{ "$schema": "./evidence-authority-standard-v1.schema.json", "companion": { "title": "Machine-readable companion to the Evidence-Authority Standard, version 3.0", "status": "Restates version 3.0 of the text. Where this companion and the text differ, the text governs. The version's DOI, its issue date and the hash of its text are written into this file when the version is deposited.", "identifierNote": "Proposition ids P1 to P5, P7, P9 and P10, P3a to P3d, P6a to P6c and P8a to P8c, the 27 evidence class ids and the four verdicts are the text's own (\"P6\" and \"P8\" are not proposition ids). The id answer_change, the rule ids R1 to R8, the decision-procedure step ids, the jurisdiction-rule ids, the supply-record kinds, the payer-decision reaches and the P6a claim forms, the market-step steps, the P5 claim forms and named-channel kinds, the P2 terms, the date kinds (state and event) and the trial-status identifiers are this companion's names for things the text states without an identifier.", "testVectors": "evidence-authority-standard-v1.test-vectors.json", "schema": "evidence-authority-standard-v1.schema.json", "licence": "CC-BY-4.0", "classificationTestSet": "classification-test-set-v3.0.json" }, "standard": { "title": "Which Evidence Settles Which Claim", "subtitle": "The AlphaCitation Proposition Taxonomy and Evidence-Authority Standard", "version": "3.0", "issued": "2026-10-24", "doi": "10.5281/zenodo.23594909", "conceptDoi": "10.5281/zenodo.23577316", "author": "Ozue C. Ezeife", "authorOrcid": "0009-0007-8504-0827", "publisher": "AlphaCitation Research (Akunudo LLC-FZ), Dubai, United Arab Emirates", "licence": "CC-BY-4.0", "licenceUrl": "https://creativecommons.org/licenses/by/4.0/", "textFile": "evidence-authority-standard-v1.md", "textSha256": "64baaf9c854030a294d3505150eb5b72584c73e9337701fb639193c854281bad", "textSha256Note": "The sha256 of the Markdown text deposited on Zenodo as this version (LF line endings), written at deposit.", "versioning": "Versions are numbered semantically. A change that can alter an existing verdict raises the major number. Such changes include what settles a proposition, a jurisdiction or time rule, the meaning of a verdict, and any addition (a proposition, an evidence class, an authority, a market) that changes the verdict a source already judged would receive. An addition that changes no such verdict raises the minor number. A correction that changes no rule raises the patch number. The rules for classifying the claims in an answer (Annex B) are versioned in the same way: a rule that changes how a sentence an earlier version classified is classified, or that assigns a sentence to a proposition whose definition in section 4 does not cover it, raises the major number; a rule that classifies a sentence no earlier version classified, within the definitions of section 4 and without deciding what settles it, raises the minor number.", "changes": [ "2.0, 23 October 2026, after a critique of version 1.0 received that day (it is not peer review): two listings of one pharmacy that bracket the claim's date within three days each side now support and no longer settle (P5); a medicine is investigational only while a study of the use is ongoing on the claim's date, a new sub-proposition (P3d); P8 is divided into the regulatory safety statement (P8a, per market) and a safety finding (P8b, international); \"settles\" is defined as a verdict on authority, distinct from interpretation and adjudication (section 2); a listing that does not show the product for sale, and a supply record of unstated kind, settle nothing; the machine-readable files, the test vectors, the reference implementation and the conformance rule are named (section 7); AlphaCitation's own software is described in its own section (section 9). Verdicts change for P3, P5 and P8 claims, so this is a major version (doi:10.5281/zenodo.23584875).", "2.1, 23 October 2026: Annex B, on dividing an answer into claims and assigning each to a proposition, with a classification test set that measures a classifier and is not part of conformance (section 7); two clarifications: that a status claim qualified only by a phrase such as \"for use\", \"for sale\" or \"for distribution\" is a registration claim (P1); and that label content other than a condition, population, use, safety statement or clinical effect maps to no proposition (P2); plainer wording of the P5 rule in the brief and the summary table, which a reader had taken to mean that pharmacy listings only support; the annex of evidence classes renamed Annex A; section 9 naming version 2.0 where it describes software; the versioning of classification rules and the addresses that name no version (section 7); and section 10, open questions for the next major version. No verdict that a source receives for a proposition, market and date changes, so this is a minor version (doi:10.5281/zenodo.23588555).", "3.0, 24 October 2026, after an external review of version 2.1 (it is not peer review): the claim's market is fixed by the market step, which takes the market the answer states, else the question's, else the market the deploying system declares, records which step governed and never infers a market (section 2; Annex B, M1 to M7); P6 is divided into P6a (reimbursed or covered, settled by a payer's decision within its reach), P6b (health technology assessment recommendation) and P6c (formulary listing), with two new evidence classes; a formulary the sentence does not name makes a formulary-listing claim that no source can be matched to (Annex B, C9 and E2); P8c, a safety signal, is added, with a new evidence class, and never establishes causation, and its negation is that a review found no new signal; the answer change is settled per market, by observations of that market; an availability claim with no word of breadth takes the same claim form as its negation (P5); a hedged claim is recorded as a hedged unit, visible as its own category and never judged (Annex B, E5); a stated date governs only its clause, an undated earlier time leaves the claim's date not determinable, and the answer's date is read in the market's local time (Annex B, T3, T4 and T7); section 7 states the release history, a stability window and how changes are proposed and recorded; a draft of Annex B was measured against the classification test set and the results are reported (section 9). Before release, Annex B was sharpened where two blind labellers of a development set of real AI answers, and three machine readers of the test set, read its wording two ways, and the questions that versions 2.1 and the draft of 3.0 had left open were decided: a date the answer gives for an event dates an event claim, judged against the record of the event (Annex B, T6; Rule 7), and for a claim about a state, a stated period that contains the answer's date is read as the answer's date (T2); one unit per use, adverse effect, endpoint or study (U1); a status named only in a noun phrase, and a reference back to a claim already made, make no unit (U5); a list's lead-in makes no unit, a label's section heading supplies its predicate, and an entry whose heading is not given makes no claim (U7); a bare \"Yes\" or \"No\" asserts or denies the question's proposition (U9); P2 covers the legal category of supply, which in the EU the Commission's decision states, and the dose, route, form or restricted programme the authorisation permits, and a statement of who may receive the medicine, while a statement that a group must not receive it is a label warning, P8a (C2, C4, C7); P5 has a named-channel form, settled by the regulator's decision or label that provides a regulatory access route for the medicine by name or by the named supplier's own record, and a stock form, which nothing settles (C6); P6b covers added-benefit and value ratings (C9); \"investigational\" with no use named is read through P1 and \"being studied\" with none is P3d, P3c covers observational studies, and P4 covers a guideline named by its issuer, while a recommendation attributed to unidentified guidelines is a P4 claim that is not determinable (C10 to C12); a finding of no new safety signal is P8c negative (C14); a claim about a class makes its proposition for the class (E11); which uses of \"may\" hedge a claim (E5); a market attached to a noun, a body whose remit is part of a country, which governs a claim about its own decision, and places below the country, recorded by ISO 3166-2 codes, for which an authority's record speaks and a supply record does not (M1, M6); answers that differ at one time are not the answer change (C18). Verdicts change for claims whose market only the question or the deploying system states, for coverage, safety-signal and answer-change claims, for unqualified availability claims, for event claims, for claims about a place below the country, a named channel, stock, a class, the terms of a label, an HTA rating and a guideline named by its issuer or by none, so this is a major version." ], "previousVersions": [ { "version": "1.0", "doi": "10.5281/zenodo.23577317" }, { "version": "2.0", "doi": "10.5281/zenodo.23584875" }, { "version": "2.1", "doi": "10.5281/zenodo.23588555" } ] }, "terms": [ { "id": "proposition", "section": "2", "text": "One checkable statement inside an answer. Annex B sets out how an answer is divided into propositions." }, { "id": "evidence_class", "section": "2", "text": "The kind of record a source is: one of 27, listed in Annex A." }, { "id": "authority", "section": "2", "text": "The body that issues a record. A record of a class only an authority issues (Annex A, first list) speaks for the jurisdiction of the authority that issued it and nothing else. An authority cited for a class it does not issue settles nothing: an EMA \"authorisation\" does not exist." }, { "id": "claim_market", "section": "2", "text": "The country or bloc the claim is about, as ISO 3166-1 codes, or ISO 3166-2 codes for a place below the country (Annex B, M6), fixed by the market step. It is the market the answer states for the claim, in the sentence or in a heading or earlier clause the sentence continues, where naming a market's regulator, payer or health technology assessment body states that market; otherwise the market stated in the question; otherwise the market the deploying system declares for its user, as configuration; otherwise it is unresolved (Rule 5). The first step that states a market governs, even a market word that names no market (\"worldwide\"); a later step that states a different market is recorded as a conflict and never governs. A market is never inferred from the user's address, language, spelling, currency, units or time zone. Every verdict records the step that fixed the market. Annex B (M1 to M7) applies the step to the words of an answer. For centrally authorised medicines, EU bodies speak for the 27 member states and for Iceland, Liechtenstein and Norway, which adopt corresponding decisions under the EEA Agreement; a nationally authorised medicine is settled by the national record." }, { "id": "claim_date", "section": "2", "text": "The date of the answer, or the earlier date the answer itself states for the claim (\"as of October 2023\"). Annex B (T1 to T7) fixes it clause by clause." }, { "id": "settles", "section": "2", "text": "A source settles a claim when it has the authority to decide it: it is of a class this standard names for the proposition, issued by an authority competent to issue it, speaks for the claim's market where the proposition is settled per market, meets the time test of Rule 7 (in force on the claim's date, or, for an event claim, the record of the event issued by the answer's date), and meets every further condition section 4 and section 5 set for it. That is the first of three questions. The second, interpretation, is whether the record, read correctly, concerns the claim's product, population, endpoint and date and says what the claim says. The third, adjudication, is whether the claim is then supported, contradicted or unresolved. This standard answers the first only (section 8). A source that settles is competent to establish what it records; its class alone does not establish that a reported effect is reliable. Where this text says that a source settles that something is so, or that a claim is settled false, it means that the source settles the claim and, read as the cited study read it, records that it is so or contradicts it." } ], "evidenceClasses": [ { "id": "authorisation_decision", "group": "authority_issued" }, { "id": "register_entry", "group": "authority_issued" }, { "id": "authorised_label", "group": "authority_issued" }, { "id": "regulatory_opinion", "group": "authority_issued" }, { "id": "regulator_assessment_report", "group": "authority_issued" }, { "id": "regulator_safety_communication", "group": "authority_issued" }, { "id": "safety_signal_record", "group": "authority_issued" }, { "id": "institutional_guidance", "group": "authority_issued" }, { "id": "payer_decision", "group": "authority_issued" }, { "id": "hta_appraisal", "group": "coverage_records" }, { "id": "formulary_listing", "group": "coverage_records" }, { "id": "trial_registry_record", "group": "trials_and_appraised" }, { "id": "trial_protocol", "group": "trials_and_appraised" }, { "id": "trial_results_posting", "group": "trials_and_appraised" }, { "id": "trial_publication_of_record", "group": "trials_and_appraised" }, { "id": "conference_abstract", "group": "trials_and_appraised" }, { "id": "systematic_review", "group": "trials_and_appraised" }, { "id": "clinical_guideline", "group": "trials_and_appraised" }, { "id": "head_to_head_trial", "group": "trials_and_appraised" }, { "id": "appraised_indirect_comparison", "group": "trials_and_appraised" }, { "id": "supply_record", "group": "market_and_manufacturer" }, { "id": "launch_statement", "group": "market_and_manufacturer" }, { "id": "manufacturer_statement", "group": "market_and_manufacturer" }, { "id": "longitudinal_observation", "group": "ai_answer_observations" }, { "id": "single_observation", "group": "ai_answer_observations" }, { "id": "secondary_commentary", "group": "other" }, { "id": "case_report_or_forum", "group": "other" } ], "classGroups": [ { "id": "authority_issued", "annexHeading": "Issued only by an authority" }, { "id": "coverage_records", "annexHeading": "Coverage records" }, { "id": "trials_and_appraised", "annexHeading": "Trials and appraised evidence" }, { "id": "market_and_manufacturer", "annexHeading": "Market and manufacturer" }, { "id": "ai_answer_observations", "annexHeading": "Observations of AI answers" }, { "id": "other", "annexHeading": "Other" } ], "authorityIssuedClasses": [ "authorisation_decision", "register_entry", "authorised_label", "regulatory_opinion", "regulator_assessment_report", "regulator_safety_communication", "safety_signal_record", "institutional_guidance", "payer_decision" ], "jurisdictionRules": [ { "id": "claim_market", "text": "The source must speak for the claim's market; where a proposition is settled per market, the source must speak for every country of the claim's market (Rule 2)." }, { "id": "international", "text": "International evidence: the claim's market does not govern." }, { "id": "named_source_scope", "text": "The named source, at the version in force, within its own stated scope: the guideline (P4) or the formulary (P6c) the claim names; the claim's market does not govern." }, { "id": "composite", "text": "Each part on its own terms: the ongoing study international (P3d), the indication per market (P2)." }, { "id": "none", "text": "Nothing settles the proposition (P10)." } ], "propositions": [ { "id": "P1", "name": "Registered or authorised", "definition": "The medicine holds a marketing authorisation, or a current registration, in a market.", "jurisdictionRule": "claim_market", "jurisdictionText": "Claim's market", "settledBy": [ { "class": "authorisation_decision", "jurisdictionRule": "claim_market" }, { "class": "register_entry", "jurisdictionRule": "claim_market", "condition": "current listing only" }, { "class": "authorised_label", "jurisdictionRule": "claim_market" } ], "supportedBy": [ "regulatory_opinion", "institutional_guidance", "manufacturer_statement", "launch_statement", "secondary_commentary" ], "timeRule": "In force on the claim's date (Rule 7). A label in force is part of the authorisation record.", "evidenceText": "Settled by the competent authority's authorisation decision, register entry or authorised label for that market. A label in force is part of the authorisation record: the EU summary of product characteristics is Annex I to the European Commission's decision, the conditions of the authorisation, including the legal category of supply, are Annex II, and the labelling and package leaflet are Annex III. Supports, never settles: a regulatory opinion, institutional guidance, a manufacturer's or launch statement, commentary." }, { "id": "P2", "name": "Authorised indication, population or terms of supply and use", "definition": "The medicine is authorised in a market for a stated condition, population or use, or on stated terms of supply or use, stated as what the authorisation permits: its legal category of supply (such as prescription only), its dose, its route, its form, or a restricted programme it requires for every supply.", "jurisdictionRule": "claim_market", "jurisdictionText": "Claim's market", "settledBy": [ { "class": "authorised_label", "jurisdictionRule": "claim_market" } ], "supportedBy": [ "authorisation_decision", "regulatory_opinion", "regulator_assessment_report", "manufacturer_statement" ], "timeRule": "The authorised label in the version in force on the claim's date (Rule 7).", "evidenceText": "Settled only by that market's authorised label, in the version in force, and, for the legal category of supply or a restricted programme, also by the authorisation decision where it states it: in the EU, Annex II to the Commission's decision (\"Conditions or restrictions regarding supply and use\") states the legal category, and the summary of product characteristics does not. A register's category is not an indication, and a guideline is not the licence. A phrase that names the scope of an authorisation, such as \"for use\", \"for sale\" or \"for distribution\", is not a use: a status claim qualified only by one is P1 (Annex B, C3). A risk, warning or contraindication in the label is P8a, and an effect from its clinical section is P7. Supports, never settles: the authorisation decision (except as to the legal category or restricted programme it states), a regulatory opinion, a regulator's assessment report, a manufacturer's statement.", "terms": { "ids": [ "use", "legal_category", "restricted_programme", "dose", "route", "form" ], "default": "use", "settledByTerm": [ { "id": "legal_category", "settledBy": [ { "class": "authorised_label", "jurisdictionRule": "claim_market" }, { "class": "authorisation_decision", "jurisdictionRule": "claim_market", "condition": "where the decision states the legal category of supply (in the EU, Annex II to the Commission's decision)" } ], "supportedBy": [ "regulatory_opinion", "regulator_assessment_report", "manufacturer_statement" ] }, { "id": "restricted_programme", "settledBy": [ { "class": "authorised_label", "jurisdictionRule": "claim_market" }, { "class": "authorisation_decision", "jurisdictionRule": "claim_market", "condition": "where the decision states the restricted programme it requires for every supply" } ], "supportedBy": [ "regulatory_opinion", "regulator_assessment_report", "manufacturer_statement" ] } ], "otherTerms": "Every other term (a use, condition or population, a dose, a route, a form) is settled only by the authorised label; the authorisation decision supports it." } }, { "id": "P3", "name": "Investigational", "definition": "The medicine is being studied for a use for which it is not authorised in the market.", "jurisdictionRule": "composite", "jurisdictionText": "Registry international; indication per market", "settledBy": [], "composedOf": [ "P3d", "P2" ], "supportedBy": [ "trial_registry_record", "trial_publication_of_record", "manufacturer_statement" ], "timeRule": "Each part on its own terms (Rule 7). Where \"investigational\" or \"experimental\" names no use, the parts are P3d and P1, and the P1 part follows Rule 3.", "evidenceText": "No single source settles P3. It is composite: that an interventional study of that use is ongoing on the claim's date (P3d, international), and that the market's authorised label does not carry that use (P2, per market), each settled on its own terms. Where the claim names no use, its parts are that an interventional study of the medicine is ongoing (P3d) and that the medicine holds no marketing authorisation in the market (P1, per market). Only a status word (\"investigational\", \"experimental\") makes such a claim (Annex B, C10). A registered study that is not ongoing on the claim's date does not make a medicine investigational. A registry record, a publication of record or a manufacturer's statement supports P3.", "composedOfWithoutUse": [ "P3d", "P1" ] }, { "id": "P3a", "name": "Trial registered", "parent": "P3", "jurisdictionRule": "international", "jurisdictionText": "International", "settledBy": [ { "class": "trial_registry_record", "jurisdictionRule": "international" } ], "supportedBy": [ "trial_publication_of_record", "manufacturer_statement" ], "timeRule": "In force on the claim's date (Rule 7).", "evidenceText": "Registration (P3a) is settled by the registry record; a publication of record or a manufacturer's statement supports it." }, { "id": "P3b", "name": "Trial design or planned endpoints", "parent": "P3", "jurisdictionRule": "international", "jurisdictionText": "International", "settledBy": [ { "class": "trial_registry_record", "jurisdictionRule": "international", "condition": "the registry record version in force on the date asked" }, { "class": "trial_protocol", "jurisdictionRule": "international" } ], "supportedBy": [ "trial_publication_of_record" ], "timeRule": "The registry record version in force on the date asked; a later amendment cannot rewrite an earlier registration.", "evidenceText": "Design or planned endpoints (P3b) are settled by the registry record version in force on the date asked, or the published protocol; a later amendment cannot rewrite an earlier registration, and a publication of record supports it." }, { "id": "P3c", "name": "Trial result reported", "parent": "P3", "jurisdictionRule": "international", "jurisdictionText": "International", "settledBy": [ { "class": "trial_results_posting", "jurisdictionRule": "international" }, { "class": "trial_publication_of_record", "jurisdictionRule": "international" } ], "supportedBy": [ "conference_abstract", "manufacturer_statement", "secondary_commentary" ], "timeRule": "In force on the claim's date (Rule 7).", "evidenceText": "A reported result of a study, interventional or observational (P3c), is settled by results posted to a registry or the study's publication of record; a conference abstract, a manufacturer's release or commentary supports it." }, { "id": "P3d", "name": "Ongoing", "parent": "P3", "definition": "On the claim's date, an interventional study of the use is ongoing: its registry record, in the version in force on that date, states an ongoing overall status.", "jurisdictionRule": "international", "jurisdictionText": "International", "settledBy": [ { "class": "trial_registry_record", "jurisdictionRule": "international", "condition": "the record's version in force on the claim's date (its posting interval), stating the study's overall status" } ], "supportedBy": [ "trial_publication_of_record", "manufacturer_statement" ], "timeRule": "The registry record version in force on the claim's date: effectiveFrom and effectiveTo are that version's posting interval (Rule 7).", "evidenceText": "That the study is ongoing (P3d) is settled only by its registry record in the version in force on the claim's date, stating an ongoing overall status: not yet recruiting, recruiting, enrolling by invitation, or active and not recruiting (ClinicalTrials.gov's terms; another registry's status is read as its equivalent, and a status with no equivalent settles nothing). A version stating the study completed, terminated, suspended or withdrawn settles that this study was not ongoing on that date; it never settles that no study of the medicine exists. A version that states no status, states it as unknown, or states an expanded-access status settles nothing. A publication of record or a manufacturer's statement supports P3d.", "trialStatuses": { "ongoing": [ "not_yet_recruiting", "recruiting", "enrolling_by_invitation", "active_not_recruiting" ], "notOngoing": [ "completed", "terminated", "suspended", "withdrawn" ], "settlesNothing": [ "available", "no_longer_available", "temporarily_not_available", "approved_for_marketing", "withheld", "unknown" ], "missing": "not_determinable" } }, { "id": "P4", "name": "Guideline recommendation", "definition": "A clinical guideline recommends the medicine, or its class, for a use: the guideline the claim identifies by its name or by its issuer, or guidelines the claim does not identify, which no source can be matched to (Annex B, C12).", "jurisdictionRule": "named_source_scope", "jurisdictionText": "The guideline's own scope", "settledBy": [ { "class": "clinical_guideline", "jurisdictionRule": "named_source_scope", "condition": "the guideline the claim identifies, by its name or by its issuer, at the version in force" } ], "supportedBy": [ "systematic_review", "secondary_commentary" ], "timeRule": "The guideline the claim identifies, at the version in force on the claim's date (Rule 7).", "evidenceText": "Settled by the guideline the claim identifies, at the version in force, within its own stated scope and population; the claim's market does not govern. A claim that names only the issuer is about that issuer's guideline for the use. A claim that attributes a recommendation to guidelines it does not identify is not determinable (section 6): no source can be matched to it. A systematic review and commentary support P4.", "unidentifiedGuideline": "not_determinable" }, { "id": "P5", "name": "Launched or available", "definition": "The medicine is on sale or supplied in a market.", "jurisdictionRule": "claim_market", "jurisdictionText": "Claim's market", "settledBy": [ { "class": "launch_statement", "jurisdictionRule": "claim_market", "condition": "a manufacturer's dated statement that the product has launched in that market" }, { "class": "supply_record", "jurisdictionRule": "claim_market", "condition": "within its own reach: a distributor's listing or a procurement record; a licensed pharmacy's listing under the pharmacy-listing rule" } ], "supportedBy": [ "authorisation_decision", "register_entry", "authorised_label", "manufacturer_statement" ], "timeRule": "In force on the claim's date (Rule 7). A pharmacy listing is in force on its own date only; two listings that bracket the claim's date support at most.", "evidenceText": "Settled by a manufacturer's dated statement that the product has launched in that market, or by a supply record (a distributor's listing or a procurement record) within its own reach. A licensed pharmacy's listing settles only that the pharmacy listed the product for sale on the listing's own date; a listing that does not show the product for sale settles nothing, and nor does a supply record that does not say whether it is a distributor's listing, a procurement record or a licensed pharmacy's listing: each is not determinable (section 6). Two listings of the same pharmacy that both show it for sale, one dated before the claim's date and one after it, each within three days of it, support and do not settle that it was listed on the claim's date: the product may have left the listing between the two reads. A listing dated the claim's date is judged on its own. A listing is not proof of stock and does not establish market-wide supply. A listing dated the claim's date therefore settles a claim that the medicine is not available anywhere in the market, which it contradicts, and only supports a claim that the medicine is available across the market. A claim that the medicine is available in the market without a word of breadth (\"available in the UAE\") takes the same claim form as a claim that it is not available anywhere there: a claim and its negation are one proposition, and the evidence that settles one settles the other (Annex B, C6). A claim that the medicine is available across the market needs a word of breadth, and a claim that it is not available across the market is that claim's negation, settled by the same evidence. A claim that the medicine can or cannot be obtained through a named channel is settled, for a regulatory access route (a named-patient or special-access import route, compassionate use, a restricted programme), only by the market regulator's own decision that provides the route for that medicine by name: its authorisation decision or authorised label (a restricted programme the label requires), or its decision granting the route for the medicine (an import permit or a compassionate-use authorisation that names it), each an authorisation_decision or authorised_label. For a named supplier, it is settled by that supplier's own supply record, as above. The regulator's published rules for a route, which name no medicine, support the claim and never settle it: they show that the route exists, not that the medicine can be obtained through it. A record of another channel supports it. A claim about stock is settled by no class this version names: a listing is not proof of stock, and the claim is not determinable (section 6). The authorisation decision, a register entry, the authorised label and other manufacturer statements support P5 and never settle it, except that an authorisation decision or label that itself provides a regulatory access route for the medicine by name settles a named-channel claim about that route: registration does not prove supply.", "supplyRecordKinds": [ { "id": "distributor_listing", "text": "A distributor's listing: settles P5 within its own reach." }, { "id": "procurement_record", "text": "A procurement record: settles P5 within its own reach." }, { "id": "pharmacy_listing", "text": "A licensed pharmacy's listing: settles only that the pharmacy listed the product for sale on the listing's own date." } ], "pharmacyListing": { "settlesOnly": "that the pharmacy listed the product for sale on the listing's own date", "inForce": "own_date_only", "bracketing": { "listings": 2, "samePharmacy": true, "bothShowForSale": true, "oneBeforeClaimDate": true, "oneAfterClaimDate": true, "maxDaysEachSide": 3, "listingOnClaimDate": "judged on its own", "verdicts": "one verdict for the pair, which supports and never settles", "atMost": "supports" }, "claimForms": [ { "id": "anywhere_in_market", "text": "A claim that the medicine is not available anywhere in the market, or that it is available in the market without a word of breadth (Annex B, C6): a listing dated the claim's date settles it.", "pharmacyListingVerdict": "settles" }, { "id": "across_market", "text": "A claim that the medicine is available across the market, or that it is not available across the market.", "pharmacyListingVerdict": "supports" } ], "notProofOf": [ "stock", "market-wide supply" ], "notForSale": "not_determinable" }, "supplyRecordKindUnstated": "not_determinable", "claimForms": [ { "id": "anywhere_in_market", "text": "A claim that the medicine is not available anywhere in the market, or that it is available in the market without a word of breadth (Annex B, C6)." }, { "id": "across_market", "text": "A claim that the medicine is available across the market, which needs a word of breadth, or its negation, that it is not available across the market (Annex B, C6)." }, { "id": "named_channel", "text": "A claim that the medicine can or cannot be obtained through a named channel: a regulatory access route or a named supplier (Annex B, C6)." }, { "id": "stock", "text": "A claim about stock, including stock at a named supplier, which no class this version names settles: a listing is not proof of stock (Annex B, C6)." }, { "id": "channel_kind", "text": "A negative claim about a channel named only by kind (\"not dispensed by pharmacies\"): P5 with the channel recorded and no form, which is not determinable (Annex B, C6). An affirmative claim through such a channel takes the first form." } ], "unrecordedFormJudgedAs": "across_market", "namedChannel": { "kinds": [ { "id": "regulatory_route", "text": "A regulatory access route: a named-patient, special-access or personal-use import route, compassionate use, or a restricted programme the sentence does not say is the only way the medicine is supplied. Settled only by the market regulator's own decision that provides the route for the medicine by name: its authorisation decision or authorised label (a restricted programme the label requires), or its decision granting the route for the medicine (an import permit or a compassionate-use authorisation that names it), recorded as an authorisation decision. The regulator's published rules for a route, which name no medicine, support the claim and never settle it.", "settledBy": [ { "class": "authorisation_decision", "jurisdictionRule": "claim_market", "condition": "the regulator's decision that provides the route for the medicine by name, including an import permit or a compassionate-use authorisation that names it" }, { "class": "authorised_label", "jurisdictionRule": "claim_market", "condition": "a restricted programme the label requires" } ], "supportedBy": [ "institutional_guidance", "register_entry", "supply_record", "launch_statement", "manufacturer_statement" ] }, { "id": "supplier", "text": "A named supplier: a named pharmacy, distributor or hospital. Settled by that supplier's own supply record, under the rules for that record's kind; a licensed pharmacy's listing dated the claim's date settles it, and whether the listing is the named supplier's is interpretation.", "settledBy": [ { "class": "supply_record", "jurisdictionRule": "claim_market", "condition": "the named supplier's own supply record, under the rules for its kind" } ], "supportedBy": [ "launch_statement", "authorisation_decision", "register_entry", "authorised_label", "institutional_guidance", "manufacturer_statement" ] } ], "otherChannel": "A record of another channel supports the claim.", "kindUnstated": "not_determinable", "channelNamedOnlyByKind": "not_determinable" }, "stock": "not_determinable" }, { "id": "P6a", "name": "Reimbursed or covered", "definition": "A payer covers or reimburses the medicine, in the market or for the members of a payer or plan the claim names.", "jurisdictionRule": "claim_market", "jurisdictionText": "Claim's market", "settledBy": [ { "class": "payer_decision", "jurisdictionRule": "claim_market", "condition": "within its reach: a decision that covers the market's population settles both claim forms; one payer's or plan's decision settles a claim naming that payer or plan, and only supports a claim of coverage across the market; a decision that does not state its reach settles nothing" } ], "supportedBy": [ "hta_appraisal", "formulary_listing", "manufacturer_statement", "secondary_commentary" ], "timeRule": "In force on the claim's date (Rule 7).", "evidenceText": "P6a is settled only by a payer's coverage decision for its own market, within its reach. A decision that covers the market's population settles a claim of coverage in the market and a claim that names that payer; the decision of one payer or plan settles a claim that names that payer or plan and only supports a claim of coverage across the market; a decision that does not state its reach settles nothing. Whether a decision's indication, population and eligibility are the claim's is interpretation (section 8). An HTA appraisal, a formulary listing, a manufacturer's statement and commentary support P6a and never settle it: a recommendation that does not bind a payer does not establish reimbursement.", "payerDecision": { "reaches": [ { "id": "market", "text": "A decision that covers the market's population (a national scheme)." }, { "id": "scheme", "text": "The decision of one payer or one plan." } ], "claimForms": [ { "id": "market", "text": "A claim that the medicine is reimbursed or covered in the market.", "schemeDecisionVerdict": "supports" }, { "id": "named_payer", "text": "A claim that a payer or plan the claim names covers the medicine; whether the decision is that payer's is interpretation.", "schemeDecisionVerdict": "settles" } ], "reachUnstated": "not_determinable", "unrecordedFormJudgedAs": "market", "reachByPlace": "A decision may state its reach as places, recorded with ISO 3166-1 codes or, for a place below the country, ISO 3166-2 codes (Annex B, M6). Covering the whole population of its places, it settles a claim of coverage in a market it covers in full and a claim that names its payer, and supports a claim of coverage in a market it covers only in part. Covering only part of the population, which it then states, it is one plan's decision: it settles a claim that names the plan and only supports a claim of coverage in the place." } }, { "id": "P6b", "name": "HTA recommendation", "definition": "A health technology assessment body recommends, or does not recommend, the medicine for a use, or rates its added benefit, therapeutic value or cost-effectiveness for a use.", "jurisdictionRule": "claim_market", "jurisdictionText": "Claim's market (the jurisdictions the appraisal speaks for)", "settledBy": [ { "class": "hta_appraisal", "jurisdictionRule": "claim_market" } ], "supportedBy": [ "manufacturer_statement", "secondary_commentary" ], "timeRule": "In force on the claim's date (Rule 7).", "evidenceText": "P6b is settled only by the published appraisal of the body the claim is about, for the jurisdictions the appraisal speaks for (a NICE technology appraisal speaks for England; its application in Wales is the Welsh Government's direction, a different record); another jurisdiction's appraisal is a declared benchmark (Rule 2), and a manufacturer's statement and commentary support it." }, { "id": "P6c", "name": "Formulary listing", "definition": "The medicine is on a formulary or list, such as a hospital's, an insurer's or a national formulary, or an essential medicines list; a formulary the claim does not name is recorded as unnamed, and no source can be matched to it (Annex B, C9).", "jurisdictionRule": "named_source_scope", "jurisdictionText": "The formulary's own scope", "settledBy": [ { "class": "formulary_listing", "jurisdictionRule": "named_source_scope" } ], "supportedBy": [ "payer_decision", "manufacturer_statement", "secondary_commentary" ], "timeRule": "In force on the claim's date (Rule 7).", "evidenceText": "P6c is settled only by the named formulary's own listing, at the version in force, within its own stated scope; a payer's decision, a manufacturer's statement and commentary support it.", "unidentifiedFormulary": "not_determinable" }, { "id": "P7", "name": "Efficacy result", "definition": "The medicine produced a stated effect on a stated endpoint in a stated population.", "jurisdictionRule": "international", "jurisdictionText": "International", "settledBy": [ { "class": "trial_publication_of_record", "jurisdictionRule": "international" }, { "class": "systematic_review", "jurisdictionRule": "international" }, { "class": "regulator_assessment_report", "jurisdictionRule": "international" }, { "class": "authorised_label", "jurisdictionRule": "international", "condition": "the label's clinical section" } ], "supportedBy": [ "trial_results_posting", "conference_abstract", "manufacturer_statement" ], "timeRule": "In force on the claim's date (Rule 7).", "evidenceText": "Settled by the trial's publication of record, a systematic review, a regulator's assessment report or an authorised label's clinical section, all international. Posted results, a conference abstract and a manufacturer's statement support P7. An unappraised posted result is a reported result (P3c), not an efficacy result." }, { "id": "P8a", "name": "Regulatory safety statement", "definition": "The medicine's authorised label in a market, or that market's regulator in a safety communication, states a risk, warning, contraindication or adverse effect.", "jurisdictionRule": "claim_market", "jurisdictionText": "Claim's market", "settledBy": [ { "class": "authorised_label", "jurisdictionRule": "claim_market", "condition": "the label's safety sections" }, { "class": "regulator_safety_communication", "jurisdictionRule": "claim_market" } ], "supportedBy": [ "case_report_or_forum", "secondary_commentary", "manufacturer_statement" ], "timeRule": "In force on the claim's date (Rule 7).", "evidenceText": "P8a is settled only by that market's authorised label, in its safety sections, and by that market's regulator's safety communications. A label or communication from another market supports it as a declared benchmark (Rule 2), and a systematic review is irrelevant to it: a review cannot say what a label carries. Case reports, forums, commentary and manufacturer statements support all three." }, { "id": "P8b", "name": "Safety finding", "definition": "The medicine is associated with a stated adverse effect.", "jurisdictionRule": "international", "jurisdictionText": "International", "settledBy": [ { "class": "systematic_review", "jurisdictionRule": "international" } ], "supportedBy": [ "trial_publication_of_record", "regulator_assessment_report", "authorised_label", "regulator_safety_communication", "safety_signal_record", "case_report_or_forum", "secondary_commentary", "manufacturer_statement" ], "timeRule": "In force on the claim's date (Rule 7).", "evidenceText": "P8b is settled by a systematic review (international). A trial's publication of record, a regulator's assessment report, a label's safety section and a regulator's safety communication, from any market, support P8b and do not settle it. Case reports, forums, commentary and manufacturer statements support all three." }, { "id": "P8c", "name": "Safety signal", "definition": "A regulator or pharmacovigilance body has identified a signal that the medicine may be associated with a stated adverse effect, or is assessing one; its negation is that such a body has identified no new signal, or has closed its assessment of a signal without finding a causal association.", "jurisdictionRule": "international", "jurisdictionText": "International", "settledBy": [ { "class": "safety_signal_record", "jurisdictionRule": "international" }, { "class": "regulator_safety_communication", "jurisdictionRule": "international" } ], "supportedBy": [ "regulator_assessment_report", "case_report_or_forum", "secondary_commentary", "manufacturer_statement" ], "timeRule": "In force on the claim's date (Rule 7).", "evidenceText": "P8c is settled by a regulator's or pharmacovigilance body's safety signal record, or by its safety communication, from any market: the claim is that a body raised the signal, which the body's own record establishes wherever it sits. A P8c settlement establishes that the body identified, or is assessing, the signal, and never that the medicine causes the effect; a negative settlement establishes only that the body's review identified no new signal, or closed its assessment, and never that the medicine does not cause an effect; a signal record supports P8b and never settles it. A regulator's assessment report supports P8c. Case reports, forums, commentary and manufacturer statements support all three." }, { "id": "P9", "name": "Comparative", "definition": "One medicine is better, worse or no different from another on a stated endpoint.", "jurisdictionRule": "international", "jurisdictionText": "International", "settledBy": [ { "class": "head_to_head_trial", "jurisdictionRule": "international" }, { "class": "appraised_indirect_comparison", "jurisdictionRule": "international", "condition": "with stated limits" } ], "supportedBy": [ "secondary_commentary" ], "timeRule": "In force on the claim's date (Rule 7).", "evidenceText": "Settled by a head-to-head trial or an appraised indirect comparison with stated limits, both international. Commentary supports P9. Separate trials set side by side neither settle nor support." }, { "id": "P10", "name": "Recommendation by the answer", "definition": "The answer tells the reader to choose, use, continue, stop or avoid a medicine or a class of medicines.", "jurisdictionRule": "none", "jurisdictionText": "None", "settledBy": [], "supportedBy": [], "neverSettled": true, "timeRule": "Not applicable: nothing settles P10.", "evidenceText": "Nothing settles P10. A recommendation is never judged true or false; it is assessed through the propositions it rests on, P1 to P9." }, { "id": "answer_change", "name": "The answer change", "definition": "AI answers changed.", "jurisdictionRule": "claim_market", "jurisdictionText": "Claim's market (the markets the observations observed)", "settledBy": [ { "class": "longitudinal_observation", "jurisdictionRule": "claim_market", "condition": "preserved observations under a longitudinal design: a fixed battery, the engine and parameters recorded, a statistical floor" } ], "supportedBy": [ "single_observation" ], "timeRule": "The observations' own dates (Rule 7).", "evidenceText": "A claim that AI answers changed is settled only by preserved observations under a longitudinal design: a fixed battery, the engine and parameters recorded, a statistical floor. A single answer supports and never settles. Paper No. 01 shows the design and where a study can fall short of it. It admitted 64 of 67 cycles and declared one registered movement, a verdict the paper says depends on the reading of its band rule. Its battery was a maintained set of question slots with text changes documented. The model field each engine returned was not recorded, and the paper's post-publication note records that, for Perplexity, the per-request parameters were not stored. Observations speak for the markets they observed: an answer-change claim is settled per market, under the market step (section 2), and observations of one market are a declared benchmark for another (Rule 2). Whether observations speak for engines, parameters or framings of a question they did not observe is interpretation (section 8). A claim that answers differ at one time, between engines or framings, states no change over time and is not the answer change (Annex B, C18)." } ], "rules": [ { "id": "R1", "section": "5", "text": "Each proposition names the only evidence that can settle it.", "statements": [], "related": [ "Section 3: Section 4 names the classes that only support; any other class is irrelevant." ] }, { "id": "R2", "section": "5", "text": "A foreign regulator's record never settles a local claim.", "statements": [ "Where a proposition is settled per market (P1, P2, P5, P6a, P6b, P8a and the answer change), the source must speak for every place of the claim's market (each country of a group, or the subdivision a claim is about: Annex B, M6), so one country's authority never settles a claim about the Gulf states together, a subdivision's body never settles a claim about its country, and a supply record speaks for the places Annex B, M6, assigns it.", "A record for another market is a declared benchmark: it supports and never grounds a finding." ] }, { "id": "R3", "section": "5", "text": "A register settles registration only, and \"not listed\" settles nothing.", "statements": [ "A register entry settles P1 and nothing else.", "A read that found no matching record, found the product only under a status not read as current, or could not read the register settles nothing.", "A copy whose currency is not assured settles only up to the date its currency is evidenced." ] }, { "id": "R4", "section": "5", "text": "An EMA opinion is not the European Commission's decision.", "statements": [ "The EMA recommends; the Commission decides. An EMA opinion supports an EU authorisation (P1) and never settles it.", "A Commission decision is matched to its opinion by the EMA procedure number, never by date." ] }, { "id": "R5", "section": "5", "text": "An unknown or unspecified jurisdiction is unresolved, never false.", "statements": [ "Where a proposition is settled per market, a claim whose market the market step (section 2) leaves unresolved, because no step states one or the one stated is unrecognised or \"global\", or a source that does not state its market, is not determinable." ] }, { "id": "R6", "section": "5", "text": "Institutional guidance is not authorisation.", "statements": [ "Bodies that do not authorise medicines, such as the Dubai Health Authority, issue guidance, which supports a registration claim and settles none." ] }, { "id": "R7", "section": "5", "text": "No retroactive judgement.", "statements": [ "An answer is judged only against evidence in force on the claim's date or, for an event claim, against the record of the event issued by the answer's date (below).", "For a claim about a state, a source that came into force later, or had ceased to be in force, does not settle it: a later decision is an evidence change, not a historical error.", "A pharmacy listing is in force on its own date only; two listings that bracket the claim's date support at most (P5).", "A source with no effective date, or a date that is not valid ISO 8601, decides nothing.", "An event claim (Annex B, T6) asks when an event took place. It is judged against the record of that event, of a class that settles the proposition, issued on or before the answer's date. A record issued after the answer's date does not settle it. A record that later ceased to be in force, because the authorisation was withdrawn, the label revised, the appraisal replaced or the registry record updated, still settles when the event it records took place, unless before the answer's date it was annulled, retracted or corrected as to that event. A register copy settles the date it records for the event whatever its currency on the answer's date; Rule 3 bounds claims about a state. An answer of October 2026 saying that sotagliflozin \"was approved in the EU in April 2019\" is settled by the decision of 26 April 2019, although the authorisation was withdrawn in 2022. Whether the date the record gives for the event falls within the claim's date, or, for an undated event claim, on or before the answer's date (Annex B, T6), is adjudication (section 8).", "Dates are never merged: claim, event or decision, entry into and exit from force, currency, retrieval and recording. A superseded record is closed, never rewritten." ] }, { "id": "R8", "section": "5", "text": "Unknown is not false.", "statements": [ "A claim that no source settles is unknown, whether its sources only support it, are irrelevant to it or are not determinable (section 6): no finding may be raised on it, and it is never counted as an error.", "A hedged claim (Annex B, E5) is recorded and reported as hedged; it is not judged, and it is never counted as an error, whatever settles it." ] } ], "verdicts": [ { "id": "settles", "label": "Settles", "meaning": "A class the proposition names, from an authority competent to issue it, for the claim's market where that applies, in force on the claim's date or, for an event claim, the record of the event issued by the answer's date (Rule 7)", "mayRestOnIt": "A conclusion, including a finding, once the record is read correctly and the claim adjudicated against it (section 8)" }, { "id": "supports", "label": "Supports", "meaning": "A supporting class; a settling class from another market (a declared benchmark); two listings of one pharmacy that both show the product for sale and bracket the claim's date within three days each side (P5); one payer's or plan's decision for a claim of coverage across the market (P6a); or an authority cited for a class it does not issue, where what it issues may support", "mayRestOnIt": "Corroboration, never a finding" }, { "id": "irrelevant", "label": "Irrelevant", "meaning": "A class the proposition does not list; an authority cited for a class it does not issue, where nothing it issues may support; a source that fails the time test of Rule 7; any source for a recommendation (P10)", "mayRestOnIt": "Nothing" }, { "id": "not_determinable", "label": "Not determinable", "reportedAs": "not assessable", "meaning": "The claim's or source's market is unresolved; the register read found nothing, found the product only under a status not read as current, or could not be read; a date is missing or invalid; the source's currency is not assured for the date asked; a pharmacy listing does not show the product for sale, or a supply record does not say which record it is (P5); a payer's decision does not state its reach (P6a); a registry version states no study status, an unknown one or an expanded-access status (P3d); the claim names no guideline or formulary it can be matched to (P4, P6c); the claim is about stock, or a negative claim about a channel named only by kind (P5); or the claim maps to no proposition", "mayRestOnIt": "Nothing: unknown, never false" } ], "verdictRecord": { "unit": "Each source gets one verdict per proposition, market and date; two listings of one pharmacy that bracket the claim's date under P5 get one verdict together, which is at most Supports. Every verdict decides authority only (section 2).", "records": [ "the rule that decided it", "a one-sentence reason", "the step that fixed the claim's market", "its limitations by dimension, for the checks it reached" ], "abstention": "Abstention is per claim: one claim that is not assessable leaves the rest of the answer assessable." }, "limitationDimensions": [ "authority", "jurisdiction", "time", "accessibility" ], "decisionProcedure": { "note": "The order in which this companion applies the text's conditions, so that every input has exactly one verdict. Time is applied before class: a source not in force on the claim's date is irrelevant whatever its class (section 6; Rule 7). Each step names the text that decides at it.", "steps": [ { "id": "S6-proposition", "basis": "section 6", "decides": "The claim maps to no proposition: not determinable." }, { "id": "P10", "basis": "section 4 (P10), section 6", "decides": "Any source for a recommendation: irrelevant." }, { "id": "S2-claim-date", "basis": "section 2", "decides": "The claim's date cannot be fixed (the answer's date or a stated date is missing or not valid ISO 8601, the stated date is later than the answer's, the answer gives an earlier time without a date (Annex B, T4), or a past-tense state is placed at an earlier time with no date (T6)): not determinable. For a claim that dates a state, a stated period that contains the answer's date is read as the answer's date (T2). An event claim's date is the stated time at its precision, even a period that contains the answer's date; an undated event claim (a past-tense event with no time, a time with no year, \"recently\" or \"initially\") is dated the answer's date (T6)." }, { "id": "S6-no-source", "basis": "section 6; section 4 (P4, P5 and P6c)", "decides": "The claim is of a form no source can be matched to, whatever the source: it attributes a recommendation or a listing to a guideline or formulary it does not identify (P4, P6c), it is about stock, it is a negative claim about a channel named only by kind, or it is a named-channel claim that does not record whether the channel is a regulatory access route or a named supplier (P5): not determinable." }, { "id": "R7", "basis": "Rule 7, section 6", "decides": "A date that is not valid ISO 8601, or a dated claim against a source with no effective date: not determinable. A source not in force on the claim's date, including a pharmacy listing on any other date than its own: irrelevant. For an event claim, the record of the event must have been issued on or before the answer's date, and its force ending later does not matter; a record issued after the answer's date, or annulled, retracted or corrected as to the event by then: irrelevant. Rule 3's currency bound applies to claims about a state only." }, { "id": "P3", "basis": "section 4 (P3)", "decides": "P3 is composite: no single source settles it; a supporting class supports, any other class is irrelevant. Its parts are P3d and P2, or, where \"investigational\" or \"experimental\" names no use, P3d and P1." }, { "id": "R1", "basis": "Rule 1, section 3", "decides": "A class the proposition does not name as settling: supports when section 4 lists it as supporting, otherwise irrelevant. For a named-channel claim (P5) the classes are its kind's, and a record of another channel supports. For a P2 claim about the legal category of supply or a restricted programme the authorisation decision also settles." }, { "id": "S2-authority", "basis": "section 2 (Authority), Rules 4 and 6, section 6", "decides": "A class only an authority issues, cited for an authority that does not issue it: supports where what the authority issues may support the proposition, otherwise irrelevant." }, { "id": "R5", "basis": "Rule 5", "decides": "Per-market proposition with an unresolved claim market, or a source that does not state its market: not determinable." }, { "id": "R2", "basis": "Rule 2", "decides": "Per-market proposition and a source that does not speak for every place of the claim's market: supports (a declared benchmark). A source of a class only an authority issues, an HTA appraisal or a formulary listing that speaks for a country speaks for each of its subdivisions, and one whose reach is a subdivision speaks for that subdivision only; a launch statement or a supply record speaks for the place it states and for every place that contains it, and for no other; a place with both an ISO 3166-1 and an ISO 3166-2 code is read as its ISO 3166-2 code (Annex B, M6)." }, { "id": "R3", "basis": "Rule 3", "decides": "A register read that found no current listing, or could not be read; a copy whose currency is not evidenced for the claim's date: not determinable." }, { "id": "P3d", "basis": "section 4 (P3d)", "decides": "A registry record version that states no study status, an unknown one or an expanded-access status: not determinable. An ongoing status settles that the study was ongoing; completed, terminated, suspended or withdrawn settles that this study was not." }, { "id": "P5", "basis": "section 4 (P5)", "decides": "A supply record that does not say which record it is, or a pharmacy listing that does not show the product for sale: not determinable. A pharmacy listing for a claim that the medicine is available across the market: supports. Two listings of one pharmacy, one dated before the claim's date and one after it, each within three days, judged together: supports at most. A listing dated the claim's date is judged on its own. A named supplier's pharmacy listing dated the claim's date settles as a listing does for the first claim form." }, { "id": "P6a", "basis": "section 4 (P6a)", "decides": "A payer decision that does not state its reach: not determinable. One payer's or plan's decision, including a decision that covers only part of its places' population, or a decision whose places cover the claim's market only in part, for a claim of coverage across the market: supports." }, { "id": "S6-settles", "basis": "section 6", "decides": "Every condition of Settles holds: settles. A P8c settlement establishes that the body identified, or is assessing, the signal, never that the medicine causes the effect. For an event claim, whether the date the record gives for the event falls within the claim's date is adjudication (section 8)." } ] }, "claimDate": { "rule": "The date of the answer, or the earlier date the answer itself states for the claim (\"as of October 2023\"). Annex B (T1 to T7) fixes it clause by clause.", "statedDatePrecision": "A stated date keeps the precision the answer gave it: \"as of October 2023\" is 2023-10, and a source must be in force throughout it. For a claim that dates a state, a stated period that contains the answer's date (\"as of October 2026\" in an answer of 23 October 2026) is read as the answer's date (T1): the answer cannot speak for the rest of the period. An event claim keeps its stated period even where the period contains the answer's date (\"approved in October 2026\"), and the date the record gives for the event is compared with the whole period (T6).", "dateFormat": "ISO 8601 calendar dates: YYYY, YYYY-MM, YYYY-MM-DD, or a date and time.", "eventClaim": "Where the sentence states when an event that the proposition records took place, the unit is an event claim, and its claim's date is the stated time at its precision (T2, first and third sentences). Such events are: the grant, refusal, suspension or withdrawal of an authorisation, or a change to its label (\"approved in February 2025\", \"granted on 10 February 2025\"); a launch; a payer's, HTA body's or formulary's decision (\"NICE recommended it in September 2026\"); a study's registration, start, completion or report (\"reported in October 2026\"); and a regulator's safety communication or the opening of a signal. Every other unit dates a state. \"As of [date]\" always dates a state (E3). A predicate in the past tense of an event this rule lists, with no time stated (\"was approved\", \"was launched\", \"was withdrawn\"), is an undated event claim: its claim's date is the answer's date, the unit records that the event is placed at any time on or before it, the record of the event settles it if it was issued by then (Rule 7), and in adjudication the date the record gives for the event is compared with any time on or before the answer's date. An affirmative predicate in the past tense of an event this rule lists, with a stated time with no year (\"approved on 10 February\") or with \"recently\" or \"initially\", adds no date: the unit is an undated event claim, and the words are recorded for adjudication. A negative one (\"was not approved on 10 February\", \"was not recently approved\"), and a state with a stated time with no year (\"as of February\"), leave the claim's date not determinable (T4). \"Recently\" with a present or present-perfect predicate (\"has recently been approved\") leaves it a state on the answer's date, and the word is recorded. A predicate in the past tense of a state, with no time stated (\"was available\", \"was covered\", \"was investigational\"), places the state at an earlier time without a date: the claim's date is not determinable (T4). A predicate in the present or present perfect (\"is approved\", \"has been approved\", \"remains unapproved\") dates a state on the answer's date. \"Since\" with a date or year (\"approved since 2022\", \"since its FDA approval in 2017\") makes two units: an event claim dated to the stated time, and a state claim on the answer's date. \"Since\" with an undated event noun (\"since its FDA approval\") makes no unit for the event (U5). A time stated relative to the answer's date (\"last year\", \"in March this year\", \"two years ago\") is resolved from the answer's date (T7) at its own precision: \"last year\" in an answer of 23 October 2026 is 2025. \"Soon after\" an event the answer does not date leaves the claim's date not determinable (T4). An event claim is judged against the record of that event (section 5, Rule 7).", "dateKinds": [ { "id": "state", "text": "Every unit that is not an event claim dates a state; \"as of\" always dates a state, and a past-tense state with no time stated leaves the claim's date not determinable (Annex B, E3, T4, T6). Sources must be in force on the claim's date." }, { "id": "event", "text": "A unit whose sentence states when an event the proposition records took place (Annex B, T6). Its claim's date is the stated time at its precision; it is judged against the record of the event issued on or before the answer's date (Rule 7), and the date the record gives for the event is compared with the claim's date in adjudication." }, { "id": "undated_event", "text": "A past-tense predicate of such an event with no time stated, a stated time with no year, or \"recently\" or \"initially\" (Annex B, T6). Its claim's date is the answer's date; it is judged against the record of the event issued on or before the answer's date (Rule 7), and the date the record gives for the event is compared with any time on or before the answer's date in adjudication." } ] }, "scope": { "isNot": [ "It is neither clinical judgement nor a regulatory determination. It does not say whether a medicine is right for a patient, grades no clinical evidence and decides no legal status; the authority's record remains the determination.", "It decides authority, not truth. Interpretation (whether a record, read correctly, concerns the claim's product, population, endpoint and date and says what the claim says) and adjudication (whether the claim is then supported, contradicted or unresolved) belong to other steps, as does whether a source may be used at all (its licence and terms). A source of a settling class is competent to establish what it records; whether a reported effect is reliable is a question of the evidence's quality, which frameworks for grading evidence address and this standard does not." ] }, "p8": { "note": "A safety claim not assigned to P8a, P8b or P8c maps to no proposition (section 6).", "notAnId": "P8" }, "conformance": { "rule": "An implementation conforms to a version when it reproduces every test vector of that version: for each, the claim's date, the verdict, the deciding rule and, where the vector states them, whether the registry record settles that a study was ongoing or that it was not (P3d) and the step that fixed the claim's market, with whether a later step conflicted.", "vectors": "evidence-authority-standard-v1.test-vectors.json", "referenceImplementation": { "name": "@alphacitation/evidence-authority", "version": "3.0.0", "licence": "Apache-2.0", "source": "https://alphacitation.com/research/standard-v1/alphacitation-evidence-authority-3.0.0.zip" } }, "p6": { "note": "\"P6\" is no longer a proposition: a claim mapped to it is not assessable (section 4, P6).", "notAnId": "P6" }, "marketStep": { "steps": [ { "id": "answer", "rule": "M1", "text": "The market the answer states for the claim governs: in the sentence, or in a heading or earlier clause the sentence continues. A market stated once for coordinated predicates (\"not approved or sold in the UAE\") states it for each (U2). A market attached to a noun of the clause (\"a UAE-licensed physician\", \"a Saudi patient\") states the market of that clause's claim. A market stated in a later sentence does not reach back to an earlier one. Naming a market's regulator, payer or health technology assessment body, or an instrument only that regulator requires (a REMS), states that market, for example: the FDA, a REMS or Medicare, the United States; the European Commission or the EMA, the EU (section 2); the Emirates Drug Establishment or the Ministry of Health and Prevention, the United Arab Emirates; the Saudi Food and Drug Authority, Saudi Arabia; the Health Sciences Authority, Singapore. Naming a body whose remit is part of a country states that part (M6): the Dubai Health Authority, Dubai; the Department of Health Abu Dhabi, Abu Dhabi; NICE, England; the Scottish Medicines Consortium, Scotland. Naming a plan that covers part of a place's population, such as Thiqa (the Abu Dhabi Government's programme for UAE nationals), states that place, Abu Dhabi. Where one sentence states a market in words and also names a body of a different or narrower market for the same claim, the body's market governs a claim about that body's own decision (P1 and P2 where the body is named as the authority that decided, as in \"approved by the FDA\"; P6a in the named-payer form; P6b; and P8a where the body is the regulator; this list is complete), and the market stated in words governs any other claim; the other market is recorded as a conflict. \"In the UK, NICE recommends it\" is a P6b claim about England; \"According to the Dubai Health Authority, it is registered in the UAE\" is a P1 claim about the United Arab Emirates. A market the sentence states, in words or by naming a body, governs over one stated in a heading or earlier clause it continues." }, { "id": "question", "rule": "M2", "text": "Otherwise, the market stated in the question governs." }, { "id": "configuration", "rule": "M3", "text": "Otherwise, the market the deploying system declares for its user, as configuration, governs. The record says that it came from configuration." }, { "id": "unresolved", "rule": "M5", "text": "Otherwise, the market is unresolved: for a proposition settled per market, the claim is not determinable (Rule 5)." } ], "governs": "The first step that states a market governs, even where it states a market word that names no market (M6); a later step that states a different market is recorded as a conflict and never governs. The verdict then records the step that stated the word, and the market's codes as unresolved. A place below the country and its country are different markets: a claim about one, under a question about the other, records a conflict.", "conflict": "A later step that states a different market is recorded as a conflict and never governs.", "neverInferredFrom": [ "IP address", "language", "spelling", "currency", "units", "time zone" ], "marketWords": "Market words. \"Worldwide\", \"globally\" and \"internationally\" name no market and are unresolved. A named group of countries is the list of its members: \"the Gulf states\" and \"the GCC\" are AE, BH, KW, OM, QA and SA; \"the EU\" is its 27 member states, and Rule 2 then requires a source that speaks for every one. \"Europe\", with no EU body or \"EU\" named, is unresolved. A place below the country is recorded by its ISO 3166-2 code: an emirate, a country or province of the United Kingdom, or a US state by its own (AE-DU for Dubai, AE-AZ for Abu Dhabi, GB-ENG for England, GB-SCT for Scotland, US-CA for California); a city by the code of the subdivision that contains it, with the city's name recorded (SA-01 and Riyadh). A place that has its own ISO 3166-1 code and is also listed as a subdivision of a country in ISO 3166-2 (Puerto Rico, PR and US-PR; Réunion, RE and FR-974) is recorded by its ISO 3166-2 code, as part of that country; a source speaks for such a place only where the law under which it was issued applies there, so EU decisions speak for Réunion (FR-974) and not for New Caledonia (FR-NC). A source of a class issued only by an authority (Annex A, first list), an HTA appraisal or a formulary listing that speaks for a country speaks for each of its subdivisions and cities. A launch statement and a supply record speak for the place where the supply they record took place, as the record states it, and for every place that contains it, and for no other: a listing of a pharmacy in Abu Dhabi speaks for Abu Dhabi and for the United Arab Emirates, so it settles that the pharmacy listed the product in each (P5), and it does not speak for Dubai; a national launch statement speaks for the country and for no one emirate; and a listing speaks for a claim about a city only where the pharmacy is in that city. A source of a class issued only by an authority, an HTA appraisal or a formulary listing whose reach is a subdivision speaks only for that subdivision, so it never settles a claim about the country (Rule 2). A payer's reach is recorded with the same codes and, where it covers only part of the place's population, with that population: such a decision is one plan's decision (P6a), which settles a claim that names the plan and only supports a claim of coverage in the place.", "recorded": "Every verdict records the step that fixed the market (section 2)." } }