Somatic/Embodied Interface Domain Profile
Verification requirements
| ID | What must be established |
|---|---|
SE-01 | Intended use, affected body or action, operating authority, responsible roles, and regulatory boundary are established. |
SE-02 | People and operators receive timely, accessible information about material sensing, actuation, adaptation, limits, uncertainty, and change. |
SE-03 | Protected choice, refusal, pause, override, disengagement, and safe transition remain operational within legitimate clinical or safety authority. |
SE-04 | Safeguards scale with severity, coupling strength, duration, susceptibility, uncertainty, reversibility, adaptation, and interacting systems. |
SE-05 | Biological, neural, movement, sensory, health, disability, and derived data remain necessary, bounded, protected, and legitimately governed. |
SE-06 | Material model, data, user-state, environment, hardware, or use changes trigger lifecycle review inside a validated adaptation envelope. |
SE-07 | Incidents and material near misses are detectable, containable, traceable, reviewable, and connected to competent response and remedy. |
SE-08 | Bodily-benefit, wellness, medical-purpose, safety, performance, accessibility, adaptation, and long-term-effect claims stay within direct evidence and authorization. |
Unresolved high-consequence uncertainty cannot be averaged into a positive Profile determination.
Evidence and claim boundary
Evidence may include intended-use and regulatory records, hazard analysis, system and human-factors tests, clinical or performance evidence, device and model change controls, data flows, interoperability tests, monitoring, incidents, and user research.
The current baseline is research-bounded. Regulated functions require current Source Profiles and competence matching the body system, device, population, function, claim, and jurisdiction. This Profile does not establish regulatory authorization, clinical efficacy, physiological causation, safety and effectiveness, disability status, or legal compliance.
Composition and stewardship
Compose with Developmental Interaction, Emotional Autonomy, Relational Architecture, and current Source and Deployment Profiles for medical devices, clinical practice, accessibility, privacy, cybersecurity, product safety, and other governing domains.
The Somatic/Embodied Interface Division is the corresponding stewardship identity.