eHealth in Hungary
Key figures
9.7M
inhabitants
7.3%
of health expenditure in relation to GDP in 2021
165
hospitals
The Hungarian health care system has a single health insurance fund and is highly centralised
Since 2022, the Ministry of the Interior has administered the healthcare financing system through the National Institute of Health Insurance Fund Management - Nemzeti Egészségbiztosítási Alapkezelő (NEAK). NEAK is responsible for ensuring the provision, financing and monitoring of healthcare services.
On the other hand, local county hospitals are responsible for planning and managing inpatient care at the county level, under the supervision of National Directorate-General for Hospitals.
The digitalization of the healthcare system is part of the government-led DJP digital strategy
The Hungarian government has already initiated the digitalization of the health system through its national patient record in 2017. The national patient record is now accessible through the National eHealth Infrastructure - Elektronikus Egészségügyi Szolgáltatási Tér (EESZT). It is a central IT system, which ensures communication between all health care service providers.
The Ministry of Interior is in charge of managing and executing Digital Health projects. Telemedicine is regulated through Directive 2020/559/HU, covering reimbursement of e-prescriptions, treatments and therapies (mandatory prerequisites: identification, data protection and suitable equipment).
The Innovation Center of Semmelweis University gathers actors of eHealth ecosystem in a supportive environment and infrastructures
How to access the Hungarian digital health market?
1. Obtain the authorization to enter the market from National Institute of Pharmacy and Nutrition
The main activity of the National Institute of Pharmacy and Nutrition - Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet (OGYÉI) is to provide the public with safe, effective and quality health technologies in accordance with the regulations. OGYÉI examines the notifications on the quality of medicines and medical devices. It is also OGYÉI’s task to authorize the manufacture, distribution of health technologies (including digital health technologies, such as softwares and apps).
2. Proceed to medical investigation by OGYÉI and obtain certification
OGYÉI can grant permission for the use of medical devices bearing or not yet bearing the CE marking if the clinical examination is performed in Hungary.
The Authority is authorized to act on behalf of the Hungarian government of the member state to ensure that the requirements of the Medical Device Regulations are applied. OGYEI is also the Designating Authority of the Hungarian notified bodies which can certify medical devices. The Designating Authority is a body, which has the authorization to designate and control the notified bodies located in Hungary.
3. Obtain reimbursement for the medical device by the National Institute of Health Insurance Fund Management (NEAK)
Currently, there are no specific guidelines about the public reimbursement of digital health technologies. Hence, obtaining a CE marking and compliance with the MDR regulation do not result in an accelerated procedure to public reimbursement. It is possible to enter the Hungarian digital health market via providing solutions directly to patients (without public reimbursement) or via collaboration with private health care providers.
Government authorities
Ensure efficient operation and cooperation within the healthcare system
Hubs and innovation clusters
They bring together and facilitate the incubation of new technologies
Training courses
Universities and their groups that offer training and support for digital health innovations
Specific link
The Health Technology Assessment Center facilitates the implementation of innovative solutions and has active working relationships with international biotech research companies