Digital healthcare in Poland
Key figures
37.7M
inhabitants
6.45%
of GDP earmarked for healthcare spending in 2019
16
voivodies (provinces)
The healthcare system is decentralized on three territorial levels
The ministry of health shares its responsibilities with three levels of governance: municipalities oversee primary care, counties are responsible for county hospitals and "voivodeships" (provinces) are responsible for large regional hospitals.
The healthcare system is based onsocial health insurance (SHI). The National Health Fund (NHF) is the sole purchaser of this system. It operates through its 16 voivodeships, which manage the purchase of healthcare services in the regions.
The digital healthcare ecosystem operates in close collaboration between key players
The Centre de la eSanté is leading national activities to develop the digitalization of the healthcare system. By 2023, the national online patient account platform (IKP) had up to 17 million accounts created. This result is the fruit of the Online Health Center for 2023-2027 strategy.
The Innovation Department of the Ministry of Health defines the guidelines for the development of digital health, such as the programme for the development of digital health 2022-2027. He leads the "Map of the Ministry of Health for Innovations" project, a directory of innovative digital medical solutions. Entrepreneurs can already submit their project on this platform to be published in the future directory.
How do you access the Polish market?
1. Obtain market authorization and register your solution with the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products.
The Office for Registration of Medicines, Medical Devices and Biocidal Products is responsible for the registration, supervision and control of medical devices in Poland. To obtain authorization to place your solution on the market, you will need to submit various documents: a marketing authorization application, a product identity declaration and a document confirming the company's legal status. The same authority is responsible for organizing clinical trials.
2. Submit your solution for a clinical trial (Health Technology Assessment - HTA) to the Agency for Health Technology Assessment and Pricing System (AOTMiT).
Proceeding to an evaluation by the AOTMiT is a necessary step in obtaining reimbursement for your solution. The aim is to assess the cost-effectiveness of the device. Depending on the outcome of the evaluation, the Ministry of Health decides whether or not to use public funds to reimburse the solution.
3. Obtain reimbursement after discussion with the National Health Fund (NFZ)
After clinical evaluation of the device, the Ministry of Health decides whether the solution will be reimbursed by the public fund. Public healthcare funding is mainly managed by the NFZ.
Government authorities
In charge of health product evaluation and legislation
Innovation hubs and poles
They bring together and facilitate the incubation of new technologies
.Training
Universities and their groups that train and support digital health innovations
Specific link
The Supreme Medical Chamber has launched an initiative to connect and support doctors who want to implement their digital health solution in Poland