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Life sciences and healthcare in Poland – briefing of recent legal changes in 2025

Publication date: June 02, 2025

The new organizational model of Primary Health Care facilities and the introduction of the institution of a medical proxy have been in force since 1 January 2025. It has introduced changes to the functioning of primary health care, primarily through the creation of teams consisting of a family doctor, nurse and midwife, who jointly provide care for the patient. Nurses and midwives will cease to function as independent practices with their own patient lists. From 2025, they will form teams with primary health care doctors, which means that when a patient chooses a doctor, they automatically accept the entire care team. Patient declarations about choosing a specific nurse or midwife lose their validity. This raises concerns, because approximately 1,600 entities run independent nursing and midwifery practices, serving approximately 8 million patients, which may lose the ability to continue operating after the changes, moreover, the regulations do not specify precisely the principles on which independent nursing and midwifery practices are to be included in primary health care teams, which raises uncertainty and even greater concerns among the nursing community.

The new model fits into broader plans for the development of coordinated care in primary care, which is to provide comprehensive treatment of chronic diseases, from diagnostics, through pharmacotherapy, to monitoring the patient’s condition. As part of this model, a coordinator is appointed to organize tests, visits and consultations, improving the flow of information between service providers.

The legal basis for these changes is the Act of 27 October 2017 on primary health care (Journal of Laws of 2025, item 515), in particular Article 9 and Article 16.

Changes to the catalogue of occupational medicine examinations are aimed at earlier detection of lifestyle diseases and improving the health of employees. Art. 229 § 4 of the Act of 26 June 1974, the Labor Code (Journal of Laws of 2025, item 277, as amended) states that an employer cannot allow an employee to work without a valid medical certificate stating that there are no contraindications to performing work at a given post. On 28 October 2024, Polish Deputy Minister of Health announced the planned expansion of the scope of occupational medicine examinations. This change results from the modification of the “Prophylaxis 40 plus” program. The new set of examinations will include additional, mandatory examinations that every employee will have to perform. These are the following examinations:

– lipid profile – a test that allows assessing the risk of circulatory system diseases,

– measurement of blood glucose levels – key in diagnosing diabetes,

– body mass index (BMI) calculation – identification of overweight or obese people,

– blood creatinine measurement – assessment of kidney function.

Additionally, as part of preventive care, employees can also undergo tests such as mammography, cytology or PSA (prostate cancer marker) testing, which are voluntary and available as part of preventive programs.

The costs of the tests are financed from the state budget if the tests are carried out in facilities participating in the “Prevention 40 PLUS” program. Otherwise, the costs may be charged to the employer.

The issue of medical examinations is also regulated by the Polish Regulation of the Minister of Health and Social Welfare of 30 May 1996 on conducting medical examinations of employees, the scope of preventive health care for employees and medical certificates issued for the purposes provided for in the Labor Code (consolidated text: Journal of Laws of 2023, item 607).

The implementation of the whistleblowing system imposes new obligations on medical facilities in terms of reporting irregularities and protecting reporting persons. The implementation results from the Act of 14 June 2024 on the Protection of Whistleblowers (Journal of Laws, item 928), which came into force on 25 September 2024 and imposes on organisations, including healthcare entities employing at least 50 people, the obligation to create safe and confidential channels for reporting irregularities. Facilities must provide employees with channels enabling anonymous or confidential reporting of violations of the law, irregularities or abuses related to the activities of the entity, including, for example, corruption, violations of public health or public procurement. People reporting irregularities should be protected from any retaliatory actions, such as dismissal, intimidation, demotion or other forms of repression. The protection also covers the confidentiality of the whistleblower’s personal data. Facilities must have competent persons or teams designated to handle reports, who will conduct explanatory proceedings and take appropriate corrective actions.

Changes in the rules for issuing medical certificates resulting from the Polish Regulation of the Minister of Family, Labor and Social Policy of February 20, 2025 amending the regulation on determining the templates of medical certificates (Journal of Laws 2025, item 241) will affect diagnostic and administrative processes in medical facilities. In 2025, there are to beintroduced uniform regulations on the principles and procedure for issuing medical certificates, which will allow for greater transparency and consistency of the adjudication procedures regardless of the purpose of the certificate (e.g. pensions, care allowances, sick leave). Thanks to staff and organizational changes (including the creation of adjudication centers that include several social insurance institution branches), the waiting time for issuing a certificate is to be significantly shortened. In addition, adjudicating physicians will be able to be employed under employment contracts or civil law contracts, which is to increase the availability and efficiency of the adjudicating staff. They will also be relieved of the administrative and technical activities related to the preparation of documentation by medical assistants. The process is to be digitized and electronically converted – decisions will be entered and sent in electronic form, which will improve access to documentation and speed up administrative processes for both medical facilities and social insurance institutions.

Introduction of single-person adjudication in both instances in Social Insurance Institution regarding disability pensions. Decisions will be issued by a single person in both the first and second instance. The proposed solution will enable effective use of medical staff while guaranteeing the possibility of reconsidering the case within the proceedings conducted before the Social Insurance Institution, with the necessary guarantees of impartiality. In the event of an objection or the need to reconsider the case, the decision will be made by a specialist doctor with the appropriate specialization. The Chief Physician of the Social Insurance Institution will exercise the superior supervision over medical decisions. He will be supported in the quality control of medical decisions by supervisory inspectors. It is worth emphasizing that this is only a draft act (print no. 1246) that has been submitted to the Sejm.

The hospital reform announced by the Polish Minister of Health is intended to streamline the operation of hospitals, improve financial management and better adapt medical infrastructure to the needs of patients. This reform is based on three pillars: deregulation, transformation and the so-called inverted pyramid of benefits, i.e. moving some procedures from hospitals to outpatient specialist care and primary health care . Facilities will be able to create consortia and cooperate, which is to limit inefficient competition and better use human resources and infrastructure. Debts of facilities are to be transformed into loans granted by the National Economy Bank, which is to improve the financial stability of hospitals. The reform is to introduce territorial maps of benefits, thanks to which the medical offer will be better tailored medical care to the health needs of residents of individual regions. It is also planned to transform acute surgical departments into elective ones, which is to improve management and treatment efficiency.

The Act of 5 December 2024 amending the Act on health care services financed from public funds and certain other acts (Journal of Laws of 2025, item 129) has already entered into force and regulates such issues as:

– safety and availability of medicines and medical devices – Article 43a of the Act specifies the principles of free supply of medicines, foodstuffs for particular nutritional uses and medical devices based on the reimbursement list,

– financing medical tasks – mechanisms have been introduced for the transfer of targeted subsidies from the Medical Fund to cover the costs of implementing specific health tasks,

– the catalogue of entities entitled to receive subsidies for the implementation of health tasks has been extended, including the possibility of granting subsidies for investments subject to a positive opinion from the competent authority,

– changes in the regulations regarding the transfer of financial resources, which aim to better adapt financing to the needs of medical facilities and patients.

– adjustment of regulations on the financing and organisation of medical activities, including detailed regulations on the creation of recovery programmes for medical entities with financial problems.

The Act of 28 April 2011 on the Healthcare Information System (Journal of Laws of 2025, item 302, as amended) introduces the obligation to provide a wider range of data concerning both patients and service providers, including detailed information on medical personnel, equipment and the availability of hospital beds. Moreover, the amendment provides for automatic downloading of data from hospital systems (HIS) and other IT systems of healthcare facilities, which is to reduce the administrative burden on staff. The system enables wider access to e-services for patients, including electronic medical records, e-referrals, e-prescriptions and new functions related to healthcare management. Art. 12 establishes an IT system (SIM) for collecting, processing and sharing data on provided, granted and planned healthcare services, service providers, medical workers and service recipients. The administrator of the SIM is a unit subordinate to the Minister of Health, and the data administrator is the Minister himself. Art. 24 of the same Act provides for the collection of detailed data on healthcare resources, including medical devices and personal protective equipment, and specifies the deadlines and manner of transferring such data by service providers.

The government’s draft bill on the National Cardiology Network aims to create an integrated cardiology care system that will provide patients with access to highly specialized services throughout the country. The network is to bring together specialized cardiology centers that will cooperate in the diagnosis, treatment and rehabilitation of circulatory system diseases. Diagnostic and therapeutic standards throughout the network will be unified, and the use of specialized equipment and medical staff will be optimized. This involves shortening the waiting time for cardiology procedures and diagnostics. This draft is from May 9, 2025 and is currently in the Senate.

There are planned increases in minimum basic salaries for healthcare workers from July 2025. The increases apply to all professional groups in healthcare – doctors, nurses, midwives, paramedics, pharmacists, physiotherapists, laboratory diagnosticians, as well as non-medical workers such as medical caregivers or orderlies. The changes result from the increase in the average salary in the national economy for 2024, which according to the Central Statistical Office amounted to PLN 8,181.72, which is PLN 1,026 more than a year earlier. This amount is the basis for calculating minimum wages in healthcare. The introduction of the increases is the result of annual indexation, in accordance with the act on the method of determining the lowest basic salary in medical entities. The minimum basic salary for medical specialists will increase by approximately PLN 1,488 to approximately PLN 11,863. Pharmacists and other medical workers with specialization and higher education can count on a raise of approximately PLN 1,324, which will increase their minimum salary to approximately PLN 10,554. The minimum basic wages will range from approximately PLN 4,666 to PLN 4,860, while the maximum wages will range from approximately PLN 6,860 to PLN 14,550, depending on the professional group and work factors. The issue of remuneration is generally regulated by the Act of 8 June 2017 on the method of determining the minimum basic salary of certain employees employed in medical entities (consolidated text: Journal of Laws of 2022, item 2139). It is particularly worth taking a closer look at Article 3. It can be concluded from it that each year, as of 1 July, the medical entity increases the basic salary of an employee performing a medical profession and an employee employed in basic activities who does not perform a medical profession.

The Service Provider Potential Register System (SEPS) is to be implemented by the National Health Fund. At the moment, it is only a draft act of 14 April 2025 amending the Act on the Healthcare Information System and amending the Act on Population Protection and Civil Defense. It is to enter into force on 1 January 2027. The aim of SEPS is to collect and update information on the potential of healthcare entities, i.e. their human resources, equipment and premises in real time. This system is to improve the management of healthcare services and improve healthcare planning in Poland. Service providers will be required to regularly enter and update data on, among others, the number of medical personnel, available equipment, the number and type of hospital beds, infrastructure, medical gas resources, blood and blood component supplies. The system is to enable better analysis of the availability of healthcare services, as well as rapid response to changes, e.g. in crisis situations such as epidemics. The introduction of SEPS is also to simplify settlement and control processes in relations between the National Health Fund and medical facilities. Data on medical staff resources, medical devices and personal protective equipment will be reported at a specified frequency (monthly, annually or within 30 days of a change). Data on hospital bed occupancy will be transferred automatically within 30 minutes of a change in status, which will improve patient care in emergency situations and prevent admission refusals.

Changes in the life sciences sector.

About 40% of life sciences companies plan to increase research and development (R&D) investments in 2025, responding to challenges such as patent lapses and the need for innovation. Biotech and pharmaceutical companies are focusing on R&D to curb revenue declines, as expiring drug patents could threaten sales of more than $300 billion by 2030.

The implementation of modern technologies, such as artificial intelligence and digital twins, allows for shortening the time needed to develop new therapies, reducing costs and minimizing the risk of failures in clinical trials. As many as 77% of industry leaders predict an increase in the number of mergers and acquisitions in 2025 as a complement to innovation strategies, which is to help companies expand their product and service portfolio and strengthen their competitiveness on the market. Thanks to these technologies, it is possible to virtually model and test new drugs at early stages of development, which shortens the time needed to develop a therapy and significantly reduces the financial risk associated with a high percentage of failures in research (up to 90%). Digital twins allow for precise analyses and simulations that previously required expensive and time-consuming laboratory and clinical tests. AI supports research and development processes by analyzing huge data sets, identifying potential drug candidates and predicting their effectiveness and safety. As a result, the process of developing new therapies becomes more efficient and faster, which is crucial in the face of growing pressure on innovation and market competitiveness. In addition, AI enables the optimization of clinical trials through better patient selection, monitoring treatment effects in real time and predicting possible complications, which increases the effectiveness and safety of trials.

Directive (EU) 2022/2555 of the European Parliament and of the Council of 14 December 2022 concerning measures for a high common level of cybersecurity across the Union, amending Regulation (EU) No 910/2014 and Directive (EU) 2018/1972 and repealing Directive (EU) 2016/1148 (NIS 2 Directive) (OJ EU L 333, 2022, p. 80) requires entities to implement appropriate technical and organizational measures to protect their IT systems from cyber threats. Digital twins that are part of these systems must also be secured, in accordance with the requirements of the Directive.

Also of importance for digital twin technologies based on big data is the Data Act 2023/2854, which regulates the exchange of data between businesses, consumers and public administrations.

Digitalization of medical records – the expansion and integration of Electronic Medical Records (EMR) will enable doctors and patients to easily and quickly access test results, treatment plans and medical history, which will speed up diagnosis and treatment and improve the coordination of care between various facilities and specialists. For several years now, every doctor and medical facility has been required to report medical events in this system . These issues are regulated in the Act of 28 April 2011 on the information system in health care (Journal of Laws of 2025, item 302, as amended). This Act concerns the principles of maintaining and sharing Electronic Medical Records. Amendments introduced by 2025 extend the scope of EMR, enabling the integration of medical data from various facilities and access by patients and doctors to the full medical history, test results and treatment plans.

Regulation (EU) 2016/679 of the European Parliament and of the Council – GDPR regulates the protection of personal data, including medical data, providing patients with the right to control their data and their secure processing, and in the context of the digitalization of EDM, guarantees that access to medical records takes place in accordance with the highest standards of privacy and security.

The National Healthcare Digital Transformation Plan for 2023–2027 is a document defining the goals and financial resources for the development of digital solutions in healthcare, including the expansion and integration of EDM. It supports investments in IT infrastructure, system interoperability and education of medical personnel.

The implementation of certified AI tools will help doctors make more accurate and faster diagnostic and therapeutic decisions, relieving medical staff and allowing them to focus on individual patient care. Certified AI tools are those that have undergone a formal assessment and obtained appropriate certificates confirming their effectiveness, safety and compliance with regulations. Since February 2, 2025, the Regulation (EU) 2021/0106 of the European Parliament and of the Council (AI Act) has been in force, regulating the use of AI systems, especially those with high risk, which include medical tools supporting diagnostics and therapy. The AI Act requires that AI systems used in healthcare be certified, meet high standards of safety, transparency and human oversight. This act provides a legal framework for the safe and ethical use of AI in medicine, which allows for the relief of medical staff while maintaining the responsibility of the doctor.

The Act of 28 April 2011 on the health care information system (Journal of Laws of 2025, item 302, as amended) introduces the obligation to use modern, certified digital tools, including AI, that support diagnostic and therapeutic processes. It imposes on medical facilities the requirement to provide appropriate staff training and monitor the effectiveness and safety of the AI solutions used.

Article 12 of the Code of Medical Ethics regulates the principles of using AI in medical practice, emphasizing the need for informed patient consent to the use of AI tools. Moreover, the final medical decision always belongs to the doctor, and AI has a supporting function, not a replacement for the specialist.

Automation of administrative and medical processes, such as visit management, patient registration or test result validation, will reduce the workload of employees and improve the functioning of facilities. The legal basis for the automation of administrative and medical processes in 2025 is primarily the government’s draft amendment to the Act on the Healthcare Information System, which introduces a new “Service Provider Potential Record System” (EPS). This draft provides for the digitization and automation of key processes, such as visit management, patient registration or test result validation, which aims to improve the functioning of medical facilities and reduce the workload of employees. Additionally, since February 2, 2025, new EU regulations on artificial intelligence (AI act) in medicine have been in force, which regulate the use of AI in diagnostic and administrative processes, emphasizing the need for ethical and controlled use of these technologies by medical personnel. These regulations have an impact on the automation of medical processes, while ensuring safety and responsibility

Investments in cybersecurity will ensure the protection of sensitive patient data, which is crucial in the era of growing digital threats. The government’s cybersecurity budget in 2025 amounts to PLN 4 billion, which indicates that digital security is a priority, also in the healthcare sector. These funds are to support, among others, local governments and public institutions, including medical facilities. National Health Fund programs offering co-financing of up to PLN 900,000 for the purchase and implementation of modern technologies securing IT systems of medical facilities, which directly translates into the protection of patient data. This year, the Ministry of Digital Affairs announced the creation of new computer incident response teams (CSIRT) for healthcare and energy. It allocated PLN 27.6 million from the National Reconstruction Plan for this purpose.

The Polish Ministry of Health has announced a competition for the digital transformation of healthcare, allocating over PLN 3.1 billion for this purpose from the National Recovery and Resilience Plan. The competition is aimed at healthcare entities belonging to hospital networks. The aim is to develop digital services in healthcare, which is to bring, among other things, faster diagnosis and treatment thanks to better access to medical records, full integration of Electronic Medical Records, easier access to test results and support for doctors with artificial intelligence tools. An important element is also increasing the cybersecurity of patient data.

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