High-Risk AI System

An AI system that is either listed in Annex III or otherwise meets the Act’s criteria (Article 6) for placing individuals' safety or fundamental rights at elevated risk; such systems are subject to mandatory risk-management, data governance, technical documentation, human oversight, robustness requirements and conformity assessment before market placement. High-risk classification triggers registration in the EU database and ongoing post-market monitoring and reporting obligations.

An artificial intelligence system that makes, or is a substantial factor in making, a consequential decision. Consequential decisions include those related to education, employment, financial services, housing, insurance, legal services, or healthcare. Developers and deployers of high-risk AI systems must use reasonable care to avoid algorithmic discrimination.

An automated decision system that poses a significant risk of harm to individuals or groups. High-risk determinations consider factors including the system purpose, reach, data sensitivity, and potential for irreversible harm. Organizations deploying high-risk AI must conduct impact assessments and implement appropriate safeguards.

An AI system assessed as high-risk where a combination of the severity and likelihood of potential harms from its outputs or decisions, the scale of affected persons or systems, and the deployment context (e.g., safety-critical systems, decisions affecting legal rights, health, essential services or economic functions) indicate material risk; the classification applies across the AI lifecycle (development, testing, deployment, monitoring, decommissioning).

An AI system whose intended use falls within the domains and use-cases exhaustively listed in Annex III and which, by virtue of that use, poses significant risks to health, safety, or fundamental rights. High-risk systems are subject to mandatory conformity assessments, detailed lifecycle obligations (risk management, data governance, documentation, human oversight, logging, and post-market monitoring) before being placed on the Union market or put into service.

AI systems designated under a risk-based approach consistent with the EU AI Act as posing significant risks to health, safety or fundamental rights — e.g., systems used in healthcare, safety-critical infrastructure, HR selection, biometric identification or law enforcement — and therefore subject to enhanced conformity assessment, documentation and market surveillance requirements.

An AI system that falls within the EU and national high-risk categories established by the draft and applicable EU Regulation; such systems are subject to mandatory risk management, conformity assessments, technical documentation, registration, and enhanced post-market monitoring. The designation is determined by sector- and use-based lists aligned with the EU AI Regulation and any national additions.

An AI system identified in Annex III or otherwise determined to present substantial risks to health, safety or fundamental rights in specific application areas (e.g., critical infrastructure, employment, law enforcement, migration); such systems are subject to mandatory requirements including risk-management, data governance, technical documentation and conformity assessment obligations.

An AI system whose deployment or outputs have substantial potential to affect fundamental rights, critical public functions, safety, or essential services; classification is outcomes-oriented and triggers additional obligations such as impact assessments, registration and independent audits.

AI systems defined as those that pose significant potential to affect fundamental rights, public safety, health, or critical infrastructure; these systems are subject to stricter requirements including registration, algorithmic impact assessments, conformity assessments, certification, and ongoing monitoring.

AI systems identified as having the potential to significantly affect fundamental rights or critical public or private functions. The policy uses this risk-based classification to prioritize such systems for additional safeguards, testing, conformity assessment and sectoral regulation.

An AI system classified as high-risk where its deployment or outputs have a significant potential to impact individuals' rights, safety, or fundamental freedoms (for example intrusive biometric surveillance or socially intrusive scoring), triggering enhanced obligations such as DPIAs, conformity assessments, registration, pre-deployment testing, and stricter oversight.

AI systems classified as having significant potential impacts on fundamental rights, safety, or critical decision‑making; such systems are subject to stricter risk assessments, pre‑deployment evaluation, registration, enhanced oversight, and other compliance obligations.

AI systems deployed in critical sectors such as healthcare, education, justice, and employment where errors or failures could significantly affect individuals' rights, safety, or access to essential services. Under ENIA these systems are subject to rigorous pre-deployment evaluations, ongoing monitoring, and stricter governance measures.

A category of AI systems identified by the law as posing substantial risk to fundamental rights, public safety, or critical infrastructure; such systems will be subject to enhanced obligations (risk assessment, monitoring, transparency, and mitigation) and stricter compliance requirements throughout their lifecycle.

An AI system identified in Annex III whose intended use poses significant risk to health, safety or fundamental rights and which is therefore subject to mandatory requirements (e.g., data governance, documentation, human oversight), conformity assessment procedures and registration before being placed on the Union market.

AI systems identified under the AI Act and adopted in transposition as those used in safety-critical or rights-sensitive contexts (e.g., biometric identification, critical infrastructure, employment, healthcare) that can materially affect health, safety or fundamental rights; such systems are subject to mandatory conformity assessment, documentation, registration and stricter governance and oversight obligations.

An AI system whose intended use is listed in Annex III of the Act and that poses significant risks to health, safety or fundamental rights; such systems are subject to stringent requirements including risk management, data governance, documentation, human oversight, conformity assessment and registration. The classification determines which systems must undergo mandatory assessments and surveillance.

AI systems whose intended use or context creates a high potential for adverse impacts on health, safety, or fundamental rights (e.g., in critical infrastructure, employment, biometric identification, or essential public services). Such systems are proposed to be subject to mandatory obligations like technical documentation, conformity assessment, human oversight, and transparency measures across their lifecycle.

AI systems classified as 'high-risk' are those deployed in contexts (e.g., critical infrastructure, law enforcement, employment, education, healthcare, biometric identification) where malfunction or misuse can lead to significant harm to safety or fundamental rights; such systems are subject to enhanced conformity assessment, oversight and mitigation measures under the Communication's risk-based approach.

AI systems posing high risks to health, safety, and fundamental rights, classified in accordance with Article 6 of the AI Act in conjunction with Annexes I and III. These systems are subject to stringent requirements and obligations.

An AI system that falls within the list in Annex III of the Act or constitutes a safety component of a product covered by Annex I, thereby triggering mandatory requirements including risk management, data governance, technical documentation, human oversight, conformity assessment, registration and post‑market monitoring before being placed on the EU market.

AI systems identified under Annex III of the EU AI Act that pose significant risks to health, safety, or fundamental rights.

AI systems that have significant potential impacts on fundamental rights, safety, or important societal functions; these systems are subject to stricter oversight and compliance measures consistent with EU/EEA frameworks. The Action Plan adopts the EU/OECD-aligned concept to guide assessments and prioritisation of regulatory and ethical safeguards.

AI systems classified as high-risk are those deployed in sectors or use-cases where their operation can materially affect health, safety, or fundamental rights (e.g., critical infrastructure, healthcare, judicial or biometric identification). The Strategy adopts the EU-aligned conception and emphasizes mapping, assessment, and specific governance measures for such systems.

AI systems identified by the Plan as posing substantial potential harm to individuals, property or public interest; such systems are subject to mandatory measures including registration, pre-deployment impact assessments, third-party conformity assessment and enhanced monitoring. The classification triggers stricter governance, certification and reporting requirements.

Systems and specific use-cases listed in Annex III whose operation may materially impact health, safety or fundamental rights; providers of these systems must implement comprehensive risk‑management, data governance, technical documentation, human oversight and resilience measures, undergo conformity assessment and affix CE marking before placing them on the market.

An AI system classified by the law as having the potential to cause substantial harm to individuals, groups, or public interests; such systems are subject to enhanced requirements including impact assessments, mitigation measures, documentation, and monitoring proportional to their risk profile.

An AI system whose operation can materially affect fundamental rights, access to public services, legal status or core economic entitlements; such systems trigger mandatory impact assessments, pre‑deployment conformity checks, periodic audits and entry in the national registry. The bill explicitly includes sensitive categories (e.g., biometric identification, credit scoring, health diagnostics, employment decisions, and public‑sector adjudications) as examples of high‑risk uses.

An AI system category identified by the draft as presenting substantial risks to safety, fundamental rights, public order or other critical interests; such systems are subject to enhanced obligations including risk assessments, conformity procedures and registration with the national registry. The classification is risk-based and tied to enumerated sectors/uses specified in the bill (e.g., biometric, judicial, safety-critical applications).

AI applications identified as having a significant potential to cause harm or affect fundamental rights, such as systems used in medical diagnostics, financial credit decisions, law enforcement, employment, and educational assessments. High-risk classification triggers enhanced oversight, registration, pre-deployment testing, periodic audits, and mandatory compliance measures.

An AI system classified by SDAIA's risk model as posing significant potential harm to individuals, groups, or societal values, thereby triggering mandatory documentation, impact assessments, validation/testing regimes, and heightened governance and assurance measures. High-risk systems require demonstrable mitigation measures and may be subject to external assessment and sectoral regulator oversight.

AI systems identified as high‑risk under the EU AI Regulation and adopted by the draft—those that may significantly affect health, safety or fundamental rights and therefore must undergo conformity assessment, be registered, maintain technical documentation, and implement risk‑management and post‑market monitoring.

AI systems identified as having significant potential to impact individuals' fundamental rights, health, safety, or essential societal functions; such systems require enhanced scrutiny, more rigorous assessments, and additional safeguards.

AI systems explicitly listed in Annex III of the Regulation because they pose significant risks to health, safety or fundamental rights. Providers of these systems must comply with mandatory requirements on data governance, risk management, human oversight, robustness, cybersecurity, technical documentation, logging, conformity assessment, registration and post‑market monitoring before placing them on the Union market.

A category adopted from the EU AI Act comprising AI systems that pose significant risks to health, safety, or fundamental rights and are therefore subject to mandatory requirements (e.g., risk management, technical documentation, conformity assessment, registration and post‑market monitoring). The draft uses this term to identify systems that must follow the Act’s prescriptive compliance regime.

AI systems whose deployment is assessed to create substantial risks to individuals, public interest, critical infrastructure, or societal functions and which therefore trigger enhanced obligations such as pre-deployment impact/risk assessments, mitigation measures, documentation, registration or conformity assessment under the draft.

AI systems that, by virtue of their purpose, deployment context, or potential impacts, can create significant risk to safety, health, fundamental rights or other serious harms; examples include medical diagnostic tools, autonomous vehicles, and systems used in justice processes. The bill requires differentiated regulatory requirements, registration and conformity procedures for such systems.

An AI system classified by the Act as posing a high risk to health, safety, or fundamental rights and listed in its Annexes; such systems are subject to stringent lifecycle requirements including data governance, technical documentation, human oversight, robustness, and mandatory conformity assessment prior to market placement.

AI systems or uses classified by the bill as presenting significant risks to fundamental rights, safety, or democratic principles and consequently subject to mandatory requirements including documented risk-management systems, pre-deployment conformity checks, continuous monitoring, lifecycle impact assessments and prescribed mitigation measures.

A category within the bill's risk taxonomy (unacceptable, high, limited, minimal) denoting systems whose operation poses substantial or material risks to fundamental rights, triggering stricter obligations such as mandatory impact assessments, deeper testing, third-party auditability and prior notification to authorities.

Systems classified by the draft as posing substantial potential impact on fundamental rights or public interests; such classification triggers enhanced obligations (e.g., impact assessments, registration, audits, and third-party conformity assessment). The bill sets criteria and a tiered framework to determine high-risk status across sectors and applications.

A category of AI systems that, by their purpose, scope or impact, have significant potential to affect fundamental rights, health, safety or socioeconomic conditions; such systems are subject to mandatory impact assessments, registration or conformity assessment, enhanced monitoring, and periodic audits under the bill.

An AI system classified as posing significant potential for harm or public impact under the bill's risk-tiering framework; such systems are subject to mandatory impact assessments, conformity assessments, pre-deployment authorization or conditional approval, enhanced documentation, human oversight requirements and periodic audits.

An AI system classified by the law as presenting a high risk to fundamental rights, safety, or public interest, including systems used in critical infrastructure, health-related inference, law enforcement, migration controls, education and employment decision-making, and biometric recognition. High-risk designation triggers mandatory prior registration, human-rights impact assessment, pre-market evaluation and enhanced monitoring and documentation obligations.

AI systems that are listed in Annex III or otherwise identified by the Regulation as posing significant risks to health, safety or fundamental rights; such systems are subject to mandatory requirements including risk management, data governance, technical documentation, human oversight, robustness measures, conformity assessment and registration in the EU database.

AI systems whose deployment or application can substantially affect fundamental rights, safety, or critical public functions; identified through a risk-based classification aligned with EU frameworks and subject to stricter oversight, documentation, and conformity requirements. The Blueprint recommends aligning Greece's definition with the EU AI Act to determine which systems trigger mandatory assessments and controls.

A category of AI systems to be defined and classified in the law's executive by-laws that covers systems whose deployment may substantially affect health, safety, fundamental rights, or other critical public interests (e.g., certain healthcare, biometric, or critical infrastructure applications), triggering enhanced oversight, licensing, and compliance requirements.

An AI system that falls within the categories referenced in Annex III of the EU AI Act (e.g., critical infrastructure, education, employment, law enforcement, migration, biometric identification, healthcare, essential services) and is therefore subject to mandatory conformity assessment, risk management, and stricter compliance requirements under this law.

AI systems framed by the Strategy (aligned with contemporary EU terminology) as posing significant risks to health, safety or fundamental rights, and therefore subject to stricter oversight, monitoring, and potential regulatory or compliance measures under national and EU frameworks.

AI systems classified as high‑risk based on criteria from Regulation (EU) 2024/1689 and national extensions; such systems are subject to mandatory risk assessments, documentation, conformity assessment, technical testing, and ongoing market surveillance as defined by the law and subsequent delegated decrees.

An AI system classified as 'high-risk' because, by its intended purpose, it may cause significant harm to health, rights, public order, or other protected interests; owners/operators of such systems have enhanced obligations for risk identification, assessment, mitigation, testing and continuous monitoring.

AI systems whose operation can substantially affect consequential decisions (e.g., those affecting legal rights, access to government services, or costs), triggering heightened oversight, approval, and mitigation requirements under the statute.

An AI system classified under the Bill as operating in sensitive domains (e.g., health, justice, social services) or otherwise materially affecting Moroccan residents or critical infrastructure; such systems are subject to enhanced obligations including pre-deployment conformity assessments, monitoring, and stricter oversight.

AI applications or systems identified as having a demonstrable potential to significantly impact fundamental rights, health, safety, or fair access (examples cited include certain healthcare diagnostics, biometric identification, criminal justice tools, and critical infrastructure). The appreciation calls for targeted, legally binding measures, mandatory impact assessments, documentation, conformity assessment and enhanced supervision for such systems.

AI systems that are either listed in the Act's annexes or are used in contexts that significantly affect health, safety or fundamental rights (e.g., critical infrastructure, education, employment, law enforcement, biometric identification); such systems are subject to mandated risk-management, conformity assessment, documentation and registration requirements.

AI applications anticipated to be designated in implementing regulations as posing significant risks to health, safety, fundamental rights, or public welfare—examples include medical diagnostic systems, financial credit scoring, law enforcement and judicial applications, critical infrastructure management, and educational assessment—subject to heightened licensing, certification, and oversight requirements.

AI systems identified by the Guideline as likely to cause significant adverse impacts on individuals, financial stability, or market integrity; these systems are subject to enhanced scrutiny, stricter risk-management controls, greater disclosure obligations, and prior QCB approvals.

A legal category for AI applications whose deployment or use poses a significant risk to life, bodily integrity, property, or fundamental rights; examples include biometric identification, critical infrastructure controls, personnel assessment, emergency services, credit/essential services, and state investigative/immigration uses. Systems so classified trigger enhanced obligations such as pre-deployment impact assessments, mandatory technical safeguards, heightened transparency, ongoing monitoring, and detailed documentation.

An AI system classified as 'high‑risk' when it is connected to regulated goods or safety components or when its use falls within designated sensitive sectors (e.g., biometrics, critical infrastructure, education, employment, access to essential services, migration, justice, and democratic processes). Such systems are subject to mandatory risk management, human oversight, technical documentation, conformity assessment and, where applicable, CE marking under the draft law.

AI systems which, by their sector or intended purpose, present significant risk to health, safety or fundamental rights and are therefore subject to enhanced requirements (e.g., conformity assessment, human oversight, documentation and post-market monitoring) under the Decree and the EU AI Act.

An AI system identified by function or as an AI component of a regulated product (listed in the Act's Annexes) that poses significant risks to health, safety or fundamental rights and is therefore subject to mandatory conformity assessment, risk-management, documentation and post‑market obligations.

Systems whose design, deployment or outputs may significantly affect fundamental rights or democratic processes, and which therefore attract stronger regulatory duties, such as enhanced transparency, conformity assessment and oversight obligations.

Defined in the AI Act (Annex III) as systems used in critical sectors or functions that create substantial risks to individuals’ rights or safety. High-risk systems are subject to stricter obligations including conformity assessment, documentation, transparency and post-market monitoring.

AI systems that pose significant risks to health, safety, or fundamental rights, requiring strict conformity assessments and human oversight.

'High-risk AI systems' are those identified in Annexes to the AI Act, posing significant risks to health, safety, or fundamental rights, and are subject to stringent requirements.

Under the EU AI Act, a 'high-risk AI system' is an AI system that either functions as a safety component of a product covered by specific EU harmonization legislation or is used in critical areas like biometric identification, critical infrastructure, or law enforcement, posing significant risks to individuals.

High-risk AI systems are those identified in the EU AI Act as having the potential to cause significant harm to people's health, safety, or fundamental rights. These include AI systems used in critical infrastructure, education, employment, law enforcement, migration, and the administration of justice, or those used as safety components of products. They are subject to stringent requirements, including conformity assessments, risk management, and human oversight.

AI systems explicitly listed in Annex III of the EU AI Act, including applications in critical infrastructure, education, employment, law enforcement, and justice, requiring extensive obligations due to their potential impact on safety and fundamental rights.

High-risk AI systems are those classified under the EU AI Act due to their potential to cause significant harm to health, safety, or fundamental rights. The KI-MIG details national procedures for their conformity assessment, risk management, and human oversight.

AI systems identified under the AI Act as posing significant risks to health, safety, or fundamental rights, subject to stricter requirements and conformity assessments.

AI systems identified as posing significant potential harm to health, safety, or fundamental rights, including those used as safety components in products or in critical areas like biometric identification, critical infrastructure, education, employment, and law enforcement.

AI systems classified under the EU AI Act taxonomy (notably Articles 6–8 and the Annexes) as posing a significant risk to health, safety or fundamental rights, and therefore subject to mandatory conformity assessments, technical documentation, risk‑management and supervisory obligations at EU or national level.

A High‑Risk AI System is any AI whose deployment or outputs may substantially affect individuals' health, safety, fundamental rights or the outcomes of administrative procedures; such systems are eligible for stricter lifecycle governance, additional testing, validation and conformity assessment requirements. The Secretariat may classify categories as high‑risk and impose proportional compliance paths and oversight measures.

AI systems that have substantial potential to affect fundamental rights, safety, or public interests; the draft gives examples such as automated diagnostic tools, biometric identification systems, decision support for social benefits or immigration, and critical‑infrastructure control systems.

AI systems that are identified in Annex III as posing significant risks to health, safety or fundamental rights, including systems used in critical sectors; these systems are subject to enhanced obligations such as mandatory risk‑management, data governance, testing, human oversight, logging, conformity assessment and registration prior to market placement.

AI systems whose purpose or foreseeable impact affects fundamental rights or critical societal functions—such as systems used in health, criminal justice, employment, credit scoring or essential public services—and which are therefore subject to mandatory DPIAs, third‑party conformity assessment, pre‑deployment certification, registration and heightened monitoring requirements under the bill.

An AI system whose design, intended purpose or deployment may significantly affect fundamental rights, safety, health, economic or other critical interests and therefore requires heightened oversight; high‑risk systems trigger obligations such as mandatory impact assessments, documentation, registration and, where applicable, third‑party conformity assessment. High risk is determined by criteria set out in the bill and sectoral specifications.

AI systems falling within the Annexes and criteria of the EU AI Act as adopted into national implementation, which under LN 226 are subject to mandatory risk management, technical documentation, conformity assessment, registration, post‑market monitoring and enhanced transparency and oversight obligations by providers and importers.

A category in the draft risk‑based framework for AI systems whose intended use or potential impacts pose significant risks to fundamental rights, safety, health, critical infrastructure, or other protected interests; such systems are subject to prior conformity assessment, registration, impact assessment, and stricter governance measures. The drafts specify examples and regulatory obligations tied to this classification.

AI systems classified as posing material risks to life, safety, health, or fundamental rights, typically used in critical sectors such as energy and water, medical care and medical devices, critical infrastructure, employment and credit decisions, transport, and public sector systems. High‑risk designation triggers mandatory duties like impact assessments, prior verification/confirmation, safety testing, stricter transparency, documentation, monitoring, and incident reporting.

Any AI system classified under the bill's risk‑level framework as presenting a high expected risk to fundamental labor rights, workplace health or non‑discrimination; such systems are subject to enhanced obligations (e.g., registration, conformity assessment, third‑party audits, and stricter documentation and impact assessment requirements). The bill also distinguishes other tiers (null/low, limited, unacceptable) within its risk classification scheme.

An AI system classified as high‑risk under the categories listed in Annex III (e.g., safety components, critical infrastructure, biometric identification, employment decisions, essential services), which must meet detailed requirements including risk management, dataset quality, technical documentation, human oversight, conformity assessment and registration before being placed on the market.

Systems falling into categories listed in the EU AI Act and transposed by national implementing measures; by virtue of their intended use they pose significant risks to health, safety, fundamental rights or other regulated interests and are therefore subject to enhanced conformity requirements, oversight and market surveillance.

An AI system designated as high‑risk based on sectoral lists aligned with the EU AI Regulation; such systems are subject to stringent obligations including data governance, technical documentation, risk management, human oversight, conformity assessment, CE‑type marking, and registration.

AI systems that, by intended purpose and impact (including those listed in the Act's Annexes), present significant risks to health, safety or fundamental rights and are therefore subject to mandatory risk management, data governance, technical documentation, human oversight, conformity assessment and registration requirements.

Systems listed in Annex III or otherwise designated as high‑risk because they pose significant risks to health, safety or fundamental rights; they are subject to extensive pre‑market and post‑market obligations including risk management, data governance, technical documentation, human oversight, conformity assessment and mandatory registration.

AI systems that are specifically intended to autonomously make, or be a substantial factor in making, consequential decisions that have a material legal, or similarly significant, effect on the provision or denial to any consumer of critical services or opportunities. (While explicitly defined in other Virginia AI legislation like HB 2094, the Commission's mandate to prevent discrimination implicitly covers such systems).

High-risk AI systems are those identified by regulatory frameworks, such as the EU AI Act, as having the potential to cause significant harm to health, safety, or fundamental rights. These systems are subject to stringent requirements regarding conformity assessment, risk management, and market surveillance.

AI systems that pose a significant risk of harm to the fundamental rights, safety, or well-being of individuals, or to critical infrastructure, national security, or democratic institutions, triggering enhanced requirements for risk management, transparency, testing, and oversight. The determination is based on severity and probability of harm, context of use, and mitigation measures.

AI systems identified based on their potential to cause significant harm to health, safety, fundamental rights, or critical infrastructure, necessitating stricter regulatory oversight and compliance requirements.

High-risk AI systems are those identified under the AI Act as posing significant risks to fundamental rights and safety, necessitating stricter regulatory requirements. These systems are subject to rigorous conformity assessments, risk management systems, human oversight, and robust data governance to mitigate potential harms.

AI systems that could directly affect individuals' lives or rights in critical areas such as healthcare, justice, credit rating, public safety, or employment decisions, and are subject to stricter regulatory requirements.

High-risk AI systems are those classified as posing significant risks to the health, safety, or fundamental rights of individuals, as detailed in Annex III of the EU AI Act. These systems are subject to stringent requirements and conformity assessments due to their potential impact in critical sectors.

While not explicitly defined, the strategy acknowledges the need for future legislation to differentiate between various types of AI systems, their risk levels, and specific applications, mirroring international trends in AI governance. This implies a future classification of 'high-risk AI systems' that will be subject to more rigorous controls.

These systems are subject to stringent requirements under the EU AI Act, including conformity assessments, risk management systems, human oversight, and robust data governance. Nkom will primarily focus on market surveillance for these systems.

These systems are categorized into two types: AI used as safety components in critical infrastructures or products covered by EU product safety legislation, and AI used in sensitive areas like employment, education, law enforcement, migration, and justice. They require robust risk assessment, high-quality datasets, logging, documentation, human oversight, and cybersecurity.

AI systems covered by Annex III of the AI Act that are subject to mandatory requirements under the AI Act; these systems are the focus of mandatory documentation, conformity, and oversight obligations, and are within the remit of Article 77 authorities when fundamental‑rights issues arise.