The Ministry of Health has submitted a far-reaching amendment that would revise the Healthcare Digitalisation Act, the Medicinal Products Act, and the Health Services Act. The amendment represents the first stage of implementing the EU Regulation on the European Health Data Space (EHDS). In addition, it is expected to introduce a number of purely national measures that go beyond what the EHDS directly requires. So, what exactly is being planned?
Healthcare Digitalisation Act
Act No. 325/2021 Sb., on Healthcare Digitalisation, has been in effect since January 2022 and provides the core legal framework for the digital transformation of the Czech healthcare system. It introduced key elements of the country's electronic healthcare infrastructure, including the Integrated Data Interface, the Shared Health Record, the eReferral system, and the National Electronic Health Portal.
What changes does the amendment introduce in response to the EHDS?
As an EU regulation with direct applicability, the European Health Data Space (EHDS) Regulation does not require transposition into national law. However, it obliges Member States to designate the competent authorities and notify the European Commission of those authorities by 26 March 2027. The amendment seeks to fulfil this obligation by explicitly designating the Ministry of Health as the authority responsible for digital health, the health data access body, and the national contact point for both the primary and secondary use of health data. Market surveillance of electronic health record systems is to be carried out through the National Centre for Electronic Health. The individual functions are expected to be organisationally separated in order to prevent conflicts of interest.
The amendment also codifies new patient rights in relation to electronic health records. Patients will be entitled, free of charge, to:
- add their own information to their health records, although such entries must not alter records created by healthcare professionals;
- request the correction of their electronic health records;
- grant access to their records to a healthcare provider of their choice;
- request the transfer of their records to another healthcare provider, a health insurance company, or the Czech Social Security Administration; and
- restrict access to their data.
Patients are expected to exercise these rights through the National Electronic Health Portal, the eHealth Card (eZKarta), or directly through their healthcare provider. For individuals who cannot or do not wish to use digital tools, the details are to be set out in a decree governing assisted or non-digital exercise of these rights.
In cases of an immediate threat to life, the amendment introduces a "break the glass" mechanism, under which a healthcare provider may access records even where the patient has restricted access to them. Any such access must be registered in the medical records, and the patient must be informed without undue delay.
The EHDS identifies the following categories as priority health data:
- patient summaries;
- electronic prescriptions and medicinal product dispensing records;
- medical imaging, including accompanying reports;
- laboratory test results; and
- discharge reports.
The amendment further requires healthcare providers to maintain these records in a standardised European format, with the technical requirements to be specified by the Ministry of Health in line with the European Commission's implementing acts. Every healthcare provider will also be required to connect to the National Contact Point and report the necessary technical information. Failure to comply with this obligation will constitute an administrative offence.
What does the amendment introduce that goes beyond the EHDS?
One of the most significant autonomous changes is the introduction of an obligation for healthcare providers to maintain medical records exclusively in electronic form starting from 1 January 2029. After that date, paper records would be permitted only in exceptional circumstances, such as serious technical disruptions, including power outages or information system failures.
The electronic referral system (eReferrals) is also set to become mandatory. While referrals can currently be issued in any form, the amendment would make electronic referrals the standard, with paper versions reserved only for technical outages.
The amendment also introduces an entirely new concept: the registered exchange network. This would serve as a standardised communication channel enabling healthcare providers to fulfil their obligations when transferring medical records without having to establish direct connections with every other organisation in the system. Exchange networks could be operated only by public sector entities, contributory organisations, health insurance companies, or healthcare providers, with private commercial entities excluded. Operation of such networks would be subject to conformity verification by the Ministry of Health.
The amendment further strengthens the data framework of the National Health Information System (NHIS). In particular, the National Register of Reimbursed Health Services is to be expanded to include health and social care services, with the Ministry of Labour and Social Affairs and the Czech Social Security Administration also newly required to provide data. The amendment introduces the possibility of making NHIS data available in the form of synthetic data, meaning artificially generated datasets that replicate the statistical characteristics and structure of real-world data while containing no identifiable personal data. In addition, the Institute of Health Information and Statistics (IHIS) is expected to gain direct automated access to the ePrescription system, replacing the current model based on anonymised data provided with a time delay. Finally, the Shared Health Record is set to be expanded from 1 January 2031 to include an electronic pregnancy record.
When will the changes take effect?
The amendment envisages a phased implementation, with different provisions taking effect at different times. The basic framework for the registered exchange network, the designation of authorities responsible for implementing the EHDS, and the expansion of the NHIS registers are expected to take effect on the day following the publication of the amendment. The mandatory use of electronic referrals (eReferrals) is scheduled to be introduced from 1 July 2027, with the requirement extending to all referrals from 1 January 2028. From 1 January 2029, healthcare providers will be required to maintain medical records exclusively in electronic form. The full framework for the primary use of health data under the EHDS, including patients' rights relating to electronic health records, is expected to become operational from 26 March 2029, with additional categories of health data being brought within scope from 26 March 2031. The electronic pregnancy record is expected to be introduced from 1 January 2031.
The Ministry of Health has proposed that the Chamber of Deputies approve the proposed amendment already at its first reading, in view of the obligation to notify the European Commission of the designated competent authorities by 26 March 2027. Importantly, this amendment represents only the first stage of EHDS implementation. Further implementation measures, particularly in the areas of the secondary use of health data and integration with the HealthData@EU infrastructure, are planned by the Ministry in subsequent legislative stages. These measures are intended to align with the phased coming into effect of the EHDS individual provisions.
Conclusion
The amendment will primarily affect healthcare providers, who will be required to adapt their information systems to new technical standards, introduce fully electronic record-keeping and referral workflows, and connect to the National Contact Point. At the same time, the amendment seeks to minimise the administrative and technical burden by introducing centralised services and allowing healthcare providers to fulfil their obligations through registered exchange networks.
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