The regulation of medical software, including mHealth apps

Copyright © 2025 LexisNexis
Published by a LexisNexis Life Sciences expert
Practice notes

The regulation of medical software, including mHealth apps

Copyright © 2025 LexisNexis

Published by a LexisNexis Life Sciences expert

Practice notes
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This Practice Note discusses the regulation of medical software with an emphasis on mHealth (mobile health), medical and healthcare apps within the fast-paced setting of digital health innovation. It considers medical device regulation, health and social care regulation, product safety and consumer protection laws, Data protection laws, and privacy Requirements. It also looks at the assessment process for healthcare apps in England.

What is mHealth?

Medical software is a subsection of eHealth or digital health, terms which are used to describe medical services delivered by electronic or digital means. mHealth (or mobile health) is the use of wireless (eg mobile) communication devices, such as mobile phones and smart watches, for medical, health and well-being purposes, including medical and healthcare mobile applications (apps). mHealth, therefore, is a specific subsection of medical software that refers to healthcare wireless communication Platforms and apps, whether operated on mobile devices, in the cloud or on other platforms.

Apps for diagnosing, treating and preventing diseases (medical apps) and apps for Monitoring and improving fitness, lifestyle and well-being (referred to

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Jurisdiction(s):
United Kingdom
Related legal acts:
Key definition:
Data protection definition
What does Data protection mean?

In an employment context, this refers to the obligation on an employer to protect the data of its employees and ensure that it complies with the law on how it uses the employees' data.

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