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EUAITransparencyIG - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

: EU AI Transparency Custom Codes - TTL Representation

Active as of 2026-06-18

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

# - resource -------------------------------------------------------------------

 a fhir:CodeSystem ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "EUAIActCodeSystem"] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: CodeSystem EUAIActCodeSystem</b></p><a name=\"EUAIActCodeSystem\"> </a><a name=\"hcEUAIActCodeSystem\"> </a><p>This case-sensitive code system <code>http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem</code> defines the following codes:</p><table class=\"codes\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td style=\"white-space:nowrap\">ai-system<a name=\"EUAIActCodeSystem-ai-system\"> </a></td><td>AI System</td><td/></tr><tr><td style=\"white-space:nowrap\">high-risk-ai<a name=\"EUAIActCodeSystem-high-risk-ai\"> </a></td><td>High-Risk AI System</td><td/></tr><tr><td style=\"white-space:nowrap\">gpai<a name=\"EUAIActCodeSystem-gpai\"> </a></td><td>General Purpose AI</td><td/></tr><tr><td style=\"white-space:nowrap\">model-card<a name=\"EUAIActCodeSystem-model-card\"> </a></td><td>AI Model Card</td><td/></tr><tr><td style=\"white-space:nowrap\">ai-generated<a name=\"EUAIActCodeSystem-ai-generated\"> </a></td><td>AI Generated Result</td><td/></tr><tr><td style=\"white-space:nowrap\">human-override<a name=\"EUAIActCodeSystem-human-override\"> </a></td><td>Human Override</td><td/></tr><tr><td style=\"white-space:nowrap\">human-validation<a name=\"EUAIActCodeSystem-human-validation\"> </a></td><td>Human Validation</td><td/></tr><tr><td style=\"white-space:nowrap\">human-correction<a name=\"EUAIActCodeSystem-human-correction\"> </a></td><td>Human Correction</td><td/></tr><tr><td style=\"white-space:nowrap\">ai-transparency-info<a name=\"EUAIActCodeSystem-ai-transparency-info\"> </a></td><td>AI Transparency Information</td><td/></tr><tr><td style=\"white-space:nowrap\">patient-information-provided<a name=\"EUAIActCodeSystem-patient-information-provided\"> </a></td><td>Patient Information Provided</td><td/></tr><tr><td style=\"white-space:nowrap\">patient-explanation-requested<a name=\"EUAIActCodeSystem-patient-explanation-requested\"> </a></td><td>Patient Explanation Requested</td><td/></tr><tr><td style=\"white-space:nowrap\">patient-explanation-provided<a name=\"EUAIActCodeSystem-patient-explanation-provided\"> </a></td><td>Patient Explanation Provided</td><td/></tr><tr><td style=\"white-space:nowrap\">accuracy<a name=\"EUAIActCodeSystem-accuracy\"> </a></td><td>Accuracy</td><td/></tr><tr><td style=\"white-space:nowrap\">sensitivity<a name=\"EUAIActCodeSystem-sensitivity\"> </a></td><td>Sensitivity</td><td/></tr><tr><td style=\"white-space:nowrap\">specificity<a name=\"EUAIActCodeSystem-specificity\"> </a></td><td>Specificity</td><td/></tr><tr><td style=\"white-space:nowrap\">robustness<a name=\"EUAIActCodeSystem-robustness\"> </a></td><td>Robustness</td><td/></tr><tr><td style=\"white-space:nowrap\">clinically-validated<a name=\"EUAIActCodeSystem-clinically-validated\"> </a></td><td>Clinically Validated</td><td>The AI system has completed clinical validation.</td></tr><tr><td style=\"white-space:nowrap\">not-clinically-validated<a name=\"EUAIActCodeSystem-not-clinically-validated\"> </a></td><td>Not Clinically Validated</td><td>The AI system has not completed clinical validation.</td></tr><tr><td style=\"white-space:nowrap\">validation-in-progress<a name=\"EUAIActCodeSystem-validation-in-progress\"> </a></td><td>Validation In Progress</td><td>Clinical validation is currently in progress.</td></tr><tr><td style=\"white-space:nowrap\">technical-validation-only<a name=\"EUAIActCodeSystem-technical-validation-only\"> </a></td><td>Technical Validation Only</td><td>Only technical or syntactic validation has been performed.</td></tr><tr><td style=\"white-space:nowrap\">triage<a name=\"EUAIActCodeSystem-triage\"> </a></td><td>Triage and Prioritization</td><td/></tr><tr><td style=\"white-space:nowrap\">screening<a name=\"EUAIActCodeSystem-screening\"> </a></td><td>Screening</td><td/></tr><tr><td style=\"white-space:nowrap\">second-opinion<a name=\"EUAIActCodeSystem-second-opinion\"> </a></td><td>Second Opinion</td><td/></tr><tr><td style=\"white-space:nowrap\">diagnostic-support<a name=\"EUAIActCodeSystem-diagnostic-support\"> </a></td><td>Diagnostic Support</td><td/></tr><tr><td style=\"white-space:nowrap\">treatment-planning<a name=\"EUAIActCodeSystem-treatment-planning\"> </a></td><td>Treatment Planning</td><td/></tr><tr><td style=\"white-space:nowrap\">prognosis<a name=\"EUAIActCodeSystem-prognosis\"> </a></td><td>Prognostic Prediction</td><td/></tr><tr><td style=\"white-space:nowrap\">ce-mark<a name=\"EUAIActCodeSystem-ce-mark\"> </a></td><td>CE Mark</td><td>Indicates whether the device has a CE mark.</td></tr><tr><td style=\"white-space:nowrap\">notified-body-id<a name=\"EUAIActCodeSystem-notified-body-id\"> </a></td><td>Notified Body ID</td><td>Identifier of the notified body.</td></tr><tr><td style=\"white-space:nowrap\">expected-lifetime<a name=\"EUAIActCodeSystem-expected-lifetime\"> </a></td><td>Expected Lifetime</td><td>The expected lifetime of the AI system.</td></tr><tr><td style=\"white-space:nowrap\">medical-purpose<a name=\"EUAIActCodeSystem-medical-purpose\"> </a></td><td>Medical Purpose</td><td>The intended medical purpose.</td></tr><tr><td style=\"white-space:nowrap\">target-population<a name=\"EUAIActCodeSystem-target-population\"> </a></td><td>Target Population</td><td>The intended target population.</td></tr><tr><td style=\"white-space:nowrap\">eu-ai-database-id<a name=\"EUAIActCodeSystem-eu-ai-database-id\"> </a></td><td>EU AI Database Identifier</td><td>Identifier for an AI system registration in the EU AI database or an equivalent AI system registry.</td></tr><tr><td style=\"white-space:nowrap\">primary-use<a name=\"EUAIActCodeSystem-primary-use\"> </a></td><td>Primary Use</td><td>Processing for direct patient care.</td></tr><tr><td style=\"white-space:nowrap\">secondary-use<a name=\"EUAIActCodeSystem-secondary-use\"> </a></td><td>Secondary Use</td><td>Processing for research, AI training, policy making, or other permitted secondary-use purposes.</td></tr><tr><td style=\"white-space:nowrap\">ehr<a name=\"EUAIActCodeSystem-ehr\"> </a></td><td>Electronic Health Records (EHRs)</td><td>Electronic health data from electronic health records (Art. 51 1a).</td></tr><tr><td style=\"white-space:nowrap\">health-factors<a name=\"EUAIActCodeSystem-health-factors\"> </a></td><td>Health Determinants</td><td>Data impacting health, including socioeconomic, environmental and behavioural determinants (Art. 51 1b).</td></tr><tr><td style=\"white-space:nowrap\">healthcare-resources<a name=\"EUAIActCodeSystem-healthcare-resources\"> </a></td><td>Aggregated Healthcare Data</td><td>Aggregated data on healthcare needs, resources, access and financing (Art. 51 1c).</td></tr><tr><td style=\"white-space:nowrap\">pathogen-data<a name=\"EUAIActCodeSystem-pathogen-data\"> </a></td><td>Pathogen Data</td><td>Data on pathogens impacting human health (Art. 51 1d).</td></tr><tr><td style=\"white-space:nowrap\">admin-claims<a name=\"EUAIActCodeSystem-admin-claims\"> </a></td><td>Administrative and Claims Data</td><td>Health-related administrative data, including claims and reimbursement data (Art. 51 1e).</td></tr><tr><td style=\"white-space:nowrap\">human-genomic<a name=\"EUAIActCodeSystem-human-genomic\"> </a></td><td>Human Genomic Data</td><td>Human genetic, epigenomic and genomic data (Art. 51 1f).</td></tr><tr><td style=\"white-space:nowrap\">molecular-omics<a name=\"EUAIActCodeSystem-molecular-omics\"> </a></td><td>Molecular Omic Data</td><td>Other human molecular data, such as proteomic, transcriptomic, metabolomic, lipidomic and other omic data (Art. 51 1g).</td></tr><tr><td style=\"white-space:nowrap\">device-generated-personal<a name=\"EUAIActCodeSystem-device-generated-personal\"> </a></td><td>Device-Generated Personal Data</td><td>Person-generated electronic health data automatically generated by medical devices (Art. 51 1h).</td></tr><tr><td style=\"white-space:nowrap\">wellness-apps<a name=\"EUAIActCodeSystem-wellness-apps\"> </a></td><td>Wellness Application Data</td><td>Data from wellness applications (Art. 51 1i).</td></tr><tr><td style=\"white-space:nowrap\">professional-status<a name=\"EUAIActCodeSystem-professional-status\"> </a></td><td>Healthcare Professional Data</td><td>Data on the professional status, specialization and institution of healthcare professionals (Art. 51 1j).</td></tr><tr><td style=\"white-space:nowrap\">public-health-registry<a name=\"EUAIActCodeSystem-public-health-registry\"> </a></td><td>Public Health Registries</td><td>Data from population-wide health data registries (Art. 51 1k).</td></tr><tr><td style=\"white-space:nowrap\">medical-mortality-registry<a name=\"EUAIActCodeSystem-medical-mortality-registry\"> </a></td><td>Medical and Mortality Registries</td><td>Data from medical registries and mortality registries (Art. 51 1l).</td></tr><tr><td style=\"white-space:nowrap\">clinical-trial<a name=\"EUAIActCodeSystem-clinical-trial\"> </a></td><td>Clinical Trial Data</td><td>Data from clinical trials, clinical studies and performance studies (Art. 51 1m).</td></tr><tr><td style=\"white-space:nowrap\">medical-device-other<a name=\"EUAIActCodeSystem-medical-device-other\"> </a></td><td>Other Medical Device Data</td><td>Other health data from medical devices (Art. 51 1n).</td></tr><tr><td style=\"white-space:nowrap\">medicinal-device-registry<a name=\"EUAIActCodeSystem-medicinal-device-registry\"> </a></td><td>Medicinal and Device Registries</td><td>Data from registries for medicinal products and medical devices (Art. 51 1o).</td></tr><tr><td style=\"white-space:nowrap\">research-cohort-survey<a name=\"EUAIActCodeSystem-research-cohort-survey\"> </a></td><td>Research Cohorts and Surveys</td><td>Data from research cohorts, questionnaires and health-related surveys (Art. 51 1p).</td></tr><tr><td style=\"white-space:nowrap\">biobank<a name=\"EUAIActCodeSystem-biobank\"> </a></td><td>Biobank Data</td><td>Health data from biobanks and associated databases (Art. 51 1q).</td></tr><tr><td style=\"white-space:nowrap\">representative<a name=\"EUAIActCodeSystem-representative\"> </a></td><td>Representative</td><td>Data are sufficiently representative of the target population.</td></tr><tr><td style=\"white-space:nowrap\">error-free<a name=\"EUAIActCodeSystem-error-free\"> </a></td><td>Error-Free</td><td>Data are free of errors to the best extent possible.</td></tr><tr><td style=\"white-space:nowrap\">complete<a name=\"EUAIActCodeSystem-complete\"> </a></td><td>Complete</td><td>Data are complete with regard to the intended purpose.</td></tr><tr><td style=\"white-space:nowrap\">relevant<a name=\"EUAIActCodeSystem-relevant\"> </a></td><td>Relevant</td><td>Data are relevant for the intended purpose.</td></tr></table></div>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:url [ fhir:v "http://example.org/fhir/eu-ai-transparency/CodeSystem/EUAIActCodeSystem"^^xsd:anyURI] ; # 
  fhir:version [ fhir:v "0.1.0"] ; # 
  fhir:name [ fhir:v "EUAIActCodeSystem"] ; # 
  fhir:title [ fhir:v "EU AI Transparency Custom Codes"] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:experimental [ fhir:v false] ; # 
  fhir:date [ fhir:v "2026-06-18T12:04:51+00:00"^^xsd:dateTime] ; # 
  fhir:publisher [ fhir:v "Selina Adlberger"] ; # 
  fhir:description [ fhir:v "Custom codes used in this IG to represent AI transparency, data-use, provenance, technical documentation, data-quality, and human-oversight documentation concepts."] ; # 
  fhir:caseSensitive [ fhir:v true] ; # 
  fhir:content [ fhir:v "complete"] ; # 
  fhir:count [ fhir:v "55"^^xsd:nonNegativeInteger] ; # 
  fhir:concept ( [
fhir:code [ fhir:v "ai-system" ] ;
fhir:display [ fhir:v "AI System" ]
  ] [
fhir:code [ fhir:v "high-risk-ai" ] ;
fhir:display [ fhir:v "High-Risk AI System" ]
  ] [
fhir:code [ fhir:v "gpai" ] ;
fhir:display [ fhir:v "General Purpose AI" ]
  ] [
fhir:code [ fhir:v "model-card" ] ;
fhir:display [ fhir:v "AI Model Card" ]
  ] [
fhir:code [ fhir:v "ai-generated" ] ;
fhir:display [ fhir:v "AI Generated Result" ]
  ] [
fhir:code [ fhir:v "human-override" ] ;
fhir:display [ fhir:v "Human Override" ]
  ] [
fhir:code [ fhir:v "human-validation" ] ;
fhir:display [ fhir:v "Human Validation" ]
  ] [
fhir:code [ fhir:v "human-correction" ] ;
fhir:display [ fhir:v "Human Correction" ]
  ] [
fhir:code [ fhir:v "ai-transparency-info" ] ;
fhir:display [ fhir:v "AI Transparency Information" ]
  ] [
fhir:code [ fhir:v "patient-information-provided" ] ;
fhir:display [ fhir:v "Patient Information Provided" ]
  ] [
fhir:code [ fhir:v "patient-explanation-requested" ] ;
fhir:display [ fhir:v "Patient Explanation Requested" ]
  ] [
fhir:code [ fhir:v "patient-explanation-provided" ] ;
fhir:display [ fhir:v "Patient Explanation Provided" ]
  ] [
fhir:code [ fhir:v "accuracy" ] ;
fhir:display [ fhir:v "Accuracy" ]
  ] [
fhir:code [ fhir:v "sensitivity" ] ;
fhir:display [ fhir:v "Sensitivity" ]
  ] [
fhir:code [ fhir:v "specificity" ] ;
fhir:display [ fhir:v "Specificity" ]
  ] [
fhir:code [ fhir:v "robustness" ] ;
fhir:display [ fhir:v "Robustness" ]
  ] [
fhir:code [ fhir:v "clinically-validated" ] ;
fhir:display [ fhir:v "Clinically Validated" ] ;
fhir:definition [ fhir:v "The AI system has completed clinical validation." ]
  ] [
fhir:code [ fhir:v "not-clinically-validated" ] ;
fhir:display [ fhir:v "Not Clinically Validated" ] ;
fhir:definition [ fhir:v "The AI system has not completed clinical validation." ]
  ] [
fhir:code [ fhir:v "validation-in-progress" ] ;
fhir:display [ fhir:v "Validation In Progress" ] ;
fhir:definition [ fhir:v "Clinical validation is currently in progress." ]
  ] [
fhir:code [ fhir:v "technical-validation-only" ] ;
fhir:display [ fhir:v "Technical Validation Only" ] ;
fhir:definition [ fhir:v "Only technical or syntactic validation has been performed." ]
  ] [
fhir:code [ fhir:v "triage" ] ;
fhir:display [ fhir:v "Triage and Prioritization" ]
  ] [
fhir:code [ fhir:v "screening" ] ;
fhir:display [ fhir:v "Screening" ]
  ] [
fhir:code [ fhir:v "second-opinion" ] ;
fhir:display [ fhir:v "Second Opinion" ]
  ] [
fhir:code [ fhir:v "diagnostic-support" ] ;
fhir:display [ fhir:v "Diagnostic Support" ]
  ] [
fhir:code [ fhir:v "treatment-planning" ] ;
fhir:display [ fhir:v "Treatment Planning" ]
  ] [
fhir:code [ fhir:v "prognosis" ] ;
fhir:display [ fhir:v "Prognostic Prediction" ]
  ] [
fhir:code [ fhir:v "ce-mark" ] ;
fhir:display [ fhir:v "CE Mark" ] ;
fhir:definition [ fhir:v "Indicates whether the device has a CE mark." ]
  ] [
fhir:code [ fhir:v "notified-body-id" ] ;
fhir:display [ fhir:v "Notified Body ID" ] ;
fhir:definition [ fhir:v "Identifier of the notified body." ]
  ] [
fhir:code [ fhir:v "expected-lifetime" ] ;
fhir:display [ fhir:v "Expected Lifetime" ] ;
fhir:definition [ fhir:v "The expected lifetime of the AI system." ]
  ] [
fhir:code [ fhir:v "medical-purpose" ] ;
fhir:display [ fhir:v "Medical Purpose" ] ;
fhir:definition [ fhir:v "The intended medical purpose." ]
  ] [
fhir:code [ fhir:v "target-population" ] ;
fhir:display [ fhir:v "Target Population" ] ;
fhir:definition [ fhir:v "The intended target population." ]
  ] [
fhir:code [ fhir:v "eu-ai-database-id" ] ;
fhir:display [ fhir:v "EU AI Database Identifier" ] ;
fhir:definition [ fhir:v "Identifier for an AI system registration in the EU AI database or an equivalent AI system registry." ]
  ] [
fhir:code [ fhir:v "primary-use" ] ;
fhir:display [ fhir:v "Primary Use" ] ;
fhir:definition [ fhir:v "Processing for direct patient care." ]
  ] [
fhir:code [ fhir:v "secondary-use" ] ;
fhir:display [ fhir:v "Secondary Use" ] ;
fhir:definition [ fhir:v "Processing for research, AI training, policy making, or other permitted secondary-use purposes." ]
  ] [
fhir:code [ fhir:v "ehr" ] ;
fhir:display [ fhir:v "Electronic Health Records (EHRs)" ] ;
fhir:definition [ fhir:v "Electronic health data from electronic health records (Art. 51 1a)." ]
  ] [
fhir:code [ fhir:v "health-factors" ] ;
fhir:display [ fhir:v "Health Determinants" ] ;
fhir:definition [ fhir:v "Data impacting health, including socioeconomic, environmental and behavioural determinants (Art. 51 1b)." ]
  ] [
fhir:code [ fhir:v "healthcare-resources" ] ;
fhir:display [ fhir:v "Aggregated Healthcare Data" ] ;
fhir:definition [ fhir:v "Aggregated data on healthcare needs, resources, access and financing (Art. 51 1c)." ]
  ] [
fhir:code [ fhir:v "pathogen-data" ] ;
fhir:display [ fhir:v "Pathogen Data" ] ;
fhir:definition [ fhir:v "Data on pathogens impacting human health (Art. 51 1d)." ]
  ] [
fhir:code [ fhir:v "admin-claims" ] ;
fhir:display [ fhir:v "Administrative and Claims Data" ] ;
fhir:definition [ fhir:v "Health-related administrative data, including claims and reimbursement data (Art. 51 1e)." ]
  ] [
fhir:code [ fhir:v "human-genomic" ] ;
fhir:display [ fhir:v "Human Genomic Data" ] ;
fhir:definition [ fhir:v "Human genetic, epigenomic and genomic data (Art. 51 1f)." ]
  ] [
fhir:code [ fhir:v "molecular-omics" ] ;
fhir:display [ fhir:v "Molecular Omic Data" ] ;
fhir:definition [ fhir:v "Other human molecular data, such as proteomic, transcriptomic, metabolomic, lipidomic and other omic data (Art. 51 1g)." ]
  ] [
fhir:code [ fhir:v "device-generated-personal" ] ;
fhir:display [ fhir:v "Device-Generated Personal Data" ] ;
fhir:definition [ fhir:v "Person-generated electronic health data automatically generated by medical devices (Art. 51 1h)." ]
  ] [
fhir:code [ fhir:v "wellness-apps" ] ;
fhir:display [ fhir:v "Wellness Application Data" ] ;
fhir:definition [ fhir:v "Data from wellness applications (Art. 51 1i)." ]
  ] [
fhir:code [ fhir:v "professional-status" ] ;
fhir:display [ fhir:v "Healthcare Professional Data" ] ;
fhir:definition [ fhir:v "Data on the professional status, specialization and institution of healthcare professionals (Art. 51 1j)." ]
  ] [
fhir:code [ fhir:v "public-health-registry" ] ;
fhir:display [ fhir:v "Public Health Registries" ] ;
fhir:definition [ fhir:v "Data from population-wide health data registries (Art. 51 1k)." ]
  ] [
fhir:code [ fhir:v "medical-mortality-registry" ] ;
fhir:display [ fhir:v "Medical and Mortality Registries" ] ;
fhir:definition [ fhir:v "Data from medical registries and mortality registries (Art. 51 1l)." ]
  ] [
fhir:code [ fhir:v "clinical-trial" ] ;
fhir:display [ fhir:v "Clinical Trial Data" ] ;
fhir:definition [ fhir:v "Data from clinical trials, clinical studies and performance studies (Art. 51 1m)." ]
  ] [
fhir:code [ fhir:v "medical-device-other" ] ;
fhir:display [ fhir:v "Other Medical Device Data" ] ;
fhir:definition [ fhir:v "Other health data from medical devices (Art. 51 1n)." ]
  ] [
fhir:code [ fhir:v "medicinal-device-registry" ] ;
fhir:display [ fhir:v "Medicinal and Device Registries" ] ;
fhir:definition [ fhir:v "Data from registries for medicinal products and medical devices (Art. 51 1o)." ]
  ] [
fhir:code [ fhir:v "research-cohort-survey" ] ;
fhir:display [ fhir:v "Research Cohorts and Surveys" ] ;
fhir:definition [ fhir:v "Data from research cohorts, questionnaires and health-related surveys (Art. 51 1p)." ]
  ] [
fhir:code [ fhir:v "biobank" ] ;
fhir:display [ fhir:v "Biobank Data" ] ;
fhir:definition [ fhir:v "Health data from biobanks and associated databases (Art. 51 1q)." ]
  ] [
fhir:code [ fhir:v "representative" ] ;
fhir:display [ fhir:v "Representative" ] ;
fhir:definition [ fhir:v "Data are sufficiently representative of the target population." ]
  ] [
fhir:code [ fhir:v "error-free" ] ;
fhir:display [ fhir:v "Error-Free" ] ;
fhir:definition [ fhir:v "Data are free of errors to the best extent possible." ]
  ] [
fhir:code [ fhir:v "complete" ] ;
fhir:display [ fhir:v "Complete" ] ;
fhir:definition [ fhir:v "Data are complete with regard to the intended purpose." ]
  ] [
fhir:code [ fhir:v "relevant" ] ;
fhir:display [ fhir:v "Relevant" ] ;
fhir:definition [ fhir:v "Data are relevant for the intended purpose." ]
  ] ) . #