TCRLAS v2.0 · WORKING DRAFT
Healthcare products & services. Independent evidence. Assess the five healthcare H1–H5 dimensions independently. Category, intended use, claims and jurisdiction shape the requirements. CVA and maturity remain separate.
TCRLAS overview TCRLAS guide Methodology library Acronyms & shorthand CVA rubric Assessment scopes Nine-milestone assessment Human milestone review CVA assessment HSE assessment CDA guide Launch guide Domain comparison Private by design: this browser-only draft is held in memory. Refreshing, leaving this page or closing it loses unsaved work. Export your JSON for safekeeping and import it to continue. No automatic storage, accounts, database or submission. Do not enter patient-identifiable information or confidential business details. JSON exports are unencrypted.
Enable JavaScript to edit assessments, charts and local JSON. The guides and PDFs remain readable without it.
Export complete JSON Import JSON Export Python reference input Reset assessment
Independent maturity record Milestone: NE — not assessed.
CVA and HSE never assign maturity. Export this record, open the milestone tool, and import it there to review maturity. Import its exported record here to continue. All profiles and evidence remain in the complete JSON.
Open independent milestone assessment → Healthcare evidence assessment (HSE) Scores are ordinal evidence anchors, not probabilities. NE is unassessed. A zero needs an adverse evidence rationale. HSE N/A requires a documented applicability reason, reviewer and date; it is never converted into a score.
H1 — Regulatory and legal pathway H1 assessment NE — not evaluated 0 / 6 1 / 6 2 / 6 3 / 6 4 / 6 5 / 6 6 / 6 N/A — reviewed non-applicability H1 score slider
Inspect all H1 evidence anchors (0–6) 0: No credible lawful pathway for proposed activity, or known prohibitive legal issue.1: Possible product/service category and governing authorities hypothesized.2: Preliminary intended use, jurisdiction, classification and required permissions identified.3: Documented category-specific compliance plan, qualified owners and evidence requirements.4: Key regulatory assumptions supported by qualified review/interactions; required preparations underway.5: Applicable requirements for the specific proposed activity substantially verified and fulfilled or controlled, with documented gaps.6: Applicable permissions, quality/legal obligations and continuing compliance demonstrated for ongoing defined operations.H1 evidence, confidence and rationale Source / reference (not uploaded or fetched) Evidence date Evidence reviewer Verification status unreviewed claimed verified contradicted Assessor confidence unassessed low medium high Rationale / supporting notes Contrary evidence / uncertainty Next evidence needed N/A applicability reason (when relevant)
H2 — Clinical / service effectiveness and safety evidence H2 assessment NE — not evaluated 0 / 6 1 / 6 2 / 6 3 / 6 4 / 6 5 / 6 6 / 6 N/A — reviewed non-applicability H2 score slider
Inspect all H2 evidence anchors (0–6) 0: No credible evidence for essential claims, or reliable evidence contradicts essential claims.1: Health benefit or service outcome hypothesized.2: Relevant scientific rationale, baseline performance and evidence plan drafted.3: Credible measurement framework with appropriate preliminary analytical/clinical/service evidence.4: Independent or relevant-environment evidence supports intended claims and safety for the defined stage.5: Strong externally reviewed evidence and adverse-event/service-safety controls support proposed scope.6: Robust repeatable clinical/service performance and continuing monitoring appropriate to claims demonstrated.H2 evidence, confidence and rationale Source / reference (not uploaded or fetched) Evidence date Evidence reviewer Verification status unreviewed claimed verified contradicted Assessor confidence unassessed low medium high Rationale / supporting notes Contrary evidence / uncertainty Next evidence needed N/A applicability reason (when relevant)
H3 — Payer, purchaser and access H3 assessment NE — not evaluated 0 / 6 1 / 6 2 / 6 3 / 6 4 / 6 5 / 6 6 / 6 N/A — reviewed non-applicability H3 score slider
Inspect all H3 evidence anchors (0–6) 0: No viable purchaser, payment route or access path identified.1: Potential payer, consumer, employer, provider or public purchaser posited.2: Coverage, cash-pay, contracting and/or procurement options preliminarily researched.3: Credible buyer and payment route documented with price, adoption barriers and access assumptions.4: External customer, purchaser or payer feedback supports meaningful payment and adoption possibility.5: Payment contracts or strongly supported ability/willingness to pay and practical market access demonstrated.6: Repeatable payment and equitable, operationally sustainable market access demonstrated.H3 evidence, confidence and rationale Source / reference (not uploaded or fetched) Evidence date Evidence reviewer Verification status unreviewed claimed verified contradicted Assessor confidence unassessed low medium high Rationale / supporting notes Contrary evidence / uncertainty Next evidence needed N/A applicability reason (when relevant)
H4 — Commercial delivery and channels H4 assessment NE — not evaluated 0 / 6 1 / 6 2 / 6 3 / 6 4 / 6 5 / 6 6 / 6 N/A — reviewed non-applicability H4 score slider
Inspect all H4 evidence anchors (0–6) 0: No credible route to intended customers/patients/providers.1: Potential clinical, direct-to-consumer, employer, public or distribution pathway identified.2: Candidate delivery, referral, procurement, support and distribution entities identified.3: Working channel plan with buyer journey, fulfillment, data flows and support responsibilities.4: Credible commitments or pilots from delivery/channel participants; service logistics mapped.5: Verified functioning customer access and delivery with appropriate support and responsible parties.6: Repeatable geographically/operationally relevant service or product delivery at scale.H4 evidence, confidence and rationale Source / reference (not uploaded or fetched) Evidence date Evidence reviewer Verification status unreviewed claimed verified contradicted Assessor confidence unassessed low medium high Rationale / supporting notes Contrary evidence / uncertainty Next evidence needed N/A applicability reason (when relevant)
H5 — Healthcare execution system H5 assessment NE — not evaluated 0 / 6 1 / 6 2 / 6 3 / 6 4 / 6 5 / 6 6 / 6 N/A — reviewed non-applicability H5 score slider
Inspect all H5 evidence anchors (0–6) 0: Indispensable qualified clinical, quality, operational or contracting capability absent without solution.1: Candidate qualified parties and organizational structure hypothesized.2: Initial accountable roles for clinical/regulatory/quality/delivery identified.3: Documented execution matrix, partner plan, agreements needed, funding and governance for next milestone.4: Qualified parties, essential agreements and resources demonstrably committed for next milestone.5: Execution network delivers safely, with relevant qualified systems, contingencies and documented oversight.6: Repeatable resilient multi-party operation and required continuing healthcare oversight demonstrated.H5 evidence, confidence and rationale Source / reference (not uploaded or fetched) Evidence date Evidence reviewer Verification status unreviewed claimed verified contradicted Assessor confidence unassessed low medium high Rationale / supporting notes Contrary evidence / uncertainty Next evidence needed N/A applicability reason (when relevant)
Critical blocker register Record which activity a blocker affects. A restriction on launch does not by itself prohibit lawful preparatory research.
Add blocker Commercial Launch Decision Separate named human review for a defined offering, scope and jurisdiction. GO is never produced by scores or checklist completion. CONDITIONAL refers only to activities already permitted.
Read the decision guide → Applicable launch requirements Scope being reviewed Jurisdiction: not specified
Qualified reviewers determine each requirement’s applicability for this exact scope. Changing scope clears previous requirement reviews.
These prompts are a working framework, not an exhaustive legal checklist. Review each against intended use, claims and jurisdiction with qualified people. Unreviewed or unresolved mandatory requirements prevent recording GO/CONDITIONAL.
Offering, intended use, claims, users, jurisdiction and launch scope — unreviewed Offering, intended use, claims, users, jurisdiction and launch scope status unreviewed unresolved verified not_applicable Offering, intended use, claims, users, jurisdiction and launch scope evidence Source / reference (not uploaded or fetched) Evidence date Evidence reviewer Verification status unreviewed claimed verified contradicted Assessor confidence unassessed low medium high Rationale / supporting notes Contrary evidence / uncertainty Next evidence needed N/A applicability reason (when relevant)
Applicable legal permissions and qualified review — unreviewed Applicable legal permissions and qualified review status unreviewed unresolved verified not_applicable Applicable legal permissions and qualified review evidence Source / reference (not uploaded or fetched) Evidence date Evidence reviewer Verification status unreviewed claimed verified contradicted Assessor confidence unassessed low medium high Rationale / supporting notes Contrary evidence / uncertainty Next evidence needed N/A applicability reason (when relevant)
Evidence supports claims and intended benefits — unreviewed Evidence supports claims and intended benefits status unreviewed unresolved verified not_applicable Evidence supports claims and intended benefits evidence Source / reference (not uploaded or fetched) Evidence date Evidence reviewer Verification status unreviewed claimed verified contradicted Assessor confidence unassessed low medium high Rationale / supporting notes Contrary evidence / uncertainty Next evidence needed N/A applicability reason (when relevant)
Delivery, accountable owners, continuity, support and incident controls — unreviewed Delivery, accountable owners, continuity, support and incident controls status unreviewed unresolved verified not_applicable Delivery, accountable owners, continuity, support and incident controls evidence Source / reference (not uploaded or fetched) Evidence date Evidence reviewer Verification status unreviewed claimed verified contradicted Assessor confidence unassessed low medium high Rationale / supporting notes Contrary evidence / uncertainty Next evidence needed N/A applicability reason (when relevant)
Buyer/payment route, pricing, costs and available capital — unreviewed Buyer/payment route, pricing, costs and available capital status unreviewed unresolved verified not_applicable Buyer/payment route, pricing, costs and available capital evidence Source / reference (not uploaded or fetched) Evidence date Evidence reviewer Verification status unreviewed claimed verified contradicted Assessor confidence unassessed low medium high Rationale / supporting notes Contrary evidence / uncertainty Next evidence needed N/A applicability reason (when relevant)
Named decision authority and documented review — unreviewed Named decision authority and documented review status unreviewed unresolved verified not_applicable Named decision authority and documented review evidence Source / reference (not uploaded or fetched) Evidence date Evidence reviewer Verification status unreviewed claimed verified contradicted Assessor confidence unassessed low medium high Rationale / supporting notes Contrary evidence / uncertainty Next evidence needed N/A applicability reason (when relevant)
Classification review before any restricted activity — unreviewed Classification review before any restricted activity status unreviewed unresolved verified not_applicable Classification review before any restricted activity evidence Source / reference (not uploaded or fetched) Evidence date Evidence reviewer Verification status unreviewed claimed verified contradicted Assessor confidence unassessed low medium high Rationale / supporting notes Contrary evidence / uncertainty Next evidence needed N/A applicability reason (when relevant)
Health data privacy/security, consent and appropriate safeguards — unreviewed Health data privacy/security, consent and appropriate safeguards status unreviewed unresolved verified not_applicable Health data privacy/security, consent and appropriate safeguards evidence Source / reference (not uploaded or fetched) Evidence date Evidence reviewer Verification status unreviewed claimed verified contradicted Assessor confidence unassessed low medium high Rationale / supporting notes Contrary evidence / uncertainty Next evidence needed N/A applicability reason (when relevant)
Payer, purchaser or cash-pay access route; no assumption of reimbursement — unreviewed Payer, purchaser or cash-pay access route; no assumption of reimbursement status unreviewed unresolved verified not_applicable Payer, purchaser or cash-pay access route; no assumption of reimbursement evidence Source / reference (not uploaded or fetched) Evidence date Evidence reviewer Verification status unreviewed claimed verified contradicted Assessor confidence unassessed low medium high Rationale / supporting notes Contrary evidence / uncertainty Next evidence needed N/A applicability reason (when relevant)
Human launch decision UNDECIDED GO CONDITIONAL HOLD NO_GO Decision reviewer Decision review date Decision authority / capacity Decision rationale and alternatives Accountable action owner Permitted scope / limits Monitoring, adverse-event / stop triggers Next review date
Unassessed decision: no authorization recorded.
Export complete JSON
HSE five-axis profile HSE five-axis profile Legal pathway: not evaluated; Evidence: not evaluated; Payment: not evaluated; Delivery: not evaluated; Execution: not evaluated. Missing values are not plotted as zero. Legal pathway NE Evidence NE Payment NE Delivery NE Execution NE Incomplete numeric profile: no filled polygon. NE = not evaluated; N/A = documented non-applicability; zero is an actual evaluated score. Neither chart determines TCRLAS or authorizes a decision.
H1: NEH2: NEH3: NEH4: NEH5: NEWorking methodology, not externally validated. No numerical cutoff grants investment, clinical, regulatory or launch authorization. A qualified human must review the proposed action and applicable obligations.
Read the methodology PDFs → 