2023: Russian Ministry of Digital Development creates industrial center for import substitution of software in the field of pharmaceuticals
The Ministry of Digital Development of the Russian Federation has created an industrial competence center for import substitution of software in the field of pharmaceuticals. It was joined by several large pharmaceutical companies, including R-Pharm, Pharmstandard, Biocad, Pharmasintez, Nanolek, ChemRar and Velpharm. Read more here.
2022: Roszdravnadzor makes it easier to update healthcare IT solutions
In December 2022, it became known about the decision of Roszdravnadzor to simplify the update of IT solutions in the field of healthcare. This is about making it easier to make changes to software registered as a medical product.
The regulator allowed to refine the software, provided that its profile and purpose are preserved. The agency will automatically check the sensitivity and specificity of software on datacets that were used in clinical trials of the product with a certain frequency. The indicators after the software update should be no worse than when the product was originally registered.
 | As for the problem of rapid software product change: we see a solution related to the approach that it does not matter what changes have occurred in the software product, it is important for us that it works no worse. With the same sensitivity, with the same specificity, at least not less than what was stated at registration. Of course, if the purpose of the software product is not replaced, if we do not switch from X-rays to images of a different kind or analysis of other data. In this case, of course, an assessment will be required at the entrance to the market, - said Dmitry Pavlyukov, deputy head of Roszdravnadzor. |  |
According to him, subject to periodic verification of the software product, Roszdravnadzor "will not limit the possibilities of its change, transformation, refinement, starting from the interface and ending with its filling."
| | We see a track that will allow this to be done automatically, using those datasets on which the software product was undergoing clinical trials, "added Dmitry Pavlyukov. | |
2021: Roszdravnadzor began registering medical software with artificial intelligence for the highest risk class
The Federal Service for Supervision in the Field of Health of the Russian Federation (Roszdravnadzor) began to register medical software with artificial intelligence for the highest risk class of potential use of medical devices. The first to receive such a registration certificate was the Third Opinion module . Radiographs " for the analysis of X-ray and fluorographic images, developed by the startup" Platform "Third Opinion." Read more here.
2020
The Ministry of Health of the Russian Federation has updated the requirements for the documentation of medical software
On December 21, 2020, the Ministry of Justice of the Russian Federation registered an order of the Ministry of Health of the Russian Federation, which, among other things, defines new requirements for documentation of medical software. We are talking about amendments to the profile order No. 11n of January 19, 2017, which will enter into force on January 1, 2021.
The main change is the emergence of a new chapter II, which is called: "Requirements for the content of the technical documentation of the manufacturer (manufacturer) for software that is a medical device." It contains 24 requirements, starting with the name of the software and ending with "information about the initial release or the latest revision of the technical documentation for the software."
Among them are items on the purpose of the medical device, the source of the dataset, which are used as an algorithm, description and characteristics of the program, technical and hardware requirements, information on the order of installation and removal, versions of the software and ways to update it, as well as requirements for the qualification of persons for installing and using the software.
The document also talks about protection against unauthorized interference, assessment of risks and vulnerabilities, ways to protect against them, including antivirus programs, multi-level access and cryptographic protection.
Based on the explanations given by Roszdravnadzor, the software is considered a medical product if it is intended for:
- control of equipment operation and monitoring of its functioning;
- receipt of diagnostic data from the equipment, their accumulation and calculation in automatic mode;
- monitoring of human body functions and transmission of the obtained data (including through wireless technologies);
- calculation of dose selection parameters (irradiation, drug, radiopaque substance, etc.);
- processing data obtained from diagnostic medical equipment, transferring it to planning and therapy systems;
- processing of medical images (including changes in their quality, color resolution, etc.).[1]
Mishustin accelerated the registration of medical software
Prime Minister Mikhail Mishustin signed a decree on the accelerated registration of digital platforms in the healthcare sector. The press service of the Cabinet of Ministers announced this on November 27, 2020.
We are talking about software that is used to help doctors diagnose cancer, plan surgical techniques, monitor the health of elderly patients with chronic diseases and rehabilitate patients.
Such digital solutions, as reported in the signed government decree, will undergo the state registration procedure in one stage. This will speed up the launch of innovative developments in the healthcare sector, increase the efficiency, availability and quality of medical care for citizens.
This issue, as reported in the government, was discussed at a meeting of the Presidium of the Coordination Council under the government to combat the spread of coronavirus (COVID-19) infection on November 23, 2020. According to Mikhail Mishustin, the one-stage procedure for registering software products for medical devices will allow you to quickly apply the latest developments in medical practice.
The decree signed by Mishustin also concerns artificial intelligence technologies. Earlier in November 2020, the Ministry of Health of the Russian Federation announced plans to launch an AI platform by the end of the year. A special industry platform is being created that will combine impersonal medical data, provide access to it by domestic developers and researchers for marking data and creating ready-made solutions, as well as medical organizations for ready-made solutions based on artificial intelligence, its first phase, including a set of ready-made solutions.[2]
The criteria by which software in Russia will be classified as medical devices have been changed
On February 14, 2020, Roszdravnadzor changed the criteria for classifying medical software as medical devices. This follows from the information message of the department posted on its website. download
Roszdravnadzor announced the cancellation of its information letter "On Registration of Software," created on December 30, 2015. [1] At the same time, the agency informs about the posting on its website of another letter, "On Software," dated February 13, 2020.
It, as noted by Roszdravnadzor, contains the position of the commission of its subordinate institution, the All-Russian Research and Testing Institute of Medical Technology (VNIIIMT), on issuing conclusions to requests related to the circulation of medical devices. The letter also contains the position of the institution on the classification of software to medical devices, including the exact criteria for such a ranking.
As explained to TAdviser in the association of developers and users of artificial intelligence "National Base of Medical Knowledge" (NBMZ), software that is a medical device is subject to technical and clinical tests, examination and subsequent state registration. The association also noted that the letter "On software registration," created in 2015, also contained criteria for classifying software as medical devices, but they were abstract.
The position of the VNIIIMT Institute, contained in the information letter "On Software," compiled in 2020, is as follows. A medical device is a software if:
- is a program for a computer or its modules, regardless of the hardware platform used, as well as methods of placing software and providing access to it;
- is not part of another medical device;
- intended by the manufacturer for medical care;
- The result of the software is an automatic interpretation.
In particular, interpretation can use artificial intelligence technology, as well as a set of data obtained from medical devices admitted to circulation in accordance with the established procedure or entered by medical professionals to provide appropriate assistance. In addition, the interpretation may correspond to the parameters set by the health care professional that influence clinical decision-making.
They are not interpretations of data, for example, such methods and technologies used in software:
- display of data received from a medical device, including in a given format;
- calculation by given formulas;
- Translation between units
- construction of statistical reports and graphs;
- Raster or Vector Image Editor
- alarm of deviations in data if possible;
- display of initial data and subject to setting parameters;
- alarm of deviations by the user;
- Create screen forms, business processes, reporting, and other views that are used to automate the medical organization's business processes during software operation.
As examples of software that is a medical device, the institute cites the following products:
- Software for the doctor to view an individual anatomical ZD model based on computed tomography images;
- Software to support medical decision-making in case of stroke;
- Software to help the doctor diagnose malignant neoplasms;
- Software to help a doctor diagnose tuberculosis or viral meningitis in children;
- Medical Decision Support for Colorectal Cancer Risk
- Software to help the doctor diagnose arrhythmia;
- Software to assist the doctor in planning the technique of surgical operations;
- Software to assist the doctor in performing morphometric measurements;
- Remote health monitoring software for elderly patients with comorbid chronic diseases;
- Software for the development of an individual rehabilitation program;
- Software used as prescribed by a physician to calculate by a diabetic patient at high risk of hypoglycemia a bolus dose of insulin based on carbohydrate intake, expected physical activity, and pre-meal blood glucose levels;
- Software of the radiological system for archiving and transmitting images for obtaining, storing, transmitting, processing and viewing images by a doctor.
As examples of non-medical device software, the institute designates developments such as:
- Software designed to automate the administrative and economic activities of a medical organization;
- Software, including mobile applications designed by the manufacturer to promote a healthy lifestyle and create a responsible attitude in people to preserve and promote health, maintain active longevity, which measures/calculates the number of steps, walking/running speed, pulse, number of calories/fluids spent and/or consumed, weight, body mass index, etc.
- medical information systems of a medical organization, laboratory ICs, electronic medical record management software, image archiving and transmission systems, if such software does not contain data interpretation functions;
- Software, including its update, used to manage the medical device and monitor its operability;
- Software that uses data from one or more medical devices but is not intended to provide medical care. For example, software that encrypts and/or combines data obtained from one or more medical devices for further transmission;
- Software for the exchange of text and/or voice messages, electronic documents, photographic images, video, audio recordings/streams and other data between a medical professional and a patient, their registration, storage and access to them in the provision of medical care, including using telemedicine technologies, or for appointment;
- Software for accounting, planning and monitoring of routine maintenance and scheduled repair of medical devices;
- Software for an unlimited range of users, which has educational, popular science, reference and information purposes, including the choice of a medical specialist.
The NBMZ TAdviser association said that the set of criteria relating software to medical devices is clear and transparent.
| | If the software is intended by the manufacturer for the provision of medical care and if this software somehow interprets the medical information submitted to it, then such software should be referred to as a medical device. If there are no such signs, then this is the most common software and it is not necessary to register it as a medical device. For the market, this is of great importance, - noted in the NBMZ. | |
As an example of the positive effect of the innovation in the association, the fact was cited that, thanks to it, ordinary electronic medical record management systems, medical information systems, electronic registrars ceased to be in some cases a medical device. Namely, when they lack the functions of supporting medical decision-making, as well as do not form hints to a medical professional and do not interpret the information entered.
The association also drew attention to the fact that from the concept of "medical device," in particular, all administrative and economic software, reference books and mobile applications for patients on a healthy lifestyle are made.
2019
The issue of simplifying the registration of medical software does not shift from the dead center
To resolve issues related to medical software, three working groups will be created at the initiative of the Federal Service for Supervision of Healthcare (Rosszdravnadzor). They will help to take into account the opinion of all stakeholders when resolving industry issues, the National Medical Knowledge Base (NBMZ) told TAdviser in October 2019 at the Association of Developers and Users of Artificial Intelligence Systems in Medicine.
As follows from the minutes of the industry regulatory workshop held by Rossdravnadzor on October 17, which TAdviser reviewed, the following working groups will be established:
- on the issues of establishing criteria for classifying software as medical devices, as well as their classification by classes of potential risk of use and types;
- on the issues of forming requirements for the technical and operational documentation of medical software, as well as issues of conducting technical and clinical trials;
- on improving the procedure for registering medical software (software).
Roszdravnadzor expects from "interested parties" the proposal of candidates for inclusion in the working groups. The agency accepts proposals until October 25. The NBMZ clarified to TAdviser that all three created groups will carry out their work under Roszdravnadzor.
In the direction of improving the procedure for registering medical software, the industry, as well as the Skolkovo Foundation, is actively working. The NBMZ Association and Skolkovo propose to simplify the state registration of medical software without registering it as a medical device.
There may be different options for this simplification. Thus, Skolkovo, together with the Center for Competence in Regulatory Regulation, the Pepeliaev Group Law Firm and with the participation of the NBMZ Association, has developed a draft Federal Law on Amendments to the Federal Law "On the Basics of Protecting the Health of Citizens." He proposes to introduce the concept of medical software (MPO), a special procedure for its state registration and the ability not to subject it to some types of software included in the MPO and that software that is not it.
To date, as TAdviser was told in the NBMZ, the bill was considered at the working group of the ANO "Digital Economy" and, in accordance with its decision, is additionally being worked out by the Competence Center for Regulatory Regulation with authorized federal executive bodies of the Russian Federation (FOIV).
Business is an active supporter of the adoption of the bill. Among the companies supporting the bill are Sberbank, USM Group, Megafon, 1C, MTS, Post Modern Technologies.
| | The same companies that are not his supporters are some of those who have already conducted their medical software through the state registration, which is laid for medical devices. They argue that since they managed to adapt to it, it may not be necessary to make the exceptions proposed by the bill, "the NBMZ told Tadviser. | |
As for the Ministry of Health of the Russian Federation, the association told TAdviser that the department refuses to support the bill. In response to TAdviser's repeated appeal regarding the position on the bill, the Ministry of Health did not provide comments.
Roszdravnadzor so far, they say in the NBMZ, also does not support the bill, believing that the problem of registering medical software must be solved without changing the law, according to which this software is now registered as a medical device - at the level of by-laws.
| | It is necessary to look for mutually acceptable solutions, which the working groups will do, - said TAdviser in the NBMZ. | |
In Roszdravnadzor itself, TAdviser could not comment on their position.
As for the initiative of the association aimed at withdrawing medical software from registration as a medical device, it consists in changing by-laws.
| | We agree with the current wording of Article 38 of the 323-FZ that medical software is a type of medical device. But to speed up the launch of new products on the market, we propose to make point changes to the orders of the Ministry of Health to solve the problem of a long and complex procedure for registering medical software as a medical device, - explained TAdviser in the NBMZ. | |
However, as follows from the statement of the association, its proposals also did not receive the support of the state.
| | At the end of last year, NBMZ sent its proposals for changing by-laws to Roszdravnadzor. In response, at the beginning of 2019, the department simply repeated the NBMZ well known to us and the situation with the legislative regulation of medical devices described in the appeal and essentially refused to recognize the relevance of this issue, limiting itself to a standard unsubscribe, the NBMZ says. | |
It had, as stated in the association, the following form:
| | Thus, in accordance with the current regulatory legal acts, the measures taken to date to simplify and speed up the procedure for registering medical devices in terms of software are sufficient. However, the proposals submitted will be considered in the preparation of the relevant draft regulations in accordance with the regulatory action plans | |
At the same time, the arguments for the withdrawal from the registration procedure as a medical device of medical software from the NBMZ association and Skolkovo are the same. As such, they denote the lack of material nature and material carrier in medical software, the speed and frequency of updates, iterative development, validation methods other than a medical device.
| | Requirements for medical devices often cannot be applied to medical software. In practice, registration of medical devices is a process lasting about a year, and the introduction of changes to the dossier, if accompanied by an examination, is about six months. In this regard, according to the current regulatory procedure, by the time the software product is registered, it is already outdated. Software product updates can take place every month and more often, which in turn carries the need to make changes to the registration dossier documents - explained Evgenia Meshkova, head of legal initiatives at the Skolkovo Foundation Development and Planning Department, to TAdviser. | |
She also noted that in the event of the discovery of an appeal of an unregistered medical device or discrepancies between the medical device and the documents of the registration dossier, the person who sells such a device can be brought to administrative and criminal liability.
"National Medical Knowledge Base" Promotes Medical Software Registration Bill
On July 12, 2019, it became known that Ministry of Health it refuses to support the draft federal law "On Amendments to the Federal Law" On the Basics of Health Protection of Citizens, "proposing, in particular, to introduce the concept medical software (MPO), a special procedure for its state registration, as well as the possibility of not subjecting it to some types of software included in the MPO and the one ON that is not it. More. here
Notes
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