Healthcare AI 2025

POLAND Law and Practice Contributed by: Barbara Kiełtyka, Jakub Gładkowski and Małgorzata Kiełtyka, Kieltyka Gladkowski KG Legal

The following strategies are used to address this issue: • One strategy is regulatory mapping, which involves reviewing regulations and recording key obligations across jurisdictions to identify overlaps. • Another strategy is a modular, risk-based approach that classifies AI systems for compliance. This approach is used in Data Act and GDPR compli - ance testing. • Another innovative solution is regulatory sandbox - es. The EU and some Member States use these to enable safe experimentation with new technologies in controlled conditions. • In the context of GDPR and health data, con - ducting a DPIA (personal data protection impact assessment) is fundamental. Combinations of strategies are possible to achieve this goal. The most important thing is to properly char - acterise the product.

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