What Informed Consent in Digital Health & AI-Driven Care (2026 Standards) requires
Informed consent in digital health environments must be specific, granular, freely given, and easily revocable. It requires clear disclosure of AI involvement, data uses (including secondary and international transfers), risks of algorithmic bias, and limitations of digital tools. Dynamic and electronic consent mechanisms are expected, with audit trails and easy withdrawal processes. Special rules apply for vulnerable populations and high-risk AI applications.
Pillar: Medical & Healthcare · Authority: EDPB, FDA, WHO, Multiple National DPAs · Version: 1.0.0 · Last updated:
Primary source: https://gdpr.eu/article-7-conditions-for-consent/
SHA-256 integrity: 5803bede16be8fddca34cd03fc47ba96a8866ff23afd9f0c17f048daeadaa1eb
Primary Citations — 4 traced to source
- GDPR Article 7 - Conditions for consent & Recital 32
- EDPB Guidelines 05/2020 on consent
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