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23 Aug 2019

App Regulation: NICE's Evidence Standards Framework


Staying up-to-date with the latest app regulations and standards is essential for app developers.

National Institute for Health and Care Excellence’s (NICE) Evidence Standards Framework for Digital Health Technologies shows the value of digital health technologies in the UK health and care system by requiring apps to provide evidence of their effectiveness.

Due to the rapid development of digital health technologies, these standards require apps to demonstrate a high level of clinical effectiveness. According to Public Health England, this includes providing evidence that an app improves outcomes for patients and users, provides value for money, meets user needs, as well as that it is stable and simple to use, and that people actually use it.


There are a number of key points to consider when incorporating NICE’s Evidence Standards Framework into app development:
  • How the framework defines risk:
Within NICE’s Framework, digital health technologies can be classified by their potential risk. Risk to service users is defined as the chance of harm coming to the service user from using the digital health technology, including health and wellbeing consequences if there is not good quality care provided by the technology. Economic risk is defined as the chance of harm coming to the commissioning organisation from the digital health technology, including commissioning a technology that needs services to be redesigned.
  • Functional classification for technologies with more than 1 function:
The highest risk function of digital health technologies should be used to define its functional classification. For example, providing treatment would be the highest risk function in an app that provides information on and treatment of a condition.
  • Health/fitness trackers and other similar apps:
The framework applies to digital health technologies being considered for commissioning within the UK health and care system, including health/fitness trackers and other similar apps. In this sense, the framework can be applied to apps for use by the wider public, as well as those that cater to specific health and care needs.

Click here to read NICE’s full Evidence Standards Framework for Digital Health Technologies, and here to access their user guide.

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