Evidence standards framework for digital health technologies

Regulation and technical standards

The NICE ESF is designed to stand alongside other standards, regulation and guidance from national bodies about using digital health technologies (DHTs), including data-driven technologies in the UK health and care system.

The regulatory landscape for digital healthcare and artificial intelligence (AI) are still at a formative stage. Regulation and best practice guidance are likely to change significantly over the coming years as we learn how best to manage the risks and benefits of digital and AI healthcare.

In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for the regulation of safety, quality and efficacy of medical devices including software as a medical device. The MHRA has announced the Software and AI as a Medical Device Change Programme, which aims to ensure that medical device regulation is fit for purpose for software, including AI.

The Care Quality Commission (CQC) regulates and inspects health and social care services in England. CQC does not provide detailed guidance on the adoption of technologies but some technologies that are used in the delivery of care may be within the remit of CQC inspections.

We will continue to review and update the NICE ESF to ensure that it is up to date with the regulatory landscape in the NHS.

The exact regulatory requirements applicable to each DHT will depend on its intended purpose and where in the health and care system it is intended to be used. Many of the DHTs covered by the ESF are not within the remit of regulation by the MHRA or the CQC. However, there are technical standards and guidance that are relevant to these DHTs. For example, a DHT designed to improve efficiency should meet the requirements of ISO 82304‑1 for healthcare software.

Standards in the health and care system

The NHS has also developed some standards to help ensure DHTs used within the health and care system meet the expected technical standards. The Digital Technology Assessment Criteria (DTAC) is designed to give staff, patients and citizens reassurance that all DHTs used in the NHS meet national standards. These criteria are based on legalisation and best practice across 5 categories. DHTs can pass or fail in 4 categories: clinical safety, data protection, technical security and interoperability, and obtain a score in the 5th: usability and accessibility.

Health technology evaluation and NICE

NICE has produced the ESF to help evaluators in the health and care system to assess DHTs. NICE also develops guidance on DHTs, does its own evaluations of DHTs that are regulated as medical devices or in vitro diagnostics, and publishes guidance or advice as a result of these evaluations.

NICE guidance includes an in-depth evaluation of the clinical and cost effectiveness of a DHT that is considered for use in the NHS across England. The evaluation is usually done within the NICE medical technologies evaluation programme (MTEP) or diagnostics assessment programme (DAP), depending on the intended purpose of the DHT. The evaluation process takes around 1 year and includes the appraisal of the evidence by an independent committee supported by professional and patient experts. It results in a recommendation about whether the DHT should be used by the NHS or not. More information about the development of NICE guidance for DHTs is in the section on MTEP in NICE health technology evaluations: the manual.

NICE advice is produced by a faster process that does not include a recommendation on NHS use. Instead, NICE advice (such as medtech innovation briefings; MIBs) includes a description of a regulated medical device or in vitro diagnostics, and its place in the care pathway, a critical appraisal of the available evidence and some expert opinion. More information is on NICE's webpage on medtech innovation briefings.

Meeting the evidence standards in the ESF does not constitute a NICE evaluation, NICE recommendation or endorsement, nor NICE guidance. The ESF is not an entry point to these programmes.

The ESF has been designed to include some areas that are common to NICE evaluation programmes. These include demonstrating effectiveness and showing a value proposition. An assessment of health inequalities would also be included in a NICE evaluation. The deployment considerations included in the ESF would be considered to be outside of scope for NICE guidance or advice.