The Ministry of Health of the Russian Federation has developed a draft Procedure for maintaining the federal register of citizens entitled to the provision of medicines, medical devices, and specialized medical food products at the expense of budgetary funds (hereinafter referred to as the “Draft”).
Recall that Federal Law N 206-FZ of July 13, 2020 “On Amendments to Certain Legislative Acts of the Russian Federation on the Provision of Citizens with Medicines, Medical Devices, and Specialized Health Food Products” in order to coordinate the activities of federal executive bodies, executive bodies constituent entities of the Russian Federation, local government bodies, medical organizations of the state, municipal and private health systems in terms of providing citizens with medicines, medical devices, and specialized medical food products at the expense of budget allocations, it is envisaged to maintain the Federal register of citizens entitled to the provision of medicines, medical devices, and specialized health food products at the expense of budgetary allocations from the federal budget and the budgets of the constituent entities of the Russian Federation (hereinafter referred to as the federal register). The procedure for maintaining the federal register, including the procedure for accessing the information contained in it, the procedure and terms for submitting information to the specified register, are established by the Government of Russia.
The Draft is posted on the federal portal of draft regulatory legal acts. In relation to this project, based on the results of public discussions that ended on August 10, 2020, a number of improvements were made.
The revised Draft establishes that the federal register is kept in electronic form using an automated system by making a registry entry with the assignment of a unique register entry number and indicating the date of its entry.
The Federal Register contains information about such categories of citizens as:
• disabled people, disabled children;
• citizens who have the right to receive state social assistance in the form of social services for the provision of necessary medicines, medical devices, and/or medical food products;
• persons under dispensary supervision in connection with tuberculosis;
• citizens suffering from diseases included in the list of life-threatening and chronic progressive rare (orphan) diseases;
• citizens in need of palliative care;
• categories of citizens who are entitled to free drugs and medical devices or with a fifty percent discount.
Information about the above categories of citizens is provided daily from specialized patient registers and from health information systems at various levels.
According to the specified draft procedure, the register will contain the following information:
• surname, name, patronymic (if any) of the beneficiary;
• date of birth and place of residence;
• details of the passport and compulsory medical insurance policy;
• information about citizenship;
• diagnosis of the disease (condition) and its ICD code;
• name, registration number, OKPO code of the medical organization where the citizen is served.
The Ministry of Health of the Russian Federation is the operator of the information system and ensures its uninterrupted functioning, and is also responsible for maintaining the confidentiality of data contained in the federal register.
According to the summary of proposals following the results of public discussion of the Project, it was proposed to amend paragraph 8 of the Draft in connection with the following. The procedure established that the Ministry of Health of Russia ensures the confidentiality of information contained in the Federal Register, as well as the storage and protection of such information in accordance with the legislation on the protection of personal data. At the same time, according to paragraph 8 of the Draft, access to the federal register is provided by the Ministry of Health of Russia to federal state bodies, the list of which is approved by the Government of the Russian Federation. According to paragraph 4 of the Draft, the Federal Register is a federal information system, consisting of regional segments. In this regard, the mechanism of functioning of the Federal Register, which contains information about citizens entitled to drug provision at the expense of the budgets of the constituent entities of the Russian Federation, is not clear, if only federal state bodies have access to it.
This remark was taken into account and clause 8 of the Procedure for maintaining the federal register was supplemented in the part that access to the federal register is provided by the Ministry of Health of Russia in accordance with the Regulation on the unified state information system in the field of health care, approved by the Government of the Russian Federation dated May 05, 2018 N 555. In particular, registered users who have undergone proper identification and authentication are granted access to the information contained in the federal register.
Also, in the process of public discussions, the developer noted that the functionality of the Federal Register will take into account not only the main disease of a citizen but also the accompanying one. Filling the Federal Register with information from state information systems in the field of healthcare of the constituent entities of the Russian Federation is possible both in electronic form and through the use of the functionality of the Federal Register.
The introduction of this procedure is planned from September 1 of this year.
September 1, 2020
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