The rapid growth of mobile technology has made ‘apps’ an integral part of our lives. But what are the risks of using such apps to make decisions about our health? David Edwards, head of the healthcare sector team at Harrison Drury, looks at the legal considerations for healthcare professionals.
As the use of mobile devices such as smart phones and tablets continues to intensify, there will inevitably be an increase in the number of dedicated apps.
In the healthcare sector, this has led to a rising number of specialist apps, specifically targeted at medical and healthcare professionals.
However, with such technology comes obvious risks, particularly where the apps are of a substandard quality.
What’s the industry guidance on medical apps?
Many apps are perfectly safe; however when it comes to those which are specifically aimed at professionals, such as doctors, nurses, and pharmacists, it is necessary for adequate regulation to be in place to ensure that they do not pose a threat to public health.
The Medicines & Healthcare products Regulatory Agency (MHRA) produced a guidance note in 2014 regarding medical device software including apps.
The guidance clarifies which apps should be classified as “medical devices” and states:
“There are a number of words likely to contribute to MHRA determining if an app is a medical device. These include: amplify, analysis, interpret, alarms, calculates, controls, converts, detects, diagnose, measures, monitors.”
Once an app falls within the definition of a medical device it is classified according to its risk. The risk classification will then determine whether regulatory and compliance requirements are necessary.
What kind of apps would warrant regulation?
For example, an app that contains something as simple as a medical text book or dictionary may not warrant regulation. However, one that calculates patient data with a view to aiding diagnosis or therapy may need to be registered with the MHRA.
If the app falls within the definition of a “medical device” and poses sufficient risk to a patient’s wellbeing, the manufacturer must be registered as a class 1 medical device manufacturer.
The manufacturer will then need to prove that their app conforms to the Medical Device Directive. This also involves making an application to the MHRA.
Once this process is completed, the app can carry a CE mark which demonstrates that it has full regulatory backing, and that it reaches the standards stipulated by the European Union.
Does the NHS ‘recommend’ medical apps?
There are other methods of ensuring that apps are of a sufficient standard, including the NHS App Library, which is currently being upgraded.
The National Information Board is using the Health Apps Library to consider how a wider endorsement model for patient-focused health apps could be implemented.
Due to the potential risks involved with using an unregulated app, it is important that healthcare professionals understand and assess each app to ensure that it complies with the relevant regulations.
David Edwards is head of the healthcare team at Harrison Drury and is an expert in regulatory and compliance legal matters.
If you are a healthcare professional and have any queries regarding the apps that you use, or any other legal matter contact David 01772 258 321.