can have confidence in.

    If you wish to recommend health apps to patients, it would obviously be prudent to suggest an NHS endorsed one so that there's some assurance about the quality of the app. While the NHS Health Apps Library is being upgraded, there are still some apps to be found via the NHS Choices website. The Royal College of Physicians also offers some advice on the subject.
  2. If patients present the results of any home monitoring via an app, it may not necessarily be any more problematic than them presenting a written log of these same results, especially if they have entered the data themselves.
  3. When patients attend a consultation with medical information derived from an app, make sure you listen to their concerns just as you would if the information came from any other source. It may also help to explain to them that much like the health information on the internet, the reliability of health apps is highly variable. The popularity of an app does not necessarily equate to its quality.
  4. If you encounter a situation where a patient has come to harm due to using an app that may be classified as a medical device, such as a delay in seeking medical review due to being falsely reassured by an app, it would be advisable to contact the MHRA.

Patient safety is of paramount importance and requires vital information from reporting. This helps the MHRA understand how these medical devices are impacting on patient health and safety. If you are concerned about the accuracy of an app you can report it to the MHRA.


This article was correct at publication on 11/03/2016. It is intended as general guidance for members only. If you are a member and need specific advice relating to your own circumstances, please contact one of our advisers.

Dr Ellie Mein

Medico-legal adviser

MB ChB MRCOphth GDL LLM

Ellie joined the MDU as a medico-legal adviser in 2013. Prior to this she worked as an ophthalmologist before completing her Graduate Diploma in Law in Birmingham.

See more by Dr Ellie Mein