@pikaa-ai/pikaa 0.3.1 → 0.3.4

package/skills/clinical-decision-support/references/evidence_profiles.md

@@ -1,153 +0,0 @@
-# GRADE Evidence Profiles
-
-## Purpose
-
-An evidence profile transparently records a human panel's judgments about a body of evidence for each important outcome. It is not an article-scoring shortcut and does not produce a patient-care recommendation.
-
-Use the current [GRADE Book](https://book.gradepro.org/) and the [GRADE Working Group](https://www.gradeworkinggroup.org/) as the controlling methodology. The GRADE Book is replacing the older handbook with progressively updated content.
-
-## Non-Automation Rule
-
-Never:
-
-- infer certainty from keywords, abstracts, p-values, journal name, or study design alone;
-- count checklist items to calculate certainty;
-- treat one study's risk-of-bias judgment as certainty in a body of evidence;
-- equate certainty with recommendation strength;
-- assign recommendation strength without an Evidence-to-Decision process and a responsible panel;
-- invent source citations or downgrade/upgrade rationales.
-
-The bundled checker verifies structure, allowed labels, human attribution, rationale, and source linkage. It does not alter or endorse a judgment.
-
-## Unit of Assessment
-
-Rate certainty separately for every critical or important outcome. Include desirable and undesirable effects. Different outcomes may have different:
-
-- bodies of evidence;
-- risk-of-bias concerns;
-- directness;
-- precision;
-- reporting bias;
-- certainty.
-
-Do not collapse all outcomes into a single study-level grade.
-
-## Required Profile Fields
-
-### Question
-
-- Population
-- Intervention/exposure/index approach
-- Comparator/reference
-- Outcomes and time horizons
-- Setting and decision context
-
-### Sources
-
-For every source include:
-
-- stable source ID;
-- full citation;
-- URL or DOI;
-- publication type;
-- version/date;
-- access date when content is living.
-
-### Effect
-
-For each outcome record:
-
-- measure and direction;
-- absolute and relative effects when appropriate;
-- confidence or credible interval;
-- participants and studies;
-- follow-up/horizon;
-- missingness;
-- whether the estimate is adjusted;
-- applicability limits.
-
-Do not convert an effect into a clinical instruction.
-
-## Certainty Domains
-
-Every domain entry requires a judgment, rationale, source IDs, and human reviewer role.
-
-### Risk of Bias
-
-Use a design-appropriate tool. Describe how limitations could change the estimated effect. Do not use a numeric quality score as a substitute.
-
-### Inconsistency
-
-Examine the direction and magnitude of effects, interval overlap, heterogeneity, and plausible explanations. A statistical heterogeneity value alone is not the judgment.
-
-### Indirectness
-
-Compare population, intervention/exposure, comparator, outcome, time horizon, setting, and evidence pathway with the framed question.
-
-### Imprecision
-
-Use decision-relevant thresholds and the range of effects compatible with the interval. Do not apply unsupported universal event-count rules.
-
-### Publication Bias
-
-Consider missing studies/results, selective reporting, small-study effects, sponsorship patterns, registrations, protocols, and reporting availability.
-
-### Upgrading Considerations
-
-When the selected GRADE approach permits, a panel may consider large effects, dose-response gradients, or plausible residual confounding. Each requires explicit methodology, rationale, and citations. “Statistically significant” is not an upgrading reason.
-
-## Final Certainty
-
-Allowed labels:
-
-- high;
-- moderate;
-- low;
-- very low.
-
-Record:
-
-- the final human judgment;
-- who made it and in what role;
-- date;
-- domain-to-final-rating rationale;
-- dissent or unresolved issues;
-- source IDs.
-
-The label describes confidence in an estimate for an outcome in a defined context. It is not a recommendation and does not imply safety, effectiveness, or authorization.
-
-## Evidence to Decision
-
-Recommendation development is outside the automated helper. A qualified panel using an applicable GRADE Evidence-to-Decision framework must explicitly consider, as relevant:
-
-- priority of the problem;
-- desirable and undesirable effects;
-- certainty of evidence;
-- values and variability;
-- resources and cost effectiveness;
-- equity;
-- acceptability;
-- feasibility.
-
-Keep the evidence profile and any later recommendation record separate and traceable.
-
-## Quality-Control Checklist
-
-- [ ] Search and selection methods are documented.
-- [ ] Outcome definitions and horizons match the question.
-- [ ] All important benefits and harms are represented.
-- [ ] Effect estimates include uncertainty.
-- [ ] Each domain has a human judgment and rationale.
-- [ ] Every rationale links to source IDs.
-- [ ] The final certainty is outcome-specific.
-- [ ] Conflicts of interest and panel roles are recorded.
-- [ ] Disagreements and updates are versioned.
-- [ ] No patient-specific or treatment directive appears.
-
-## Helper
-
-```bash
-python3 scripts/evidence_profile_check.py assets/evidence_profile_template.json
-```
-
-The distributed template intentionally contains unresolved judgments. A non-zero result is expected until qualified humans complete it.

package/skills/clinical-decision-support/references/model_biomarker_evaluation.md

@@ -1,152 +0,0 @@
-# Aggregate Model and Biomarker Evaluation
-
-## Boundary
-
-Evaluate a locked model, assay, or prespecified biomarker rule using synthetic or aggregate validation summaries. Do not:
-
-- ingest individual records;
-- discover or optimize a threshold;
-- assign a class or risk to a person;
-- match a person to a test or intervention;
-- state clinical validity, utility, safety, or fitness for deployment.
-
-## Define the Target
-
-Record:
-
-- evaluation target and version;
-- biomarker category using FDA-NIH BEST terminology;
-- intended research purpose;
-- target population, setting, prevalence, and outcome horizon;
-- intended user and non-clinical decision role;
-- inputs, output, threshold, and threshold provenance;
-- development, tuning, internal-test, and external-validation datasets;
-- whether evaluation is temporal, geographic, site-based, or population-based.
-
-Do not call a random split from one source “external validation.”
-
-## Analytical and Clinical Questions
-
-Keep separate:
-
-1. **Analytical validation** — measurement accuracy, precision, detection limits, reproducibility, interference, specimen stability.
-2. **Clinical validation** — association or predictive performance for the defined context.
-3. **Clinical utility** — whether use improves meaningful outcomes compared with alternatives.
-
-The bundled evaluator addresses only selected aggregate clinical-validation performance summaries. It cannot establish any of the three.
-
-## Performance Dimensions
-
-### Discrimination
-
-Depending on the target:
-
-- sensitivity and specificity;
-- predictive values, with prevalence/context;
-- likelihood ratios;
-- C statistic/AUC with uncertainty;
-- time-dependent discrimination for censored outcomes.
-
-Do not report accuracy alone when classes are imbalanced.
-
-### Calibration
-
-Calibration asks whether predicted probabilities agree with observed frequencies. Evaluate:
-
-- calibration-in-the-large;
-- calibration slope;
-- calibration plots with uncertainty;
-- observed versus predicted risk across meaningful ranges;
-- integrated or absolute calibration error when justified.
-
-The standard-library helper accepts calibration bins and reports a weighted absolute gap. Binning loses information and does not replace individual-level calibration analysis in an approved environment.
-
-Primary overview: [Van Calster et al., calibration](https://pubmed.ncbi.nlm.nih.gov/31842878).
-
-### Overall Accuracy and Utility
-
-Use proper scoring rules and decision-curve/net-benefit methods only with a prespecified, defensible decision context. Do not imply utility from AUC or accuracy. Utility evaluation that changes care is outside this skill.
-
-### Uncertainty
-
-Report intervals for performance estimates and explain resampling or analytic methods. The helper uses Wilson intervals for aggregate proportions. It does not model correlated observations, clustering, repeated measurements, censoring, or verification bias.
-
-## External Validation
-
-Apply the original locked model without refitting. Document:
-
-- differences in case mix, prevalence, setting, workflow, and measurement;
-- eligibility and missingness;
-- sample-size rationale based on precision targets, not a blanket event rule;
-- calibration, discrimination, and any prespecified utility measure;
-- subgroup performance;
-- model failures and unusable inputs;
-- whether recalibration was separate from validation.
-
-See [BMJ 2024 external-validation guidance](https://www.bmj.com/content/384/bmj-2023-074820) and [sample-size methodology](https://pmc.ncbi.nlm.nih.gov/articles/PMC8352630).
-
-## Subgroup and Fairness Evaluation
-
-Before analysis:
-
-- identify groups based on intended use, evidence, and stakeholder input;
-- document category provenance and limitations;
-- set minimum precision and disclosure rules;
-- plan intersectional analyses where feasible;
-- define metrics and acceptable uncertainty;
-- evaluate measurement and label validity;
-- plan investigation and mitigation, not only detection.
-
-Report:
-
-- representation and missingness;
-- performance and calibration with intervals;
-- data quality and failure rates;
-- distribution shift;
-- human-AI interaction where relevant;
-- observed differences without declaring a group deficient.
-
-No single parity metric establishes fairness. Equal metrics can coexist with inequitable outcomes, and unequal metrics may reflect case mix, measurement, structural conditions, or model behavior that requires investigation.
-
-## Biomarker-Specific Controls
-
-- Pre-specify specimen, assay, platform, software, quality controls, units, and threshold.
-- Preserve continuous information where appropriate.
-- Separate prognostic association from treatment-effect interaction.
-- Blind assay assessment to outcome when feasible.
-- Account for batch/site effects and failed measurements.
-- Validate thresholds independently.
-- Report analytical validity before clinical interpretation.
-- Use REMARK for tumor prognostic markers.
-
-## Change Control and Monitoring
-
-For each release record:
-
-- immutable model/assay version;
-- data and code versions;
-- planned changes and rationale;
-- validation protocol and acceptance criteria;
-- subgroup/calibration regression tests;
-- human-factors impact;
-- approval and rollback;
-- monitoring cadence and drift triggers;
-- incident handling and retirement.
-
-Never update a threshold or model silently after viewing performance.
-
-## Aggregate Evaluator
-
-Input contains only:
-
-- group labels and aggregate denominators;
-- confusion counts;
-- aggregate calibration bins;
-- provenance and validation metadata.
-
-Output contains bounded descriptive metrics, uncertainty, suppression, and documented gaps. It never outputs a person-level class or recommendation.
-
-```bash
-python3 scripts/model_biomarker_evaluation.py \
-  assets/aggregate_model_evaluation_template.json
-```

package/skills/clinical-decision-support/references/privacy_and_disclosure.md

@@ -1,144 +0,0 @@
-# Privacy, De-identification, and Disclosure
-
-## Boundary
-
-The skill never reads PHI, raw records, free-text notes, images, sequences, or row-level data. The checklist records a human process; it does not de-identify data.
-
-Do not paste sensitive information into a template to see whether it passes.
-
-## HHS Methods
-
-The HIPAA Privacy Rule at 45 CFR 164.514 provides two methods for de-identification:
-
-1. **Expert Determination** — a qualified expert applies generally accepted statistical and scientific principles, determines that re-identification risk is very small, and documents methods and results.
-2. **Safe Harbor** — specified identifiers of the individual and relatives, employers, or household members are removed, and the covered entity has no actual knowledge that the remaining information could identify an individual alone or in combination.
-
-Primary sources:
-
-- [HHS de-identification guidance](https://www.hhs.gov/hipaa/for-professionals/special-topics/de-identification/index.html)
-- [45 CFR 164.514](https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-C/part-164/subpart-E/section-164.514)
-
-The checklist cannot determine whether an organization is a covered entity/business associate, whether information is PHI, or whether a method was correctly applied.
-
-## Safe Harbor Categories
-
-The human review must address all categories:
-
-1. names;
-2. geographic subdivisions smaller than a state, subject to ZIP-code rules;
-3. date elements more specific than year, with the age-90 rule;
-4. telephone numbers;
-5. fax numbers;
-6. email addresses;
-7. Social Security numbers;
-8. medical record numbers;
-9. health-plan beneficiary numbers;
-10. account numbers;
-11. certificate/license numbers;
-12. vehicle identifiers and serial numbers;
-13. device identifiers and serial numbers;
-14. web URLs;
-15. IP addresses;
-16. biometric identifiers;
-17. full-face photographs and comparable images;
-18. other unique identifying numbers, characteristics, or codes.
-
-Parts and derivatives can still be identifiers. HHS specifically notes that free text is not exempt and can contain listed identifiers or identifying context.
-
-## Expert Determination Record
-
-Record without embedding the sensitive data:
-
-- expert qualifications and independence;
-- data context and recipients;
-- anticipated data linkages and attacker knowledge;
-- methods and assumptions;
-- risk threshold and rationale;
-- mitigation and residual risk;
-- validity period and change triggers;
-- documentation location and approval.
-
-Do not claim that hashing, pseudonymization, encryption, a data-use agreement, or a low cell count alone constitutes Expert Determination.
-
-## Aggregate Disclosure
-
-Aggregate tables can still disclose information through:
-
-- small cells;
-- row/column totals;
-- differencing across releases;
-- rare combinations;
-- nested geographies;
-- longitudinal patterns;
-- extreme values;
-- genomics;
-- external linkage.
-
-Controls may include:
-
-- minimum cell thresholds;
-- primary suppression;
-- complementary suppression;
-- category aggregation;
-- top/bottom coding;
-- rounding or perturbation under an approved method;
-- release coordination;
-- query budgets;
-- access controls and data-use agreements;
-- secure enclaves;
-- expert review.
-
-There is no universal small-cell threshold that proves HIPAA de-identification. The table generator defaults to 11 only as a conservative operational safeguard and applies complementary suppression within a row. The data steward must select policy.
-
-## Template Status Values
-
-For each category use:
-
-- `not_present` — documented inventory confirms absence;
-- `removed` — documented transformation confirms removal;
-- `generalized` — allowed generalization documented and approved;
-- `expert_reviewed` — addressed under the referenced Expert Determination;
-- `unresolved` — not complete.
-
-Every non-unresolved status needs evidence text. Never include an example identifier in evidence.
-
-## Actual-Knowledge and Residual-Risk Review
-
-Document:
-
-- free-text review;
-- derived fields;
-- linkage and differencing;
-- unusual occupations or events;
-- rare diseases/combinations;
-- dates and ages;
-- geography;
-- longitudinal uniqueness;
-- recipient context;
-- prior releases;
-- residual identifiers.
-
-Escalate uncertainty. Do not mark the checklist complete merely because all obvious columns were removed.
-
-## Output Language
-
-Allowed:
-
-> Documentation checklist complete for the selected method. This output is not a HIPAA compliance or de-identification determination.
-
-Not allowed:
-
-> HIPAA compliant.
-
-> Safe to publish.
-
-> Anonymous.
-
-## Script
-
-```bash
-python3 scripts/deidentification_checklist.py \
-  assets/deidentification_checklist_template.json
-```
-
-The distributed template is unresolved by design.

package/skills/clinical-decision-support/references/regulatory_and_governance.md

@@ -1,104 +0,0 @@
-# Regulatory and Governance Context
-
-Checked 2026-07-23. This is orientation for research documentation, not legal advice or a regulatory determination.
-
-## FDA Clinical Decision Support
-
-FDA issued the current **Clinical Decision Support Software** final guidance in January 2026 and reissued it on January 29, 2026. It explains how FDA interprets the statutory criteria for certain CDS software functions excluded from the device definition under section 520(o)(1)(E) of the FD&C Act and distinguishes those functions from device software functions.
-
-Do not turn the guidance into a self-certification score. Regulatory status depends on the complete function and intended use, including:
-
-- who uses the function;
-- what information it acquires, processes, or analyzes;
-- the output and its role in prevention, diagnosis, or treatment;
-- whether the healthcare professional can independently review the basis;
-- time criticality, automation, and reliance;
-- patient/caregiver use and other applicable digital-health policies.
-
-This skill intentionally stays outside patient-specific and live clinical functions. An artifact title, disclaimer, or “human in the loop” statement does not by itself make software non-device.
-
-Source: [FDA Clinical Decision Support Software, final guidance (January 2026)](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-decision-support-software).
-
-## FDA AI-Enabled Device Lifecycle
-
-Use these sources only to identify documentation themes for research governance:
-
-- [Predetermined Change Control Plan for AI-Enabled Device Software Functions](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence) — final guidance, August 2025. A PCCP describes planned modifications, methods to develop/validate/implement them, and impact assessment; FDA reviews it within a marketing submission.
-- [AI-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/artificial-intelligence-enabled-device-software-functions-lifecycle-management-and-marketing) — draft guidance, January 2025; **not for implementation** as of the check date.
-- [Good Machine Learning Practice for Medical Device Development](https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles) — FDA page points to the January 2025 IMDRF final principles.
-- [Transparency for Machine Learning-Enabled Medical Devices](https://www.fda.gov/medical-devices/software-medical-device-samd/transparency-machine-learning-enabled-medical-devices-guiding-principles) — joint guiding principles, June 2024.
-
-Recurring lifecycle themes:
-
-- representative data and independent test sets;
-- performance of the human-AI team;
-- clinically relevant testing across intended conditions;
-- known limitations, confidence intervals, gaps, and failure modes;
-- monitoring, issue investigation, change notification, and version traceability;
-- training/test data characterization and subgroup performance.
-
-These sources do not authorize this skill to create a medical device or a submission.
-
-## ONC HTI-1 Transparency
-
-The HTI-1 final rule added the Decision Support Interventions certification criterion at 45 CFR 170.315(b)(11). Its scope is certified health IT and the configurations defined in the rule; it is not a universal certification checklist for every research model.
-
-For predictive DSIs in scope, the rule and ONC materials emphasize source attributes covering:
-
-- developer and funding;
-- output type, purpose, intended population, users, and decision role;
-- cautioned out-of-scope uses and known limitations;
-- development data and input features;
-- fairness process;
-- external validation;
-- quantitative performance;
-- ongoing maintenance;
-- update, continued-validation, and fairness-assessment schedules.
-
-They also describe intervention risk management for predictive DSIs supplied by certified health IT developers. Use these categories as a useful transparency crosswalk only when relevant; do not claim ONC certification.
-
-Sources:
-
-- [HTI-1 final rule](https://www.federalregister.gov/citation/89-FR-1391)
-- [ONC HTI-1 DSI fact sheet](https://www.healthit.gov/wp-content/uploads/2023/12/HTI-1_DSI_fact-sheet_508.pdf)
-- [ONC DSI final-rule presentation](https://healthit.gov/wp-content/uploads/2024/01/DSI_HTI1-Final-Rule-Presentation_508.pdf)
-
-## ICH E6(R3), E9, and E9(R1)
-
-Use ICH only when the artifact concerns clinical-trial planning, conduct, analysis, or evidence interpretation.
-
-The current consolidated E6(R3) Step 4 guideline combines the principles, Annex 1, and Annex 2. It was adopted June 16, 2026 after Annex 2 reached Step 4 on June 3, 2026. Relevant governance themes include:
-
-- quality by design and proportionate risk management;
-- clear roles, oversight, and documented decisions;
-- fit-for-purpose data and computerized systems;
-- data integrity, metadata, auditability, and traceability;
-- privacy and confidentiality;
-- protocol and statistical-analysis-plan alignment;
-- management of deviations, incidents, and important changes;
-- fitness-for-purpose considerations for real-world data.
-
-ICH E9 provides statistical principles for clinical trials. E9(R1), adopted November 20, 2019, requires alignment of the clinical question, estimand, design, conduct, analysis, and interpretation. Its estimand attributes and intercurrent-event strategies should be pre-specified; sensitivity analyses assess robustness to assumptions.
-
-Sources:
-
-- [ICH E6(R3) consolidated Step 4 guideline (June 2026)](https://database.ich.org/sites/default/files/ICH%20E6(R3)_Step4_FinalConsolidatedGuideline_2026_0616_.pdf)
-- [ICH E9(R1) estimands and sensitivity analysis](https://database.ich.org/sites/default/files/E9-R1_Step4_Guideline_2019_1203.pdf)
-- [ICH efficacy guideline index](https://www.ich.org/page/efficacy-guidelines)
-
-ICH alignment must be assessed by the sponsor and relevant authorities. A script cannot establish GCP conformity.
-
-## Governance Crosswalk
-
-| Documentation field | FDA/AI theme | ONC HTI-1 theme | ICH theme |
-|---|---|---|---|
-| Intended use/users/population | Function and intended use | Purpose/source attributes | Trial objective/population |
-| Limitations/out-of-scope use | Labeling/transparency | Cautioned use | Protocol constraints |
-| Data provenance | Dataset characterization | Development details | Data origin/fitness |
-| External validation | Clinically relevant testing | External-validation process | Evidence reliability |
-| Subgroup/fairness | Representative performance | Fairness process | Population relevance |
-| Human factors | Human-AI team | Intended decision role | Feasibility/quality |
-| Monitoring/change control | TPLC/PCCP | Maintenance schedule | Quality management |
-| Audit trail | Submission/version evidence | Source attributes | Essential records/metadata |
-
-Treat the crosswalk as a documentation aid, never a conformity assessment.

package/skills/clinical-decision-support/references/safety_and_scope.md

@@ -1,103 +0,0 @@
-# Safety and Scope
-
-## Intended Use
-
-Use this skill only to create or check research, evaluation, documentation, and governance artifacts from synthetic or aggregate data.
-
-Acceptable examples:
-
-- an intended-use statement for a retrospective model evaluation;
-- an aggregate subgroup performance report;
-- a statistical analysis plan;
-- a GRADE evidence-profile shell for a human panel;
-- a release-gate traceability matrix;
-- a de-identification process checklist.
-
-## Prohibited Use
-
-Do not:
-
-- accept or produce a record about a person;
-- infer a diagnosis, prognosis, phenotype, biomarker class, or eligibility for a person;
-- recommend or compare care options for a person;
-- provide medication, dose, schedule, monitoring, or contraindication instructions;
-- triage, assign urgency, create an alarm, or suggest escalation;
-- deploy logic in an EHR, bedside tool, portal, order set, or alerting workflow;
-- represent output as clinical advice, a validated medical device, or an authorized clinical system;
-- claim legal, regulatory, quality-system, or HIPAA compliance.
-
-No disclaimer makes an otherwise prohibited workflow acceptable.
-
-## Stop Conditions
-
-Stop and do not process the input when any of the following is present:
-
-- names, record numbers, contact details, precise locations, or person-linked dates;
-- row-level records, timelines, notes, images, signals, or sequences;
-- a request about “this patient,” “this result,” or an individual case;
-- instructions to choose a therapy, test, dose, disposition, or urgency;
-- instructions to push output to a live clinical system;
-- an assertion that passing a checklist proves authorization or compliance.
-
-Explain the boundary briefly. For care, direct the requester to a licensed healthcare professional and locally validated, appropriately authorized systems. For privacy, regulatory, or legal determinations, direct them to qualified organizational reviewers.
-
-## Required Intended-Use Elements
-
-An artifact is incomplete unless it states:
-
-1. **Purpose** — the specific research or governance question.
-2. **Users** — named roles, not “clinicians” broadly.
-3. **Population scope** — aggregate cohort or synthetic data only.
-4. **Decision role** — descriptive, evaluative, or governance support.
-5. **Excluded uses** — every prohibited use above.
-6. **Data level** — aggregate or synthetic, with no PHI/raw rows supplied.
-7. **Limitations** — known gaps, assumptions, transportability, and failure modes.
-8. **Human review** — required roles and approval status.
-9. **Versioning** — owner, version, release date, changes, and retirement criteria.
-10. **Monitoring** — drift, calibration, subgroup performance, incidents, and review cadence when applicable.
-
-## Human Review Matrix
-
-| Artifact | Minimum review roles |
-|---|---|
-| Evidence profile | systematic-review methodologist; domain experts; panel chair |
-| Cohort report | statistician/epidemiologist; data steward; domain expert |
-| Survival plan | statistician with time-to-event expertise; domain expert |
-| Model/biomarker evaluation | prediction-model methodologist; assay/domain expert; fairness reviewer |
-| Privacy checklist | privacy official or qualified de-identification expert |
-| Logic traceability | system owner; independent validator; governance approver |
-| Regulatory context | qualified legal/regulatory counsel |
-
-Review completion must be recorded by the responsible organization. The scripts do not authenticate reviewers or approvals.
-
-## Safe Language
-
-Prefer:
-
-- “The aggregate evaluation estimated…”
-- “Performance differed across evaluated subgroups; causes and practical importance require review.”
-- “The evidence panel judged certainty as…; rationale and sources are recorded.”
-- “This checklist is complete; it is not a compliance determination.”
-- “External validation has not been performed.”
-
-Avoid:
-
-- “The model is safe/fair/clinically valid.”
-- “This biomarker means the patient should…”
-- “The tool is FDA compliant/approved.”
-- “The dataset is HIPAA compliant.”
-- “The recommendation is Grade 1A” without the framework, panel process, outcome-specific judgments, and source trail.
-
-## Audit Trail
-
-Record:
-
-- immutable artifact ID and version;
-- source versions and access dates;
-- data provenance and cut date;
-- code version and command;
-- declared thresholds before analysis;
-- reviewer roles, dates, decisions, and unresolved objections;
-- change reason, validation evidence, rollback plan, and retirement decision.
-
-Do not put secrets, credentials, or patient information in audit logs.