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 test these approaches with the digital health community.

We are offering grants of up to £10,000 and further support for about 6-8 teams who are going through or facing a journey through the regulatory process, or who are otherwise interested in regulation issues. Projects will run in the period July 2025 to January 2026.

The proposed work should be in digital health (including AI for healthcare) and support your and/or others’ regulatory journey. 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 more broadly to support your regulatory journey, if applicable. We will make our expertise available to you and you, in turn, will agree to act as early stage testers 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:

• Do an analysis of how regulation will impact your plans for the market access of your innovation

• Do an analysis of how different design choices in a product will impact what regulation it is subject to

• 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 how providers in a particular field are or are not going through a regulatory process

• Analyse past regulatory submissions

• Carry out post-market surveillance

• 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

• up to £10,000 funding

• early access to our support products (requirements engineering model, collaboration platform etc.)

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

• collaboration to develop research bids

We expect

• participation in our research (interviews, focus groups)

• trialling our products (requirements engineering model, collaboration platform etc.) 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