At the RADIANT CERSI, we know that the regulation of digital health and AI in healthcare are challenging areas for developers and innovators, as we discuss in our prior research.

We are exploring various approaches to help the digital health and healthcare AI community, including structured ways in which software (including AI) can be developed while continuously meeting compliance requirements. We wish to develop and evaluate collaboratively these approaches with the digital health community.

We are offering grants of up to £10,000 to 6–8 teams who are facing and addressing regulatory challenges in digital health and AI in healthcare.

You are eligible to apply if:

• You are currently navigating the regulatory process and wish to share your challenges and learning with the RADIANT-CERSI community, or

• You are engaged in regulatory issues and have developed practical solutions or insights to overcome challenges in this space.

This is an exciting opportunity to share what you’ve learned and help shape the future of healthcare innovation. PROJECTS WILL RUN IN THE PERIOD JULY 2025 TO DECEMBER 2025.

We discuss types of projects below, but we are very happy to discuss a range of projects. If you have a good idea, but you are uncertain if it fits the brief, do get in touch.

Applicants can be companies (including social enterprises), academics, clinicians, or charities. You need to operate in the UK, but you can be facing regulatory challenges beyond the UK.

You need to describe a specific project. In addition to this, we will work with you to make the challenges you encounter, the suggestions and solutions on how to solve them more broadly beneficial to the community of innovators. We will make our expertise available to you and you, in turn, will agree to act as early stage evaluators of our ideas and products. You will also agree to produce a publicly available report about your funded project and broader journey.

Our definition of regulation as relating to digital health and healthcare AI is broadly-scoped but includes software-as-a-medical device, AI-as-a-medical device, data regulation, and AI regulation (i.e., the EU AI Act).

Examples of projects

A project could be around understanding regulatory issues to support market access of a new technology, presenting evidence to support a regulatory application, or working with end users. You could:

• Analyse the impact of regulation on a product or sector, e.g. costs

• Consult with clinicians, patients or other stakeholders on a relevant topic to enhance important aspects of your innovation that matter in the regulatory approval (e.g., trust that a product is safe, explainability, etc.) 

• Analyse how standards vary internationally for the regulation of a particular technology

• Analyse past regulatory submissions

• Describe how you are implementing or have implemented a post-market surveillance plan for your product

• Develop a resource to help others’ regulatory journey, e.g. a framework or a chatbot

• Study expectations around regulation among your stakeholders

We offer

• advice and mentorship to make your regulatory journey/solutions/recommendations more impactful

• up to £10,000 funding

• invitations to take part in our programme of seminars, workshops and roundtables in regulatory science for DH and HAI

• collaboration with student projects, possibly multi-year with PhD students

• collaboration to develop research bids

We expect

• participation in our research (interviews, focus groups)

• contributing and evaluating RADIANT-CERSI toolkit and helping us to refine them

• interaction with the RADIANT network and activities, including stakeholder groups

• openness of results: willingness to publish a report on your project

• consideration of future research funding applications within the RADIANT network