All business entities, regardless of their ownership and specialization, who conduct medical practice, will soon work in the electronic health care system (EHS).
For this last year, the Cabinet of Ministers of Ukraine passed the relevant resolution, which provides for the requirement to ensure the mandatory registration and work of licensees in ESOZ from March 31, 2023. This requirement also applies to laboratory establishments.
Digitization of the medical field will allow the formation of a single space of medical data, in which all information about the patient’s health, namely: information about the condition, information about immunization, laboratory tests, hospitalizations, etc., will be stored centrally and protected.
Thus, for more effective clinical decision-making, access to the patient’s complete medical history will be available to all attending physicians to whom the patient applies, regardless of the institution in which the patient receives medical care – communal or private. At the same time, the patient will be able to independently grant access to his data to medical professionals.
What requirements apply to laboratories?
According to Clause 13 of the licensing conditions for the conduct of economic activity in medical practice, approved by the Resolution of the Cabinet of Ministers of Ukraine dated March 2, 2016 No. 285, the licensee of medical practice is obliged, among other things: to register in the Register of Business Entities of the Electronic Health Care System and to ensure the initial entry – accounting medical documentation in the system in accordance with the legislation.
The relevant norm applies to all legal entities, regardless of their organizational and legal form, and to individual entrepreneurs who conduct economic activity from medical practice. Regardless of whether the business entity is already engaged in the specified type of economic activity, or receives a license for the first time.
At the same time, it should be emphasized that business entities do not need to obtain new licenses or make changes to existing licenses for medical practice upon registration in the ESOZ.
What data must laboratories enter?
Currently, there is a mandatory requirement for licensees, in particular for exclusively laboratory establishments, to enter the following information in the Register of medical records, referral records and prescriptions in the ESOZ:
- in accordance with subparagraph 1 of paragraph 4 order of the Ministry of Health of Ukraine dated February 29, 2020 No. 587 “Some issues of maintaining the Register of medical records, referral records and prescriptions in the electronic health care system”) – medical records and referral records related to the provision of medical services within the framework of the state guarantee program (for all medical service providers who have entered into contracts from NSZU), as well as all other institutions that are obliged to provide medical care to patients free of charge in accordance with the law or contract;
- in accordance with subparagraph 3 of paragraph 4 of the order – medical records of persons suspected of being infected or with a confirmed diagnosis of the coronavirus disease (COVID-19) (for all health care institutions and natural persons – entrepreneurs who have received a license to carry out economic activities from medical practice ).
Other medical records may be entered into the system by the licensee of medical practice with the consent of the patient in accordance with the procedures for maintaining the relevant registers. In the future, the complete transition to digital accounting of all medical documentation will take place gradually and will require additional changes to regulatory and legal acts.
How do laboratories prepare for work in the ESOZ?
If your institution is not registered and has never worked with the EHOZ, you must first of all choose a medical information system (MIS) that has the necessary functionality for the operation of the laboratory in the EHOZ.
This is a special software that is developed by private companies and provides data entry into the EHS. Today, there are more than 30 such systems, each of which has successfully passed testing for compliance with the technical and protection requirements established by the state.
The list of connected MIS can be found on the system’s website – ehealth.gov.ua in the section “Connected MIS to the EHS”.
Detailed instructions for choosing an MIS and registering with the ESOZ are available on the system’s website: https://bit.ly/2HKG6pJ
If the institution (laboratory) already has a medical (laboratory) information system that is not connected to the EHS, then you can both expand your software infrastructure by implementing the above software into the existing one, and ensure the connection of your system to the central database of the EHS.
If you intend to connect, you need to act according to the following algorithm:
- to determine which functionality of the EHS will be necessary for your laboratory;
- develop such functionality;
- obtain a certificate of compliance of the integrated system of information protection (CSSI) with the requirements established by the DSSSIS;
- submit a request to the administrator of the ESOZ Central Bank (SE “Elektronne Zdrovyya” for conducting testing;
- successfully pass the test and obtain a conclusion on the functional compliance with the technical requirements;
- if necessary, conduct training among users.
This algorithm will take time to implement. However, after that, your medical (laboratory) information system will become a full-fledged part of the EHS.
For questions about connecting to the electronic health care system, please contact the administrator of the Central Bank of ESOZ: email@example.com
More details about MIS connection: https://ehealth.gov.ua/yak-pidklyuchyty-mis-do-systemy-ehealth/