POLAND Law and Practice Contributed by: Barbara Kiełtyka, Jakub Gładkowski and Małgorzata Kiełtyka, Kieltyka Gladkowski KG Legal
combines liability for medical errors in the traditional sense with liability for the actions of AI. Some market actors propose creating special com - pensation funds or insurance systems that would cov - er damage caused by AI. Such a model could work similarly to third-party liability insurance for motor vehicles. For example, there could be third-party liabil - ity insurance for AI robots. 4.2 Patient Harm and Malpractice The issue of liability for AI errors in medicine was discussed in 4.1 Liability Framework , where it was explained that the main problem is attribution of liabil - ity for AI’s actions. AI errors in medical practice can affect, for example, diagnoses and test results, which can then result in a physician making inappropriate recommendations given the circumstances. In such cases, a distinction can be made between liability based on fault, pursuant to Article 415 of the Polish Civil Code, if the act is unlawful, and liability based on the attribution of improper behaviour, which can be used to establish liability. Therefore, liability for damage caused by AI should view AI primarily as a tool in the hands of humans. Strict liability can be distinguished if the use of a given device can be deemed to involve an increased risk of harm. In this framework, the ability to seek compensa - tion for damage caused by AI depends on establish - ing the culpable conduct of the owner, possessor or other person controlling these technologies and on demonstrating a causal link between their operation and the harm caused. Equitable liability can also be distinguished; ie, the legal norm imposing the obligation to redress dam - ages refers to the principles of social coexistence. 4.3 Risk Management Requirements Traditional risk management addresses known and easily predictable risks, but the case of artificial intel - ligence is much more sophisticated. Artificial intelli - gence systems in medicine are classified by the AI Act as high-risk systems. Therefore, they require pre- market compliance assessments before implementa -
tion and undergo regular evaluations throughout their lifecycle. Data quality is assessed, as risk mitigation requires high-quality data feeding the system. Clear informa - tion must be provided to users and regulators, human oversight of the AI system’s operation is essential, and systems must be accurate, robust, and safe in opera - tion. The European Parliament resolution of 20 October 2020 with recommendations to the Commission on a civil liability regime for artificial intelligence (2020/2014 (INL)) even proposed mandatory liability insurance for end-users (operators) or producers for high-risk sys - tems, to the extent that liability would not fall within, or go beyond, product liability regulations. The insurance market is adapting to these requirements, and policies proposed by insurance companies should cover civil liability for damage caused by AI systems, AI system failures, hacker attacks, data leaks, and cyber threats. 4.4 Defences and Limitations Possible limitations of liability or defences in health - care AI include, but are not limited to: • contribution of the end user (when demonstrating non-compliance with the instructions); • system defect independent of human control; • demonstration of due diligence of the responsible person; and • fault of another entity in the chain of contractors, suppliers or subcontractors. In the context of medical procedures, it is important to properly manage the patient’s awareness of the possible potential risks resulting from the use of AI software in diagnostic procedures and in the thera - peutic process. Liability will also be limited by proper organisational supervision of the clinic and the work environment of medical procedures, by obtaining appropriate certifi - cates for the use and approval of AI algorithms appro - priate for medical use. It is an open question how to determine the priority of responsibility in the multi-entity chain of providing
97
CHAMBERS.COM
Powered by FlippingBook