--- title: "AI Act Prohibited Practices, Definition | MedTech Terms" description: "Article 5 practices banned outright in the EU, including subliminal manipulation and untargeted facial-recognition scraping." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ai-act-prohibited-practices#term", "name": "AI Act Prohibited Practices", "description": "Article 5 lists AI practices that are prohibited in the Union, including subliminal or manipulative techniques causing significant harm, exploitation of vulnerabilities, social scoring by public authorities, real-time remote biometric identification in public spaces for law enforcement (with narrow exceptions), untargeted scraping of facial images to build databases, emotion inference at work or school (with medical and safety exceptions), and biometric categorisation inferring sensitive attributes.", "url": "https://medtechterms.com/terms/ai-act-prohibited-practices", "termCode": "ai-act-prohibited-practices", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/ai-act-prohibited-practices#article", "headline": "AI Act Prohibited Practices", "description": "Article 5 practices banned outright in the EU, including subliminal manipulation and untargeted facial-recognition scraping.", "url": "https://medtechterms.com/terms/ai-act-prohibited-practices", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/ai-act-prohibited-practices" }, "about": { "@id": "https://medtechterms.com/terms/ai-act-prohibited-practices#term" }, "articleSection": "Regulatory", "inLanguage": "en", "keywords": "AI Act Prohibited Practices, Regulatory, medical device, MedTech", "author": { "@type": "Person", "name": "Christian Espinosa", "jobTitle": "Founder, Blue Goat Cyber", "url": "https://bluegoatcyber.com" }, "publisher": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "isPartOf": { "@type": "WebSite", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "datePublished": "2026-07-25", "dateModified": "2026-07-25", "citation": [ { "@type": "CreativeWork", "name": "Regulation (EU) 2024/1689, Article 5", "url": "https://eur-lex.europa.eu/eli/reg/2024/1689/oj", "publisher": { "@type": "Organization", "name": "EUR-Lex" } }, { "@type": "CreativeWork", "name": "European Commission - Medical Devices", "url": "https://health.ec.europa.eu/medical-devices-sector_en", "publisher": { "@type": "Organization", "name": "European Commission" } }, { "@type": "CreativeWork", "name": "IMDRF Documents", "url": "https://www.imdrf.org/documents", "publisher": { "@type": "Organization", "name": "IMDRF" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/eu-ai-act#term", "name": "EU AI Act", "url": "https://medtechterms.com/terms/eu-ai-act" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ai-act-high-risk-system#term", "name": "High-Risk AI System (EU AI Act)", "url": "https://medtechterms.com/terms/ai-act-high-risk-system" } ] }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Terms", "item": "https://medtechterms.com/terms" }, { "@type": "ListItem", "position": 3, "name": "Regulatory", "item": "https://medtechterms.com/terms?cat=Regulatory" }, { "@type": "ListItem", "position": 4, "name": "AI Act Prohibited Practices", "item": "https://medtechterms.com/terms/ai-act-prohibited-practices" } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. [Terms](/terms) 3. [Regulatory](/terms?cat=Regulatory) 4. AI Act Prohibited Practices [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[AI / ML in Devices](/ecosystems/ai-ml)[Global Markets](/ecosystems/global-markets) # AI Act Prohibited Practices Article 5 practices banned outright in the EU, including subliminal manipulation and untargeted facial-recognition scraping. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed July 25, 2026 ## Definition Article 5 lists AI practices that are prohibited in the Union, including subliminal or manipulative techniques causing significant harm, exploitation of vulnerabilities, social scoring by public authorities, real-time remote biometric identification in public spaces for law enforcement (with narrow exceptions), untargeted scraping of facial images to build databases, emotion inference at work or school (with medical and safety exceptions), and biometric categorisation inferring sensitive attributes. ## What this means in practice Most MedTech products sit well outside these categories, but emotion-inference features in workplace-wellness or education-adjacent digital health products can trigger the prohibition. The medical-purposes exception is narrow: it applies when emotion inference is genuinely part of a medical device's intended purpose, not a marketing add-on. ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory High-Risk AI System (EU AI Act) AI systems captured by Article 6 of the EU AI Act because they are safety components of regulated products or listed in Annex III. ](/terms/ai-act-high-risk-system)[ Software & AI EU AI Act EU regulation establishing risk-based requirements for AI systems, including most medical AI. ](/terms/eu-ai-act) ### More in Regulatory · Same category [ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Regulatory 510(k) Summary vs 510(k) Statement Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request. ](/terms/510k-summary-vs-statement)[ Regulatory 513(g) Request for Information(513(g)) Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification. ](/terms/513g)[ Regulatory Abbreviated 510(k) 510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards. ](/terms/abbreviated-510k) Cited by Where this term appears across MedTech Terms. Ecosystems (3) - [Regulated Pathways](/ecosystems/regulated-pathways) - [AI / ML in Devices](/ecosystems/ai-ml) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 EUR-Lex· 1 European Commission· 1 IMDRF· 1 1. [1 Regulation (EU) 2024/1689, Article 5 Verified EUR-Lex eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2024/1689/oj) 2. [2 European Commission - Medical Devices Verified European Commission health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector_en) 3. [3 IMDRF Documents Verified IMDRF imdrf.org ](https://www.imdrf.org/documents) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Navigating an FDA or EU MDR submission? Blue Goat Cyber supports the cybersecurity content of premarket submissions, from threat models to the 524B narrative. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Regulatory Sources 3 Updated 7/25/2026 [Compare with another term](/compare?a=ai-act-prohibited-practices) Learn in 60 seconds Card Lesson Quiz Article 5 practices banned outright in the EU, including subliminal manipulation and untargeted facial-recognition scraping. - · Most MedTech products sit well outside these categories, but emotion-inference features in workplace-wellness or education-adjacent digital health products can trigger the prohibition. - · The medical-purposes exception is narrow: it applies when emotion inference is genuinely part of a medical device's intended purpose, not a marketing add-on. Remember this Article 5 practices banned outright in the EU, including subliminal manipulation and untargeted facial-recognition scraping. Related terms - [EU AI Act ](/terms/eu-ai-act) - [High-Risk AI System (EU AI Act) ](/terms/ai-act-high-risk-system) You may also need Auto-suggested from Regulatory and shared keywords. - [AI Act Serious Incident Reporting ](/terms/ai-act-serious-incident-reporting) - [Fundamental Rights Impact Assessment(FRIA) ](/terms/ai-act-fria) - [General-Purpose AI Model(GPAI) ](/terms/ai-act-gpai) - [In-House IVDs (Article 5(5)) ](/terms/ivdr-in-house-devices) - [Performance Study Application (IVDR) ](/terms/ivdr-performance-study-application) - [PMA Supplement Types ](/terms/pma-supplement-types) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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