Author: *Rozelle Kane1
1. Academic and Clinical Digital Lead Cambridge, UK
*Correspondence to [email protected]
Disclosure: The author has declared no conflicts of interest.
Keywords: AI, digital health, European health, interoperability, regulation.
Citation: EMJ Innov. 2025;9[Suppl 2]:16-19. https://doi.org/10.33590/emjinnov/HKCG9059
INTRODUCTION
As expected, conversations focused on AI were ever-present, with over 90 panels referencing AI either directly or tangentially, including titles such as ‘Safer, Smarter, Faster: What AI Needs to Work in Healthcare’ and ‘Algorithms at the Bedside: Hype or Help?’.
HLTH provides an intersection of industry ambition, care delivery insight, and strategic investment through which to assess real progress. Of note was the strong presence of panels focused on outcomes-based commissioning and workflow integration, signaling a shift in emphasis from what technology can do to what it must deliver.
Two important evolutions stood out. First, a broader and more confident representation of European health technology companies, with many presenting system-integrated solutions. Second, a meaningful increase in clinician presence across panels and roundtables, both as product builders and as critical friends. These trends signal a global market that is not only innovating but learning how to self-correct.
This feature offers a synthesis of HLTH Europe 2025’s most relevant discussions, focusing on global convergence, the role of clinical voices, regulatory evolution, and what it truly means to scale innovation responsibly.
ELEVATING EUROPEAN HEALTH TECH: FROM EDGE TO CENTRE
From main-stage sessions to exhibitor showcases, companies from Germany, the Netherlands, Sweden, Finland, and Spain shared models of care that prioritise prevention, citizen engagement, and data interoperability. While venture capital still leans heavily westward, the dialogue is changing. The spotlight on EU companies revealed a quieter strength: digital tools embedded into publicly funded systems, with rigorous evidence bases and aligned outcomes.
These conversations were notably reinforced by the presence of government agencies such as Germany’s Bundesministerium für Gesundheit (BMG), the Dutch Ministry of Health, and Nordic innovation authorities, highlighting the strategic alignment between industrial innovation and public service delivery.
Finnish teams played a particularly visible role, with several panels and exhibits focused on real-world evidence infrastructure, patient-held records, and connected data platforms. Finland’s national Kanta Services, with its integrated approach to eHealth, was repeatedly cited as a leading example of how data connectivity and citizen trust can coexist at scale.
These discussions highlighted a key theme: Europe’s competitive edge in digital health may well depend on its ability to harmonise data access policies across borders while preserving the ethical and regulatory safeguards that underpin public confidence.
Among the startups making waves were a Netherlands-based AI triage tool for primary care integration, and a Spanish platform combining remote patient monitoring with behavioural nudges for diabetes management.
Importantly, these companies are no longer seen as ‘early-stage’ disruptors, but as integral to a broader reshaping of global digital health markets.
FROM PITCH TO PRACTICE: CLINICIANS IN THE INNOVATION ECOSYSTEM
A clear evolution from prior HLTH conferences was the prominent integration of clinicians, not just as speakers, but as evaluators, co-developers, and end-users. Sessions such as ‘Docs Who Build’ and ‘Frontline AI: Lessons from Deployment’ showcased practicing general practitioners, hospitalists, and nurses discussing the tangible impacts (and limitations) of digital solutions.
This increased clinical voice reflects a growing understanding that credibility, adoption, and impact are contingent on frontline buy-in and clearer pathways to reimbursement.
Speakers shared examples where co-design improved not only the user interface but also core workflows and patient safety outcomes. In ‘All ears: Ambient listening in healthcare’, Terri Couts, Chief Digital Officer at The Guthrie Clinic, Sayre, Pennsylvania, USA, expressed the importance of context in deploying ambient, and the need for clinical oversight. This shift towards meaningful, multi-level partnership between clinical and technical stakeholders was celebrated as an essential condition for any innovation seeking to move beyond the demo phase.
REGULATION AND REIMBURSEMENT: MATURITY OVER MOMENTUM
Several sessions were devoted to regulatory readiness and reimbursement alignment, especially for AI as a Medical Device. The FDA’s Digital Health Center of Excellence, European regulators, and private stakeholders discussed the pressing need for convergence in standards, especially for adaptive algorithms and real-world validation.
Delegates from the UK and Europe consistently noted that government priorities are shifting towards national digital infrastructure that delivers measurable efficiency, equitable access, and pathway standardisation. However, navigating regulatory landscapes, particularly under evolving frameworks like the EU’s AI Act and Health Data Regulation, remains a persistent challenge for digital-first companies.
In an online article about its new Life Sciences Strategy (LSS), MedTech Europe, Brussels, Belgium, summed up this sentiment well, saying: “Streamlined, predictable, and innovation-friendly rules are essential to ensure timely patient access and global competitiveness.”1
An important thread was the need to embed economic evaluation earlier in the innovation lifecycle. A standout session titled ‘The Business Case for Better Care’ brought together USA payers, NHS commissioners, and global economists to explore how funding decisions could better reward digital tools that reduce inequity, lower long-term costs, or increase care productivity. Outcomes-based reimbursement models were discussed as promising, but hard to implement without standardised metrics and interoperable data.
THE TRANSFORMATION OF REGULATORY FRAMEWORKS FOR DIGITAL AND DATA, EUROPE AND THE UK
The inconsistencies and inefficiencies valuing and evaluating digital tools was a clear theme amongst panels. Whilst familiar pharmaceutical frameworks, like phased evaluations and randomised controlled trials, were referenced, they may struggle to accommodate the rapid iteration and deployment cycles of digital tools. At HLTH, experts proposed hybrid solutions, including adaptive trials, real-world prospective evaluations, and Bayesian approaches that accommodate evolving algorithms while maintaining safety oversight.
Europe’s own regulatory evolution formed part of this discussion. Given the publication of the European Health Data Space (EHDS) regulation in March 2025,2 the delivery of this was in focus. This marks a 2-year journey to conformity with the regulation for member states. Shruti Gangwal, Regulatory Lead, BSI Netherlands, acknowledged in the panel ‘Regulatory as a business enabler for health tech startups’ that the EU had experienced ‘harmonisation’ challenges and highlighted the EU commission’s new life sciences strategy.3
There was broad consensus that robust evaluation that is tailored, proportionate, and repeatable is the cornerstone of trust in digital health. New frameworks must support, rather than replicate, legacy approaches, and regulators must match their ambition to that of the innovators they oversee.
MOVING BEYOND THE PILOT PHASE: THE PROVIDER’s PERSPECTIVE
Another unmissable thread at HLTH 2025 was the growing maturity of implementation discussions. Scale was no longer a vague aspiration, but a detailed operational challenge. Speakers from NHS England, Australia’s Digital Health Agency, and Kaiser Permanente shared lessons on change management, procurement, and governance models. Their reflections were strikingly similar: scaling technology requires as much attention to contracts, training, and workflow integration as to the tool itself.
Implementation teams stressed the need to balance national strategy with local delivery, and to resist vendor lock-in where it undermines long-term flexibility. Shared digital infrastructure, rather than individual point solutions, was repeatedly presented as the endgame.
CONCLUSION: A GROUNDED, GLOBAL, CLINICIAN-LED FUTURE
HLTH Europe 2025 brought an injection of glamour and a can-do approach to the healthcare innovation space. This socialisation of change is really one of the most pivotal pieces to the puzzle.
Congratulations to the team for shepherding a broader, more disciplined, and more globally inclusive conversation. The signals are clear: the future of digital health will not be won in pitch rooms or with patents. It will be shaped in care settings, procurement meetings, policy frameworks, and in partnership with those delivering care.
For the EMJ Innovations community, the opportunity is clear: to build and evaluate technologies that earn their place in systems not only by design, but by delivery.