The way Europe assesses new health technologies has changed, and the scope is widening every year. Since 12 January 2025, every new cancer medicine and advanced therapy medicinal product (ATMP) entering the European Union has been subject to a Joint Clinical Assessment (JCA) under the EU Health Technology Assessment Regulation (HTAR, Regulation (EU) 2021/2282). The remit grows from here: high-risk medical devices and Class D in vitro diagnostics (IVDs) phase in from 2026, orphan medicinal products from 2028, and all remaining medicinal products from 2030. Each year a larger share of the pipeline will be assessed jointly, and the clinical evidence behind these products will be examined against a common European standard.
In June 2026 the European Commission published the first JCA report, on tovorafenib (Ojemda), an orphan medicine for paediatric low-grade glioma. It is an early but concrete signal of what assessors expect from the evidence behind a new technology, and the expectations are demanding. For any team developing digital measures, the message is clear: the time to build evidence that meets these expectations is now, not at submission.
Accelerating and widening access to safe, effective and innovative health technologies that bring value to patients and the healthcare system is essential for improving health outcomes, reducing disparities, and supporting sustainable, patient-centred care in an increasingly complex and resource-constrained environment. As joint assessment becomes the default route for more products, the quality and comparability of the underlying evidence determines whether innovation reaches patients quickly or stalls in repeated national reviews.
The first JCA report offers two lessons that bear directly on digital measures. First, the assessment scope was defined through a broad set of PICO questions spanning several patient populations, and the developer was able to submit evidence against only part of them. Second, the pivotal trial lacked a direct comparator, so the relative effect rested on an indirect comparison that the assessors judged highly uncertain. The pattern is consistent across HTA practice: assessors reward evidence that is comparative, relevant to the populations in scope, and measured with instruments they recognise and trust.
Although the JCA is an EU instrument and NICE operates in UK, the expectations it codifies travel well beyond Europe. NICE and other HTA bodies are watching the comparative, outcome-focused standard the JCA is setting, so analysing the first published report is useful for any developer planning HTA interactions in any jurisdiction. A digital measure that satisfies one national question but cannot support a robust comparison across populations will struggle wherever it is assessed.
The scope of a JCA is set through the PICO framework: Population, Intervention, Comparator, and Outcome. Because member states can each request their own combinations of population, comparator and outcome, a single product can face many PICOs at once, as the first report showed. Digital measures bear most directly on the Outcome element, and well-designed measures also help define and characterise the relevant populations.
A digital measure that is validated, fit-for-purpose and sensitive to change can supply a patient-relevant outcome that holds up across multiple PICOs and comparators, rather than one that answers only a single national question. This is often where evidence either survives joint assessment or falls apart, and it is where a structured, standardised approach to building digital measures makes the difference.
Technology and regulatory complexity. Digital health technologies (DHTs) evolve quickly, while regulatory and HTA requirements differ across bodies and jurisdictions. Developers must satisfy regulators and several HTA bodies at once, often with evidence that was not designed with joint assessment in mind. Without a clear, shared approach, the same digital measure is re-justified again and again, which slows access and inflates cost.
Mission members (interested parties) will select a use case to serve as a proof of concept for how:
1) Simulation Workshop
2) Case Study Generation
3) Evaluation and Proof of Concept
4) Submit to NICE
5) Review Outcomes
Join DEEP and other sponsors on this mission to take the right steps towards successful HTA interactions!
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