Developers

All developers' guidance

Explore the regulations and best practice principles related to AI and digital technology in health and care.

Technology idea

Steps to consider Why is it important? Guidance type
Is your technology a medical device? It’s your responsibility as a developer to determine whether your digital healthcare technology is a medical device. Required
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
Determining the intended purpose of your software medical device You need an intended purpose statement to place your medical device on the UK health and social care market. Required
Aligning the intended purpose and value proposition Aligning the intended purpose and value proposition of your digital technology is vital to placing your technology on the health and social care market. Best practice
Understanding UK MDR 2002 regulations for medical devices To place a medical device on the market, there are certain requirements you need to meet. Required
Planning for management systems, including a quality management system If you're building a medical device, you need to implement a quality management system. Required
Planning for evidence generation Plan for evidence generation that proves your digital technology is safe, and clinically and cost effective. Best practice
Understanding routes to NICE health technology assessment Understand how NICE does health technology assessments. 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
Generating evidence for screening tests used by the NHS If you’re developing screening tests for the NHS, you will need to generate specific evidence which meets a higher bar. Best practice
Complying with Ionising Radiation (Medical Exposure) Regulations (IR(ME)R) IR(ME)R governs the safe use of medical devices that use ionising radiation. Required
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

Technology development

Steps to consider Why is it important? Guidance type
Getting a UKCA mark Before you place medical devices on the market in England, Wales and Scotland you need to get a UK Conformity Assessed (UKCA) mark or a relevant CE mark. Required
Meeting quality management system requirements To meet the requirements of the law you need to create and maintain quality management systems (QMS) for medical devices. Required
Meeting risk-management requirements for medical devices To deploy a compliant healthcare technology safely, you need to implement a risk management system. Required
Meeting design requirements of the UK Medical Device Regulations To meet UK regulations, you need to show you’ve designed medical devices to the appropriate safety standards. Required
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
Does your medical device need a clinical investigation? To get a UKCA mark for your medical device, you may need to prove its safety through a clinical investigation. Required
Demonstrating clinical performance with a Clinical Evaluation Report (CER) To get a UKCA mark for medical devices, you need to include a Clinical Evaluation Report (CER) in your application documentation. Required
Generating evidence for NICE health technology assessment If you want NHS England to adopt your digital technology, undergoing a NICE health technology assessment can help. Here is what you need to consider. 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

Placing a technology on the UK market

Steps to consider Why is it important? Guidance type
What it means to place medical devices on the UK market Here's what placing a product on the market means in relation to medical devices. Required
Registering your medical device Before you place medical devices on the market, you should register each device with the MHRA. Here’s how. Required
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

Technology in use

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
Post-market surveillance of medical devices After your medical device is placed on the UK market, you should monitor the device and report any safety incidents to the MHRA. This is known as post-market surveillance. 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

Updating your technology

Steps to consider Why is it important? Guidance type
Changing your technology after deployment When updating digital technologies or medical devices that are already on the UK health and social care market, you will need to follow certain requirements. Required
Improving or updating digital technologies after deployment What you need to consider when you improve or update an already live technology. Best practice

Regulations that govern the use of data

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

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