Unleashing the power of data in Health

The deal on the European Health Data Space will provide European’s with better control over their personal health data and enable greater privacy

By Maria da Graça Carvalho

Maria da Graça Carvalho (PT, EPP) is Parliament's Rapporteur for the proposal for a Council regulation establishing the Joint Undertakings under Horizon Europe

05 Apr 2024

The European Parliament, the Council and the Commission have finally sealed the deal on what is, without exaggeration, a landmark in the history of healthcare in Europe. With the European Health Data Space (EHDS), we are one-step closer to unleashing the enormous potential of data for heath.

The EHDS is a part of the digital transition, which is one of the major pillars of the EU’s long-term strategy. A strategy that can be traced back to the General Data Protection Regulation, published in 2016, but that received a major impulse during the present legislature.

Among the many legislative files approved over the last few years are the Data Governance Act, the Data Act – of which I was negotiator for the EPP – and, more recently, the Artificial Intelligence ACT (IA ACT), in which the EU is a pioneer.

All these files share two prerogatives: the goal of ensuring that the European Union achieves leadership in the development and use of new technologies; and the assurance that this is done under the frame of a strong set of ethical principles.

Presently, we are already in the process of creating the practical conditions to implement this reform. For example, I am rapporteur for the ‘AI Factories’ regulation, recently approved at the ITRE committee in the European Parliament, which is an amendment to the regulation of the European high-performance computing joint undertaking (EuroHPC) aimed at ensuring that the new European network of supercomputers is fit for the purpose of Artificial Intelligence.

We need AI to harness the potential of data, and we need data for virtually every field. The potential of data for Health, however, sits in a category of its own.

Data can greatly improve the understanding that policy makers, health professionals and researchers have of diseases, thus leading to better public health strategies, better drugs and therapies. It can improve hospital practices, saving lives and achieving cost-effectiveness gains in the process. It can accelerate the development of vaccines. It can allow health experts to develop individualised, less-intrusive, therapeutic approaches, to the benefit of the patients.

The list of possibilities is endless and we finally have the legal architecture, including the EHDS and all the other files that I have mentioned, to start turning possibilities into realities.

Formally, the main goal of the EHDS is to grant all EU citizens a better control over their personal health data. Including allowing patients to access their clinical histories while travelling in the European Union, using this information to pick-up prescriptions in different Member-States and willingly sharing it with health professionals for treatment purposes. This is what we call the primary use of health data. However, in my view, it is the secondary use of this information, by researchers and national authorities, which promises to be a game changer.

Keeping control of the information in the hands of the citizens was a prerogative for the European Parliament. The final agreement includes an opt-out clause for patients that do not wish to share their health data, leaving the decision on whether to include this clause in the hands of individual Member States.

However, I am convinced that the majority of Member-States will choose this path. Furthermore, I also believe that most patients, once given all the assurances about the restricted and anonymous nature of the information shared, will understand its tremendous potential for the common good.

In partnership with


This article was produced in partnership with Roche.