Regulation - Digital product or service

This means digital health and care technologies including apps, software, artificial intelligence (AI) and digital platforms or services.

If you would like to understand what regulations apply to digital health technologies (DHTs), and how to meet them, visit the AI and Digital Regulations Service. You can learn more about what regulations to follow and how to evaluate effectiveness. The website is aimed at both developers of AI and digital technology, or adopters who will buy or use DHTs in health and social care.

If you are thinking of building a digital service, you should consider whether to include an Application Programming Interface (API) as part of your service. APIs allows other digital services and applications to connect to your service to send or receive information, and they promote integration and also digital innovation. NHS England (formally NHS Digital) has an API platform that makes it easier to build APIs for health and care. For more details, see the API platform page on the NHS England (formally NHS Digital) website.

There is a set of national baseline criteria for DHTs entering the NHS and social care. It is governed by the Digital Technology Assessment Criteria (DTAC) for health and social care. DTAC is designed to be used by healthcare organisations to assess suppliers at the point of procurement or as part of a due diligence process, to make sure new digital technologies meet minimum baseline standards. For developers, it sets out what is expected for entry into the NHS and social care. You can download the assessment criteria on the DTAC website. If your innovation uses personal data, then you must comply with the Data Protection Act. This is also covered within DTAC.

NICE has published an evidence standards framework (ESF) for digital health technologies. The ESF is intended to be used by technology developers to inform their evidence development plans, and by decision makers who are considering commissioning a digital health technology. The framework is made up of a section on evidence for effectiveness standards and another section on evidence for economic impact standards. Read more on how to use these standards.

Some software applications are considered to be medical devices. If your innovation falls under this category, then you should meet the requirements of the UK MDR 2002 and register the innovation with the MHRA.