At the end of 2022, the Ministry of Health submitted a draft amendment to Act No. 372/2011 Sb., on Health Services ("Health Services Act") and implementing Decree No. 98/2012 Sb., on Medical Records, which is intended to help with the digitisation of the Czech healthcare system. One of the main objectives of the draft amendment is the development of digital agendas at the Ministry of Health.
This objective should be achieved in particular by strengthening the legal certainty of health service providers in keeping medical records in a purely electronic form so that this form becomes the primary method of medical record keeping. Paper agendas are to remain only in the position of substitute processes that can only be used when the electronic form is not available. Although the current legislation allows for such keeping of medical records, mainly the technical requirements for the same are currently insufficiently regulated. In practice, medical records are still mostly kept in paper form or in a combined way. Let us briefly summarise the proposal for new "more digital" rules in this area.
New definition of medical records
Currently, medical records are not precisely defined and there may be doubts about what providers are supposed to record as part of their keeping. Therefore, it is proposed to redefine medical records as a set of information that a provider is obliged to keep, store and process for the purpose of providing health services to a specific patient, regardless of whether it was obtained from the patient, another provider or other persons or by the provider’s own activities. The draft amendment also introduces a negative definition of medical records - this will not include information obtained by a provider in connection with the provision of health services, including from medical records processed by the provider, if the purpose of processing such information is not the provision of health services to a specific patient, but solely for another purpose (this may include, for example, supporting documents and documents for billing health insurance companies, files kept for the purposes of complaints, litigation, etc.).
Requirements for patient signing of records
The draft amendment also seeks to enshrine a requirement for the level of signing of the electronic medical record by the patient. In particular, the signing of informed consent by the patient to the provision of a health service is widely used in practice via tablets or smart phones, although there is no convincing legislative anchor for such a procedure. The draft amendment introduces an obligation to sign documents in electronic form with a qualified or dynamic biometric electronic signature. In order to be a dynamic biometric signature, the device should enable the collection of data for the analysis of signature characteristics associated with the typical behaviour of the signatory (time, pressure, acceleration, etc.). However, neither Czech nor European law defines a dynamic biometric signature, which may cause interpretation problems if the draft amendment is approved in the current wording. This effort to combine the highest available standard of electronic signature with the most practical option may seem understandable to some, especially in the context of the future European Digital Identity Wallet, which will allow the holder to easily use a qualified electronic signature. However, until its introduction, only dynamic biometric signature would remain usable in practice. The lack of its definition and the current negative attitude of the Czech Office for Personal Data Protection towards its use do not help this option much. Therefore, the draft amendment will have to be revised in this respect.
Sharing medical record data
The draft amendment also introduces horizontal rules for sharing medical record data.
First of all, it responds to the practical needs and introduces the possibility for health service providers to share data from medical records for scientific and research purposes or for statistical purposes. The prerequisite for such sharing is the anonymisation or pseudonymisation of the data so that it is not possible to identify a specific natural person from the records and to further handle the data. Under the draft amendment, such information will no longer be considered medical records and can be shared by the law itself for the above purposes.
Another type of sharing is the sharing of medical record data between health care providers. The draft amendment should facilitate such sharing by establishing a uniform output format into which records from the electronic medical records should always be convertible. This will be determined by the standard of e-health under the Act on Health Care Electronisation, which will be issued by the Ministry of Health.
Last but not least, the draft amendment aims to prepare the conditions for keeping medical records in electronic form in a way that would enable their international sharing, in particular through the creation of standards that will allow the generation and international sharing of standardised reports using trust services under the eIDAS Regulation.
Despite the existence of certain ambiguities, the draft amendment to the Health Services Act and the implementing Decree can be seen as a step towards greater support for e-health in the Czech Republic. In addition to the regulation of electronic medical records, the major proposed change also includes the introduction of a completely new definition of telemedicine. We brought you details of this proposal in our article here.