Publication date: July 07, 2026
The development of artificial intelligence in medicine is no longer just a futuristic vision. Algorithms now support diagnostics, test result analysis, and disease prevention, and Polish medical law is beginning to address the challenges involved. The 2025 amendment to the Code of Medical Ethics explicitly addresses the use of AI by physicians for the first time, imposing obligations regarding patient information, obtaining informed consent, and the use of certified systems. However, the question arises: where does the role of technology end and the physician’s responsibility begin?
Amendment to the Code of Medical Ethics from 2025
The 2025 amendment to the Code of Medical Ethics addressed the use of artificial intelligence in medical practice for the first time in the history of Polish medical law. Because AI systems are defined as high-risk systems in the EU regulation on artificial intelligence, necessary procedural steps are identified before their practical application. The Code of Medical Ethics stipulates that four criteria must be met: informing the patient about the use of AI in the therapeutic process or when making a diagnosis; obtaining the patient’s informed consent to the use of AI. According to the AI Act, algorithms approved for medical use and holding appropriate certificates should be used. It is recommended that AI systems support physicians in their work rather than replace them. Therefore, the final decision regarding the use of AI algorithms in medicine rests with the physician. This emphasizes the need for continuous improvement in medical knowledge and the ability to adapt to new technologies.
The obligation to inform the patient that artificial intelligence will be used in the diagnosis or therapeutic process
Properly informing a patient about the use of artificial intelligence is understood as providing accurate information about the fact and characteristics of the AI system being used. This obligation also involves obtaining the patient’s informed consent to the use of AI systems, which means informing the patient about the possible benefits and risks of the proposed actions and the possibility of using other actions, as well as ensuring the patient knows and understands how the AI system being used works. Physicians should consider the circumstances and personality traits of the individual patient, ensuring that information is provided in an appropriate manner that allows for understanding the content of the message being communicated. The essence of the need for information is that AI systems are not infallible, and although the physician makes the final decision, the patient is aware of the potential risks arising from the use of AI systems. It is fundamentally crucial to respect two important patient rights: the right to information and the right to consent to healthcare services.
The obligation to obtain informed consent from the patient to use artificial intelligence in the diagnostic or therapeutic process
A written declaration of intent is not necessary to obtain patient consent; an oral statement or conduct that leaves no doubt as to the expression of intent is sufficient, although this can pose numerous evidentiary challenges in the event of a lawsuit against the doctor. If patients have been informed of the use of artificial intelligence in the diagnostic or therapeutic process, their consent to the provision of healthcare services will also include consent to the use of AI to provide these services, without the need for separate consent for the initial use of AI. When using AI systems in clinical practice, a distinction must be made between situations where the algorithm is crucial to the service being provided, for example, influencing the patient’s subsequent decisions without the doctor’s consent or with minimal consent. In such cases, informing the patient and obtaining their consent is essential. However, when algorithms merely support the doctor’s work, patient consent is not strictly required, but it is recommended to inform them about the use of AI systems.
The obligation to use artificial intelligence algorithms that are approved for medical use and have appropriate certificates
According to the AI Act, algorithms approved for medical use and with appropriate certificates must be used, given that medical practice may impact the health or life of the patient. The European system for the safety and market approval of products meeting EU requirements requires testing products using AI systems for compliance with standards and obtaining a certificate of conformity with the CE marking. Most medical software produced in the European Union requires external auditing and certification. A medical device can be software whose manufacturer has intended for use in at least one of the specific medical applications specified in the Medical Devices Regulation. The use of scientifically unverified therapeutic methods is prohibited. Software can be used for various purposes, for example, to control other medical devices, provide information that supports further therapeutic or diagnostic decisions, or assist in the interpretation of results generated by other devices.
The final diagnostic and therapeutic decision is always made by the doctor
The fourth regulation, Article 12 of the Code of Medical Ethics, aims to emphasize that artificial intelligence supports physicians in their work, rather than replaces them. Because scientific considerations about artificial intelligence are relatively new, societies still harbor many doubts about increasing the use of artificial intelligence, especially in classified high-risk systems. Furthermore, it is currently impossible for artificial intelligence to replace certain traits that physicians are capable of exercising, such as empathy and intuition.
Prospects and forecasts for the use of artificial intelligence in the work of doctors
The use of artificial intelligence in preventive medicine offers broad prospects thanks to the rapid analysis of millions of data points, which aims to enable early detection of disease. In such cases, the same conditions specified in Article 12 of the Code of Medical Ethics must be met as for treatment and diagnostic procedures. Currently, AI algorithms are increasingly equal to or even superior to qualified physicians in their preventive care. However, the novelty of the technology and the suggestion that AI is solely intended to facilitate physicians’ work contribute to many people’s skepticism about the further development of AI in preventive medicine. According to researchers, AI is ideal for preventing cardiovascular disease through remote monitoring of hypertension, and the algorithms can analyze, in addition to individual parameters, medical history, genetic predisposition, and lifestyle factors.
Legal status of Code of Medical Ethics
The Code of Medical Ethics was adopted in 1991 during the Extraordinary Second National Congress of Physicians. It is adopted and amended by the Supreme Medical Chamber. Although it is an important act for the medical profession, it does not have the status of a statute and, within the meaning of the Constitution, is not a legal act; instead, it is based on the Act on Medical Chambers. Physicians, as a professional group, have professional self-government, which influences regulations related to professional ethics. Resolutions in the Polish legal system are internal acts, regulating, among other things, the ethical principles of individual professions. The resolution addresses general ethical standards, respect for human rights, and upholding the dignity of the medical profession, which is further defined as physician conduct that does not undermine trust in the profession.
The dynamic development of artificial intelligence systems in medicine raises significant questions regarding liability for erroneous diagnostic or therapeutic decisions made using AI algorithms. This issue remains one of the most challenging in contemporary medical law, as current regulations do not yet provide a uniform model for liability for damages caused by AI systems.
Generally, according to Article 12 of the Code of Medical Ethics, the final diagnostic and therapeutic decision rests with the physician. This means that even when using advanced AI algorithms, the physician is not released from the obligation to exercise due diligence and critically evaluate the obtained results. If a physician thoughtlessly bases a diagnosis solely on the AI system’s indications, they may be subject to civil, professional, and in certain cases criminal liability for harm caused to the patient.
However, liability may also apply to healthcare providers, especially when the damage results from improper organization of the treatment process, the use of an uncertified AI system, or a lack of appropriate oversight procedures for the software used. The hospital or clinic is responsible for ensuring the organizational security of the healthcare services provided and for using tools that meet legal requirements and safety standards.
In certain situations, the manufacturer or supplier of an AI system may also be liable. This applies primarily to software malfunctions, design errors, improper model training, or the product’s noncompliance with the requirements of the AI Act and medical device regulations. In such cases, product liability or contractual liability provisions may apply.
Particular difficulties arise, however, when an incorrect diagnosis results from the so-called autonomous learning process of an AI system. Artificial intelligence systems lack legal personality and therefore cannot be held accountable independently. This necessitates determining which of the participants in the process – the doctor, the medical facility, the manufacturer, or the technology provider – actually contributed to the damage.
The doctrine emphasizes that with the further development of artificial intelligence, it will be necessary to create clearer regulations regarding liability for damage caused by AI systems in healthcare. The current legal framework relies primarily on the application of provisions analogous to traditional medical liability and product liability.
The 2008 Act on Patients’ Rights and the Patient Ombudsman contains regulations complementary to the Code of Medical Ethics, but without addressing the topic of artificial intelligence. Patients have the right to information regarding, among other things, diagnosis, proposed diagnostic and treatment methods, and the foreseeable consequences of their use or omission, as well as the right to information about the type and scope of healthcare services provided by the healthcare provider.
The 1996 Act on the Profession of Physicians and Dentists regulates the obligation to practice the profession in accordance with current medical knowledge, available methods and means of preventing, diagnosing, and treating diseases, in accordance with the principles of professional ethics, and with due diligence. In the case of the use of artificial intelligence in medicine as a high-risk system, this means the obligation, stipulated in the KEL, to use certified and approved systems.
Because the field of artificial intelligence is a relatively new field of study and few legal acts have been created to date to regulate its operation, the vast majority of clinic and hospital regulations still do not directly address the use of artificial intelligence systems in healthcare services. However, indirect references can be found, such as specifying the institution’s purpose as, among other things, teaching and research activities in connection with the provision of healthcare services and health promotion, including the implementation of new treatment methods and medical technologies, which include artificial intelligence systems.
The dynamic development of artificial intelligence in healthcare means that existing legal regulations may prove insufficient in the coming years. Developing clear rules of accountability for AI-supported decisions and maintaining a balance between innovation and patient safety will be crucial. Despite technological advances, humans – physicians – should continue to play a central role in the diagnostic and therapeutic process, bearing responsibility for the patient’s well-being.