eHealth in Poland
Key figures
37.7M
inhabitants
6.45%
health expenditures in relation to GPD in 2019 (in %)
16
voivodeships
The healthcare system is highly decentralized on three territorial levels
The Ministry of Health shares its responsibilities with three levels of governance: municipalities oversee primary care; counties responsible for county hospitals; and “voivodeships” (provinces) responsible for larger regional hospitals.
The healthcare system is based on social health insurance (SHI). The National Health Fund (NHF) is the sole purchaser of this system. It operates through the 16 voivodeship, which manage the purchase of healthcare services in the regions.
The healthcare system is highly decentralized on three territorial levels
The Polish eHealth Center leads national activities to develop digital health in the country. In 2023, the electronic patient account (IKP) had up to 17 million accounts created. This is the fruit of the Strategy of the e-Health Centre for 2023-2027.
The Innovation Department at the Ministry of Health sets guidelines for the development of digital health solution such as the eHealth Development Programme 2022-2027. It leads the "Innovation Map of the Ministry of Health" project, a directory of innovative digital health solutions. Entrepreneur can already submit their project on this platform so it can be published in the future directory.
How to access the Polish market?
1. Get the marketing authorization and register your solution at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products is responsible for the registration, supervision and control of medical devices in Poland. To obtain authorization to bring your solution to the market, you will need to submit various documents: a marketing authorization application, a declaration of product identity and a document confirming the legal status of the marketing authorization holder. The same authority is competent regarding organization of clinical trials.
2. Submit your solution for health techonology assessment (HTA) appraisal to the Agency for Health Technology Assessment and Tariff System (AOTMiT)
Proceed to a health technology assessment by AOTMiT is a necessary step to obtain the reimbursement of your solution. The medical device has to go through a clinical study to assess its cost-effectiveness. According to the result of the evaluation, the Ministry of Health decides whether to use public funds to reimburse the solution.
3. Obtain reimbursement after discussion with NFZ (National Health Fund)
After proceeding to clinical evaluation of the device, the Ministry of Health decides if the solution will be reimbursement by public fund. Public funding for health care is mostly handled by the National Health Fund (NHF).
Government authorities
In charge of the evaluation and legislation of health products
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 Supreme Medical Chamber started an initiative that aims to connect and support doctors who wish to implement their digital health solution in Poland