Supporting innovation: clear approval pathways and evidence standards for AI-driven digital health technologies

The significant growth and advancement of data-driven technologies and the possibilities being unleashed by AI have the potential to revolutionise health and social care delivery. But through my role as NICE’s director of scientific advice, I’ve seen first-hand the problems innovators face when navigating the path to market. They can end up missing important steps or focusing their time and resources in the wrong areas. For practitioners, patients, and the public to benefit from these technological advances and put their trust in them, we must make it easier for developers and adopters to understand what good levels of evidence for digital health technologies look like. We must make approval pathways easier to follow and expectations clearer for all.

Here at NICE, we’ve already begun this important work. Our evidence standards framework for digital health technologies aims to ensure new technologies introduced into the health and care system are clinically effective and offer economic value, by providing universal evidence standards. We expect to publish an updated version of the framework in autumn 2022. This will incorporate digital and data-driven technologies with embedded AI, including those that utilise adaptive algorithms.

NICE is in the process of commissioning an academic partner to work with us, and other strategic partners, on the classification of AI. We are considering the implication of this on evidence requirements and evaluation methods for our health technology assessments. This is exciting, future-focused work and I look forward to sharing our learnings as we progress.

My team here at NICE is also helping to support developers of digital health technologies that have been successfully selected for Phase 4 of the AI in Health and Care Award. Run by the Accelerated Access Collaborative, in partnership with NHSX and the National Institute for Health Research, it aims to accelerate the testing and evaluation of the most promising AI technologies. The award will make £140 million available over 4 years. We are providing a Medtech Early Technical Assessment (META) Tool gap analysis to a number of the winning entries. This is one of our scientific advice services. It aims to identify evidence gaps and key research questions before technologies proceed to guidance development. I’m proud to support this fantastic initiative.

Another project we’re involved with is the development of a multi-agency advisory service. NICE is working in partnership with the Care Quality Commission, Health Research Authority and Medicines and Healthcare products Regulatory Agency to create a single source of information and advice for developers and adopters of AI and data-driven tech.

By assisting developers to navigate the regulatory and health technology assessment landscape, we can help them to focus on key issues early in development. This should make the journey from proof-of-concept to market more efficient and ensure that technology developers have the right evidence and approvals when they approach commissioners and adopters. In addition, adopters tell us that they have low levels of awareness of best practice in identification, adoption and deployment of this type of technology. Providing information and advice in these areas should help to facilitate operational efficiencies, improved clinical outcomes and cost savings. We envisage that the tools approved for use will be those that bring the most benefit to people using heath and care services.

Last month, I was pleased to join my system partner colleagues on the panel of an NHS AI Virtual Hub event about the new service. The project is still in the early stages of development but we received a great deal of interest and welcomed a broad range of participants. If you were not able to join, a recording is now available on the NICE YouTube channel.

Help shape the new service

We're inviting developers and adopters of AI and data-driven technologies to register to help shape the new advisory service. If you expect to become a future user of the service and would like to take part in its development, now is your opportunity to get involved. Engagement could include:

• interviews

• Q&A sessions

• user testing

• consultations.

With your input, we plan to launch the new service in spring 2022.

NHS AI Lab is funding the development of the multi-agency advisory service. The AI Lab was established to help address the challenges faced by those developing, commissioning and adopting AI technologies.