TAdviser Interview: the Deputy Minister of Health Elena Boyko – about priorities of digitalization of the Russian medicine

Elena Boyko: Over time there are new purposes, new technological capabilities of solving of tasks. The fact that earlier it seemed important looks trivial today. If the intensification of work of health workers, then today this change of the system of the organization of health care was the initial purpose of development and creation of information systems in health care. For last years legal outlines of future digital circuit of health care which were enshrined in the federal law in 2017, bylaws were defined. Today it is obvious that the relation to our activity both out of, and in medical community exchanged considerably. Digitalization is a priority, the necessary tool providing modern requirements to processes of the organization of a health care system. Now profile specialists – and, first of all, the Minister of Health Veronika Igorevna Skvortsova – plan transformation of the different directions of a health care system taking into account digit. Now we project new processes, and it is necessary to finish information systems further. I think that change of my status is just connected with the fact that the problem of digital transformation of health care became the state priority.

Elena Boyko: For a start let's understand terms. Judging by a question context, I understand that Uniform State Health Information System is understood as a certain uniform digital space of health care of the country in general.

Elena Boyko: Which is created.

Elena Boyko: Yes, therefore it is not absolutely correct to claim that tens of billions were spent for Uniform State Health Information System. Less than one billion rubles are spent for creation of subsystems of Uniform State Health Information System for all years since launch.

Elena Boyko: Not only. It and creation of communication systems, services of data storage, development and adaptation of software, development of methodology and training of specialists. If to speak about Uniform State Health Information System, then it is a federal system at which functions according to the law and the order of the Government of the Russian Federation on this system are absolutely accurately defined. Certainly, this link between all state systems of subjects which should provide a common information space or a digital circuit of health care. Today some tasks set for a federal system are implemented completely, some – partially. And if we speak about a federal system, then its advantage is obvious to both organizers of health care, and the practicing health workers, and citizens.

To organizers a system helps to manage health care resources. For example, we know what number of students it is necessary to admit to medical schools taking into account age of the working doctors in different regions of the country. We see where we are located today and where it is necessary to place the medical organizations taking into account criteria of availability of medical care to primary link, for the narrow-purpose directions. Uniform State Health Information System helps to define in what localities these criteria are not met. Using this information organizers make decisions about construction new hospitals, clinics, infirmaries, on involvement of the private medical organizations in the program of state guarantees, on purchase of mobile complexes. The centralized purchases of drugs Ministry of Health Russia are also made according to data Uniform State Health Information System, and now we using a new subsystem still analyze the weighted average prices of purchases of the subjects of the Russian Federation.

Uniform State Health Information System provides communication between the national centers and parent organizations for each profile in subjects, and doctors in regions, thanks to it, can get advice of the colleagues from the national centers. For citizens we opened the Personal account of the patient which services are also provided on the uniform portal of state services (EPGU) using Uniform State Health Information System.

Elena Boyko: Not only making an appointment, but also on medical examination, routine inspections, and obtaining information on medical insurance company, execution of the policy of compulsory health insurance. These are basic services, and it is clear that they will develop, now with the Ministry of Telecom and Mass Communications planned superservices for EPGU. In the federal draft "Creation of a Uniform Digital Circuit on the basis of Uniform State Health Information System" of the National Health care project the indicator – a possibility of receiving by each citizen of access to the electronic medical documents is designated.

If to speak about a digital circuit, then in regions there were global changes too. First, medical information systems or the fact that at all very famous – electronic medical records are not some exception to the rules. They are conducted in all medical organizations. At least, in head. Now there is a task that all structural divisions worked in these systems too. The medical organizations already generate information in a digital format. It is already possible to work with it. Business processes of regional health care are automated too. In all subjects centralized systems are created.

The most important for the sake of what it becomes – succession of delivery of health care, increase in efficiency of its rendering. The purpose, clear today for implementation, - to make so that to the doctor, to whatever medical institution of people addressed, was it is regulated history of his disease, the appointed treatments, medicamentous exceptions is available. It will allow to increase the accuracy of diagnostics and efficiency of treatment.

Elena Boyko: Well, "the person who wants to carry a beautiful beard looks at first not shaven". These are scale-up problems. Succession, including, interregional, will provide Uniform State Health Information System when all structural divisions of the medical organizations (and it is tens of thousands) are connected to it and available to the analysis and processing will begin to create digital medical documents, databases. After adoption of law (about information technologies in health care) the new subsystem of Uniform State Health Information System – the register of electronic medical documents was entered. This database stores on each patient information on what electronic documents on him were created what type, where they are stored – in what medical organization. This subsystem will provide to the citizen an opportunity to get access to the document through EPGU. Also the citizen will be able to share this document with the doctor with whom he will consider necessary. The law was adopted in 2017, became effective in 2018. Then, in 2018 we began to create this register, and now we connect to it all subjects of the Russian Federation.

In respect of the federal project it is specified that all medical organizations should be connected to the register. I think that in 2019-2020 we will connect head organizations, and in 2020-2021 – their structural divisions. Thus, succession will be provided.

Elena Boyko: I think that it is real. Certainly, there are subjects of the Russian Federation which lag behind. At them problems since the program of upgrade went. We will bring up them strenuously especially as they have funds for it now, and we have bases according to the law.

Elena Boyko: In this direction there are results too. We separated support of adoption of medical solutions into several directions. The first are help systems. They do not require any difficult certification, do not transform rather work of the doctor but only help. All this that now is in different manuals, medical textbooks, instructions. For example, compatibility of medicines. Reference books are built in medical information systems which work in clinics, hospitals. It is the tool of the doctor, and developers of systems considerably progressed in his creation.

The second direction – more advanced. Recently there was a law which will take effect since 2022, about uniform clinical recommendations. These are the documents developed by professional non-profit organizations, containing the structured information based on scientific proofs concerning prevention, diagnostics, treatment and rehabilitation including protocols of treatment of the patient, and the description of the sequence of actions of the health worker taking into account the course of a disease, existence of complications and associated diseases. In fact, it is algorithms by which doctors should be guided at delivery of health care.

Elena Boyko: Yes, it is unconditional, they will be approved and to be reviewed at least once each three years.

Elena Boyko: Yes, precisely. Provide information support of actions of doctors.

Elena Boyko: For example, obtain information from medical literature, magazines, materials of conferences, reports of parent organizations. The base teaches it in medical schools. If we digitize clinical recommendations, then it will be possible to implement more difficult algorithms in medical information systems. They will prompt to doctors what to pay attention to and what diagnostic testings need to be made, depending on the anamnesis of the patient, his age, chronic diseases. We will be engaged in it within the National Health care project. It will be necessary to develop the medical systems taking into account each profile.

Here change in our approaches just clearly is visible. It is not just automation of the processes existing earlier, it is reorganization of processes, and then already their digitization. From logic of creation of certain forms and medical documents we pass to information maintenance of medical processes.

At last, the third direction is a possibility of use of the Big saved-up Data to train the machine. It is perspective and today in our country a number of the companies and organizations seriously are engaged in developments in the field of artificial intelligence. The digital data created in medical information systems are aggregated and processed in anonymous form in centralized systems. Structured data contain information on the appointed medicines, therapies, results of treatment. It is the valuable data for medical science which will form the basis of creation of medicine of the future.

During creation of systems in health care on regional and at the federal level the principle of a datacentrichnost is applied. An important task – to provide unity of formats, and further we will pass to a new step of support of adoption of medical solutions. And the speech goes only about support today, but not replacement of the doctor.

Elena Boyko: The machine is a tool, is used as the second opinion. It is necessary to understand that the human body is individual and more difficult, than any algorithm. If it is defined that the person at such disease needs to make three procedures, the doctor can tell, no, this person needs to make four procedures or two. And the doctor bears complete responsibility for this solution. The machine, certainly, can help. Let's say both the doctor, and the machine in parallel can decrypt a computer tomography. So it as certain additional check.

Elena Boyko: Clinical recommendations will have to be used in medical information systems. But approaches should be uniform. Therefore the subsystem of maintaining the normative reference information which use is obligatory for all developers of medical information systems develops in Uniform State Health Information System.

Elena Boyko: Telemedicine, really, is in all subjects, for the last few years regions purchased the equipment, acquired experience of use. In 2017-2018 all hospitals and clinics were connected to the Internet. Thus, they have an opportunity to work in perimeter of telemedicine consultations. The Ministry of Health, in turn, created a federal telemedicine system, connected more than 700 parent organizations of subjects (the regional hospitals which are organizations of so-called third level - a comment of TAdviser) which can get round the clock emergency and planned telemedicine advice on different medical profiles in the National medical research centers. In subjects there was already a practice when the organizations of the first and second level can address for consultation on some case the specialist of the subject in the organization of the third level. If a complex case, then the National center is connected.

Now we are faced by a task to provide compliance of telemedicine consultations to requirements of regulating legal documents. After acceptance 242 laws, throughout, the order of the Ministry of Health on an order of carrying out telemedicine consultations describing scenarios the doctor-doctors the doctor patient was issued. Strict requirements are stated in the order, for example: participants – doctors and patients – should understand with whom they interact remotely. If the person calls the doctor anonymously and, let us assume, will tell "I have a headache", it will not be telemedicine consultation. It will be just council, "is ringing to the friend", something like that. And when the doctor and the patient are identified, interaction happens in the legal framework. Participants of telemedicine "communication" should understand accurately what their rights and what responsibility of the parties. Therefore the first requirement is an identification. The second – the result of interaction should be documented and be kept as the medical documentation signed the doctor (UKEP) strengthened by the electronic signature.

Thus, our task now – to make so that all telemedicine consultations conformed to these requirements, doctors need to be provided to UKEP that information exchange in a digital format was legitimate, citizens should be identified by means of a unified identification and authentication system (Unified identification and authentication system) of the Electronic government.

Elena Boyko: If you do not trust for any reason for the doctor, then it is necessary to see other doctor. Remote consultations according to the law are resolved, but did not receive large-scale use yet. They are not entered into the state health care system, but also in a private health care system are not especially applied too. In the law it is designated that primary address can be organized remotely, but only for consultation, collecting of the anamnesis. After the internal address when the doctor already appointed therapy, he will be able to adjust it remotely. For example, if from the patient data on pressure are obtained, and the doctor will see that therapy worked, he means will be able to lower a medicine dosage.

Elena Boyko: It can be reduced and.

Elena Boyko: Yes. The diagnosis remotely cannot be made.

The perspective direction is remote observation of the state of health by means of medical products. It is necessary to define perhaps remote observation for what diseases and what statuses. Perhaps, over time it will be entered for treatment of some chronic noninfectious diseases. For this purpose, first, the reliable and registered medical products are necessary - in Russia such are developed. Secondly, approbation, the proof of efficiency, understanding is necessary how to implement it not to overload the doctor with a permanent information stream from personal medical devices.

Elena Boyko: Different methods of the organization of receiving and processing of such information are possible. For example, the specialized service medical organizations, will continuously obtain data from devices, using information systems, to analyze them and to notify the doctor at the essential or set deviations.

In clinic in Perm I saw work of mobile application in which patients from risk group with cardiovascular diseases can enter data on the pressure for observation by doctors. Now cardiovascular diseases are the leading cause of death in the Russian Federation. High pressure can be a harbinger of these diseases. It is necessary to monitor pressure, in time to adjust it. Elderly people as a rule treat introduction of the data more responsibly. And so far as concerns 30-40-year-old, difficulties begin. Today they can remember and enter data, and tomorrow – to forget. As a result in half of cases observation breaks because patients just forget to enter this information. From here the output, devices should be such that the person entered nothing, and devices could transfer data. It is necessary to develop technologies. But also citizens should treat more responsibly the health, the main focus on prevention, the digit should help with it.

Elena Boyko: One more important point – personal data protection. Digital gadgets which measure something and somewhere send from anybody permissions are not asked. They become more and more convenient, and it is healthy when you can drive not only the car or the house, but also the organism. If devices of foreign production, then often all data "depart" somewhere to Google and are stored definitely not on servers of the Russian Federation. Now even scales from a permission and without permission can send data. Who, as well as for what purpose uses these data unclear.

If citizens buy such devices, producers should inform them on what happens to their data. Responsibility is born in this case by the buyer. And the state, the medical organizations bears responsibility for what is implemented in perimeter of the state health care system. Therefore if licensing for the address in the territory of our country there undergo foreign medical products, their producers should fulfill certain requirements. Data should be transferred only to a medical information system of the organization where the patient is treated.

In general, within development of digital economy, not only in health care, we should answer many questions of data. For example, data on citizens – they are whose? National, personal? Who and in what mode can have to them access? What with them in general can be done? Volumes of digital data increase with a huge speed, and these data can bring considerable benefit, change a way of life. But there is a question – and what risks? It is necessary to understand, as single personal data have value. But when we speak about the country, about the nation...

Elena Boyko: Quite so.

Elena Boyko: Not only. It is control of diagnostic testings and the second opinion. For this purpose it is not obligatory to know the patient, results of researches, the conclusions are necessary.

The good example is in Moscow where new service, a new entity in a health care system – the reference center which remotely checks quality of diagnostics in the medical organizations is created. Connect all radiological digital equipment installed in the medical organizations to it. All diagnostic testings are stored on a centralized basis in the protected database of service. They are described and still doctors of the medical organizations decrypt. At the same time specialists the reference center selectively check results of interpretation. A task the reference center – having provided additional control and training of doctors to increase quality of researches. The doctor is a profession in which it is necessary to develop and confirm the competences regularly. Therefore each five years of the doctor undergo accreditation. Digital technologies do continuous training of doctors implementable, convenient, effective. Thanks to them work of each specialist becomes "transparent" throughout all time, but is not selective, time in 5 years. So the doctor can offer constantly information, training materials, consultations, support, to continuously increase the level of the specialist.

So, using digital, to be exact – telemedicine technologies the new organizational entity is created. Before such form of implementation of processes of the medical organizations and use of telemedicine did not exist. Our purpose – to bring to new level the system of the organization of consultation, "the second opinion", continued information support, to provide implementation and use of new regulations, clinical recommendations, so – to provide the highest level of quality and availability of medical care.

Elena Boyko: Yes, medical researches, including, telemedicine, are included in the state statistical observation. But we, certainly, scoop information not only from statistics, and from information systems.

Elena Boyko: Filling of different forms, generally. But the call before Rosstat is to collect everything using "digit".

Elena Boyko: After each rendered case of medical care the epicrisis containing information on the rendered medical services forms. This information is stored in Uniform State Health Information System in anonymous form, but to us it is enough to understand that there was a telemedicine consultation. Also we keep track of the number of the held telemedicine consultations by the National medical centers.

Elena Boyko: The priority project was concentrated on state services in the field of health care for citizens. Within the priority project we started the Personal account of the patient on the portal of state services. Information support of delivery of health care by means of the medical systems, their development, infrastructure and so on, were behind perimeter of the priority project.

Tasks of the Federal project are much wider. As a part of the national Health care project eight federal projects. They are devoted to fight against the main diseases of the population – cardiovascular and oncological diseases, to increase in efficiency of delivery of health care to children, development of primary health care, prevention of diseases, preparation of the medical personnel.

"In digit the circuit" is a providing project. It not only about state services and about IT infrastructure. Its results are the tool for implementation of other federal projects of health care.

Elena Boyko: Yes.

Elena Boyko: For six years about 107 billion rubles from the federal budget plus joint financing of the subjects of the Russian Federation are provided. The most part of means is intended for implementation in subjects, a federal part is a development of Uniform State Health Information System, competence center and also on federal institutions.

Elena Boyko: To subjects 81 billion from 107 are provided.

Elena Boyko: Yes.

Elena Boyko: For the first three years of 70%.

Elena Boyko: It is reorganization of processes of regional health care, interdepartmental interaction, development of medical information systems, their implementation in all structural divisions of the medical organizations, connection to the centralized regional systems and Uniform State Health Information System, training of health workers and also development of IT infrastructure are DPCs, computers, secure channels, etc. To the Internet infirmaries are connected by the Ministry of digital development for the budget account of the national program "Digital Economy".

Elena Boyko: Traffic will be paid for again connected medical organizations from "Digital economy". Subjects pay for those which are already connected.

Elena Boyko: In 2012.

Elena Boyko: Everything is not so bad. Generally subjects updated computers for means of regional budgets, compulsory health insurance. For the last three years more than 280 thousand units are purchased.

Elena Boyko: Yes, but it is necessary to buy computers for jobs of all health workers.

Elena Boyko: Regional systems.

Elena Boyko: Uniform State Health Information System is maintenance, development. We have no spasmodic increases in requirements here. We remained approximately in the same borders, as in previous years. Any new superentities within Uniform State Health Information System are not planned now. Only systematic development according to tasks of the Federal project.

Elena Boyko: Yes. According to the order of the Government the status of data of the organizations as only contractors for 2019-2020 is prolonged.

Elena Boyko: At the federal level we realized need of import substitution long ago therefore Uniform State Health Information System is written on the open source. We also broadcast to regions need of use of solutions, products and the equipment of mainly domestic manufacturers.

Elena Boyko: Yes, sent.

Elena Boyko: Piloted in the subordinated organization. In central office not yet.

Elena Boyko: The product needs to be developed still, but if we are told tomorrow that we should pass to it, we will cope with it too.

Elena Boyko: In 2017 the break was made – the law which set the main framework is adopted. Now we should define each part – as well as that will work. For example, on all subsystems of Uniform State Health Information System we should release orders of their functioning and interaction with the systems of regions and organizations. Should define an order and formats of electronic document management between participants of a digital circuit of health care. Level of these documents – orders of the Ministry of Health.

Elena Boyko: Perspectives are obvious. In the law it is defined that a supplier of information in the federal Uniform State Health Information System system are the medical organizations. There it is not written "the state organizations".

Elena Boyko: Everything obtained the license for delivery of health care. In Uniform State Health Information System subsystems intended for resource management of a national health care system which includes both the state and commercial organizations everything will be obliged to provide information. Accession to the transaction systems of the commercial medical organizations – too a matter of time, they will be interested to be connected to a digital circuit that it was convenient to their patients.

In the law the concept "other systems", the speech about the commercial organizations which are not medical, but which are ready to provide to citizens different services at their consent, using data of Uniform State Health Information System is also defined. It can be the platform which connects the medical organization and the patient. In government decree 447 the registration procedure of such organizations is described.

Elena Boyko: The providers of services applying for obtaining information from Uniform State Health Information System should undergo certification in FSTEC and FSB, and then to submit the application to the Ministry of Health. Further the Ministry of Health should accumulate these requests, submit for consideration of presidium of the government commission on digital economy.

Elena Boyko: Recently in Ministry of Justice the order of the Ministry of Health which approves the commitment form on registration of "other system" was registered. So the submitted applications of the organizations will be submitted for consideration of Presidium.

Elena Boyko: These are the private organizations which are engaged not necessarily in telemedicine. They develop different services – how to lead a healthy lifestyle, for example.

Elena Boyko: They will obtain information on doctors, the medical organizations, statistics.

Elena Boyko: It will receive demand, but also will complicate life that who provides similar services without thinking about personal data protection and without due documentation today. Serious growing still is necessary to this sphere.

Elena Boyko: Yes.

Elena Boyko: Quite so. And I think that I will be a little of them. My forecast - everything will come down to several large platforms based on which there will be medical services for citizens. And different service providers will be already connected to these platforms.

Elena Boyko: Perhaps. And he will bear responsibility for quality of services.

Elena Boyko: First, it is unnecessary to forget that it is after all the organizations which profit. Businessmen understood long ago that the digit is a tool which to them allows to save money. Therefore they are ready to pay IT infrastructure. Secondly, it is necessary to remember significantly different scale of the state and commercial clinics – they have less inertia. As for medical information systems, I would not tell that they functionally promoted somewhere further, than those that are used in the state medical organizations.

It is worth learning from commercial clinics to those services which they do for people. They are aimed at generation of profit. And it is natural, their KPI – that the patient returned to clinic next time. Personal accounts which they do, with a possibility of tracking, for example, of health indicators, it, really, conveniently. It is possible to note user-friendly interfaces of information systems also. But developers of systems for commercial clinics also should consider new requirements of the legislation, to develop them on an equal basis with the state organizations.

Elena Boyko: Yes, federal reference books, clinical recommendations in a digital format will be available as the uniform normative reference information to all national health care system.

Elena Boyko: In the Ministry of Health the department of digital development will continue work. It will provide preparation of regulatory legal acts and administration of projects, in interaction generally with three organizational methodological and technical centers. The first - "Competence center of digital transformation of health care" which was created based on the subordinated organization of the ministry TSNIIOIZ (Central Research and Development Institute of the organization and informatization of health care) recently. The second – the federal center which is responsible for coordination of digitalization of federal institutions of the Ministry of Health provides operation and development of departmental information systems of the ministry. Our third support is the only contractors.

Elena Boyko: Several hundred people. At the same time we select employees in Competence center now, we need still people.

Elena Boyko: Yes, in the nearest future you will get acquainted with it) He was also engaged earlier in digitalization of the social sphere.

Elena Boyko: First of all, methodology for development of information systems, taking into account the analysis of processes of a health care system. Why it is important? We approved requirements to information systems of the medical organizations and the requirement to functionality of centralized systems of the regional level. In the document it is told what functionality such systems (scheduling of ambulance should provide, the system of telemedicine consultations, a single system

laboratory researches, the central archive of medical images and others), but on each subsystem study of processes, the description of implementation of such systems is required. Involvement of profile specialists and experts is for this purpose planned.

Besides, the Competence center should provide maintenance of implementation of the Federal project in regions and federal institutions, analytics, development of the normative reference information, conceptual documents, study of questions of new technologies and important issues for digitalization of health care.

Elena Boyko: In the different directions and questions the working groups are created. A task of staff of Competence center to provide moderation of the working groups, and specialists of professional community will be participants. Methodical documents, requirements to development of information systems or to development of regulatory legal acts should become result of their work.

A lot of things depend on the organization of work of all participants involved in implementation of the Federal project and in development of digital medicine in our country. The new competent personnel, initiative experts who are really ready are necessary it is creative to work. Organize harmonious work of experts at the federal level and in regions, in it I see the main objective.

We have a dream, clear aims, there are achieved results and therefore we will continue. It is sure, implementation of the national project will positively change life of citizens of our country.