Telehealth Regulation

Is the use of telehealth permitted?

Some elements of telehealth could already be found in Czech law, but the legislation was fragmented.  In order to set the general framework, basic rules and standards for the functioning of telehealth, a new Act No. 325/2021 Coll., on electronization of healthcare, was adopted with effect from 1 January 2022.

Are there specific fields of healthcare in relation to which telehealth services are currently available, and do they involve the use of proprietary technology or platforms?

The Czech law already recognizes the ePrescription system regulated by the Medicines Act (Act No. 378/2007 Coll.). The ePrescription system is a central repository of electronic prescriptions and, with effect from 1 January 2022, also a central repository of vaccination records.  In short, the ePrescription system allows authorised persons to consult the patient's medication record, which contains data on prescribed and dispensed medicines, and allows them to view data on vaccinations administered to a particular patient. Another electronic tool in the field of sickness insurance is the eSick leave card, which is an electronic sickness absence report issued by a doctor. Also anchored in legislation is the so-called patient summary regulated in the Health Services Act (Act No. 372/2011 Coll.). This is an electronic set of patient data, which is intended primarily for the purpose of sharing information with health service providers in another EU country through the National Contact Point for eHealth.

The Act on electronization of healthcare represents the first phase of the electronization of healthcare. It sets forth the concept of eHealth, which includes, among other things, a central infrastructure, which is the so-called integrated data interface. Building an integrated data interface is intended to ensure uniform access to eHealth services and provides the basis for sharing information between healthcare services providers, patients and insurers. Patients will be able to access what information is held on them in registers via the eHealth portal.

The integrated data interface will include so-called core registers - a patient register, a provider register and a health worker register. The Act on electronization of healthcare also introduces and defines a patient identifier to replace birth numbers (personal identification numbers) and health care worker identifiers used in the health care system as unique identifiers of persons in the electronic health care system.  The main part of the law establishing the integrated data interface and personal identifiers will come into force on 1 January 2023.

The law also defines eHealth standards, the issuance of which is entrusted to the Ministry of Health. The obligation to comply with them will apply from 1 January 2026.

Does the public health system include telehealth services, and if so, are such services free of charge, subsidised or reimbursed? Where the public health system does not include telehealth services, are such services covered by private health insurance?

As it has already been mentioned above, some elements of telehealth (such as the ePrescription system and the eSick leave card) are implemented by Czech law and included in the public health system. Nevertheless, the core telemedicine services (i.e., the provision of remote health care services through digital tools) is recognized neither by the Health Services Act, nor by the Public Health Insurance Act (the Act No. 48/1997 Coll., on public health insurance, as amended). Even though the public health system does recognize and offer telemedicine services, some insurance companies already provide contributions to enable their policyholders to use telemedicine services (e.g., Ministry of the Interior Public Health Insurance Fund) or reimburse a certain number of long-distance consultations between their policyholders and healthcare professionals (e.g., General Health Insurance Company).

For the sake of completeness, it is further to be noted that the Ministry of Health of the Czech Republic has prepared the draft bill of the amendment to the Health Services Act (available in Czech only).   The draft bill provides, inter alia, a definition of telemedicine services and a general legal framework for their provision. It should also facilitate the integration of the telemedicine into the Czech public health system and the determination of reimbursement mechanisms. Currently, the draft bill is at the beginning of the legislative process (more precisely, the inter-ministerial comment procedure has been completed). Therefore, its wording is not final and may be amended significantly.

Do specific privacy and/or data protection laws apply to the provision of telehealth services?

From 1 January 2023, providers of healthcare services are obliged to record data in the scope provided for by the Act on electronization of healthcare in core registers established by the Ministry of Health for this purpose. Healthcare services providers are required to ensure a gradual transition from the birth number to the newly introduced identifiers and to use and follow data from the core registries effective 1 January 2024.

How should the cross-border transfer of personal information collected and processed in the course of telehealth services be carried out to ensure compliance with applicable privacy laws?

Czech law does not provide an explicit answer as to how should the cross-border transfer of personal information collected and processed in the course of telehealth services be carried out, as there are no Czech regulations or guidelines specifically addressing privacy matters on telehealth services. However, it could be considered that the cross-border transfer of personal data must be compliant with, inter alia:

1. GDPR;
2. Health Services Act;
3. Act No. 110/2019 Coll., on the processing of personal data;
4. Act on electronization of healthcare;
5. Act No. 326/2021 Coll., amending certain acts in connection with the adoption of the Act on electronization of healthcare;
6. Decree No. 98/2012 Coll., on medical documentation, as amended; and
7. Guidelines issued by the Ministry of Health of the Czech Republic (available in Czech only).

Are there any currently applicable codes of conduct on the use of telehealth systems and/or security of telehealth data in your jurisdiction?

There are no applicable codes of conduct on the use of telehealth systems and/or security of telehealth data in the Czech Republic.

Are any specific laws, regulations, or self-regulatory instruments expected to be adopted in the near future?

The Act on electronization of healthcare prepares the background for electronization of processes in health care with a view to making the electronic route the primary one and replacing paper-based agendas. The existing processes in the healthcare system are not changed by this act, the actual anchoring of the maintenance of medical records in electronic form is left in the existing regulation, especially in the Health Services Act.

The next phase of the electronization of healthcare should be the introduction of a health documentation index as an information system describing the basic typology of existing health documentation and bringing together metadata about the documentation.