🇨🇿 EHDS – New Era in European Health Data Regulation: More Patient Rights and a Gold Mine for Research and Innovation

The event is held in Czech language only!

Today, health data are generated during the provision of care, in the area of reimbursement, through the use of medical devices, in clinical research, and in the day-to-day operation of healthcare systems. However, their processing is no longer governed solely by the GDPR. New European legislation also governs access to data, data sharing, portability, and further use for research, innovation, regulatory activities, or public health. The webinar will focus on the EHDS Regulation and the second part of the so-called “Digital Omnibus,” which contains amendments to the GDPR and a new Data Act.

The EHDS Regulation was adopted in February 2025 with the aim of establishing a single legal and technical framework for sharing health data across the EU. It grants patients new rights, such as free and immediate access to their own electronic health records and control over their own data. Patients now have the right to restrict access to their data and the right to information about who has accessed their data. Also significant are the cross-border sharing of health records via a defined infrastructure and the introduction of the European electronic health record exchange format. The EHDS also defines the so-called secondary use of data, which is often viewed as a gold mine for research and innovation. The EHDS is also expected to have a significant impact on the IT sector and software development, particularly EHR systems, for which conformity assessment and CE marking have been newly introduced as mandatory requirements.

Participants will gain a basic understanding of the individual legal frameworks, their timelines, and the first steps they should take to prepare.

Who the webinar is for:

• Healthcare providers

• Sponsors of clinical investigations, sponsors of clinical trials, CROs, and research staff

• Manufacturers of medicinal products, medical devices, and IVDs

• All those involved in post-market surveillance, PMCF, and pharmacovigilance

• All those who need to work with health data to monitor the cost-effectiveness of treatment

• Health insurers

• Suppliers of health information systems and cloud and digital solutions

• Representatives of patient organisations

• Other entities that generate, store, share, or use health data

Lecturers:

• Mgr. Aneta Dostálová

• Ing. Aleš Martinovský

Content:

• What constitutes health data and what is the difference between personal, pseudonymised, anonymised, and aggregated data

• An overview of the legal framework governing data: the GDPR, the EHDS, the Data Act, and related data and healthcare legislation

• The EHDS Regulation, its timeline for application, and key dates

• Primary use of data and new patient rights, security, and the patient’s right to opt out

• The MyHealth@EU and HealthData@EU infrastructures and cross-border care, mandatory participation of healthcare providers and pharmacies

• Impact on IT suppliers and EHR systems (CE marking)

• Voluntary labelling of “wellness” applications

• Introduction of the European electronic health record exchange format

• Secondary use of health data—rules for making data available for research and innovation, and implications for regulation and health technology assessment

• Who may be a health data holder or health data user, and how these new roles will affect hospitals, health insurers, and manufacturers of medicinal products, medical devices, and IVDs

• What data may be made available, including data from health records, reimbursement, registries, medical devices, and completed clinical studies

• How access to data will work: dataset catalogues, applications, data permits, and secure processing environments

• Protection of patients and confidential information: anonymisation, pseudonymisation, the option to opt out, prohibited purposes, trade secrets, and intellectual property

• What the EHDS changes and which issues will continue to be assessed under the GDPR

• The Data Act and access to data generated by connected medical devices and related digital services

• The timeline for the new regulation, links to the MDR, IVDR, medicinal product regulation, AI, and cybersecurity, and recommendations on how to start preparing

Additional information:

• During the webinar, participants will have the opportunity to ask questions

• Each participant will receive a certificate of participation

• A PDF presentation will be sent to all participants

Participation fee:

• 3.900 CZK excluding VAT

• 100% cancellation fee applies after bindingly confirmed registration, but with the possibility of sending a replacement participant

Webinar hosted by:

• Porta Medica s.r.o.

  ID: 03301931, VAT: CZ03301931

  Registered office: Opletalova 1525/39, 110 00, Prague 1 - Nové Město