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Update app.js
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app.js
CHANGED
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@@ -58,7 +58,7 @@ const STEPS = [
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{
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k: "1e",
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label:
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"Consult health trusts
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req: true,
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showFor: ["research", "quality", "statistics", "innovation"],
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refs: [
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@@ -130,7 +130,7 @@ const STEPS = [
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items: [
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{
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k: "3a",
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label: "REK approval or exemption before research access/use.",
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req: true,
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showFor: ["research"],
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refs: [
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@@ -173,7 +173,7 @@ const STEPS = [
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{
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k: "4a",
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label:
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"Obtain DUA/DSA
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req: true,
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refs: [
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{ title: "HPA §21 (confidentiality)", url: "https://lovdata.no/lov/1999-07-02-64/%C2%A721" },
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@@ -205,7 +205,7 @@ const STEPS = [
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{
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k: "4d",
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label:
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"Use SPE/SAE (e.g., TSD/HUNT Cloud/SAFE). Transfers via secure channels (logging, access control, encryption).",
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req: true,
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refs: [
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{ title: "GDPR Art. 32", url: "https://gdpr-info.eu/art-32-gdpr/" },
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@@ -260,13 +260,13 @@ const STEPS = [
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{
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k: "4g",
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label:
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"Agreement aligns with SPE
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req: true,
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},
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{
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k: "4h",
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label:
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"EHDS alignment for cross-border/secondary use (permit; SPE; permitted purposes).",
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req: false,
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refs: [
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{ title: "EHDS Art. 68 (permit); Arts. 73/75 (SPE); Art. 53 (purposes)", url: "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202500327" }
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@@ -289,7 +289,7 @@ const STEPS = [
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{
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k: "5b",
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label:
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"Encrypted storage in transit/at rest,
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req: true,
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refs: [
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{ title: "GDPR Art. 32", url: "https://gdpr-info.eu/art-32-gdpr/" },
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@@ -306,14 +306,14 @@ const STEPS = [
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{
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k: "5d",
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label:
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"DPIA done before analysis (large-scale health/innovative AI/vulnerable groups) or rationale recorded.",
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req: true,
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refs: [{ title: "GDPR Art. 35", url: "https://gdpr-info.eu/art-35-gdpr/" }],
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},
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{
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k: "5e",
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label:
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"Consult DPO as required; record advice and implement recommendations.",
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req: false,
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refs: [{ title: "GDPR Arts. 37–39", url: "https://gdpr-info.eu/chapter-4/" }],
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},
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@@ -331,7 +331,7 @@ const STEPS = [
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{
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k: "5g",
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label:
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"Transfers outside EEA: lawful mechanism (adequacy/
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req: true,
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refs: [
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{ title: "GDPR Arts. 44–46", url: "https://gdpr-info.eu/chapter-5/" },
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@@ -348,7 +348,7 @@ const STEPS = [
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{
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k: "5i",
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label:
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"Data breach: notify
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req: true,
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refs: [{ title: "GDPR Arts. 33–34", url: "https://gdpr-info.eu/art-33-gdpr/" }],
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},
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@@ -536,7 +536,7 @@ const STEPS = [
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{
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k: "7g",
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label:
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"If developing an AI model: verify permission & GDPR legal basis; remove personal data or ensure vetted/validated use; respect
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req: true,
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showFor: ["research", "quality","innovation"],
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refs: [
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@@ -547,7 +547,7 @@ const STEPS = [
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{
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k: "7h",
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label:
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"If deploying on EU market: conformity/CE/registration in EU AI database where required.",
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req: false,
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showFor: ["research", "quality","innovation"],
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refs: [{ title: "AI Act Arts. 30 & 43", url: "https://ai-act-law.eu/article/30/" }],
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{
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k: "1e",
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label:
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"Consult health trusts data protection officer, retain written rationale.",
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req: true,
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showFor: ["research", "quality", "statistics", "innovation"],
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refs: [
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items: [
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{
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k: "3a",
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label: "Regional committees for medical and health research ethics (REK) approval or exemption before research access/use.",
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req: true,
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showFor: ["research"],
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refs: [
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{
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k: "4a",
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label:
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"Obtain data user or data sharing agreement (DUA/DSA or equivalent) with data provider: scope, purpose, duration, security, confidentiality, post-hoc control, return/destruction.",
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req: true,
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refs: [
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{ title: "HPA §21 (confidentiality)", url: "https://lovdata.no/lov/1999-07-02-64/%C2%A721" },
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{
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k: "4d",
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label:
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"Use Secure Processing or Secure Analysis Environment(SPE/SAE) (e.g., TSD/HUNT Cloud/SAFE). Transfers via secure channels (logging, access control, encryption).",
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req: true,
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refs: [
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{ title: "GDPR Art. 32", url: "https://gdpr-info.eu/art-32-gdpr/" },
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{
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k: "4g",
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label:
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"Agreement aligns with SPE checklists.",
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req: true,
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},
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{
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k: "4h",
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label:
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"European health data space (EHDS) alignment for cross-border/secondary use (permit; SPE; permitted purposes).",
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req: false,
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refs: [
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{ title: "EHDS Art. 68 (permit); Arts. 73/75 (SPE); Art. 53 (purposes)", url: "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202500327" }
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{
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k: "5b",
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label:
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"Encrypted storage in transit/at rest, Role-Based access control, multi-factor authentication, network segregation, key mgmt, logging with risk-based review.",
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req: true,
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refs: [
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{ title: "GDPR Art. 32", url: "https://gdpr-info.eu/art-32-gdpr/" },
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{
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k: "5d",
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label:
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"Data Protection Impact Assessment (DPIA) done before analysis (large-scale health/innovative AI/vulnerable groups) or rationale recorded.",
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req: true,
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refs: [{ title: "GDPR Art. 35", url: "https://gdpr-info.eu/art-35-gdpr/" }],
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},
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{
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k: "5e",
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label:
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"Consult Data Protection Officer (DPO) as required; record advice and implement recommendations.",
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req: false,
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refs: [{ title: "GDPR Arts. 37–39", url: "https://gdpr-info.eu/chapter-4/" }],
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},
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{
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k: "5g",
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label:
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"Transfers outside EEA: lawful mechanism (adequacy/Standard Contractual Clauses/derogations); Transfer Impact Assessment (TIA) documented; approvals/logs kept.",
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req: true,
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refs: [
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{ title: "GDPR Arts. 44–46", url: "https://gdpr-info.eu/chapter-5/" },
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{
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k: "5i",
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label:
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"Data breach: notify national data protection authority (Datatilsynet) within 72h where required; assess duty to inform subjects.",
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req: true,
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refs: [{ title: "GDPR Arts. 33–34", url: "https://gdpr-info.eu/art-33-gdpr/" }],
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},
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{
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k: "7g",
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label:
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"If developing an AI model: verify permission & GDPR legal basis; remove personal data or ensure vetted/validated use; respect intelectual propety/licensing & REK terms.",
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req: true,
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showFor: ["research", "quality","innovation"],
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refs: [
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{
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k: "7h",
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label:
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"If deploying on EU market: conformity/CE marking/registration in EU AI database where required.",
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req: false,
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showFor: ["research", "quality","innovation"],
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refs: [{ title: "AI Act Arts. 30 & 43", url: "https://ai-act-law.eu/article/30/" }],
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