Authoritative scientific boundary

Intended Use, Claims and Validation Gaps

Version 2026.7.23.2. This workspace separates executable software capability from external biological, clinical and regulatory evidence.

Approved intended use

A research-only computational platform for de-identified biomedical evidence synthesis, causal-hypothesis generation, experiment prioritization, digital-twin research, and matched classical/quantum optimization benchmarking.

Permitted research capabilities

• ingest and normalize de-identified research data
• retrieve and grade biomedical evidence with provenance
• construct falsifiable causal hypotheses
• simulate counterfactual research trajectories with uncertainty
• construct and solve versioned optimization formulations
• compare quantum simulation and physical-QPU results with classical authorities
• generate research protocols, validation plans, and abstention decisions
• generate evidence-traceable computational diagnostic differentials for verified clinician review
• generate medication, dose and treatment-order drafts for verified prescriber completion and signature
• route signed external orders or biological interventions through administrator-enabled institutional gateways

Prohibited capabilities and claims

• autonomous diagnosis
• autonomous treatment recommendation
• unsigned prescription generation for external use
• autonomous numeric dose selection or dosing without patient-specific parameters
• unreviewed medical-device actuation
• insulin-pump or implant control
• autonomous gene-editing execution
• unreviewed cell-graft authorization or dispatch
• wet-lab execution outside an approved external institutional gateway
• claiming cure, restoration, efficacy, safety, or quantum advantage without the required external evidence

Reference identifier verification

Checks DOI/PMID metadata, title agreement and detected retraction or correction signals. Human evidence review remains mandatory.

Cited title

DOIPMID

Claim and publication-language gate

Tests proposed language against registered claims. Automated clearance never replaces scientific, legal or regulatory review.

Claim keys, comma separatedProposed publication text

Claim-to-evidence ledger

Publication language is controlled by claim status and the strongest available evidence level.

Claim	Status	Evidence	Authorized wording	Owner
MSBI contains an executable, research-only biomedical computation runtime. platform-research-runtime	SUPPORTED_INTERNAL	CODE_VERIFIED production-build-gate, runtime-health-endpoint	Executable research platform; not a clinical product.	PlatformArchitecture
MSBI records evidence provenance, retrieval metadata, uncertainty, and contradiction state. evidence-provenance	SUPPORTED_INTERNAL	CODE_VERIFIED evidence-ledger, biomedical-catalog-gate	Internal provenance and contradiction controls are implemented.	EvidenceCouncilAgent
MSBI causal outputs identify falsifiable research hypotheses. causal-validity	EXTERNAL_VALIDATION_REQUIRED	SYNTHETIC_INTERNAL scd-positive-control	Causal hypotheses have internal synthetic validation and require external validation.	CausalHypothesisOrchestrator
MSBI digital-twin outputs are research forecasts with uncertainty and abstention controls. digital-twin-validity	EXTERNAL_VALIDATION_REQUIRED	SYNTHETIC_INTERNAL twin-calibration-report	Digital-twin forecasts are internally tested and not clinically validated.	TwinEngine
MSBI has demonstrated quantum advantage. quantum-advantage	NOT_ESTABLISHED	NONE No affirmative evidence	No quantum advantage has been established.	ComparatorAgent
MSBI can submit governed physical-QPU research jobs when infrastructure and administrator policy are configured. physical-qpu	EXTERNAL_VALIDATION_REQUIRED	CODE_VERIFIED qpu-policy-gate, physical-reservation-ledger	Physical-QPU adapters are governed; the default production state is disabled.	QPUOrchestrator
MSBI restores or cures disease in patients. clinical-efficacy	PROHIBITED	NONE No affirmative evidence	No clinical efficacy, restoration, or cure claim is authorized.	SentinelAgent
MSBI autonomously executes a biological or clinical intervention. biological-actuation	PROHIBITED	NONE No affirmative evidence	Autonomous actuation is prohibited; signed external execution may occur only through an administrator-enabled institutional gateway with consent, protocol and dual control.	SentinelAgent

Gap-remediation controls

Software can enforce governance and reproducibility. External cohort, wet-lab, clinical and regulatory evidence cannot be manufactured by code.

Authoritative intended-use and prohibited-use policy

intended-use · P0

IMPLEMENTED

Acceptance evidence

• versioned policy
• public API
• runtime validation

Claim-to-evidence publication gate

claim-ledger · P0

IMPLEMENTED

Acceptance evidence

• versioned claims
• language findings
• build gate

Reference identifier and retraction verification

reference-integrity · P0

PARTIAL

Acceptance evidence

• reference registry
• DOI/PMID checks
• human verification

Independent retrospective and wet-lab validation

external-validation · P0

EXTERNAL_EVIDENCE_REQUIRED

Acceptance evidence

• external cohort
• locked protocol
• independent replication

Pre-registered physical-QPU value benchmark

quantum-value · P1

EXTERNAL_EVIDENCE_REQUIRED

Acceptance evidence

• physical runs
• matched classical budget
• confidence interval

Controlled design history and quality-management evidence

quality-system · P0

PARTIAL

Acceptance evidence

• requirements traceability
• risk file
• CAPA and change control

MSBI outputs remain research hypotheses and validation plans. Clinical efficacy, restoration, cure, safety, biological actuation and quantum advantage are not established by software execution alone.

Permitted research capabilities

• ingest and normalize de-identified research data

• retrieve and grade biomedical evidence with provenance

• construct falsifiable causal hypotheses

• simulate counterfactual research trajectories with uncertainty

• construct and solve versioned optimization formulations

• compare quantum simulation and physical-QPU results with classical authorities

• generate research protocols, validation plans, and abstention decisions

• generate evidence-traceable computational diagnostic differentials for verified clinician review

• generate medication, dose and treatment-order drafts for verified prescriber completion and signature

• route signed external orders or biological interventions through administrator-enabled institutional gateways

Prohibited capabilities and claims

• autonomous diagnosis

• autonomous treatment recommendation

• unsigned prescription generation for external use

• autonomous numeric dose selection or dosing without patient-specific parameters

• unreviewed medical-device actuation

• insulin-pump or implant control

• autonomous gene-editing execution

• unreviewed cell-graft authorization or dispatch

• wet-lab execution outside an approved external institutional gateway

• claiming cure, restoration, efficacy, safety, or quantum advantage without the required external evidence

Claim

Status

Evidence

Authorized wording

Owner

MSBI contains an executable, research-only biomedical computation runtime.

platform-research-runtime

SUPPORTED_INTERNAL

CODE_VERIFIED

production-build-gate, runtime-health-endpoint

Executable research platform; not a clinical product.

PlatformArchitecture

MSBI records evidence provenance, retrieval metadata, uncertainty, and contradiction state.

evidence-provenance

SUPPORTED_INTERNAL

CODE_VERIFIED

evidence-ledger, biomedical-catalog-gate

Internal provenance and contradiction controls are implemented.

EvidenceCouncilAgent

MSBI causal outputs identify falsifiable research hypotheses.

causal-validity

EXTERNAL_VALIDATION_REQUIRED

SYNTHETIC_INTERNAL

scd-positive-control

Causal hypotheses have internal synthetic validation and require external validation.

CausalHypothesisOrchestrator

MSBI digital-twin outputs are research forecasts with uncertainty and abstention controls.

digital-twin-validity

EXTERNAL_VALIDATION_REQUIRED

SYNTHETIC_INTERNAL

twin-calibration-report

Digital-twin forecasts are internally tested and not clinically validated.

TwinEngine

MSBI has demonstrated quantum advantage.

quantum-advantage

NOT_ESTABLISHED

NONE

No affirmative evidence

No quantum advantage has been established.

ComparatorAgent

MSBI can submit governed physical-QPU research jobs when infrastructure and administrator policy are configured.

physical-qpu

EXTERNAL_VALIDATION_REQUIRED

CODE_VERIFIED

qpu-policy-gate, physical-reservation-ledger

Physical-QPU adapters are governed; the default production state is disabled.

QPUOrchestrator

MSBI restores or cures disease in patients.

clinical-efficacy

PROHIBITED

NONE

No affirmative evidence

No clinical efficacy, restoration, or cure claim is authorized.

SentinelAgent

MSBI autonomously executes a biological or clinical intervention.

biological-actuation

PROHIBITED

NONE

No affirmative evidence

Autonomous actuation is prohibited; signed external execution may occur only through an administrator-enabled institutional gateway with consent, protocol and dual control.

SentinelAgent