It seems there’s a million apps available to help you mind your health. We look at some of the more popular ones, and some of the unusual ones and guide you in what to look for in a quality health app.
The regulator for medical devices in Ireland is the HPRA. They are responsible for ensuring that EU regulations (Medical Devices Directive, Medical Devices Regulations) regarding the safe design and use of medical devices are enforced. The British equivalent organisation is the MHRA and the US organisation responsible for implementing the relevant US regulations is the FDA.
You might also want to look at what the health regulator says about mobile apps for health here: hpra mobile apps
Apps that are intended to be used for a medical purpose may fall under the definition of a medical device. The manufacturer of such medical device Apps must comply with the relevant medical devices legislation before they can be placed on the market e.g. downloaded to a mobile device for use. The CE marking process ensures the safety and performance of the App by making sure:
» the performance of the App has been adequately tested,
» any medical claims are sufficiently supported by clinical data and
» users are provided with information necessary for its safe use.
HPRA advice for apps that make any medical claims:
» Check that instructions for use are available for the app and make sure you read the instructions carefully and understand the functionality prior to use.
» Register with the manufacturer, where possible, in order to receive updates/ notices relating to the App. Check the website/ app store from where you have downloaded the app regularly for updates/upgrades, information regarding compatibility with hardware, Operating system requirements, notices etc.
» Ensure you update the App to the most current version. Note the reason for the update, which should be described on the download location and consider any potential impact of the change on future and/or prior use.
» Check that the contact details for the manufacturer are identified on the App to report any adverse events or issues.
» If you are in doubt or are unable to interpret the results obtained from the app e.g. diagnosis/ treatment suggestion/ dosage calculation etc., please contact a healthcare professional as soon as possible.
» If you see a medical device App that does not have a CE mark please contact the regulator.
Not a Patient 