Legal Guidelines in the Digitalization of Healthcare: Availability of Medical Data as a Tool for Achieving Social Objectives

Key conclusions

The volume of electronic data in medicine has increased significantly. Reformatting of the system is required

“In two and a half years, the volume of data generated at the federal level has increased eightfold. <...> The flow of information in medical documents has increased significantly,” Pavel Pugachev, Deputy Minister of Health of the Russian Federation.

“A large amount of data is emerging. <...> Today, medicine <...> accounts for about 30% of all the different profile innovations that are being developed in the world. It is a very innovation-intensive field. <...> Trends are emerging in medicine today, such as patient-centred <...> and the so-called value-centred healthcare in which we focus on treatment that is most effective in the first place. And these trends will require a reformatting of the entire healthcare system, its regulators, its economic motivators,” Vitaliy Omelyanovskiy, General Director, Center for Healthcare Quality Assessment and Control of the Ministry of Health of the Russian Federation.

“When we start talking about the arrival of new technologies, whatever they may be, <...> and increase of the availability of these technologies, this dictates to us the need to collect data not based on clinical trials, which we are used to, <...> but when we launch technologies and assess their clinical effectiveness directly in the process of patients treatment. And this also generates a certain need for digitalization and the ability and need to work with the large amount of data that is being collected from these patients. <...> New orphan technologies and new drugs with poorly studied efficacy appear, and monitoring based on these data which, of course, are personalized. And there should be an assessment of this treatment,” Vitaliy Omelyanovskiy, General Director, Center for Healthcare Quality Assessment and Control of the Ministry of Health of the Russian Federation.

Mechanisms to preserve and anonymize personal data have been developed

“The current development of information technology already makes it possible to make such technological algorithms for the protection and depersonalization of personal data, but so far only under certain restrictions. This is the first stage, which we are discussing with colleagues from the State Duma and regulators. <...> We collect personal data within the state information system, which is the national data management system, under state control, in a kind of a "sandbox" <...>. Then, we convert these personal data into special anonymized sets of data prepared for the artificial intelligence program and give access to this data to the developers of that program. This is the first stage, which is fairly refined but does not meet all the needs of artificial intelligence. However, it is the stage in which we see that the necessary level of protection for this personal data can be fully achieved, i.e. the technology is ready for this stage, and it is mandatory. We must go through it in order to move forward. The next stage is to provide accredited platforms for access to the data set, i.e. it is no longer a state platform, but a platform where these data are collected, anonymized, and given access. And the third stage is to create a data exchange where data will already be depersonalized quite well,” Aleksandr Shoitov, Deputy Minister of Digital Development, Communications and Mass Media of the Russian Federation.

Digitalization is not an end in itself. It is needed to optimize healthcare

“Is the digitalization an end in itself? Or is it a tool? On the one hand, digitalization is, of course, a tool that allows us to optimize activities. That is why we have <...> various software products that facilitate the work of doctors and the healthcare system. But, on the other hand, we have a volume of data that will then begin to generate its own decisions, and in this case we are talking about supporting management decision-making and the system of expert and physician decisions. And it will all be built based on the data that we and you collect," Vitaliy Omelyanovskiy, General Director, Center for Healthcare Quality Assessment and Control of the Ministry of Health of the Russian Federation. 

PROBLEMS

The final decision on personal data rests with the person, the patient

“We have to build on the needs of consumers and patients. <...> When a patient comes to a healthcare institution to seek medical attention which is necessary for their health, signs a consent [to process and transfer personal data], they are completely unaware of how much data they are transferring. They also do not know yet what is going to happen to these data in the future, because they do not even know yet the extent of various tests in the given medical institution,” said Albina Gadzhieva, Director, Institute for National and Comparative Law Studies, National Research University Higher School of Economics.

“The key is the expression of will of the person whose data is supposed to be processed – consent to processing of their personal data. <...> This must be a consent signed by the person, and this can be any type of electronic signature,” Milosh Wagner, Deputy Head of the Federal Service for Supervision of Communications, Information Technology, and Mass Media.

“We work with a person, a patient, we cannot make decisions for them, and they <...> carry not only their genetic information but also the genetic information of their relatives and so on. <...> These issues determine the direction in which we must work,” Vitaliy Omelyanovskiy, General Director, Center for Healthcare Quality Assessment and Control of the Ministry of Health of the Russian Federation.

Issues of access to personal data and the development of telemedicine need to be resolved

“The State Duma is considering a draft law on the basics of health protection of citizens which provides for the launch of a register of all those who holds a medical degree or are somehow connected with it. In this case, there is the issue of personal data as well. It is all being done as part of one big project. In my opinion, it is also necessary and useful, but it is very important to discuss with the expert community how access to it will be arranged,” Vladislav Davankov, Deputy of the old State Duma of the Federal Assembly of the Russian Federation.

“Telemedicine, in my opinion, can be a quick and useful way to get your health checked, <...> and this area needs to be developed. And in this case, there will be a need for lawyers as well, as there are also many issues. For example, getting access to medical digital records or getting a digital signature is almost like getting a second passport now. Thus, many experts in this field are required,” Vladislav Davankov, Deputy of the old State Duma of the Federal Assembly of the Russian Federation.

“The use of big medical data can be very beneficial, it is a very important task. <...> Leaks of medical personal data containing medical secrets are very critical. <...> Issues of depersonalization of personal data, when we transform them in such a way that using <...> data for processing by artificial intelligence we cannot determine which person the specific data is associated with, determine accurately that this person is sick and suffers from this or that disease,” Aleksandr Shoitov, Deputy Minister of Digital Development, Communications and Mass Media of the Russian Federation.

Data collection does not preclude data leakage. The medical field leads the way

“Medical data are a special category of personal data and should not be processed except in cases expressly provided for by law. <...> When developing any new technology, when gaining knowledge, access mode to these data must first be defined. <...> The purpose of the data processing should be determined, <...> only process the minimum data necessary to achieve this purpose. <...> The less data are collected, the less are leaked later,” Milosh Wagner, Deputy Head of the Federal Service for Supervision of Communications, Information Technology, and Mass Media.

“The most important issue is the protection of personal data, specifically in healthcare because <...> it poses a risk to health, to human life. <...> According to studies, healthcare is in the forefront of personal data leaks. Experts attribute this mainly to the number of personnel that the industry has and the training that is available. <...> One of the important things we will be discussing in the State Duma is the launch of either continuing professional development in healthcare or the launch of entirely new professions – a personal data protection lawyer and a healthcare lawyer. There are not many such lawyers now, <...> they are in demand, these experts can earn up to 300 thousand roubles,” Vladislav Davankov, Deputy of the old State Duma of the Federal Assembly of the Russian Federation.

The depersonalization of personal data does not guarantee full protection for the patient

“The depersonalization [of personal data] is not a panacea, it reduces the likelihood that personal data will be compromised, but it does not eliminate this possibility. <...> Access to data is not an end in itself, data are a tool, a means,” Milosh Wagner, Deputy Head of the Federal Service for Supervision of Communications, Information Technology, and Mass Media.

“Simply depersonalizing medical data is not a panacea when it comes to usefulness and efficiency of their use because, as analysis of medical record management shows, we have too much narrative when it comes to maintaining patient information. <...> In order for these data to be as useful as possible, they must be validated in terms of completeness of patient information, reliability of patient information, and structuredness of this information,” Pavel Pugachev, Deputy Minister of Health of the Russian Federation.

“The more [personal data] are depersonalized, the less useful they are,” Dmitry Ter-Stepanov, Deputy General Director – Director of Regulatory Control, Digital Economy, said.

SOLUTION

Take into account the patient's interests and their need for modern medical technology

“The Yandex search engine generates 400 thousand queries on telemedicine, <...> a huge number of patients seek this service. We see how difficult it is to introduce despite the great positive international experience that telemedicine had during the COVID outbreak. <...> Restrained development and regulation in this case leads to the fact that the patient, who wants to get this service by phone for a number of reasons, they don’t have time, busy at work, and so on <...>, will find it anyway because that’s how the market works,” Albina Gadzhieva, Director, Institute for National and Comparative Law Studies, National Research University Higher School of Economics.

New mechanisms for high-tech remote care are needed

“It is worth thinking now about a more flexible operational mechanism for adjusting regulations which, even in the pre-experimental phase, would allow the regulator to respond quickly and maybe give it more authority in what is not yet included in the experimental-legal regime. This would probably provide more security for both patients and regulate these interactions. After all, high-tech modern and safe medicine is the future for all of us, and we should strive for it,” Albina Gadzhieva, Director, Institute for National and Comparative Law Studies, National Research University Higher School of Economics, said.

For more information, go to the Roscongress Information and Analytical System roscongress.org.

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