Telemedicine and health e-documentation legislation is finally on the horizon in the Czech Republic
Thursday 2 November 2023
Milada Kurtosiova
Kocian Solc Balastik, Prague
mkurtosiova@ksb.cz
The Covid-19 pandemic brought about renewed interest in telemedicine in the Czech Republic as it did elsewhere. As is often the case, current technology and practice have overtaken legislation, which has introduced many questions and doubts, such as those concerning the responsibility of healthcare providers and about reimbursements from public health insurance companies. Enshrining telemedicine into legislation has therefore become necessary. On 19 July 2023, the Czech government approved a bill which is supposed to define the concept of telemedicine, establish a basic framework for its use and amend the legal regulation of medical documentation. This could become law perhaps as early as in 2024.[1] Health insurance companies and physicians’ representatives will be able to follow up on this step and discuss telemedicine services and reimbursements from public health insurance.
Telemedicine and conditions for its use
Existing legislation provides for the possibility of providing a whole range of health services outside a medical facility, for instance, at the patient’s home, as well as elsewhere. Examples of such services include consultation services. However, the new legislation should provide an opportunity for telemedicine to be used more widely, and not only in the field of consultation.
The definition of telemedicine in the new legislation is very general. Telemedicine shall be any provision of health services at a distance using telecommunications and information technologies or a medical device. The use of telemedicine will be subject to the fulfilment of both legal requirements and technical requirements for the quality and security of communication.
Telemedicine will become just another non-independent form of providing health services for which a particular provider will require authorisation. However, the provision of health services only as telemedicine is not anticipated, and with the current state of knowledge and technology, is hardly imaginable.
It will be possible to use telemedicine both in and outside a healthcare facility. However, it will only be possible to use telemedicine outside a healthcare facility in two scenarios: (1) if it involves the use of telemedicine without the patient’s presence in the form of telecommunications and information technologies, as the case may be also with the help of remote access or a medical device (eg, reading and describing radiological images concerning patient, but without the patient being present); or (2) if it concerns a method of obtaining information (remotely or with the help of a medical device) which constitutes medical documentation and the automatic sending of such information to health service providers (eg, the collection and transmission of data relating to the patient’s medical condition).
Detailed conditions and requirements will be determined by a decree – a by-law issued on the basis of the law. Currently, only its basic principles are known: using encrypted communication, proving the identity of both communicating parties (ie, health service provider and patient), and only using certified medical devices for example, remote monitoring of vital functions, will all be required.
Changes to legislation regarding medical documentation and its administration
Changes relating to the administration of medical documentation and its digitisation will be introduced at the same time as the new telemedicine regulations. Medical records will have to consist of specified types of information, regardless of whether the information is obtained from the patient, another health service provider, other parties, or from the health service provider’s own activities. However, due to the nature of the matter, this will only concern information relating to the provision of health services to the patient. Other patient-related information such as billing information will be protected according to privacy regulations.
It will still be possible to keep medical documentation in hardcopy, electronic format or a combination of both. Individual records will have to be authorised (ie, confirmed by a medical or other designated professional) in a manner established by law. If the medical documentation is kept in electronic format, each record will need to be provided with a unique identifier to be compliant with a special legal regulation.
Written rules for processing medical documentation
Providers will have to draft written rules for the processing/administration of medical documentation. In the rules, they will have to introduce and describe technical and organisational measures to ensure the documentation is administered in compliance with the legal requirements. The rules will be used to help them to prove that they are keeping the medical documentation and handling the patient’s data in line with the legal regulations, including privacy regulations. The details of the administration of medical documentation will be determined, as they are currently, by an implementing decree.
Will the proposed bill change?
The proposed bill is now awaiting its legislative passage through the Czech Parliament. It is likely to be subject to wider discussion and undergo certain changes. Even during the preparatory work, a number of entities, including doctors’ representatives (the Czech Medical Chamber) spoke out against the broad legal definition of telemedicine which is being considered.[2] Doctors demanded, among other things, that the fields in which telemedicine could be used be defined and that its use linked (among other things) to the patient’s existing relationship with a particular medical services provider who knows the patient personally. The condition of existing personal knowledge of a patient’s health condition was also expressed by other parties who had an opportunity to comment on the draft bill. However, it is clear from the results of the proposer’s comments that a more general definition had deliberately been chosen. The flexibility of such a definition would prevent future amendments to the legislation when the state and development of technology changes. The limits for the use of telemedicine, in addition to the legal regulations, will be determined mainly by the state of knowledge and technology, which currently still requires the patient to visit the doctor in person in most areas.
There is no doubt that enshrining the definition of telemedicine and the requirements for its use is desirable. The quality of the legislation and the possibility of using telemedicine in practice will now depend mainly on the implementing decree, which will establish the requirements. Regardless of the above, one can imagine a whole series of subsequent legal questions that the new way of providing health services will introduce. Among other things, there will be the issue of responsibility for the services provided, or compliance with the requirements for their provision, and the enforceability of the legislation. Obviously, these are issues that are by no means new. As such, in essence, the issue will be about how the already-known principles can be applied in the new framework, which will be defined by future legislation and the state of technology.
Notes
[1] Government of the Czech Republic, ‘The government has approved a draft amendment to the Health Services Act and two applications for investment incentives’, 19 July 2023 https://www.vlada.cz/cz/media-centrum/aktualne/vlada-schvalila-navrh-novely-zakona-o-zdravotnich-sluzbach-a-dve-zadosti-o-investicni-pobidky-207219 accessed 23 October 2023.
[2] Objections raised and discussion regarding the concept of telemedicine is clear from the summary of the outcome of the comments-procedure. See, Government of the Czech Republic, ‘Government draft law amending Act No 372/2011 Coll, on health services and conditions of their provision (Health Services Act), as amended’, 20 December 2022 https://odok.cz/portal/veklep/material/KORNCMACTGI2 accessed 23 October 2023.