DIME PROJECT

Accelerating market access for digital health in the EU and UK

A collaborative, AI-queryable roadmap to bring proven digital health technologies to patients across Europe, faster.

A digital health technology can be approved for sale in Europe and still take years to reach patients.

Approval is only the first step. Decisions about evidence, payment and adoption are made separately in each of the 27 EU Member States and again in the UK. DiMe is bringing together technology developers, health systems, regulators and policymakers in a 10-month project to map these requirements and build an AI-powered roadmap. Any team will be able to ask it, in plain language, which rules apply to its product, in which country, and in what order.

THE CHALLENGE

Europe has built a remarkable body of rules for digital health. The Medical Device Regulation, the EU HTA Regulation, GDPR, the AI Act and the European Health Data Space each set requirements that are well documented on their own. Together, they have never been reconciled. Reimbursement remains a national decision, made through different procedures in every Member State, and since Brexit the UK has built its own parallel system with UKCA, UK MDR, DTAC and more.

The result is a landscape where clearance is only the beginning:

Every market needs its own strategy

Most EU countries have no formal pathway for digital health, so companies rebuild their case country by country.

Evidence expectations don’t fit the technology

RCTs are often impractical for software, real-world evidence is increasingly demanded but hard to collect, and assessments built for static devices struggle with products that update continuously.

The rules are still moving

Joint clinical assessments for high-risk devices began in 2026 under the EU HTA Regulation, and the AI Act’s high-risk obligations for AI-enabled medical devices apply from August 2028.

Timelines outrun runways

Reimbursement processes are neither transparent nor uniform, and the burden falls hardest on small and mid-sized companies, which must commit resources before they know which standard will apply to them.

Every month spent decoding the system is a month that a proven technology isn’t reaching the patients who need it.

OUR APPROACH

Translational clarity, built together.

Developers need a clear, applied view of which frameworks matter for their product, in which country, and in what order. DiMe is convening DHT developers, adopters, notified bodies and policymakers in a fast-paced, 10-month pre-competitive project to build exactly that.

Together, we will:

Catalog and curate the regulations, HTA methods, reimbursement procedures and standards that shape market access for digital health across the EU and UK.

Build a knowledge engine that reconciles them and maps which requirements apply to which types of DHTs, under which circumstances.

Run a gap analysis to pinpoint where friction and uncertainty remain highest, especially for evidence standards and AI-enabled technologies.

Design and launch an interactive roadmap, queryable in plain language, so any team can ask about its product and target market and get an answer grounded in curated sources.

Partners shape the scope from month one, so the roadmap answers the questions the field is asking.

WHY JOIN

Shape the resource Europe will use, and lead in building it.

As a founding partner, you will:

Set the scope. Partners decide in month one which markets, product types and questions the roadmap covers first.

Plan with clarity. See which requirements apply to your products, compare markets and allocate evidence spend before you commit it.

Be recognized as a leader. Partners are named as the organizations that built the roadmap, featured at the launch event and in DiMe’s PR and outreach, with the chance to showcase your work as a case study.

Learn alongside peers. Work through the hardest market access questions with developers, notified bodies and policymakers in a pre-competitive setting.

Partners shape the scope from month one, so the roadmap answers the questions the field is asking.

This project builds on resources the field already relies on:

International Regulatory Pathways mapped how digital health gets cleared in eight countries, including England, France and Germany. This project picks up where that work ends, at HTA and reimbursement.

The DHT Adoption Navigator proved the model: an interactive, AI-queryable roadmap that helps life sciences teams adopt digital endpoints.

DiMe’s foundational resources, including the V3+ framework, have been accessed hundreds of thousands of times and are referenced by regulatory authorities.

DiMe research is pre-competitive, multi-stakeholder and built to clinical-quality standards on a tech timeline.

GET INVOLVED

Shape the resource Europe will use, and lead in building it.

DiMe invites digital health and medtech developers, life sciences companies, notified bodies, policymakers, associations and health systems to join as founding partners. Founding partners shape the scope before kickoff, so the sooner you join, the more the roadmap reflects your markets and your questions.

Together, we will give every proven digital health technology a clear route to patients across Europe.

Express your interest