An opinion article published in Dagens Medisin, Norway’s leading independent professional and news outlet for the health and care sector, highlights the need for stronger governance of digital health in Europe and points to Health Technology Assessment (HTA) as a key tool for informed decision-making.

The article, authored by Line Linstad and Line Silsand, our partners from the Norwegian Centre for E-health Research, references the EDiHTA project in the context of developing approaches that can better support the evaluation of digital health technologies. It argues that while traditional HTA has been developed mainly for medicines and medical devices, digital health solutions, including apps and AI tools, require more adaptive and lifecycle-based assessment methods.

The article underlines the relevance of EDiHTA’s work towards a digital health technology assessment framework that can support evidence-based, sustainable and patient-centred digital transformation in healthcare. EDiHTA aims to develop and validate a comprehensive framework for evaluating digital health technologies in real healthcare environments.

Follow this link to read the article in Dagens Medisin.

The English translation of the article is available below.

Europe lacks governance of digital health — HTA could be the key

Europe stands at a crossroads in the digitalisation of healthcare. The experience of the digital COVID certificate demonstrated that secure, cross-border use of health data is both possible and politically feasible when urgency demands it. This gave momentum to the development of the European Health Data Space (EHDS).

EHDS provides data, but not governance

The ambition is considerable: to establish a shared European infrastructure for health data that supports treatment, research, and innovation. EHDS is more than a data-sharing project — it is an entirely new knowledge infrastructure for health decisions, regulation, and innovation.

However, EHDS does not in itself resolve what is perhaps the greatest governance challenge: how should authorities actually prioritise between an ever-growing number of digital solutions, with varying levels of documented effectiveness, rapid development cycles, and significant resource demands?

HTA as a tool for responsible decision-making

To realise the full benefits of EHDS, we need tools that can translate data into a sound basis for decisions. This is where Health Technology Assessment (HTA) becomes critical. HTA is a governance tool that gathers and evaluates research-based knowledge as the foundation for strategic and policy decisions. HTA provides systematic assessment of benefit, risk, and value, and can build confidence in which digital health services actually work.

This evidence base is essential for authorities to determine which technologies should be adopted and which should be phased out of healthcare.

Technology evolves faster than assessments

Current HTA frameworks were developed for pharmaceuticals and medical devices — not for digital health services that are data-driven, adaptive, and continuously evolving. How does one assess an app or an AI tool that is updated frequently?

We need lifecycle-based and adaptive HTA that keeps pace with technological development and the use of real-world data. This is precisely where EHDS could become the enabler of digital health service evaluation, both in Norway and across EU member states.

New knowledge through the EDiHTA project

The EU project EDiHTA (European Digital Health Technology Assessment) addresses this challenge directly. The project develops shared European frameworks for how digital health technologies can be assessed throughout their entire lifecycle.

The Norwegian Centre for E-health Research is an active contributor, with the aim of linking data infrastructure and decision-making processes in a way that genuinely strengthens the scope for political action.

From knowledge to decision-making power

This points to a central gap in knowledge: we still know too little about how HTA and data infrastructure can be incorporated into an operational governance tool for authorities. Without such a link, EHDS risks becoming a data platform without clear political direction, and digitalisation a series of isolated initiatives without coherent prioritisation.

For European decision-makers, this is therefore not simply a matter of technology — it is a matter of governance. Who decides which solutions are to be adopted? On what basis? And how do we ensure that investments in digital health actually deliver better services, more equitable access, and sustainable health systems?

If Europe is to succeed in the digital transformation of healthcare, HTA must be elevated from a technical instrument to an integral part of political and strategic governance. EHDS provides the data foundation. A modernised, digitally adapted HTA framework provides the decision-making power.

The link between the two may prove decisive in determining whether Europe takes a leading role in developing a responsible, evidence-based, and sustainable digital health service — or is left with fragmented solutions and weakened governance.

Fact box:

EHDS (European Health Data Space) is described by the European Commission as a shared framework for the use and sharing of health data, supporting research, innovation, and policy. HTA is a tool for assessing the medical, economic, social, and ethical dimensions of health technology. The EU’s HTA framework also facilitates joint clinical assessments and more coordinated European collaboration, making the combination of EHDS and HTA particularly relevant in a governance context.