Informed Consent

slug: informed_consent element_type: TERM mutability: MUTABLE inline: true current_version: 0 status: seed-draft contentURI: null

@informed-consent in the AI-mediated medical context is consent that meets the classical informed-consent standard (capacity, disclosure, comprehension, voluntariness) and additionally the AI-era requirements:

1. Disclosure of AI involvement. The patient is told which AI tool participates in their care, what role it plays (diagnostic, triage, suggestion, monitoring), and what its known uncertainty / failure modes are.
2. Scope, duration, revocation. Consent for AI use in care is separately scoped from consent for AI training. Each scope is time-bound and revocable, with downstream cleanup obligations on every system that received the data.
3. Comprehension does not require expertise. The disclosure must be in language the patient can understand, not in technical specification language. Comprehension is a clinical responsibility, not a documentation formality.
4. No bundled consent. Consent for clinical care cannot be conditioned on consent for AI training or secondary research. Each is a separate decision.

Status

seed-draft · current_version: 0. Placeholder representing the AI-era extension of classical informed consent. Awaits domain author refinement.

Why this is more demanding than classical informed consent

Pre-AI informed consent assumed the physician was the locus of clinical judgment and the patient was the locus of value. AI introduces a third actor whose role, uncertainty, and training history are usually opaque to both. Without explicit disclosure + separately-scoped + revocable consent, the patient consents to a black box wearing the physician's coat.

Reasoning trail

• Beauchamp/Childress autonomy principle is the philosophical floor.
• 2025–2026 medical AI ethics literature names "transparency" and "data security" as required additions; this term operationalizes both within the consent framework.
• Aligns with federation kernel transparency IMMUTABLE and Companion L2 transparent-mediation LOCKED.
• Anticipates BCI / neurotech intersection: consent in the substrate-engineering era requires more, not less, granularity.

Related elements

• 02-patient-data-sovereignty (PRINCIPLE) — the constitutional ground
• informed-consent-architecture (RULE) — operational standard
• algorithm-disclosure-to-patient (RULE) — what the patient is told about AI's role

Awaiting domain author

Open the conversation at leviathan.life/forum/medicine.