The General Data Protection Regulation (GDPR) includes Article 22, which gives individuals the right not to be subject to decisions based solely on automated processing if these decisions significantly impact them. Exceptions to this right include individual consent, contractual necessity, or specific laws, with safeguards for the individual’s rights and interests. Quebec’s Law 25 requires transparency and allows individuals to correct inaccurate personal information used in automated decisions. Organizations using AI in healthcare should also consider provincial and territorial health information management rules and health privacy legislation.

When using AI in healthcare, legal risks to consider include breach of human rights law, breach of privacy, intellectual property infringement, and misappropriation of personality. The primary concern should be the clinical risk to the patient. Bias in AI systems used for diagnostic or treatment purposes poses a significant risk, potentially leading to discrimination or clinical harm. For example, if an AI system is trained on data from a specific patient population, it may not be suitable to diagnose or suggest treatment for individuals outside that demographic, potentially resulting in misdiagnosis or inappropriate treatment recommendations and creating liability for healthcare providers. Organizations must mitigate these risks associated with AI use in healthcare to ensure patient safety and compliance with legal regulations.

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