Medtech

National Clinical Data Repository

The National Clinical Data Repository (NCDR) is a part of the E-Health project aimed at digitizing the healthcare system of Ukraine. The NCDR contains all primary health records in digital form, allowing doctors to access them.

Background

Previously, all health records in Ukraine were stored in paper form. It created enormous problems for the national healthcare system:

Medical information about the patient was unavailable at the time of treatment.
Paper document circulation was maintained at a significant cost. Various departments of healthcare organizations manually compiled the reports.
Statistical information was outdated and essentially useless. The statistics in the reports were of poor quality. As a result, there was no statistical data to provide a comprehensive and transparent picture of the Ukrainian citizens’ health and to ensure data-driven decision-making.

The Edenlab team had to make the process of creating, collecting, and storing primary health records paperless. There was a need to digitize medical data and eliminate inefficient, outdated paperwork. Medical (clinical) data refers to health-related information associated with regular patient care or as part of a clinical trial program.

There are many categories of such data, for example: electronic health records that contain patients’ conditions, various observations, allergies, intolerances, and immunizations, administrative data, patient/disease registries, health surveys, clinical trial data, etc.

Task

The project implementation aimed to provide:

– Healthcare professionals with timely medical information during treatment
– Government officials with objective statistical information about the state of national health in Ukraine

Challenges

Only 5% of healthcare organizations were using any EHR (Electronic Health Record) systems when the NCDR was created.
There are few examples of such repositories in the world. In Ukraine, the business processes had to be thought through from scratch. The Edenlab BA team had to consider all possible causes and potential bottlenecks, keeping in mind that the solution would have to deal with the medical data of 30 million people.
Data security was brought into focus by the digitization process. Medical data of the patients should be accessible only to the right people at the right time and to the right extent. Paper-based data exchange minimized the risk of data leaks. While creating the NCDR, the Edenlab team had to carefully consider security and data protection.
Data accuracy and reliability were of prime importance. The solution had to make doctor fraud impossible, ensuring non-disputability.

The process

Edenlab team completed the following tasks:

Ensuring data reliability and health record deduplication:

When the NCDR project started, Edenlab had already built the National MPI system, ensuring that each patient had his or her unique personal health record. Solving the problem of data duplication ensures data accuracy as well as fraud protection.
The doctors sign the records they’ve saved or changed with their electronic signatures. Therefore, they bear full responsibility for data accuracy.
All information is stored as data in the MongoDB database and as documents. The data are linked to corresponding signed documents. Thus, all documents are legally valid and easily accessible.

Protecting personal information:

The NCDR stores a huge number of pseudonymized health records. The architecture of the repository ensures security. Even if some data leaks, it couldn’t be linked to particular patients and taken advantage of.
The Attribute-Based Access Control Module (ABAC) was developed for securing access to the data. Access is granted or denied by the attribute-based model. It takes into account different rules of access to information and the rights of users by analyzing specific attributes. For instance, a doctor from a particular medical institution can access the records made by colleagues from the same institution but not others.
Granting access to a health record requires the patient’s approval. The doctor can access the data only after being authorized by the owner. At present, access confirmation via an SMS has been implemented.

Patient Summary solution and the use of FHIR

Guaranteeing the availability of medical information during treatment:

To ensure that enough data will be available to the doctors for treating the patient, the Edenlab team created the Patient Summary solution, containing the most important information about the patient. It is populated from the data saved in the NCDR.

The summary is accessible to a doctor during the patient’s first visit as well as to paramedics. It is of critical importance in emergencies when the patient is unconscious and can’t provide the required medical information (for instance, blood type, intolerance of certain medicines, allergies, etc.).

Also, Edenlab used an uncommon and unique approach of updating the Patient Summary automatically from the central database.

The use of FHIR

The NCDR is built using the HL7 FHIR data transmission standard, ensuring the highest level of data interoperability.

We used FHIR resources and FHIR documents and produced Ukrainian profiles for the following FHIR resources (separately for primary and secondary care):

EpisodeOfCare
Encounter
Observation
Condition
Immunization
AllergyIntolerance
RiskAssessment
Device
MedicationStatement

Technology stack

Results

It took us six months to create the NCDR. At the moment, 620 million electronic medical records have been created in the E-health system.
Since the project’s launch, the types of clinical data for specialized outpatients were added. The Edenlab team continues to expand its functionality: at present, we are working to do the same for inpatients.

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