‘European Health Data Space - a challenge for Europe’ - report

On 26 March, the day of the entry into force of the European Health Data Space (EHDS) - a regulation of the European Parliament - the conference ‘European Health Data Space - the Challenge for Europe. Implementing solutions in the era of AI, Big Data and personalised medicine'. The event was organised by the President of the Personal Data Protection Office together with the Faculty of Law and Administration of the University of Warsaw, the Faculty of Medicine of the University of Warsaw, the Institute of Legal Sciences of the Polish Academy of Sciences and the Supreme Medical Chamber.

The conference was opened with introductory speeches by: Prof. Adam Niewiadomski - Vice-Rector of the University of Warsaw, Prof. Sławomir Żółtek - Dean of the Faculty of Law and Administration of the University of Warsaw, Prof. Bolesław Kalicki - Head of Clinical Studies at the University of Warsaw, Grzegorz Sibiga - deputy director of INP PAN, Mirosław Wróblewski - President of the Personal Data Protection Office, Łukasz Jankowski - President of the Supreme Medical Council, Grzegorz Cessak, PhD, - President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, and Konrad Zawadzki - deputy director of the Centre for Biological and Chemical Sciences at the University of Warsaw.

‘The EHDS in a way is a child of the Covid-19 pandemic, because that time made everyone realise that it was necessary to ensure the electronic exchange of medical records between European countries,’ pointed out Miroslaw Wroblewski, President of the Personal Data Protection Office.

As he also pointed out, ‘the EHDS represents a unique value for the development of both medicine and life sciences’, while ‘from the point of view of the Personal Data Protection Office, the most important aspect in the context of EHDS implementation remains ensuring the protection and security of personal data, which, after all, is at the same time about fulfilling patient rights’. - he added.

The conference was preceded by a lecture on the issue of biobanking and medical data in the age of artificial intelligence. As it turns out, there is still no act on biobanking in Poland, while quality standards and codes of conduct in this area can

Among the main topics of the conference, divided into four thematic panels, there were issues related to the models of implementation of the EHDS in the EU Member States, the challenges that Poland faces under this Regulation, including the need to create an adequate infrastructure and a secure processing environment; the problems around the designation of health data access authorities in the Member States and their role in the processing of these data; with the tasks of supervisory authorities in the context of the Regulation (including the role of the Personal Data Protection Office), a number of issues related to the secondary use of data in the context of the Regulation, and the legal issues that will arise under the EHDS, and the anticipated impact of the Regulation on the availability of medicinal products or the issue of providing funding.

Relevant issues touching on EHDS that emerged during the panel speeches include these: this Regulation is not the only common space of the European Union when it comes to data flows, as similar ones also apply to finance, energy, industry or public administration, for example. Interestingly, the EHDS also constitutes a breach in the application of Article 9 of the GDPR, as in the European Health Data Space there is the possibility of processing special category of personal data for research and innovation without asking for consent of the data subjects, which is a kind of change of trend in EU policy; important institutions that will control the processing of medical data in Poland, providing the infrastructure for this, will be, among others, Regional Centres for Digital Medicine.

The event also provided a venue for the resounding desire of various actors, both in the private and public sectors, to work together to effectively implement the objectives of the Regulation.

The lectures and discussions were also attended by employees and colleagues of the Personal Data Protection Office: Krzysztof Król - Deputy Director of the International Cooperation Department of the Personal Data Protection Office, who moderated the panel ‘The role of supervisory authorities in the field of personal data protection, AI and cyber security in the implementation of the EHDS’, Piotr Drobek - Director of the Innovation and Data Management Department of the Personal Data Protection Office, who moderated the panel ‘Secondary use of personal data’, Anna Korzecka - Deputy Director of the Law and New Technologies Department of the Personal Data Protection Office, who gave a lecture ‘The legal position of the supervisory authority in the light of the assumptions of the EHDS’, and Arwid Mednis, PhD, from the Social Team of Experts to the President of Personal Data Protection Office, who presented the topic ‘Rights of data subjects - comparison of the rights under Regulation 2025/327 with the rights under GDPR’.