| Steps to consider | Why is it important? | Guidance type |
|---|---|---|
| Creating a value proposition | If you want your digital technology to be placed on the UK health and social care market, you’ll need to create a value proposition. | Best practice |
| Planning for evidence generation | Plan for evidence generation that proves your digital technology is safe, and clinically and cost effective. | Best practice |
| Data quality considerations for training and testing | Successful digital technologies in health and social care are trained on high-quality machine learning datasets. To build healthcare technologies that adopters will buy, prioritise data quality. | Best practice |
| Researching user needs | If you do not understand user needs, your digital technology is not likely to meet them, and so adoption of your technology will be unlikely. | Best practice |
| Complying with NHS Digital clinical risk management standards | If you want to sell your digital technology to the NHS, or adopt a technology on behalf of the NHS, you need to meet certain safety standards. These are set by NHS Digital. | Required |
| Using the Digital Technology Assessment Criteria (DTAC) | Meeting the Digital Technology Assessment Criteria (DTAC) makes it more likely that adopters will buy your healthcare technology. | Best practice |
| Understanding technical standards for digital technology | To increase trust and confidence in your digital technology, you should show compliance with technical standards. | Best practice |
| Implementing a quality management system for your technology | Although not legally required for non-medical devices, implementing a quality management system (QMS) is best practice and essential to placing your technology on the market. | Best practice |
Developers - Regulations for non-medical devices
Explore the regulations and best practice principles related to AI and digital technology in health and care.
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| Steps to consider | Why is it important? | Guidance type |
|---|---|---|
| Designing clinical studies and choosing evaluation methods | You need to regularly evaluate your digital technology to show adopters and assessors it’s effective and safe. | Best practice |
| Generating evidence for NHS adopters of digital technology | If you want the NHS to adopt your digital technology, you will need to generate evidence that supports your technology’s value proposition. | Best practice |
| Qualitative research: collecting data on your digital technology | Qualitative research will give you a much richer understanding of how a user interacts with your digital technology. | Best practice |
| Steps to consider | Why is it important? | Guidance type |
|---|---|---|
| Check if you need to register with the Care Quality Commission (CQC) | If you are providing Care Quality Commission (CQC) regulated activities, you are legally required to register with them. | Required |
| Steps to consider | Why is it important? | Guidance type |
|---|---|---|
| How Care Quality Commission regulates health and social care services | If you provide a health and social care activity in England, you may need to comply with regulations from the Care Quality Commission (CQC). | Required |
| Ongoing research and service evaluation of your digital technology | Plan for ongoing research and evaluation upfront to prevent the delay or further development of your digital technology. | Best practice |
| Steps to consider | Why is it important? | Guidance type |
|---|---|---|
| Improving or updating digital technologies after deployment | What you need to consider when you improve or update an already live technology. | Best practice |
| Steps to consider | Why is it important? | Guidance type |
|---|---|---|
| Data regulations for digital health technologies: a guide | Throughout the course of your digital technology’s lifecycle, you will need to process health and social care data. Find out what legal requirements govern the use of this data and when to get research approval. | Required |
| Understanding types of health and care data | Two types of health and care data can be distinguished to help you determine when the relevant legal and regulatory frameworks apply. | Required |
| Understanding laws that regulate the use of health and care data | Get a summary of the UK General Data Protection Regulation (UK GDPR) and the Data Protection Act 2018 (DPA 2018). | Required |
| Using data during your digital technology lifecycle | At each stage of your technology’s lifecycle, you will need to use data. Find out which type is best for each stage of the development lifecycle. | Required |
| Proof-of-concept: using anonymous or artificial health data | What to consider when using anonymous or artificial health data. | Required |
| Using health data during technology development | You may need to use personal data during the development stage of the technology. You need to have a lawful basis for doing so under data protection legislation. | Required |
| How to comply with the UK GDPR as a developer | If you are using personal data, you are obliged to protect this data and comply with data protection law principles. | Required |
| Common law duty of confidentiality | You will need to get explicit consent from a patient before sharing confidential information collected about them when they were receiving care, unless there is another legal basis. | Required |
| Deploying your digital technology: using personal health data | The processing of personal data in the delivery of care (such as in the live deployment of a healthcare technology) is for direct care. | Required |
| Post-market: compatibility of technology with existing systems | When deciding whether to buy a digital technology, potential adopters will consider whether the technology is compatible with their existing systems and infrastructure. | Required |
| Extra reading on data regulations | Get extra resources on data processing here. | Best practice |
Other helpful links
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Glossary
Demystify the complex world of digital health regulation terminology with our glossary.
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Using this service
Learn how to use this service as a developer or adopter of AI or digital health technologies.
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Medical device classification
Use our guidance to help you determine if your technology is a medical device.