Security & Governance Status
An approved engagement gives the organization a Governance Decision Package that states what the available evidence supports, what remains uncertain or blocked, and whether the named clinical AI use case should Proceed, Modify, Pause, or Stop.
The engagement is bounded and time-limited. Scope and duration are set in the written Statement of Work and depend on site approvals, data readiness, and the named use case.
This page gives procurement, security, and governance reviewers what they usually have to ask for: a plain account of what is true today, what is not established, and what a future real-data pathway would require. Reviewers can assess scope in one pass, without inferring maturity that has not been demonstrated.
Reviewable in one pass
Current state, gaps, and future conditions are separated, not blended.
Written, not implied
Every statement is bounded to what current controlled records support.
Decision-ready
Evidence review, limitations, findings including null and adverse results, and a governance recommendation in one record.
Reviewed August 2026. Statements are self-reported and describe the current research environment.
Decision rights and limits
Any evaluation output is a human-owned Governance Decision Package recommending one of four outcomes: Proceed, Modify, Pause, or Stop. VitaSignal recommends; the health system decides. VitaSignal does not make the decision and does not act on patients or staffing.
The evaluation is read-only and retrospective first. Silent-mode or observational work is conditional, separately authorized in writing, and only considered after prespecified evidence gates are met. No PHI exchange is offered under the current public pathway.
- Public demonstrations
- Synthetic data only, not for clinical use
- PHI
- Not exchanged under the current public pathway
- BAA
- Currently no Business Associate Agreement is offered or in effect
- Certifications and audits
- None claimed: no third-party audit, penetration test outcome, independent attestation, or partner-environment validation has been completed
VitaSignal is a research-stage prototype, is not FDA cleared or approved, and is not available for clinical use.
Current: what is true today
Scope of the present public and research environment.
Public environment
No patient data is processed by the public surfaces. Public demonstrations run on synthetic material only.
Current evidence
Evidence is retrospective, component-specific, and mixed. There is no complete-system, prospective, clinical, workflow, fairness-benefit, transportability, or deployment validation. See Evidence and Limitations for the component-level record.
Engineering conformance
Bounded internal synthetic and static checks only. These checks are not independently authored or assessed, and they are not evidence of production interoperability, security, provenance, governance effectiveness, or partner-environment performance.
Not established
Claims a reviewer should not infer from this site or from any demonstration.
Regulatory status
Intended use, classification, and the applicable regulatory pathway remain under evaluation. No submission timing is committed.
Production security and quality controls
No production security or quality controls are asserted for the current research environment.
Clinical and workflow benefit
Documentation burden reduction, clinical utility, staffing benefit, equitable benefit, and external transportability are not established.
Subgroup governance
A planning framework only. It requires prespecified groups, adequate cell sizes, reported uncertainty, and an explicit insufficient-evidence state. It does not certify fairness or equitable benefit.
Future pathway requirements
Conditions that would have to be met before any real-data engagement could begin.
Covered-entity data pathway
Any future covered-entity pathway requires counsel-approved agreements, privacy review, and institutional governance before data exchange.
Security and quality
Requirements and controls for any future real-data environment remain implementation-specific and subject to site review. Nothing here should be read as an operating control today.
Evaluation design
Prospective or site-specific evaluation would require locally defined constructs, site-approved protocols, and prespecified analysis before any conclusion is drawn.
Planned reproducibility and semantic-provenance controls
VitaSignal has documented a concept and design target for linking research outputs to model version, source reference, timing, status, and known limitations. Implementation completeness, end-to-end lineage, deterministic re-derivation, FHIR Provenance and AuditEvent behavior, and partner-environment conformance have not been established. VitaSignal is not a clinical chatbot: no generative LLM sits in the scoring path, and narrative context is kept separate from the recorded value. No output is used for diagnosis, treatment, alerting, or any patient-care decision. External verification has not occurred.
Input
Structured metadata
Retrospective or read-only
Model
Versioned Scoring
Planned, not externally verified
Concept / planned mapping
Designed provenance record
Design target, not implemented
Structured Inputs
Research outputs are computed from structured, retrospective or approved read-only documentation metadata, not free-text prompts.
Versioned Scoring (design target)
Version-controlled research models are intended to produce deterministic outputs. No generative LLM sits in the scoring path. Deterministic re-derivation has not been established.
Designed provenance record
Concept and design target for recording model version, source reference, timing, status, and known limitations. Implementation completeness has not been established.
Re-derivation as a design goal
Re-derivation from the original input state is a design goal for governance review. Deterministic re-derivation and end-to-end lineage have not been established, and reproducibility has not been externally verified.
How do you reduce generative-output risk in research materials?
- No generative LLM is in the structured scoring path.
- Any LLM-assisted narrative, if used, is kept separate from the recorded value, grounded in approved source material, labeled as assisted text, and subject to human review.
- Version and source-reference linkage are design targets whose implementation completeness has not been established.
- This design reduces but does not eliminate hallucination, omission, citation, interpretation, or transcription risk.
Answers for healthcare-organization procurement, security, and governance teams.
The questions we hear most often during procurement review. Answers describe the current research prototype and stated design requirements. Implementation status varies by control.
Boundaries we hold - by design.
These are current, standing prohibitions, not descriptions of future architecture.
We do not write to the chart
VitaSignal produces no chart write-back today. It does not author notes, orders, or documentation that becomes part of the legal medical record.
We do not produce clinical output or automated action
VitaSignal currently provides no patient-facing or clinician-facing clinical output and takes no automated action. No orders, medication changes, or interventions are issued.
We do not train on identifiable patient data
No identifiable patient data is received or used today, and none is used to train or tune models.
We do not exchange PHI
No PHI exchange is offered under the current public pathway.
We do not sell, share, or monetize patient data
No advertising, no data brokerage, and no secondary commercial use of identifiable clinical information. This is a standing prohibition that would be carried into any future written agreement.
How data would be handled
Research data today
Research work uses de-identified retrospective data under credentialed access.
Minimum-necessary principle
Any future pathway would be scoped to only the data elements needed for the specific evaluation, with no unnecessary demographics, financial data, or unrelated clinical information.
Escalation procedures
No public operational response target is established. Any notification and escalation procedures for a future real-data pathway would be counsel-approved and defined in a written agreement.
Data retention
Any future pathway would define retention, return, and destruction terms in writing before data exchange, with no secondary use outside the agreed scope.
Need more detail?
Documentation for a specific evaluation pathway is shared with prospective design partners under NDA.