National base of medical knowledge of NBMZ
Central Federal District of the Russian Federation
The agreement with MMK on opening to Skolkovo laboratories for AI in medicine
On August 29, 2019 the National base of medical knowledge reported that it agreed with Fund of the International medical cluster about opening to Skolkovo of joint laboratory "Medical Knowledge". Read more here.
Promotion of the bill of registration of medical software
On July 12, 2019 it became known what Ministry of Health refuses to support the federal law draft "About introduction of amendments to the Federal law "About Bases of Protection of Public Health" suggesting to enter, in particular, medical software a concept (MPO), a special order of its state registration and also an opportunity not to subject it some types of the software entering into MPO and that software which it is not. The bill is considered on the working group ANO "Digital economy" and, according to its solution, is in addition studied by Competence center on normative regulation with the authorized RUSSIAN FEDERATION federal executive authorities (FEA). Business acts as the active supporter of adoption of the bill.
The bill is published on the official portal of placement of information on preparation of projects of regulatory legal acts. Public discussion of the bill began in February, 2019.
As the head of association of developers and users of artificial intelligence in medicine "National Base of Medical Knowledge" (NBMK) Boris Zingerman, NBMZ association, told being an initiator of the bill, looks for supports for its approval according to the results of public discussion.
| ||Mostly the bill finds support from business. The same companies that are not his supporters, are some of those who already carried out medical software through state registration which is put for medical products. They claim that as they managed to adapt to it, perhaps, it is not necessary to do the exceptions offered by the bill,|
told Boris Zingerman
At the same time he noted that there is a probability that the bill will be approved according to the results of public discussion in a month.
According to Boris Zingerman, basic provisions of the bill are determination of the medical software (MS); the exception of MPO and also cases at which MPO is not subject to registration; the status of the holder of RU on MPO; concept "appeal of MPO", including determination of "release of MPO"; In silico trials (which are carried out for the purpose of registration technical tests in the form of the analysis of clinical, therapeutic and other medical data and also examinations of efficiency and security); features of registration of MPO; settlement about versions of MPO; Register of MPO; pilot program for accreditation of MPO developers (pre-cert); state control and monitoring of MPO.
| ||The software which is expelled from MPO which at the same time is used by medical institutions and also some of MPO which is in structure the bill is offered to be subjected to state registration, other than that which is put for medical products. According to the offered registration, the developer of the medical software will have an opportunity to enter information on the happened changes of the product in the corresponding registration file of times a year. It will make it by means of the automatic procedure. So additional registration of a product will not be required to it. If the software class, of course, was not changed,|
explained Boris Zingerman
According to him, it is offered to exclude from the medical software the bill software, used for support of administrative and applied needs of the organizations in the field of health care, including the medical and pharmaceutical organizations; Software, used for maintenance and assistance to a healthy lifestyle of citizens and (or) social rehabilitation, not intended for diagnostics and (or) treatment and (or) medical rehabilitation of the person with participation of the health worker and (or) use in combination with medical products; Software, used for ensuring functioning, management of MPO (for accomplishment of functions of the driver) if it software does not change a class depending on potential risk of application and/or the type according to nomenclature classification of MPO stated at state registration of MPO; Software, used for accomplishment of functions of the reference book; Software, used for interaction of the patient and the health worker within delivery of health care using telemedicine technologies by exchange of audiovisual and text information, not interacting with other MPO and not intended for hands-off processing and (or) interpretation and (or) the analysis of the specified data by software tools for the purposes of delivery of health care; Software, used for other purposes according to the list approved by the Government of the Russian Federation.
As for that MPO which is offered be not to carried out by the bill through the state registration put for medical products, it is such MPO as MPO held for use in information systems in the field of health care and other information systems; MPO intended for transfer, storages, changes of formats and information display (data) on the state of health (including without limitation, images, signals and so forth) received from medical products or received from health workers (at the same time appointment should not be connected with their automatic scanning, processing and (or) interpretation and (or) the analysis of such these (results); MPO, the producer (developer) of which is accredited in accordance with the established procedure for the purposes of implementation of activities for development of MPO; MPO held for use in the territory of the international medical cluster or in territories of the innovation scientific and technology centers; other MPO, according to the list set by the Government of the Russian Federation.
Besides, Boris Zingerman specified those problems which the bill will allow to eliminate:
| ||These are such problems as application to one and all medical software of the outdated procedure of state registration of medical products - the procedure which is initially expected the "iron" products which are not undergoing almost any changes after the release; long terms of this procedure; the conventional attitude to registration of the software which is not leading to real increase in its security; impossibility of fast making changes, functions, settings and error correction; an exception of a possibility of consideration of the medical institutions ordering completions of MPO for the needs or in connection with the appearing requirements of profile departments as customers of production of the unregistered medical products; criminal prosecution which can arise after registration of MPO at detection of the fact of work with it which does not have registration yet.|| |
Agreement with Fund of the International medical cluster
The fund of the International medical cluster and "National Base of Medical Knowledge" Association will strengthen development in Russia of artificial intelligence technologies in medicine. The corresponding agreement on cooperation and participation in the meta-project on creation of the national player in the global technology market in medicine and health care was signed in June, 2019 within the St. Petersburg International Economic Forum of 2019. Possibilities of MMK will be used for creation of a basic polygon at new product development and perspective technologies by participants of NBMZ Association whom there are already more than hundred. According to experts, Russia can become the leader in use of artificial intelligence in health care and by 2023 to enter with the meta-project the world market.
The signed agreement will allow to create a zone for development and piloting of the new products and perspective technologies allowing domestic physicians to make the correct and exact diagnoses, using solutions based on artificial intelligence, even at early stages of diseases and also the center of gravity for the best foreign practices, including startups. The approved solutions will be implemented in the Russian health care system and to be offered the foreign medical organizations.
Cooperation with ARPP "Domestic Software" on development of digital health care
On April 30, 2019 the Association of software developers "Domestic Software" reported that together with Association of developers and users of artificial intelligence in medicine "National base of medical knowledge" signed the agreement on cooperation on April 29 in Moscow.
The subject of the agreement are joint activities for development and implementation of projects of digital health care mainly on the basis of domestic developments, including artificial intelligence for medicine. Within the signed document joint development of concepts, programs and methodical recommendations about development of AI for medicine and health care in Russia and also coordination of activities for formation of the information resources aimed at quality improvement and availability of the medical care provided by treatment and prevention facilities due to automation of the clinical areas of work, to assistance in the organization of effective medical and diagnostic process and implementation of developments in the field of the support systems of adoption of medical solutions (SSAMS) is supposed.
| ||It is sure that within our cooperation competences of the Russian software developers in artificial intelligence and development of digital technologies will contribute to intensive information technology development in medicine and health care. Cooperation first of all will be directed to exchange of experience. Developers will be able to understand better requirements of health care, is more effective to construct dialog with customers, to act as experts of the industry, to adjust the plans for release and implementation of the most demanded packaged software and digital technologies in the Russian health care. Information technology implementation in health care directly affects quality and development of the provided medical care and, eventually, quality of human life.|
Renat Lashin, chief executive of ARPP "Domestic Software"
| ||For us in a priority domestic developments. It is sure that they will help Russia to find the leader positions in medicine as in one of the most difficult industries and to break a tendency to a prevalence of foreign technologies in the medical equipment.|
Boris Zingerman, "NBMZ"
In Russia the uniform operator of biomedical data is created
On September 26, 2018 it became known of the beginning of implementation in Russia of the large-scale project on creation of the national operator of biomedical these citizens. The association of developers and users of the systems of artificial intelligence "National base of medical knowledge" together with medical community was engaged in it.
According to Kommersant, representatives of association, Ministry of Health, medical and insurance community already held the first meeting concerning a question of streamlining of turnover of biomedical data.
| ||The purpose – creation of an ecosystem for developments in the field of artificial intelligence. One of its components, in addition to realistic normative regulation, – bases of biomedical data at which the systems of artificial intelligence could study the correct diagnoses, – the member of consolidation Sergey Voinov told.|| |
According to him, creation of databases on group of the most widespread diseases can borrow from three to five years. He estimates the cost of creation of bases on one group of diseases at several billion rubles.
One of participants of discussion told the edition that one operator will be engaged in storage and processing of medical these Russians. Access to the platform with the depersonalized data will be got by developers — as envisioned by authors of the project, it will help development of startups in the field of artificial intelligence.
At negotiations as the member of the supervisory board of association Igor Gorbunov told Kommersant, nobody disputed need of creation for the country of similar services. The speech, according to him, generally went about a uniform of the operator. Being afraid for safety of biometric data insisted that the project should be state, the same who argued on future practice of the operator noticed that off-budget financing will be required, he noted.
Igor Gorbunov considers by some of perspective users of a system insurers. Still they had no access to medical data.
Creation of association of developers and users of the systems of artificial intelligence
RVC announced in July, 2018 creation in Russia Associations of developers and users of the systems of artificial intelligence in medicine. The association is founded with assistance of RVC for the accelerated implementation of advanced technologies of artificial intelligence in clinical practice and development of products of the markets by Neyronet and Helsnet Natsionalna of a technology initiative.
The purposes of Association is consolidation of market participants for the solution of the topical issues connected with activity in the field of creation and development of the national base of medical knowledge directed to participation in creation of federal network of collecting of primary biomedical data; ensuring equal access for the Russian developers Support systems of Adoption of Medical Solutions (SPPVR) to validirovanny biomedical data; support of market development of SPPVR for the purpose of reduction of time of diagnosis and purpose of treatment, increase in accuracy of diagnosis; creation of the available, variable, extensive expert environment in the field of development and practical application of digital technologies in a system health care.
Consolidation of efforts of the Russian developers within Association will become an important factor of development of products of the markets Neyronet and Helsnet Natsionalna of a technology initiative and the accelerated implementation of advanced technologies of artificial intelligence in clinical practice.
Developers of the innovation products for health care, the medical organizations, other market participants and also individuals became participants of Association. The Supervisory board of Association included representatives of the Russian venture capital company, All-Russian Union of Insurers, Associations of Honored Doctors, heads of the medical organizations and educational institutions.