FMI-SU | eHealth

NATIONAL SCIENTIFIC PROGRAM
"ELECTRONIC HEALTH IN BULGARIA" (e-health)

1. REQUIREMENT OF THE PROGRAM

eHealth means the use of information and communication technologies (ICT) in health products, services and processes combined with organizational change and new skills in order to improve both citizens' health and the efficiency of delivery of health services. E-health involves the collection and processing of large volumes of clinical information. There are a number of obstacles to the development of e-health in the country, such as: lack of interoperability between the various software products and systems used by doctors and medical units; there is no evidence of effectiveness in the implementation of ICT; the protection of personal data is insufficiently regulated and there is a lack of transparency in the use of the collected data; the connections between the medical establishments are broken; there are no incentives for medical institutions to participate in the exchange of clinical information; there are no good practices for cost optimization by collecting large amounts of data and analyzing the therapeutic efficacy, which will be used to make appropriate management decisions; voluminous medical records are prepared using software systems that involve the manual entry of a significant amount of information (including re-entry for various purposes).

2. PUBLIC CHALLENGES targeted by the Program:

- eHealth;

- Improving the quality and efficiency of health services;

- Speech recognition in Bulgarian in medical practice.

The program includes research activities, the results of which will allow the formation of a vision and a scientific methodology in response to the tasks of & nbsp; Ministry of Health & nbsp; for:

(a) development and pilot implementation of a unified & nbsp; electronic system & nbsp; for the management of large data sets in oncology and hematology; in university hospitals throughout the country with clinics or departments of medical oncology and hematology.

b) development and pilot implementation of a software platform for collection, processing and analysis of data for monitoring by medical institutions of the & nbsp; effect of the application of therapy & nbsp; with 13 innovative medicinal products.

3. PROGRAM TERM & ndash; UNTIL 31.12.2020

4. GENERAL PROGRAM BUDGET & ndash; BGN 2,000,000 , distributed as follows:

- 2018 & ndash; BGN 800,000

- 2019. - BGN 600,000 indicative value

- 2020 - BGN 600,000 indicative value

The financing of the activities under the Program is carried out by the Ministry of Education and Science (MES). The funds for ensuring the implementation of activities under the Program are distributed according to a partnership agreement concluded between the participants with an attached work and financial plan.

4.1. Specific eligible costs for the implementation of the program

a) Direct costs for: staff; business trips; tangible and intangible fixed assets, including equipment; external services directly related to the implementation of the program; materials, consumables and other eligible costs directly related to the implementation of the program. Team remuneration - up to 40% of direct eligible costs for the implementation of activities; business trip costs - up to 15% of direct costs; tangible fixed assets, including equipment, tools and equipment and costs of tangible fixed assets (software and information products) - up to 20% of direct costs, external services directly related to the implementation of the program - up to 15%, materials, consumables and other eligible costs directly related to the implementation of the program - up to 40% of direct costs). In the implementation of the NAP, it is permissible to make changes in the financial plan by transferring funds between the different groups of eligible direct costs, provided that the redistribution does not exceed 10% of the total amount of eligible direct costs for the respective stage. In this case, the program coordinator notifies Minthe art of education and science.

(b) Indirect costs: costs of servicing the program by the host organization and the partner organizations participating in the program; costs for financial audit of the program (servicing of the program by the leading and partner organizations - up to 7% of the total costs, and for audit & ndash; up to 1%).

5. OBJECTIVES OF THE PROGRAM

5.1. Overall goal

Improving the quality and timeliness of medical care while optimizing the costs of computerized activities and reducing the burden on medical staff with technical and administrative tasks.

The program follows the guidelines of the European Action Plan for the introduction of e-health by 2020 and is established in implementation of the National Strategy for Research Development (NSRF) 2030 to achieve specific objectives:

promoting problem-oriented research in the priority areas of the Innovation Strategy for Smart Specialization (ISIS);
Significant intensification of science's links with education, business, government and society at large;
Avoiding fragmentation in Bulgarian science by promoting integration and interaction between different public research institutes and universities in order to build a critical mass and avoid overlapping and duplication of resources.

5.2. Specific goals:

creation of methodology and technologies for ensuring the semantic interoperability and interoperability of the various types of data exchanged within the clinical diagnostic process;
ensuring semantic interoperability in integration with existing and built health information systems;
Achieving trust from patients and healthcare professionals in technologies that provide, process and present semantically compatible machine-processed information;
creation of a prototype demonstrator of a dictaphone for Bulgarian language, specialized for a selected medical field;
speech recognition in Bulgarian in the medical practice in the country through the use of modern technologies in order to assist medical professionals in preparing documentation;
development of standardized models of specific subject areas in order to assess the applied treatment and the changes in the quality of life;
Improving the quality of treatment and optimizing the costs for prevention, diagnosis and treatment of socially significant diseases with the help of an information system for management and analysis of large arrays of diverse data based on archetypal structuring of socially significant and rare diseases (cardiovascular, diabetes mellitus, onco-hematological, etc.);
Demonstrators of public services for complex assessment of the clinical and economic value in the application of medicinal products in healthcare, using standardized models of specific subject areas, describing the treatment process and the evaluation of the applied treatment and diagnostic measures.

6. EXPECTED RESULTS

Building research capacity to solve research problems in the field of e-health;
Consolidating the scientific community related to ICT applications in medicine and avoiding duplication of research costs and human resources;
developed prototypes and demonstrators of basic functions for integration and exchange of diverse data with existing and built health information systems while ensuring semantic interoperability;
dictaphone for generating text recording in Bulgarian in the field of medicine;
pilot applications to monitor and evaluate the effectiveness of treatment;
creation at the level of a national health system of a formal management modelthe continuity of health care and integration of data from existing information systems, using a problem-oriented approach and presentation of information;
Organize a public discussion with all stakeholders on the results obtained, as an example of socially engaged research.

7. SCOPE OF THE PROGRAM

The program includes the following areas:

creation of methodology and technologies for ensuring semantic interoperability of various types of data exchanged during the implementation of the clinical diagnostic process in the context of a formal model for managing the continuity of health care and functions of integration with existing and developed information systems; li>
creation of a prototype for computer support of the preparation of medical documentation (dictaphone for Bulgarian language);
development of a generalized formal model and prototype implementation of an information system for management and analysis of large arrays of diverse data, including assessment of the effect of treatment in socially significant and rare diseases (cardiovascular, diabetes mellitus, onco-hematological etc.), in 100 medical establishments from the pre-hospital and hospital care, incl. and with 13 innovative medicines.

8. BENEFICIARIES

Eligible beneficiaries are:

- accredited higher schools under Art. 85, para. 1, item 7 of the Higher Education Act (HEA);

- scientific organizations under Art. 47, para. 1 of the Higher Education Act, which form a consortium (Informal association formed on the basis of a signed partnership agreement between budget research organizations and universities for conducting research for the period of the National Research Program) of at least 7 organizations, of which predefined partners are those with a significant contribution to the published scientific results in the complex field formed by the medical and health sciences and by the computer and information sciences for the last 3 years. According to the information in the global databases for the period 2015-2017, the leading partners are the Medical University & ndash; Sofia, Sofia University & bdquo; St. Kliment Ohridski & ldquo ;, Bulgarian Academy of Sciences and the Medical University & ndash; Plovdiv.

Thus, the beneficiaries are directly responsible for the implementation of the activities under the Program. They attract as partners other universities or institutes for knowledge transfer and to increase the overall scientific capacity of the country in this field, as the lead partner attracts at least 2 partners, and the rest & ndash; at least 1. Such partners are: The Technical University & ndash; Sofia, Medical University & ndash; Varna, Medical University & ndash; Pleven, Thracian University & ndash; Stara Zagora. The partners will use the scientific infrastructure of the Laboratory Complex of the Association for Research and Development within the notified 80% for non-economic activities.

These organizations are potential beneficiaries of the Program and contribute to the objectives of the program, to shared access to relevant scientific infrastructure, an element of the National Roadmap, to transfer knowledge and increase the overall scientific capacity of the country in this area. >

For the implementation of the Program it is envisaged to form a consortium of the above mentioned scientific organizations and universities with the highest capacity, which declare readiness to perform specific tasks of the program, in accordance with the adopted indicators and indicative parameters for the implementation of the program. / p>

The consortium will be managed by an Executive Board (IS) with representatives of the partner organizations, on the basis of a signed partnership agreement, in which the funds for the implementation of the activities under the Program are allocated with an attached work and financial plan.

Program Coordinator will be proposed by the Medical University - Sofia as an organization with the highest research and infrastructure capacity in the field of medical and health sciences. The coordinator will also be the chairman of the IS.

In order to achieve a greater impact of research results on society and in particular on the economy, a Supervisory Board is introduced with representatives of business, local authorities, the Ministry of Education and Science, the Ministry of Health, the National Health Insurance Fund,Sofia Tech Park AD, non-governmental organizations to monitor and control the activities of the IS during the implementation of the Program. The main goal of the Supervisory Board is to provide socially responsible and economically important research and to increase the socio-economic impact of the results obtained.

The program is developed for a three-year period, and for each year the lead partner, in coordination with the IS, presents a report on the work done, the degree of achievement of the Program objectives and proposals for updating the work program with specific quantitative values of indicators. >

9. PROGRAM ACTIVITIES

9.1. Creation of methodology and technologies for ensuring semantic interoperability of various types of data exchanged during the implementation of the clinical-diagnostic process

To create the methodology and technologies in the e-Health program, it is necessary to perform the following tasks:

Identification and analysis of essential requirements for clinical data processing and exchange systems. Development of a formal model of these systems based on the performed analyzes. Defining and demonstrating model-based features that ensure the application of a problem-oriented approach and a high degree of abstraction.
construction of primary pseudonymous anonymous databases in order to provide a primary source for research and analysis in the field of public health based on a broad consensus and participation of the Bulgarian Medical Union, organizations of health professionals (general practitioners, specialists, nurses, etc.), state and public institutions, universities and institutes, ICT providers, etc.
creation of a model and prototype of a regional PACS (Picture archiving and communication system) based on available technical solutions, combined on innovative approaches for image analysis, generation of metrics and comparability of images from different sources in order to trace diseases, comparability of changes, increasing perceptuality in reading and diagnosing. The exchange of image information between healthcare facilities in a unified manner will be allowed. The archived information will be linked to the general formal model for managing the continuity of health care and the ones defined in item 9.1.i. essential requirements for clinical data processing and exchange systems.
creation of prototypes and demonstrators of information services for integration of the available and traditionally collected and exchanged information (both manually generated and received electronically) within the diagnostic-therapeutic process while ensuring semantic interoperability and integration functions with existing and developed information systems.
Ensuring effective semantic interoperability of e-health services by creating standard scenarios and methodology for joint application of European standards introduced in our country in the field of health informatics.
development of algorithms and technologies for automatic analysis of clinical text in order to extract and structure in archetypes of important values from electronic medical documents as basic demographic, clinical and laboratory indicators: risk factors, data on the course of the disease and applied treatment; / li>
analysis of the available archetypes and development and validation of new ones, according to the subject area of the program, as well as analysis of the applicable terminology from SNOMED.

Expected results:

Creating preconditions for overcoming the fragmentation of data generated in healthcare:

a set of defined essential requirements for clinical data processing and exchange systems;
formal model of clinical data processing and exchange systems;
built a primary pseudonymous anonymous database;
implemented prototype of regional PACS according to item 9.1.iii;
prototypes and demonstrators of semantic interoperability of health information services;
developed and validated new archetypes;
implemented technologies for automathematical analysis of clinical text and structuring into archetypes.

Performance metrics:

number of publications in the press and in specialized publications in social medicine & ndash; 15;
number of demonstrations of prototype products to healthcare professionals & ndash; 35;
number of participating visitors to the demonstrations of the prototype products - 1000;
number of medical and health establishments participating in the experimental evaluation in order to measure the improvement of the quality of the health services they offer & ndash; 50;
Assessment of the quality of the offered prototypes and the roadmap according to an online survey completed by medical professionals & ndash; 1300 polls;
number of scientific publications in specialized peer-reviewed journals and / or scientific series with impact factor (IF) and / or impact rank (SJR), and / or open access & ndash; 6;
number of anonymized data sets and open access business services 3.

9.2. Creating a prototype for computer support in the preparation of medical documentation (dictaphone for Bulgarian language)

In this module a prototype of a speech recognition system will be developed, oriented towards the preparation of medical documentation in Bulgarian. Due to the huge variety of medical terminology and forms of expression, a prototype module was initially created, covering the language and terminology in a specific medical specialty such as pathoanatomy, radiology, intensive care, anesthesiology. Subsequent stages envisage the expansion of the system with modules (and terms) for other medical specialties. The prototype shall meet the following functional requirements:

easy integration into various medical information systems;
Recognition of specialized medical vocabulary for a given medical specialty;
recognition of linguistic means of expression from the respective medical specialty;
ability to conveniently adapt and maintain a voice profile for each user;
Voice navigation and commands.

and include the following core modules:

phonetics glossary for the respective medical specialty;
a language model to be trained on a representative language corpus with texts from the respective medical specialty, created especially for the program;
voice profile customization module;
module for integration into medical information systems;
Autonomous speech recognition module

In order to maintain medical confidentiality and the right to privacy, the use of online speech recognition services is not permitted.

Expected results:

experimental demonstrator of a dictaphone for Bulgarian language, specialized in a selected medical field;
speech recognition in Bulgarian in medical practice to assist medical professionals in preparing documentation.

Performance metrics:

Technical scope of speech recognition & ndash; over 99% of the medical terminology and means of expression for the respective medical specialty;
Average accuracy for target audience & ndash; over 97% at word level;
number of medical professionals in the target user group & ndash; 30;
number of installations in university hospitals (external co-contractors) for testing with conducted trainings for work with the system and data analysis & ndash; 3;
number of demonstrations of prototype products to healthcare professionals& ndash; 6;
numerical indicators from a survey with a target group of medical professionals in order to determine how much the prototype facilitates them in the preparation of documents accompanying their work process (globally there is a 45% reduction in time to complete documentation and introduction of up to 20% more relevant content, for the prototype - 20% reduction of time for filling in documentation and introduction up to 10% more relevant content);
number of publications in the press and in specialized publications in social medicine & ndash; 10;
number of scientific publications in specialized peer-reviewed journals and / or scientific series with impact factor (IF) and / or impact rank (SJR and / or open access) & ndash; 3.

9.3. Treatment Effectiveness Assessment System (TRE): & nbsp; development and prototyping of an information system for management and analysis of large arrays of diverse data based on archetypal structuring, including assessment of the quality and effectiveness of treatment in socially significant and rare diseases (cardiovascular, diabetes, onco-hematological, etc.)

The aim of this module is to develop formal models that will serve as a basis for a systematic and automated approach to monitoring the effect of the applied treatment and on their basis to create a system for evaluation of the effectiveness of treatment (OEL). The main source of information about the BER system are the primary pseudonymous anonymous databases for public health purposes built in activity 9.1, including complete data on the prophylactic, diagnostic and treatment process in pre-hospital and hospital care, including the emergency care system. The OEL system must guarantee - based on the developed formal models, international and European standards and good practices - semantic interoperability of the data, the algorithms of the treatment-diagnostic process and the applied indicators and tools for efficiency analysis.

Using the already developed algorithms and technologies for automatic analysis of clinical text in order to extract and structure clinical and laboratory indicators from electronic health records, it is planned to develop and implement standardized models of specific subject areas.

The following activities are included in this area:

development and prototype implementation of an information system for management and analysis of large data sets in socially significant and rare diseases (cardiovascular, diabetes mellitus, onco-hematological, etc.),
development of standardized models of the specific subject areas, describing the treatment process and the evaluation of the applied treatment-diagnostic measures, especially of the conducted drug treatment. These models should include indicators to measure therapeutic outcomes;
defining specific and general indicators for measuring therapeutic outcomes and quality of life, structured in archetypes;
Identification and follow-up of clinical benefits from treatment regimens according to current treatment guidelines and validated assessment of a number of indicators defined in section 9.3.iii., including overall survival (OS), progression-free survival (PFS) ), event-free survival (EFS), clinical response, safety and other objective clinical criteria depending on the specifics of the oncological or onco-haematological disease;
developing methodologies for budget predictability based on an assessment of cost-effectiveness within the public budget, including in the application of innovative medicinal products;
preparation of a proposal for integration of the indicators for measurement of the therapeutic results and the methodologies for evaluation of the cost-effectiveness in complex systems for measurement, reporting and comparison of therapeutic efficacy, providing information for making appropriate decisions.

Expected results:

Improved quality of treatment and optimization of costs for prevention, diagnosis and treatment of socially significant diseases using an information system for management and analysis of large data sets, including indicators for measuring therapeutic outcomes and quality of life , structured in archetypes;
developed standardized models of specific subject areas in order to evaluate the applied treatment;
Demonstrators of public services for complex assessment of the clinical and economic value in the application of medicinal products in healthcare, using standardized models of specific subject areas, describing the treatment process and the evaluation of the applied treatment and diagnostic measures.

Performance metrics:

number of compared approaches to research and treatment in different diseases and their evolution & ndash; 30;
number of prepared models for cost-benefit analysis - 15;
number of months with estimated costs for treatment and diagnostic activities - 18;
number of patient-based comparisons of expected effect (benefit) of treatment / value of treatment & ndash; 15 comparisons involving over 15,000 patients;
number of publications in the press and specialized publications in social medicine - 30;
number of scientific publications in specialized peer-reviewed journals and / or scientific series with impact factor (IF) and / or impact rank (SJR) and / or open access & ndash; 20;
number of high-tech publications in magazines in the TOP 10% in the ranking of Thompson-Reuters WoS & ndash; 2;
number of data sets and open access business services & ndash; 3;
number of trainings conducted for work with the system and data analysis & ndash; 20.

10. MONITORING

The monitoring of the implementation of the program is carried out at two levels:

inspections, analyzes, preparation of interim reports and a final report based on direct and feedback between individuals and organizations regarding the implementation of the Program;
documentary or technical on-site inspection by representatives of the Ministry of Education and Science or evaluation of the implementation of the Program by an external organization. The costs of monitoring, if any, are within the estimated funds under the Program.

A Program Administrator is assigned to monitor performance & ndash; an employee of the Ministry of Education and Science, who every 6 months prepares a report on the results of the monitoring of the implementation of the Program, the degree of achievement of the objectives and indicators, as well as on the incurred financial expenses.

The Program Administrator attends all meetings of the Executive Board and the Supervisory Board, general meetings of non-voting contractors and collects data on the implementation of the Program and financial costs as well as from the reports prepared by the Contractor according to Art. item 5 of the Program, as well as from their own observations.

A working group of the Ministry of Education and Science is established for annual monitoring of the implementation of the Program, which annually prepares a report on the results of the monitoring of the implementation of the Program, the degree of achievement of objectives and indicators, as well as the financial costs incurred. If necessary, the working group shall carry out documentary and technical on-site inspections. The report concludes with reasoned recommendations to continue or suspend the implementation of the Program.

11. DEMARCATION

The scientific organizations responsible for the implementation of specific tasks of the Program include for funding only activities that are not funded by other funds under European or national programs.

Funds under the Program may not be used for activities of the same purpose financed by European Union funds, other national funding, as well as other donor programs.

12. FUNDING PROCEDURE

Within 15 days of the adoption of the Program, the Ministry of Education and Science invites the redefined beneficiaries with a contribution of over 10% of the scientific production in the field of ICT.
Within 2 months of receiving the invitation, the Lead Partner submits to the MES an agreement signed by the redefined and associated partners, which clearly defines the rules for the distribution of activities.and implementation of this program, the degree of implementation of the underlying indicators and the results obtained, the financial resources for the first financial year, incl. and the rules for access to the scientific results and the scientific equipment under the Program.
The Ministry of Education and Science concludes an agreement for financing the program with the lead partner, and an integral part of it is the signed partnership agreement together with the distribution of the activities and the financial means for their implementation. The Lead Partner undertakes to coordinate the work of the consortium and to allocate the budget to the partners.
By the end of November of the current year, the Lead Partner submits an annual report on the work done to the MES.
Within two months from the submission of the report, the MES evaluates the implementation of the activities and determines the budget for the next programming period.
The MES has the right to set additional requirements to the activities, results and target indicators, as well as to the implementation of the program.

Work plan