The use of artificial intelligence in healthcare offers unprecedented opportunities of development in diagnostics and treatment. AI’s ability to aggregate and analyze large datasets significantly improves diagnostic accuracy and predictive capabilities, yet raises concerns about patient autonomy, data privacy, and equitable access. The ‘black box’ problem and the risk of potential errors in diagnosis or treatment further complicate AI usage in medical practice. Existing regulations, such as the EU AI Act, provide foundational governance but require refinement to address specific challenges of healthcare. This study advocates for harmonized international standards, robust data protection frameworks. A new patients’ right to human-provided healthcare is also proposed.