The Ministry of Health has launched the process of building a national information database for people with malignant neoplasms and carcinoma in situ. In essence, it will represent an upgraded and updated electronic version of the so-called. cancer registry, and it will collect and store structured data on people with oncological diseases. This was announced by the press center of the health department.
The previously existing cancer registry contained data on 28 medical indicators, and the future system will cover over 120 medical indicators, with the possibility of dynamically expanding the scope. They will be introduced according to international standards and nomenclatures, in accordance with European rules and recommendations of the European Network of Cancer Registries. This will allow Bulgaria to participate directly in the European Health Data Space and the European Cancer Information System.
The information will contain data on the diagnosis, stage of the disease, treatment, therapeutic response, follow-up and vital status of patients. It will be submitted electronically in a structured and standardized format by the oncocommissions and all medical institutions that carry out diagnostic and treatment activities for patients with malignant diseases.
The goal is for Bulgaria to have complete, timely and comparable information on cancer, which is a leading factor for better planning, implementation of health policies, setting standards and making informed decisions in the allocation of resources.
The collection of this data will allow for accurate assessment of outcomes and tracking of the entire patient journey – diagnosis, treatment, survival, with the introduction of quality indicators.
The database will be part of the National Health Information System and will be administered by a specialized expert structure at the National Center for Public Health and Analysis. Collection and processing will be carried out in strict compliance with the requirements for the protection of personal data.
The registry will not be public. The data will be used for national analyses, expanding knowledge about cancer and improving care for cancer patients. Only summarized results will be published for the public. Each patient will have access to their personal medical information through their electronic health record.
In order for this entire process to happen, a regulatory basis was first provided by amending and supplementing Regulation No. 6 of 2018 on the approval of the medical standard “Medical Oncology“. Then, algorithms for entering and collecting information were created, and a new module was built in the National Health Information System (NHIS) through which the medical software of the medical institutions could exchange data.
The regulation enters into force six months after its publication in the State Gazette, which means that the actual entry of information into the newly created national database should begin no later than August of this year. With this process, the country is taking an important step towards modern, digital and transparent management of oncological information.