Federal Law no. 242-FZ dated 07/29/2017 “Amendments to Separate Legislative Acts of the Russian Federation on Issues of Applying Information Technologies in the Sphere of Healthcare”, commonly called “The Law on Telemedicine”, became effective in early 2018. The law essentially introduces amendments and additions to the Federal Law “The Fundamentals of Civilian Healthcare in the Russian Federation” no. 323-FZ dated 11/21/2011. It defines the following:

– the concept of telemedicinal technologies (information technologies that ensure the distance-based collaboration of health workers with each other, with patients and (or) their legal representatives, the identification and authentication of such individuals, the documentation of actions carried out by them when conducting conferences, consultations and distance-based medical observation of a patient’s physical well-being);

– the procedure for applying telemedicinal technologies when providing medical assistance;

– the procedure for organizing and conducting medical consultations and conferences using telemedicinal technologies;

– the rules and regulations for identifying participants in distance-based collaboration;

– the rules and regulations for maintaining disability prescriptions and lists;

– the rules and regulations for electronic documentation procedure management;

– the status of the Single State Information System in the Sphere of Healthcare (hereinafter: SSISSH);

– the SSISSH operator;

– the content of information processed in the SSISSH;

– legal basis for the functioning of the SSISSH and data exchange with other information systems;

– SSISSH information suppliers and users.

 

In this way, the definition of telemedicinal technologies allows us to emphasize the following segment areas:

1. Distance-based collaboration of healthcare workers with each other, typically understood in the format “Doctor-Doctor”.
2. Distance-based collaboration of healthcare workers with patients and (or) their legal representatives is in the format “Doctor-Patient”, which also includes “distance-based observation of a patient’s physical well-being”, and provide different ways of remote monitoring and documentation of a patient’s health record.

 

In effect, telemedicine is an integral part of the single state information system in the sphere of healthcare created in accordance with Ministry of Health and Social Development of the Russian Federation Order no. 364 dated 04/28/2011 “Approval of the Concept of Creating a Single State Information System in the Sphere of Healthcare”.

The SSISSH has been actively formalized, systematized and created in recent years, inter alia in statutory and regulatory matters. On the issue of telemedicine, most work has gone into developing the segment of the format “Doctor-Doctor”, as 2015 saw the commissioning of the Telemedicinal Information System of the Ministry of Health of the Russian Federation in order to provide the remote telemedicinal consultations using remote technologies. At the present time it includes 41 Federal telemedicinal consultation centres (more than 470 subject-matter specialists from leading Federal State Budgetary Institutions provide consultations), as well as a large number of regional consultation centres.

The basic objectives for the creation of the Telemedicinal Information System of the Ministry of Health of the Russian Federation used to be:

• consultations;
• prompt consultations by highly qualified healthcare professionals;
• information support by doctors from regional healthcare centres;
• professional advancement of doctors and nursing staff;
• diagnostics and monitoring;
• interpretation of results of diagnostic analysis;
• “second opinion” provision;
• targeted screenings;
• remote illness prevention, health monitoring and patient lifestyle management;
• knowledge transfer;
• knowledge transfer within the healthcare system.

The “Doctor-Patient” format should also include:

• consultations for the patient or his/her legal representative by a healthcare professional intended as follows:
• the prevention, collection and analysis of patients’ complaints and medical history data, assessment of the effectiveness of diagnostics and treatment, and the medical observation of a patient’s physical well-being;
• decision-making on the necessity of the visit to the office (examination, consultation).

 

Let us consider the basic issues facing the SSISSH and telemedicine at various stages of development:

1. The absence of any regulatory and legal framework.

In recent years, and especially in 2017, many regulatory and legal acts came into force that formalize the IT-based management of healthcare and which have significantly improved the situation in this area.

2. The relatively low level of IT-based healthcare management in the majority of the constituent entities of the Russian Federation.

Despite great progress in this area, many regions still have a low or basic level of IT-based healthcare management and lag behind work performance schedules, and it is inter alia possible to see a gulf between the current status of various regions, which is at odds with the idea of creating a single and uniform information and technological space.

3. Regions’ tendency to embed first and foremost the information services most relevant for them, often to the detriment of integrating and organizing informational collaboration with SSISSH segments.
4. Poor utilization of the telemedicinal technology capacity in the “Doctor-Doctor” format.

This segment of telemedicine is becoming ever more widespread, more federal and regional centres are connecting to the Telemedicinal Information System of the Ministry of Health of the Russian Federation despite certain difficulties, such as those associated with the training of doctors in telemedicinal systems since many specialists have been lukewarm in their acceptance of the computerization of clinics and have found training in the use of computer systems difficult.

5. The absence or extremely poor utilization of telemedicinal technology capacity in the “Doctor-Patient” format.

In effect, the “Doctor-Patient” format has begun to develop only since 2018. A range of problems can be observed that are associated, for instance, with the absence of any possibility for many citizens of the Russian Federation to use these services (because of the banal reason, according to some sources, that 50% of the population does not have Internet access), or the training of people to use these services. Similarly, the question of security and confidentiality when holding these consultations is not very transparent, as is the question of the doctor’s status or trust in his/her diagnosis.

6. General lack of understanding of the scale of the Project in creating the SSISSH on the part of the constituent entities of the Russian Federation.
7. The lack of a single methodology in determining the most important indices in IT-based healthcare management and analysing what they have improved at various stages of the SSISSH’s creation.
8. The problem of data security and storage in the single system of informational data.

Many patients may feel that the question of data storage, security and accessibility in single registers of healthcare information systems is not very clear.

____Reference literature:

1. Federal Law no. 242-FZ dated 07/29/2017 “Amendments to Separate Legislative Acts of the Russian Federation on Issues of Applying Information Technologies in the Sphere of Healthcare”;
2. Federal Law no. 323-FZ dated 11/21/2011 “The Fundamentals of Civilian Healthcare in the Russian Federation”;
3. Ministry of Health and Social Development of the Russian Federation Order no. 364 dated 04/28/2011 “Approval of the Concept of Creating a Single State Information System in the Sphere of Healthcare”.
4. Ministry of Health of the Russian Federation, “System Project SSISSH. Book 6. Analysis of the Results of the First Stage of the Creation of the SSISSH (2011-2015)”;
5. Ministry of Health of the Russian Federation, “Concept of the Construction and the Functioning of the Telemedicinal Consultative System of the Ministry of Health of the Russian Federation”;
6. E. Larichev, National Centre for IT-Based Management “The Single State Information System in the Sphere of Healthcare”;
7. B. Zingerman, Haematological Scientific Centre of the MH RF, “‘Patient-Doctor’ telemedicine: practical pluses and legislative minuses”;
8. I. Shilkin, All-Russian Centre of Disaster Medicine “Protection” of the Ministry of Health of the Russian Federation, “The Concept of the Creation of the Federal Telemedicinal System of the FSBI Ministry of Healthcare of the Russian Federation”;
9. B.V. Zingerman, N.E. Shklovskii-Kordi, A.I. Vorobiev, Haematological Scientific Centre of the MH RF, “The telemedicinal segment ‘Patient-Doctor'”;
10. Kommersant, Thematic Annex to “Kommersant” newspaper no. 53 dated 03/29/2018, “Review Telemedicine. The Remote Doctor”;
11. A. Gusev, “Discussion of Government Decree no. 555 on the SSISSH”, http://www.kmis.ru/blog/obsuzhdaem-proekt-polozheniia-o-egisz;
12. The base “Federal Telemedicinal Consultative Centres”, http://81.200.91.130/federalnye-tkc/;
13. E. Boiko, “The Single State Information System of Healthcare (SSISSH)”, http://www.tadviser.ru/index.php/Проект:Единая_государственная_информационная_система_здравоохранения_(ЕГИСЗ)