d4–a UK medical charity–has published a regulation guidance document to help draw further attention to the issue of health app regulation and provide practical guidance to both users and manufacturers of apps for the UK’s healthcare market.
A new app, Mersey Burns‰Û¥a clinical tool for estimating burn area percentages, prescribing fluids using Parkland, background fluids and recording patients’ details‰Û¥is the first app in the UK to be officially registered with the Medicines and Healthcare products Regulatory Agency (MHRA) as a Class I medical device as per the EU Medical Device Directive 93/42/EEC, which is the primary source of regulation governing health apps across European member states. To coincide with this, d4 have simultaneously published a new guidance document to help draw further attention to the issue of health app regulation and provide practical guidance to both users and manufacturers of apps for the UK’s healthcare market.
The guidance highlights that “There has been considerable growth in the number of health apps available for download, but the regulatory position of this new technology is not well known,” therefore the importance to raise awareness on this issue.
“Mobile Health ‘mHealth’ is a new industry and the regulatory environment is evolving,” said James Sherwin-Smith, CEO of d4. ”Regulators are necessary to safeguard the public and uphold confidence in markets that would otherwise be open to potential abuse. But regulations also need to support, and not stifle, innovation. The regulatory issues that surround health apps are complex and open to interpretation. We hope that this guide provides a useful steer for individuals and organisations alike.”
The guidance document “Regulation of health apps: a practical guide” contains information on health apps regulation in the UK, EU and USA, issues to consider when developing health apps and also advices healthcare professionals on how to support the use of these apps across their organisations.
To conclude, the document contains the following recommendations:
- Health professionals should carefully consider the risks when using apps to determine a patient’s care.
- Developers should test their apps thoroughly and maintain adequate technical documentation to evidence this.
- Publishers should ensure compliance with the necessary regulations before releasing apps on to the market.
- Organisations should investigate ways to manage the use of apps by their employees, and put in place mechanisms to identify those apps that are deemed fit for professional use.
- Patients should examine carefully the source of the apps they use to manage their health. Within Europe, health apps that influence a patient’s treatment should carry the CE mark to demonstrate their conformity with the appropriate regulation.