Data Protection

Informed Consent

Voluntary agreement after receiving relevant information.

How the laws define this

Both texts establish that informed consent requires autonomous decision-making based on receiving and understanding necessary disclosures regarding technology, specifically ensuring an individual comprehends the role or consequences of artificial intelligence and algorithmic processing without coercion. They diverge significantly in their domain focus and specific conditional rules. The Privacy Protection Authority opinion / guidance on algorithmic processing and notification obligations (automated decision‑making guidance) treats consent within a general data-processing framework, focusing on the data subject's reasonable understanding of processing purposes and explicitly ruling out implied or coerced consent in contexts with power imbalances, such as employment or essential services. Conversely, Health Care Professions: Deceptive Terms or Letters: Artificial Intelligence frames consent as a formal clinical process where a patient grants permission for a medical procedure or treatment, specifically mandating disclosures that cover risks, benefits, alternatives, and the role of AI.

Synthesised from the 2 statutory definitions below. Each one is quoted in full, with its source.

How jurisdictions differ

What is distinctive in each definition, binding law in force first.

JurisdictionInstrumentStatusWhat is distinctive
California, United StatesHealth care professions: deceptive terms or letters: artificial intelligence.In ForceThis definition expands on standard informed consent by explicitly including disclosure of the role of AI in medical procedures or treatments.
IsraelPrivacy Protection Authority opinion / guidance on algorithmic processing and notification obligations (automated decision‑making guidance)In ForceThis definition emphasizes absence of coercion or power imbalance and deems implied or coerced consent insufficient in contexts like employment or essential services.

What it triggers

  • In California, under AB 489, AI must not deceptively use terms implying it is a licensed healthcare professional.
  • In Israel, the Privacy Protection Authority's 2022 guidance on algorithmic processing sets out enhanced privacy notices for data controllers using automated processing.source

Definitions (2)

Consent that is informed and voluntary, meaning the data subject has a reasonable understanding of the purpose and consequences of processing (including algorithmic processing) and is not subject to coercion or imbalance of power; implied or coerced consent is insufficient in contexts like employment or essential services.

Informed Consent is a process where a patient grants permission for a medical procedure or treatment after receiving and understanding all relevant information, including risks, benefits, alternatives, and the role of AI. It ensures autonomous decision-making based on complete and accurate disclosure.

Not to be confused with

Consent

Informed consent requires understanding of relevant information, risks, and context-specific elements, while consent is merely a freely given, informed, and unambiguous agreement.

Explicit Consent

Informed consent focuses on comprehensive disclosure in specific contexts like healthcare or data processing, whereas explicit consent emphasizes clear demonstrability and withdrawability.

Questions and answers

What does informed consent require in California healthcare with AI?

In California, informed consent requires disclosure of risks, benefits, alternatives, and the role of AI to ensure autonomous decision-making.

What makes consent valid under Israel's data processing guidance?

Israel's data processing guidance describes consent as informed and voluntary, with reasonable understanding of processing purposes and consequences, without coercion or power imbalance; implied consent is insufficient in sensitive contexts.

How does informed consent differ in AI healthcare vs data privacy contexts?

California's definition ties it to medical procedures with AI disclosure, while Israel's guidance stresses no coercion in algorithmic data processing, both building on voluntary agreement after information.