Artificial Intelligence in Australia
High-risk AI
Law / proposed law in Australia
Australia has not enacted a standalone, comprehensive AI Act or another generally applicable AI-specific statute equivalent to the European Union’s AI Act. The current Australian approach is to apply existing technology-neutral laws, sector-specific regulation, enforceable online-safety instruments, public-sector policy and voluntary responsible-AI guidance. Whether a rule applies turns on the use case, the data and parties involved, the sector, the deployment model and the system’s effects.
The National AI Plan, released in early December 2025, sets the Australian Government’s policy direction around three objectives: capturing the opportunity, spreading the benefits, and keeping Australians safe. For regulation, the Government’s stated preference is to build on existing legal and regulatory frameworks. Targeted intervention may still be considered where existing frameworks cannot adequately address a demonstrated risk.
On 15 July 2026, Prime Minister Anthony Albanese announced proposed Australian Standards for AI and the establishment of an Office of AI within the Department of the Prime Minister and Cabinet. The proposal is expected to be considered by National Cabinet in August 2026, with legislation expected in early 2027, and may result in a more targeted mandatory framework for aspects of AI regulation in Australia.
Existing laws potentially relevant to AI include the Privacy Act 1988 (Cth), the Australian Consumer Law, competition law, copyright and other intellectual-property laws, breach of confidence, contract law, defamation, anti-discrimination law, employment and workplace-surveillance law, work health and safety law, product-liability law, directors’ duties, criminal and cybercrime law, the Online Safety Act 2021 (Cth), the Security of Critical Infrastructure Act 2018 (Cth), administrative law, financial-services and prudential regulation, health and therapeutic-goods regulation, education law and state and territory privacy, health-records, surveillance and public-sector laws. The list is not exhaustive, and no single regime governs all AI activity.
AI.gov.au was published in May 2026 as the consolidated Australian Government portal for responsible-AI guidance, tools and resources. It is operated through the National AI Centre within the Department of Industry, Science and Resources.
Automated decision-making transparency under the Privacy Act
From 10 December 2026, an Australian Privacy Principle (APP) entity must include additional information in its privacy policy under APPs 1.7–1.9 where it has arranged for a computer program to make a decision, or to do a thing substantially and directly related to making a decision, that could reasonably be expected to significantly affect an individual’s rights or interests, and personal information about the individual is used in operating that program. The policy must describe the kinds of personal information used, the kinds of decisions made solely by those programs and the kinds of decisions for which those programs do something substantially and directly related to making the decision.
These are transparency obligations. They do not, by themselves, create a general right not to be subject to automated decision-making. The Office of the Australian Information Commissioner (OAIC) consulted on implementation guidance in May 2026; the final guidance should be checked before the provisions commence.
State and territory overlays
State and territory laws can be material, particularly for public-sector, health, education, law-enforcement, surveillance and workplace uses. Relevant overlays may include privacy and health-records statutes, information-sharing laws, surveillance-device and workplace-surveillance legislation, public-records requirements, anti-discrimination law and sector-specific governance duties.
Regulatory guidance / voluntary codes in Australia
The current Australian Government framework for voluntary responsible-AI adoption is the National AI Centre’s Guidance for AI Adoption, which was released in October 2025 and is now hosted through AI.gov.au. It is available in a foundations version for early or lower-risk adoption and an implementation-guidance version for more complex or higher-risk uses. The guidance includes an AI screening tool, AI policy guide and template, AI register template and a glossary. The framework is organised around six essential practices:
- Decide who is accountable;
- Understand impacts and plan accordingly;
- Measure and manage risks;
- Share essential information;
- Test and monitor; and
- Maintain human control.
These practices are voluntary and non-binding guidance. They are designed to help organisations operationalise responsible AI consistently with existing Australian laws and risk-management expectations; they do not create an independent cause of action or substitute for sector-specific legal analysis.
Australia’s AI Ethics Principles were published in November 2019. The Voluntary AI Safety Standard, published in September 2024, later expressed responsible-AI practices through ten voluntary guardrails. The current six-practice Guidance for AI adoption is now the principal economy-wide Australian Government responsible-AI adoption guidance. References to the ten guardrails should therefore be understood as historical rather than as the current government framework.
In September 2024, the Department of Industry, Science and Resources released a proposals paper on mandatory guardrails for AI in high-risk settings. The Government has since stated that it will not proceed with those proposals at this time. The paper is therefore a historical consultation document, not law and not a currently progressing legislative regime. Its suggested high-risk criteria may still be useful as background policy material, but they must not be expressed as mandatory obligations.
The Productivity Commission’s final report, Harnessing data and digital technology, issued on 10 December 2025, recommends that AI-specific regulation be used only as a last resort where existing regulatory frameworks cannot be sufficiently adapted to handle AI related harms and technology-neutral regulation is infeasible or cannot adequately mitigate the risks. That recommendation expressly addresses the previous mandatory-guardrails proposal.
Privacy, automated decision-making and cyber guidance
On 21 October 2024, the OAIC released guidance for organisations using commercially available AI products and separate guidance for developers training or adapting generative-AI models. The OAIC emphasises that Privacy Act obligations may apply to personal information in prompts, training or fine-tuning data, system logs or other records where they contain personal information and outputs, including inferred, inaccurate or artificially generated information where it is about an identified or reasonably identifiable individual. The OAIC advises AI developers to take reasonable steps to ensure accuracy in generative AI models, such as implementing quality assurance controls to mitigate the risk of biased or inaccurate output prior to release. Public availability of data does not, by itself, establish that collection or use for model training is lawful.
The Commonwealth Ombudsman’s Automated Decision-Making Better Practice Guide was updated in March 2025 in collaboration with the OAIC and the Attorney-General’s Department. It addresses legality, procedural fairness, transparency, accountability, reviewability and system governance in government decision-making. In January 2026, the OAIC also reported on agencies’ publication of automated-decision operational information under the Freedom of Information Act 1982 (Cth) Information Publication Scheme.
On 23 May 2025, the Australian Signals Directorate’s Australian Cyber Security Centre and international counterparts published AI data-security guidance. It addresses risks across the AI lifecycle, including data-supply-chain compromise, maliciously modified or poisoned data, data drift, provenance, access controls, secure storage and integrity protection.
Commonwealth Government use
Version 2.0 of the Policy for the responsible use of AI in government took effect on 15 December 2025. It applies to non-corporate Commonwealth entities subject to specified exclusions, including defence and national-intelligence contexts, and corporate Commonwealth entities are encouraged to adopt it. The policy requires, among other things, accountable officials, transparency statements, a strategic AI-adoption position, operational governance, accountable use-case owners, internal use-case registers, staff training and impact assessment. Additional senior governance applies to higher-risk in-scope uses. These are government-policy requirements, not general economy-wide law.
The Australian Government released the AI Plan for the Australian Public Service 2025 on 12 November 2025. It is organised around the pillars of Trust, People and Tools and aims to expand safe AI capability, access and adoption across the Australian Public Service.
Appointed supervisory authority in Australia
Australia has not appointed a single statutory authority with general enforcement jurisdiction over all AI systems. There is no central Australian AI regulator equivalent to an authority administering a comprehensive AI Act.
The Australian AI Safety Institute has been announced as a key National AI Plan action and sits within the Department of Industry, Science and Resources. It replaced the previously planned AI Advisory Body, which was discontinued in February 2026. It is intended to perform technical analysis, monitoring, testing and policy-support functions and to support government agencies and existing regulators. It is not an enforcement regulator and does not displace statutory regulators or alter their legal remits.
Existing regulators continue to supervise AI-related conduct within their statutory mandates. Depending on the use case, they include the OAIC for privacy and freedom of information; the Australian Competition and Consumer Commission (ACCC) for competition and consumer protection; the eSafety Commissioner for online safety; the Australian Securities and Investments Commission (ASIC) and the Australian Prudential Regulation Authority (APRA) for financial services, markets and prudential and operational-risk matters; the Therapeutic Goods Administration (TGA) and health regulators for therapeutic goods, medical devices and health uses; workplace, safety and anti-discrimination bodies; cyber security and critical-infrastructure authorities; ombudsmen and administrative-review bodies; and state and territory regulators. A single AI deployment may engage several regulators concurrently.
Definitions in Australia
Australian legislation does not presently contain a single, generally applicable statutory definition of ‘AI system’, ‘AI technology producer’, ‘provider’, ‘deployer’ or ‘user’ for all purposes. Definitions can instead arise within particular statutes, contracts, technical standards or sector-specific rules and must be read in their own context.
The National AI Centre’s current terms page uses an Organisation for Economic Co-operation and Development (OECD)-aligned concept of an AI system: a machine-based system that infers from inputs how to generate outputs, such as predictions, content, recommendations or decisions, capable of influencing physical or virtual environments; AI systems differ in autonomy and post-deployment adaptiveness. The guidance also uses the following non-statutory role descriptions:
- AI deployer: an individual or organisation that supplies or uses an AI system to provide a product or service, whether internally or externally.
- AI technology producer: an organisation or entity that designs, develops, tests and provides AI technologies such as models and components.
- AI platform, product or service provider: an organisation or entity that provides products or services using one or more AI systems.
- AI user: an entity that uses or relies on an AI system.
The OAIC distinguishes the underlying model from the broader AI system in which it is deployed. As an explanatory matter, that broader system may also encompass data, software, interfaces and operational processes. Governance controls and human decision points may be important components of a deployment, but they should be identified as contextual system-design features rather than presented as a verbatim OAIC definition.
Prohibited activities in Australia
Australia has not enacted a comprehensive list of prohibited AI practices equivalent to the prohibited-practices regime in the European Union AI Act. AI-enabled conduct may nevertheless be prohibited, restricted or actionable under existing laws.
Existing legal prohibitions and restrictions
Depending on the facts, existing law may prohibit or regulate unlawful collection, scraping, use or disclosure of personal information; misuse of biometric information; serious invasion of privacy; misleading representations and unfair consumer practices; unlawful discrimination; defamation; copyright infringement; breach of confidence; unauthorised surveillance or workplace monitoring; computer offences, malware and unauthorised access; child sexual exploitation material; financial or professional services supplied without required authorisation; unsafe therapeutic goods or medical devices; and unlawful or procedurally unfair government decision-making.
Online-safety codes, standards and enforcement
The Online Safety Act 2021 (Cth) supports mandatory industry codes and standards for sections of the online industry. The Online Safety Codes and Standards regulate online activities involving class 1 and class 2 material. Phase 1, now referred to as the Unlawful Material Codes and Standards, focuses on class 1A and class 1B material, including seriously harmful content such as child sexual exploitation material, pro-terror material, and extreme crime and violence material. Phase 2, now reflected in the Age-Restricted Material Codes, focuses on class 1C and class 2 material, including online pornography and other age-inappropriate material. AI-generated material is treated in the same way where it falls within the relevant classification category. Requirements can apply to service categories that include designated internet services, including high-impact generative-AI designated internet services where covered by the relevant instrument. The precise obligation depends on the relevant code or standard, service category and risk profile.
The OAIC’s Clearview AI determination remains a leading illustration of existing privacy law being applied to AI-enabled facial recognition and large-scale scraping of images from publicly available online sources.
Government announcements about additional or broader restrictions on non-consensual sexually explicit AI-generated content, app distribution or search access should be described as policy proposals unless and until the relevant legislation or instrument is enacted and commenced. They should be kept separate from existing criminal offences, online-safety instruments and regulator enforcement powers.
High-risk AI in Australia
Australia has no generally applicable statutory classification or compliance regime for ‘high-risk AI’. The expression is currently a governance and policy concept, except where a particular sectoral law or instrument independently imposes risk-based obligations.
The September 2024 mandatory-guardrails proposals paper suggested that a future framework could consider adverse impacts on individual rights, health and safety; groups and collective or cultural rights; and the broader economy, society, environment and rule of law, together with the severity and extent of those impacts. Those proposed criteria never became binding law and the proposal is not proceeding at this time.
The current Guidance for AI adoption uses a risk-scaled approach. Its implementation guidance is directed to more complex or higher-risk uses and recommends stronger accountability, impact analysis, risk management, information sharing, testing, monitoring and human control. As a governance matter, indicators warranting enhanced controls may include significant effects on rights or access to services; impacts on vulnerable people or communities; safety-critical functions; opaque or difficult-to-contest outcomes; large-scale or systemic deployment; material cyber or data risks; and serious consequences from error, bias or model failure.
Organisations using AI in higher-impact contexts should, as a governance recommendation rather than a general statutory command, document use cases and accountabilities, conduct proportionate impact and legal assessments, test and monitor performance, manage data quality and provenance, maintain effective escalation and override processes, enable complaints and contestability, and integrate AI controls with existing privacy, cyber, consumer, safety and sectoral compliance systems.
Controls on generative AI in Australia
Australia has not enacted a generally applicable statute devoted exclusively to generative AI. Generative-AI development and use are regulated through existing laws and, where applicable, sectoral instruments including the Online Safety Act codes and standards.
Privacy and data
Developers and deployers should determine whether training, fine-tuning, retrieval-augmented generation, prompting, logging or other records where they contain personal information, or output handling involves personal information; whether collection, use and disclosure are lawful and fair; whether an APP notice or privacy-policy update is required; whether information is accurate and secure; whether cross-border disclosure rules are engaged; and whether access, correction, retention and deletion obligations apply. Public accessibility does not automatically make data lawful to collect or use for training.
Consent is not universally required for every handling of personal information under the Privacy Act. An entity should determine whether consent is required or relied upon, particularly for sensitive information or secondary uses, and whether another applicable permission or exception is available. The analysis depends on the relevant Australian Privacy Principle and the facts.
The OAIC treats personal information entered into an AI system and personal information contained in system output as potentially regulated, including inferred, inaccurate or hallucinated information about an identified or reasonably identifiable person. The OAIC recommends particular caution with sensitive information and publicly available generative-AI tools.
Cyber security and operational control
AI-specific security analysis should address access control, data leakage, prompt injection, insecure output handling, model inversion or extraction, maliciously modified or poisoned data, supply-chain compromise, model drift, logging, provenance, change control and incident response. Organisations subject to critical-infrastructure, prudential or other cyber security regimes must integrate AI controls with those binding requirements rather than treat AI governance as a standalone exercise.
AI-generated content transparency
The National AI Centre first published voluntary best-practice guidance on AI-generated content transparency, covering labelling, watermarking and metadata recording, on 28 November 2025. The current version, published on 22 April 2026, recommends proportionate disclosure methods such as labelling, watermarking and metadata or provenance measures. This is voluntary best-practice guidance, not a generally applicable statutory labelling regime. Separate binding obligations may arise under consumer, electoral, online-safety, privacy or sector-specific law depending on the content and context.
Enforcement / fines in Australia
Australia has no general, cross-economy AI Act enforcement or penalty regime. AI-specific or AI-relevant obligations may nevertheless be enforced under existing legislation and sectoral instruments. The regulator, cause of action, available remedy and maximum penalty depend on the particular provision, the conduct, the date of contravention and the defendant.
- A serious or repeated interference with privacy under the Privacy Act can attract a maximum civil penalty of AUD 2.5 million for a person other than a body corporate. For a body corporate, the maximum is the greater of AUD 50 million, three times the value of the benefit reasonably attributable to the conduct, or, if that value cannot be determined, 30% of adjusted turnover during the breach turnover period. Other Privacy Act contraventions have different consequences. The statutory tort for serious invasions of privacy also creates a private court pathway, subject to its elements, remedies, defences and exemptions.
- Competition and consumer law. AI-related representations, sales practices or product conduct may engage the Australian Consumer Law and competition law. For many offence and civil-penalty provisions, the maximum corporate penalty for conduct on or after 28 March 2026 is the greater of AUD 100 million, three times the reasonably attributable benefit where that value can be determined, or 30% of adjusted turnover during the breach turnover period where it cannot. Other provisions have lower maxima. The general prohibition on misleading or deceptive conduct under the Australian Consumer Law is not itself a pecuniary-penalty provision, although related conduct may contravene civil-penalty provisions and injunctions, damages, compensation and other remedies may be available.
- Online safety. Non-compliance with a standard, or with a direction to comply with a code, can result in civil-penalty proceedings. The maximum identified in eSafety’s regulatory guidance is 30,000 penalty units per contravention for an individual and five times that amount for a corporation. Different Online Safety Act contraventions may carry different maxima.
- Other regimes. AI uses may also attract regulatory orders, licence consequences, remediation, compensation, injunctions, enforceable undertakings, disqualification, criminal liability or judicial and merits review under financial-services, health, workplace, discrimination, cybercrime, critical-infrastructure, administrative-law and other sectoral regimes. Penalty figures should be rechecked on the publication date and should never be applied without identifying the specific contravention.
User transparency in Australia
Transparency is a central feature of Australian responsible-AI policy, but its legal source and effect vary. The current Guidance for AI adoption recommends sharing essential information about AI systems and maintaining human control. The National AI Centre’s AI-generated content guidance recommends proportionate disclosure, labelling, watermarking and provenance measures. These recommendations are voluntary unless another law or instrument makes disclosure mandatory in the relevant context.
Under the Privacy Act, APP entities may need to explain personal-information handling through privacy policies and APP 5 collection notices and to facilitate access and correction. From 10 December 2026, the specific automated decision-making privacy-policy disclosures described in the Automated decision-making transparency under the Privacy Act section will apply to qualifying arrangements. The OAIC’s final implementation guidance should be checked before commencement.
For Commonwealth Government entities within scope, the responsible-use policy requires transparency statements, strategic and operational governance, use-case accountability, registers, training and impact assessment. Administrative law may also require lawful authority, procedural fairness, reasons and reviewability. The OAIC’s January 2026 Information Publication Scheme report recommends improved publication of operational information about automated decision-making by government agencies.
Fairness / unlawful bias in Australia
Australia does not have a single AI fairness statute. Unfair or biased AI outcomes can nevertheless engage Commonwealth, state or territory anti-discrimination laws, employment law, consumer protection, privacy, credit, education, health, administrative law and other sector-specific duties. The applicable protected attributes, tests, exemptions, remedies and responsible parties depend on the relevant statute and context.
The current Guidance for AI adoption addresses fairness through impact analysis, stakeholder engagement, risk management, testing, monitoring and human control. The OAIC identifies bias and discrimination risks where data are incomplete, inaccurate, unrepresentative or encode historical disadvantage. These are guidance propositions unless linked to a specific legal obligation.
As a governance matter, organisations deploying higher-impact AI should test for discriminatory or materially inaccurate outcomes before and after deployment; assess performance across relevant cohorts; document limitations; monitor complaints and drift; maintain escalation and contestability pathways; and ensure that human reviewers have the authority and information needed to correct inappropriate outcomes.
Human oversight in Australia
The sixth essential practice in the current Guidance for AI adoption is to maintain human control. The guidance recommends designing systems and operating processes so that people can supervise, intervene, escalate, override or stop AI use where appropriate to the system’s risk and impact.
Human involvement should be meaningful rather than ceremonial. Reviewers need appropriate expertise, authority, information, independence and time; they should understand relevant system limitations and avoid merely endorsing an automated result. The appropriate form of oversight may range from periodic monitoring for low-impact tools to mandatory approval, dual control, escalation or prohibition of autonomous action in higher-impact contexts.
For government decision-making, human oversight must be assessed alongside statutory authority, lawful delegation, procedural fairness, reasons, evidence, recordkeeping and review rights. For private-sector systems, the necessary controls depend on the consequences of the use case and the privacy, consumer, safety, discrimination, professional, cyber security and sectoral laws engaged. Human review does not cure an otherwise unlawful system or decision.
Australia has no generally applicable statutory classification or compliance regime for ‘high-risk AI’. The expression is currently a governance and policy concept, except where a particular sectoral law or instrument independently imposes risk-based obligations.
The September 2024 mandatory-guardrails proposals paper suggested that a future framework could consider adverse impacts on individual rights, health and safety; groups and collective or cultural rights; and the broader economy, society, environment and rule of law, together with the severity and extent of those impacts. Those proposed criteria never became binding law and the proposal is not proceeding at this time.
The current Guidance for AI adoption uses a risk-scaled approach. Its implementation guidance is directed to more complex or higher-risk uses and recommends stronger accountability, impact analysis, risk management, information sharing, testing, monitoring and human control. As a governance matter, indicators warranting enhanced controls may include significant effects on rights or access to services; impacts on vulnerable people or communities; safety-critical functions; opaque or difficult-to-contest outcomes; large-scale or systemic deployment; material cyber or data risks; and serious consequences from error, bias or model failure.
Organisations using AI in higher-impact contexts should, as a governance recommendation rather than a general statutory command, document use cases and accountabilities, conduct proportionate impact and legal assessments, test and monitor performance, manage data quality and provenance, maintain effective escalation and override processes, enable complaints and contestability, and integrate AI controls with existing privacy, cyber, consumer, safety and sectoral compliance systems.
Article 6 of the EU AI Act sets out classification rules for high-risk AI systems, stating that high-risk AI systems fall within two categories: (i) safety components of products or products themselves regulated by existing EU product safety laws (listed in Annex I, e.g., medical devices, automotive AI); or (ii) used in specified areas (listed in Annex III), namely:
- Critical infrastructure: AI systems used as safety components in the management or operation of critical digital infrastructure, road traffic, or the supply of water, gas, heating or electricity.
- Education and vocational training: AI systems that determine access to education or training or otherwise impact a person's future opportunities and career development and AI systems used for monitoring and detecting prohibited behaviour during tests.
- Employment and worker management: AI systems used in hiring (including the placement of targeted job advertisements), performance evaluation, promotion or termination decisions.
- Access to essential private and public services: AI systems that evaluate eligibility for essential public services, such as social security and healthcare as well as AI systems for evaluating and classifying emergency calls and dispatching emergency services. Additionally, AI systems used to evaluate creditworthiness or during the risk assessment and pricing of life and health insurance.
- Law enforcement: AI systems used by law enforcement for risk assessments, predicting criminal activities (the risk of individuals becoming victims of crime, risk of (re-)offending or otherwise during criminal investigations), for polygraphs (i.e. 'lie detectors' or similar tools), and assessing reliability of evidence.
- Border control and migration: AI systems used to assess visa applications, asylum claims, and border security including for polygraphs (i.e. 'lie detectors' or similar tools) and for detecting, recognising or identifying individuals in migration contexts.
- Judicial and democratic processes: AI systems assisting judicial authorities with researching and interpreting facts and the law and applying the law to a set of facts. As well as AI systems used for influencing the outcome of elections or referendum or voting behaviour.
- Biometric identification and categorisation: AI systems that perform remote biometric identification are used to categorise individuals based on biometric data or other sensitive or protected attributes, and AI systems used for emotion recognition purposes.
These systems must adhere to stringent requirements to ensure they do not pose unacceptable risks or operate in a manner that protects individuals' rights and safety. The classification emphasises the importance of high standards and accountability in deploying AI in sensitive and impactful areas.
The European Commission has the power to amend the above-mentioned categories of high-risk AI systems including to modify any existing use cases or add new ones (Article 7(1) of the EU AI Act).
Where an AI system falls into one of the two categories above-mentioned but does not pose significant risk of harm to health, safety or fundamental rights, the operators of such AI systems are relieved from the requirements imposed for high-risk AI systems (except for the EU database registration). However, to benefit from such exemption, a thorough assessment must be documented and strict conditions must be met (however these conditions are currently difficult to interpret, and further guidelines from the Commission are expected).
Article 6 of the EU AI Act sets out classification rules for high-risk AI systems, stating that high-risk AI systems fall within two categories: (i) safety components of products or products themselves regulated by existing EU product safety laws (listed in Annex I, e.g., medical devices, automotive AI); or (ii) used in specified areas (listed in Annex III), namely:
- Critical infrastructure: AI systems used as safety components in the management or operation of critical digital infrastructure, road traffic, or the supply of water, gas, heating or electricity.
- Education and vocational training: AI systems that determine access to education or training or otherwise impact a person's future opportunities and career development and AI systems used for monitoring and detecting prohibited behaviour during tests.
- Employment and worker management: AI systems used in hiring (including the placement of targeted job advertisements), performance evaluation, promotion or termination decisions.
- Access to essential private and public services: AI systems that evaluate eligibility for essential public services, such as social security and healthcare as well as AI systems for evaluating and classifying emergency calls and dispatching emergency services. Additionally, AI systems used to evaluate creditworthiness or during the risk assessment and pricing of life and health insurance.
- Law enforcement: AI systems used by law enforcement for risk assessments, predicting criminal activities (the risk of individuals becoming victims of crime, risk of (re-)offending or otherwise during criminal investigations), for polygraphs (i.e. 'lie detectors' or similar tools), and assessing reliability of evidence.
- Border control and migration: AI systems used to assess visa applications, asylum claims, and border security including for polygraphs (i.e. 'lie detectors' or similar tools) and for detecting, recognising or identifying individuals in migration contexts.
- Judicial and democratic processes: AI systems assisting judicial authorities with researching and interpreting facts and the law and applying the law to a set of facts. As well as AI systems used for influencing the outcome of elections or referendum or voting behaviour.
- Biometric identification and categorisation: AI systems that perform remote biometric identification are used to categorise individuals based on biometric data or other sensitive or protected attributes, and AI systems used for emotion recognition purposes.
These systems must adhere to stringent requirements to ensure they do not pose unacceptable risks or operate in a manner that protects individuals' rights and safety. The classification emphasises the importance of high standards and accountability in deploying AI in sensitive and impactful areas.
The European Commission has the power to amend the above-mentioned categories of high-risk AI systems including to modify any existing use cases or add new ones (Article 7(1)) of the EU AI Act).
Where an AI system falls into one of the two categories above-mentioned but does not pose significant risk of harm to health, safety or fundamental rights, the operators of such AI systems are relieved from the requirements imposed for high-risk AI systems (except for the EU database registration). However, to benefit from such exemption, a thorough assessment must be documented and strict conditions must be met (however these conditions are currently difficult to interpret, and further guidelines from the Commission are expected).
Laws specifically addressing AI have not been introduced in Brazil yet. Draft Article 14 of the proposed Brazilian AI Bill specifies that high-risk AI systems include those used in critical infrastructure, education, employment, public services, financial services, emergency response, justice, healthcare, public security, and migration management. Specific controls in relation to high-risk AI systems are proposed by the Brazilian AI Bill, including that high-risk AI systems shall require an algorithmic impact assessment, considering risks, benefits and mitigation measures, and must be updated periodically (draft Article 18).
Article 6 of the EU AI Act sets out classification rules for high-risk AI systems, stating that high-risk AI systems fall within two categories: (i) safety components of products or products themselves regulated by existing EU product safety laws (listed in Annex I, e.g., medical devices, automotive AI); or (ii) used in specified areas (listed in Annex III), namely:
- Critical infrastructure: AI systems used as safety components in the management or operation of critical digital infrastructure, road traffic, or the supply of water, gas, heating or electricity.
- Education and vocational training: AI systems that determine access to education or training or otherwise impact a person's future opportunities and career development and AI systems used for monitoring and detecting prohibited behaviour during tests.
- Employment and worker management: AI systems used in hiring (including the placement of targeted job advertisements), performance evaluation, promotion or termination decisions.
- Access to essential private and public services: AI systems that evaluate eligibility for essential public services, such as social security and healthcare as well as AI systems for evaluating and classifying emergency calls and dispatching emergency services. Additionally, AI systems used to evaluate creditworthiness or during the risk assessment and pricing of life and health insurance.
- Law enforcement: AI systems used by law enforcement for risk assessments, predicting criminal activities (the risk of individuals becoming victims of crime, risk of (re-)offending or otherwise during criminal investigations), for polygraphs (i.e. 'lie detectors' or similar tools), and assessing reliability of evidence.
- Border control and migration: AI systems used to assess visa applications, asylum claims, and border security including for polygraphs (i.e. 'lie detectors' or similar tools) and for detecting, recognising or identifying individuals in migration contexts.
- Judicial and democratic processes: AI systems assisting judicial authorities with researching and interpreting facts and the law and applying the law to a set of facts. As well as AI systems used for influencing the outcome of elections or referendum or voting behaviour.
- Biometric identification and categorisation: AI systems that perform remote biometric identification are used to categorise individuals based on biometric data or other sensitive or protected attributes, and AI systems used for emotion recognition purposes.
These systems must adhere to stringent requirements to ensure they do not pose unacceptable risks or operate in a manner that protects individuals' rights and safety. The classification emphasises the importance of high standards and accountability in deploying AI in sensitive and impactful areas.
The European Commission has the power to amend the above-mentioned categories of high-risk AI systems including to modify any existing use cases or add new ones (Article 7(1) of the EU AI Act).
Where an AI system falls into one of the two categories above-mentioned but does not pose significant risk of harm to health, safety or fundamental rights, the operators of such AI systems are relieved from the requirements imposed for high-risk AI systems (except for the EU database registration). However, to benefit from such exemption, a thorough assessment must be documented and strict conditions must be met (however these conditions are currently difficult to interpret, and further guidelines from the Commission are expected).
National laws specifically addressing AI have not yet passed in Canada.
Article 5 classifies uses of AI systems into four risks. The second highest risk is a 'High-Risk Use', which refers to uses of autonomous AI systems, or safety components of products, which use presents a significant risk of affecting fundamental rights, especially if the system fails or is used improperly. As amended by the Government indications, Article 7 is also adjusted to align its terminology with a use-based approach.
Article 8 of the Chilean AI Bill establishes the rules applicable to High-Risk AI Systems:
- Risk management systems: High-Risk AI Systems will undergo a continuous iterative process of risk assessment to be conducted throughout the life cycle of the system, which will require periodic reviews and updates to seek its effectiveness and minimise the potential for failure or malfunction, based on the stated intended purpose.
- Data governance: High-Risk AI Systems using techniques that involve training models with data shall be subject to data governance commensurate with the context of use, as well as the intended purpose of the AI system, to the extent that this is technically feasible in accordance with the market segment or scope of application concerned. They should also seek to incorporate internationally accepted technical and data security standards.
- Technical documentation: The technical documentation attached to High-Risk AI Systems shall be intelligible and written in such a way as to demonstrate that the high-risk AI system complies with the rules set forth in the Chilean AI Bill.
- System of records: High-Risk AI Systems shall be designed and developed with capabilities to record safety information and events while in operation. These recording capabilities shall be in accordance with recognised common standards or specifications and the state of the art.
- Transparency mechanisms: High-Risk AI Systems shall be designed and developed with a level of transparency sufficient for operators and their intended users to reasonably understand the operation of the system, in accordance with its intended purpose.
- Human oversight mechanisms: High-Risk AI Systems shall be designed and developed so that they can be overseen by natural persons technically qualified for this function as appropriate for the implementation scenario and in a manner proportionate to the associated risks, with the aim of preventing or minimising risks to health, safety, fundamental rights, democracy and/or the environment, which may arise when High-Risk AI System is used in accordance with its intended purpose or when it is put to reasonably foreseeable misuse.
- Accuracy, robustness and cybersecurity: High-Risk AI Systems shall be designed and developed following the principle of safety by design and by default, and shall have an adequate level of accuracy, robustness, security and cybersecurity, operating consistently, reliably and robustly throughout their life cycle.
In accordance with the Government indications, Article 32 specifies how the existing rules of Article 8 are to be complied with, the contingency measures applicable to high-risk uses and the obligations imposed on operators. It also distinguishes between providers, implementers, authorised representatives, importers and distributors when assigning obligations, and considers the status of micro, small or medium-sized enterprises where that status clearly correlates with the risk of the relevant use.
The PRC has not yet established a formal categorisation of AI technologies based on their associated risk levels. Nevertheless, specific laws and regulations provide requirements for certain use cases and services with certain capabilities, and sector-specific measures increasingly address high-risk AI applications. For example:
- The GenAI Measures, the Deep Synthesis Provisions and the Recommendation Algorithms Provisions each require providers of services with public opinion attributes or social mobilisation capabilities to perform record-filing procedures and conduct security assessments in accordance with laws.
- Under the Deep Synthesis Provisions, the generated or edited information of certain deep synthesis services that may cause confusion among the public must be labelled with regard to its deep synthesis status prominently, including:
- smart dialogue or similar services that simulate a human to generate or edit texts;
- speech generation services (e.g. voice synthesis or voice imitation services);
- services that generate images or videos of people (e. face generation, face swapping, face manipulation or posture manipulation);
- immersive simulated scene generation, editing or other services;
- any other editing services that significantly alter personal identification characteristics; and
- any other services that generate or significantly alter information content.
The same labelling obligations are also reiterated in the GenAI Measures.
The regulations designed to govern virtual avatars and humanised interactive services indicate that services which may affect human emotions or encourage addiction are considered high-risk.
Article 6 of the EU AI Act sets out classification rules for high-risk AI systems, stating that high-risk AI systems are those that are either: (i) safety components of products or products themselves regulated by existing EU product safety laws (e.g., medical devices, automotive AI); or (ii) used in specified areas (listed in Annex III), namely:
- Critical infrastructure: AI systems used as safety components in the management or operation of critical digital infrastructure, road traffic, or the supply of water, gas, heating or electricity.
- Education and vocational training: AI systems that determine access to education or training or otherwise impact a person's future opportunities and career development and AI systems used for monitoring and detecting prohibited behaviour during tests.
- Employment and worker management: AI systems used in hiring (including the placement of targeted job advertisements), performance evaluation, promotion or termination decisions.
- Access to essential private and public services: AI systems that evaluate eligibility for essential public services, such as social security and healthcare as well as AI systems for evaluating and classifying emergency calls and dispatching emergency services. Additionally, AI systems used to evaluate creditworthiness or during the risk assessment and pricing of life and health insurance.
- Law enforcement: AI systems used by law enforcement for risk assessments, predicting criminal activities (the risk of individuals becoming victims of crime, risk of (re-)offending or otherwise during criminal investigations), for polygraphs (i.e. 'lie detectors' or similar tools), and assessing reliability of evidence.
- Border control and migration: AI systems used to assess visa applications, asylum claims, and border security including for polygraphs (i.e. 'lie detectors' or similar tools) and for detecting, recognising or identifying individuals in migration contexts.
- Judicial and democratic processes: AI systems assisting judicial authorities with researching and interpreting facts and the law and applying the law to a set of facts. As well as AI systems used for influencing the outcome of elections or referendum or voting behaviour.
- Biometric identification and categorisation: AI systems that perform remote biometric identification are used to categorise individuals based on biometric data or other sensitive or protected attributes, and AI systems used for emotion recognition purposes.
These systems must adhere to stringent requirements to ensure they do not pose unacceptable risks or operate in a manner that protects individuals' rights and safety. The classification emphasises the importance of high standards and accountability in deploying AI in sensitive and impactful areas.
The European Commission has the power to amend the above-mentioned categories of high-risk AI systems including to modify any existing use cases or add new ones (Article 7(1) of the EU AI Act).
Where an AI system falls into one of the two categories above-mentioned but does not pose significant risk of harm to health, safety or fundamental rights, the operators of such AI systems are relieved from the requirements imposed for high-risk AI systems (except for the EU database registration). However, to benefit from such exemption, a thorough assessment must be documented and strict conditions must be met (however these conditions are currently difficult to interpret, and further guidelines from the Commission are expected).
Article 6 of the EU AI Act sets out classification rules for high-risk AI systems, stating that high-risk AI systems fall within two categories: (i) safety components of products or products themselves regulated by existing EU product safety laws (listed in Annex I, e.g., medical devices, automotive AI); or (ii) used in specified areas (listed in Annex III), namely:
- Critical infrastructure: AI systems used as safety components in the management or operation of critical digital infrastructure, road traffic, or the supply of water, gas, heating or electricity.
- Education and vocational training: AI systems that determine access to education or training or otherwise impact a person's future opportunities and career development and AI systems used for monitoring and detecting prohibited behaviour during tests.
- Employment and worker management: AI systems used in hiring (including the placement of targeted job advertisements), performance evaluation, promotion or termination decisions.
- Access to essential private and public services: AI systems that evaluate eligibility for essential public services, such as social security and healthcare as well as AI systems for evaluating and classifying emergency calls and dispatching emergency services. Additionally, AI systems used to evaluate creditworthiness or during the risk assessment and pricing of life and health insurance.
- Law enforcement: AI systems used by law enforcement for risk assessments, predicting criminal activities (the risk of individuals becoming victims of crime, risk of (re-)offending or otherwise during criminal investigations), for polygraphs (i.e. 'lie detectors' or similar tools), and assessing reliability of evidence.
- Border control and migration: AI systems used to assess visa applications, asylum claims, and border security including for polygraphs (i.e. 'lie detectors' or similar tools) and for detecting, recognising or identifying individuals in migration contexts.
- Judicial and democratic processes: AI systems assisting judicial authorities with researching and interpreting facts and the law and applying the law to a set of facts. As well as AI systems used for influencing the outcome of elections or referendum or voting behaviour.
- Biometric identification and categorisation: AI systems that perform remote biometric identification are used to categorise individuals based on biometric data or other sensitive or protected attributes, and AI systems used for emotion recognition purposes.
These systems must adhere to stringent requirements to ensure they do not pose unacceptable risks or operate in a manner that protects individuals' rights and safety. The classification emphasises the importance of high standards and accountability in deploying AI in sensitive and impactful areas.
The European Commission has the power to amend the above-mentioned categories of high-risk AI systems including to modify any existing use cases or add new ones (Article 7(1) of the EU AI Act).
Where an AI system falls into one of the two categories above-mentioned but does not pose significant risk of harm to health, safety or fundamental rights, the operators of such AI systems are relieved from the requirements imposed for high-risk AI systems (except for the EU database registration). However, to benefit from such exemption, a thorough assessment must be documented and strict conditions must be met (however these conditions are currently difficult to interpret, and further guidelines from the Commission are expected).
Article 6 of the EU AI Act sets out classification rules for high-risk AI systems, stating that high-risk AI systems fall within two categories: (i) safety components of products or products themselves regulated by existing EU product safety laws (listed in Annex I, e.g., medical devices, automotive AI); or (ii) used in specified areas (listed in Annex III), namely:
- Critical infrastructure: AI systems used as safety components in the management or operation of critical digital infrastructure, road traffic, or the supply of water, gas, heating or electricity.
- Education and vocational training: AI systems that determine access to education or training or otherwise impact a person's future opportunities and career development and AI systems used for monitoring and detecting prohibited behaviour during tests.
- Employment and worker management: AI systems used in hiring (including the placement of targeted job advertisements), performance evaluation, promotion or termination decisions.
- Access to essential private and public services: AI systems that evaluate eligibility for essential public services, such as social security and healthcare as well as AI systems for evaluating and classifying emergency calls and dispatching emergency services. Additionally, AI systems used to evaluate creditworthiness or during the risk assessment and pricing of life and health insurance.
- Law enforcement: AI systems used by law enforcement for risk assessments, predicting criminal activities (the risk of individuals becoming victims of crime, risk of (re-)offending or otherwise during criminal investigations), for polygraphs (i.e. 'lie detectors' or similar tools), and assessing reliability of evidence.
- Border control and migration: AI systems used to assess visa applications, asylum claims, and border security including for polygraphs (i.e. 'lie detectors' or similar tools) and for detecting, recognising or identifying individuals in migration contexts.
- Judicial and democratic processes: AI systems assisting judicial authorities with researching and interpreting facts and the law and applying the law to a set of facts. As well as AI systems used for influencing the outcome of elections or referendum or voting behaviour.
- Biometric identification and categorisation: AI systems that perform remote biometric identification are used to categorise individuals based on biometric data or other sensitive or protected attributes, and AI systems used for emotion recognition purposes.
These systems must adhere to stringent requirements to ensure they do not pose unacceptable risks or operate in a manner that protects individuals' rights and safety. The classification emphasises the importance of high standards and accountability in deploying AI in sensitive and impactful areas.
The European Commission has the power to amend the above-mentioned categories of high-risk AI systems including to modify any existing use cases or add new ones (Article 7(1) of the EU AI Act).
Where an AI system falls into one of the two categories above-mentioned but does not pose significant risk of harm to health, safety or fundamental rights, the operators of such AI systems are relieved from the requirements imposed for high-risk AI systems (except for the EU database registration). However, to benefit from such exemption, a thorough assessment must be documented and strict conditions must be met (however these conditions are currently difficult to interpret, and further guidelines from the Commission are expected).
Article 6 of the EU AI Act sets out classification rules for high-risk AI systems, stating that high-risk AI systems fall within two categories: (i) safety components of products or products themselves regulated by existing EU product safety laws (listed in Annex I, e.g., medical devices, automotive AI); or (ii) used in specified areas (listed in Annex III), namely:
- Critical infrastructure: AI systems used as safety components in the management or operation of critical digital infrastructure, road traffic, or the supply of water, gas, heating or electricity.
- Education and vocational training: AI systems that determine access to education or training or otherwise impact a person's future opportunities and career development and AI systems used for monitoring and detecting prohibited behaviour during tests.
- Employment and worker management: AI systems used in hiring (including the placement of targeted job advertisements), performance evaluation, promotion or termination decisions.
- Access to essential private and public services: AI systems that evaluate eligibility for essential public services, such as social security and healthcare as well as AI systems for evaluating and classifying emergency calls and dispatching emergency services. Additionally, AI systems used to evaluate creditworthiness or during the risk assessment and pricing of life and health insurance.
- Law enforcement: AI systems used by law enforcement for risk assessments, predicting criminal activities (the risk of individuals becoming victims of crime, risk of (re-)offending or otherwise during criminal investigations), for polygraphs (i.e. 'lie detectors' or similar tools), and assessing reliability of evidence.
- Border control and migration: AI systems used to assess visa applications, asylum claims, and border security including for polygraphs (i.e. 'lie detectors' or similar tools) and for detecting, recognising or identifying individuals in migration contexts.
- Judicial and democratic processes: AI systems assisting judicial authorities with researching and interpreting facts and the law and applying the law to a set of facts. As well as AI systems used for influencing the outcome of elections or referendum or voting behaviour.
- Biometric identification and categorisation: AI systems that perform remote biometric identification are used to categorise individuals based on biometric data or other sensitive or protected attributes, and AI systems used for emotion recognition purposes.
These systems must adhere to stringent requirements to ensure they do not pose unacceptable risks or operate in a manner that protects individuals' rights and safety. The classification emphasises the importance of high standards and accountability in deploying AI in sensitive and impactful areas.
The European Commission has the power to amend the above-mentioned categories of high-risk AI systems including to modify any existing use cases or add new ones (Article 7(1) of the EU AI Act).
Where an AI system falls into one of the two categories above-mentioned but does not pose significant risk of harm to health, safety or fundamental rights, the operators of such AI systems are relieved from the requirements imposed for high-risk AI systems (except for the EU database registration). However, to benefit from such exemption, a thorough assessment must be documented and strict conditions must be met (however these conditions are currently difficult to interpret, and further guidelines from the Commission are expected).
Article 6 of the EU AI Act sets out classification rules for high-risk AI systems, stating that high-risk AI systems fall within two categories: (i) safety components of products or products themselves regulated by existing EU product safety laws (listed in Annex I, e.g., medical devices, automotive AI); or (ii) used in specified areas (listed in Annex III), namely:
- Critical infrastructure: AI systems used as safety components in the management or operation of critical digital infrastructure, road traffic, or the supply of water, gas, heating or electricity.
- Education and vocational training: AI systems that determine access to education or training or otherwise impact a person's future opportunities and career development and AI systems used for monitoring and detecting prohibited behaviour during tests.
- Employment and worker management: AI systems used in hiring (including the placement of targeted job advertisements), performance evaluation, promotion or termination decisions.
- Access to essential private and public services: AI systems that evaluate eligibility for essential public services, such as social security and healthcare as well as AI systems for evaluating and classifying emergency calls and dispatching emergency services. Additionally, AI systems used to evaluate creditworthiness or during the risk assessment and pricing of life and health insurance.
- Law enforcement: AI systems used by law enforcement for risk assessments, predicting criminal activities (the risk of individuals becoming victims of crime, risk of (re-)offending or otherwise during criminal investigations), for polygraphs (i.e. 'lie detectors' or similar tools), and assessing reliability of evidence.
- Border control and migration: AI systems used to assess visa applications, asylum claims, and border security including for polygraphs (i.e. 'lie detectors' or similar tools) and for detecting, recognising or identifying individuals in migration contexts.
- Judicial and democratic processes: AI systems assisting judicial authorities with researching and interpreting facts and the law and applying the law to a set of facts. As well as AI systems used for influencing the outcome of elections or referendum or voting behaviour.
- Biometric identification and categorisation: AI systems that perform remote biometric identification are used to categorise individuals based on biometric data or other sensitive or protected attributes, and AI systems used for emotion recognition purposes.
These systems must adhere to stringent requirements to ensure they do not pose unacceptable risks or operate in a manner that protects individuals' rights and safety. The classification emphasises the importance of high standards and accountability in deploying AI in sensitive and impactful areas.
The European Commission has the power to amend the above-mentioned categories of high-risk AI systems including to modify any existing use cases or add new ones (Article 7(1) of the EU AI Act).
Where an AI system falls into one of the two categories above-mentioned but does not pose significant risk of harm to health, safety or fundamental rights, the operators of such AI systems are relieved from the requirements imposed for high-risk AI systems (except for the EU database registration). However, to benefit from such exemption, a thorough assessment must be documented and strict conditions must be met (however these conditions are currently difficult to interpret, and further guidelines from the Commission are expected).
Article 6 of the EU AI Act sets out classification rules for high-risk AI systems, stating that high-risk AI systems fall within two categories: (i) safety components of products or products themselves regulated by existing EU product safety laws (listed in Annex I, e.g., medical devices, automotive AI); or (ii) used in specified areas (listed in Annex III), namely:
- Critical infrastructure: AI systems used as safety components in the management or operation of critical digital infrastructure, road traffic, or the supply of water, gas, heating or electricity.
- Education and vocational training: AI systems that determine access to education or training or otherwise impact a person's future opportunities and career development and AI systems used for monitoring and detecting prohibited behaviour during tests.
- Employment and worker management: AI systems used in hiring (including the placement of targeted job advertisements), performance evaluation, promotion or termination decisions.
- Access to essential private and public services: AI systems that evaluate eligibility for essential public services, such as social security and healthcare as well as AI systems for evaluating and classifying emergency calls and dispatching emergency services. Additionally, AI systems used to evaluate creditworthiness or during the risk assessment and pricing of life and health insurance.
- Law enforcement: AI systems used by law enforcement for risk assessments, predicting criminal activities (the risk of individuals becoming victims of crime, risk of (re-)offending or otherwise during criminal investigations), for polygraphs (i.e. 'lie detectors' or similar tools), and assessing reliability of evidence.
- Border control and migration: AI systems used to assess visa applications, asylum claims, and border security including for polygraphs (i.e. 'lie detectors' or similar tools) and for detecting, recognising or identifying individuals in migration contexts.
- Judicial and democratic processes: AI systems assisting judicial authorities with researching and interpreting facts and the law and applying the law to a set of facts. As well as AI systems used for influencing the outcome of elections or referendum or voting behaviour.
- Biometric identification and categorisation: AI systems that perform remote biometric identification are used to categorise individuals based on biometric data or other sensitive or protected attributes, and AI systems used for emotion recognition purposes.
These systems must adhere to stringent requirements to ensure they do not pose unacceptable risks or operate in a manner that protects individuals' rights and safety. The classification emphasises the importance of high standards and accountability in deploying AI in sensitive and impactful areas.
The European Commission has the power to amend the above-mentioned categories of high-risk AI systems including to modify any existing use cases or add new ones (Article 7(1) of the EU AI Act).
Where an AI system falls into one of the two categories above-mentioned but does not pose significant risk of harm to health, safety or fundamental rights, the operators of such AI systems are relieved from the requirements imposed for high-risk AI systems (except for the EU database registration). However, to benefit from such exemption, a thorough assessment must be documented and strict conditions must be met (however these conditions are currently difficult to interpret, and further guidelines from the Commission are expected).
Article 6 of the EU AI Act sets out classification rules for high-risk AI systems, stating that high-risk AI systems fall within two categories: (i) safety components of products or products themselves regulated by existing EU product safety laws (listed in Annex I, e.g., medical devices, automotive AI); or (ii) used in specified areas (listed in Annex III), namely:
- Critical infrastructure: AI systems used as safety components in the management or operation of critical digital infrastructure, road traffic, or the supply of water, gas, heating or electricity.
- Education and vocational training: AI systems that determine access to education or training or otherwise impact a person's future opportunities and career development and AI systems used for monitoring and detecting prohibited behaviour during tests.
- Employment and worker management: AI systems used in hiring (including the placement of targeted job advertisements), performance evaluation, promotion or termination decisions.
- Access to essential private and public services: AI systems that evaluate eligibility for essential public services, such as social security and healthcare as well as AI systems for evaluating and classifying emergency calls and dispatching emergency services. Additionally, AI systems used to evaluate creditworthiness or during the risk assessment and pricing of life and health insurance.
- Law enforcement: AI systems used by law enforcement for risk assessments, predicting criminal activities (the risk of individuals becoming victims of crime, risk of (re-)offending or otherwise during criminal investigations), for polygraphs (i.e. 'lie detectors' or similar tools), and assessing reliability of evidence.
- Border control and migration: AI systems used to assess visa applications, asylum claims, and border security including for polygraphs (i.e. 'lie detectors' or similar tools) and for detecting, recognising or identifying individuals in migration contexts.
- Judicial and democratic processes: AI systems assisting judicial authorities with researching and interpreting facts and the law and applying the law to a set of facts. As well as AI systems used for influencing the outcome of elections or referendum or voting behaviour.
- Biometric identification and categorisation: AI systems that perform remote biometric identification are used to categorise individuals based on biometric data or other sensitive or protected attributes, and AI systems used for emotion recognition purposes.
These systems must adhere to stringent requirements to ensure they do not pose unacceptable risks or operate in a manner that protects individuals' rights and safety. The classification emphasises the importance of high standards and accountability in deploying AI in sensitive and impactful areas.
The European Commission has the power to amend the above-mentioned categories of high-risk AI systems including to modify any existing use cases or add new ones (Article 7(1) of the EU AI Act).
Where an AI system falls into one of the two categories above-mentioned but does not pose significant risk of harm to health, safety or fundamental rights, the operators of such AI systems are relieved from the requirements imposed for high-risk AI systems (except for the EU database registration). However, to benefit from such exemption, a thorough assessment must be documented and strict conditions must be met (however these conditions are currently difficult to interpret, and further guidelines from the Commission are expected).
Article 6 of the EU AI Act sets out classification rules for high-risk AI systems, stating that high-risk AI systems fall within two categories: (i) safety components of products or products themselves regulated by existing EU product safety laws (listed in Annex I, e.g., medical devices, automotive AI); or (ii) used in specified areas (listed in Annex III), namely:
- Critical infrastructure: AI systems used as safety components in the management or operation of critical digital infrastructure, road traffic, or the supply of water, gas, heating or electricity.
- Education and vocational training: AI systems that determine access to education or training or otherwise impact a person's future opportunities and career development and AI systems used for monitoring and detecting prohibited behaviour during tests.
- Employment and worker management: AI systems used in hiring (including the placement of targeted job advertisements), performance evaluation, promotion or termination decisions.
- Access to essential private and public services: AI systems that evaluate eligibility for essential public services, such as social security and healthcare as well as AI systems for evaluating and classifying emergency calls and dispatching emergency services. Additionally, AI systems used to evaluate creditworthiness or during the risk assessment and pricing of life and health insurance.
- Law enforcement: AI systems used by law enforcement for risk assessments, predicting criminal activities (the risk of individuals becoming victims of crime, risk of (re-)offending or otherwise during criminal investigations), for polygraphs (i.e. 'lie detectors' or similar tools), and assessing reliability of evidence.
- Border control and migration: AI systems used to assess visa applications, asylum claims, and border security including for polygraphs (i.e. 'lie detectors' or similar tools) and for detecting, recognising or identifying individuals in migration contexts.
- Judicial and democratic processes: AI systems assisting judicial authorities with researching and interpreting facts and the law and applying the law to a set of facts. As well as AI systems used for influencing the outcome of elections or referendum or voting behaviour.
- Biometric identification and categorisation: AI systems that perform remote biometric identification are used to categorise individuals based on biometric data or other sensitive or protected attributes, and AI systems used for emotion recognition purposes.
These systems must adhere to stringent requirements to ensure they do not pose unacceptable risks or operate in a manner that protects individuals' rights and safety. The classification emphasises the importance of high standards and accountability in deploying AI in sensitive and impactful areas.
The European Commission has the power to amend the above-mentioned categories of high-risk AI systems including to modify any existing use cases or add new ones (Article 7(1) of the EU AI Act).
Where an AI system falls into one of the two categories above-mentioned but does not pose significant risk of harm to health, safety or fundamental rights, the operators of such AI systems are relieved from the requirements imposed for high-risk AI systems (except for the EU database registration). However, to benefit from such exemption, a thorough assessment must be documented and strict conditions must be met (however these conditions are currently difficult to interpret, and further guidelines from the Commission are expected).
High-risk AI in France
In France, the ACPR AI Governance Study has highlighted the necessity that credit scoring, anti-money laundering and customer protection AI systems are evaluated in a way that they ensure: (i) appropriate processing of data; (ii) performance; (iii) stability; and (iv) explainability. To do so, financial institutions must take care, from the design of algorithms onwards, to integrate operational teams, have human verification of the decisions, implement strong security measures, validation processes and to conduct regular audits.
Article 6 of the EU AI Act sets out classification rules for high-risk AI systems, stating that high-risk AI systems fall within two categories: (i) safety components of products or products themselves regulated by existing EU product safety laws (listed in Annex I, e.g., medical devices, automotive AI); or (ii) used in specified areas (listed in Annex III), namely:
- Critical infrastructure: AI systems used as safety components in the management or operation of critical digital infrastructure, road traffic, or the supply of water, gas, heating or electricity.
- Education and vocational training: AI systems that determine access to education or training or otherwise impact a person's future opportunities and career development and AI systems used for monitoring and detecting prohibited behaviour during tests.
- Employment and worker management: AI systems used in hiring (including the placement of targeted job advertisements), performance evaluation, promotion or termination decisions.
- Access to essential private and public services: AI systems that evaluate eligibility for essential public services, such as social security and healthcare as well as AI systems for evaluating and classifying emergency calls and dispatching emergency services. Additionally, AI systems used to evaluate creditworthiness or during the risk assessment and pricing of life and health insurance.
- Law enforcement: AI systems used by law enforcement for risk assessments, predicting criminal activities (the risk of individuals becoming victims of crime, risk of (re-)offending or otherwise during criminal investigations), for polygraphs (i.e. 'lie detectors' or similar tools), and assessing reliability of evidence.
- Border control and migration: AI systems used to assess visa applications, asylum claims, and border security including for polygraphs (i.e. 'lie detectors' or similar tools) and for detecting, recognising or identifying individuals in migration contexts.
- Judicial and democratic processes: AI systems assisting judicial authorities with researching and interpreting facts and the law and applying the law to a set of facts. As well as AI systems used for influencing the outcome of elections or referendum or voting behaviour.
- Biometric identification and categorisation: AI systems that perform remote biometric identification are used to categorise individuals based on biometric data or other sensitive or protected attributes, and AI systems used for emotion recognition purposes.
These systems must adhere to stringent requirements to ensure they do not pose unacceptable risks or operate in a manner that protects individuals' rights and safety. The classification emphasises the importance of high standards and accountability in deploying AI in sensitive and impactful areas.
The European Commission has the power to amend the above-mentioned categories of high-risk AI systems including to modify any existing use cases or add new ones (Article 7(1) of the EU AI Act).
Where an AI system falls into one of the two categories above-mentioned but does not pose significant risk of harm to health, safety or fundamental rights, the operators of such AI systems are relieved from the requirements imposed for high-risk AI systems (except for the EU database registration). However, to benefit from such exemption, a thorough assessment must be documented and strict conditions must be met (however these conditions are currently difficult to interpret, and further guidelines from the Commission are expected).
The KI-MIG adds a limited number of national rules relating to high-risk AI systems. These rules build on, but do not go beyond, the EU AI Act.
First, a non-public national register, kept by BNetzA, is introduced for certain high-risk AI systems listed in Annex III No. 2 of the EU AI Act (implementing Article 49(5) of the EU AI Act). Providers (or their authorised representatives) must register themselves and the system before it is placed on the market or put into service, and federal public-body deployers must likewise register, whereas public bodies of the Federal States are exempt.
Second, the KI-MIG tasks the competent market surveillance authorities with supervising testing of high-risk AI systems in real-world conditions outside regulatory sandboxes (in line with Article 60 of the EU AI Act) and requires providers to submit a testing plan to the competent authority beforehand.
Third, for particularly rights-sensitive high-risk systems within the meaning of Article 74(8) of the EU AI Act (biometrics used for law enforcement, and systems used in law enforcement, migration, asylum and border control, and the administration of justice and democratic processes), market surveillance is carried out by the independent AI Market Surveillance Chamber (KI-Marktüberwachungskammer) established within BNetzA.
Article 6 of the EU AI Act sets out classification rules for high-risk AI systems, stating that high-risk AI systems fall within two categories: (i) safety components of products or products themselves regulated by existing EU product safety laws (listed in Annex I, e.g., medical devices, automotive AI); or (ii) used in specified areas (listed in Annex III), namely:
- Critical infrastructure: AI systems used as safety components in the management or operation of critical digital infrastructure, road traffic, or the supply of water, gas, heating or electricity.
- Education and vocational training: AI systems that determine access to education or training or otherwise impact a person's future opportunities and career development and AI systems used for monitoring and detecting prohibited behaviour during tests.
- Employment and worker management: AI systems used in hiring (including the placement of targeted job advertisements), performance evaluation, promotion or termination decisions.
- Access to essential private and public services: AI systems that evaluate eligibility for essential public services, such as social security and healthcare as well as AI systems for evaluating and classifying emergency calls and dispatching emergency services. Additionally, AI systems used to evaluate creditworthiness or during the risk assessment and pricing of life and health insurance.
- Law enforcement: AI systems used by law enforcement for risk assessments, predicting criminal activities (the risk of individuals becoming victims of crime, risk of (re-)offending or otherwise during criminal investigations), for polygraphs (i.e. 'lie detectors' or similar tools), and assessing reliability of evidence.
- Border control and migration: AI systems used to assess visa applications, asylum claims, and border security including for polygraphs (i.e. 'lie detectors' or similar tools) and for detecting, recognising or identifying individuals in migration contexts.
- Judicial and democratic processes: AI systems assisting judicial authorities with researching and interpreting facts and the law and applying the law to a set of facts. As well as AI systems used for influencing the outcome of elections or referendum or voting behaviour.
- Biometric identification and categorisation: AI systems that perform remote biometric identification are used to categorise individuals based on biometric data or other sensitive or protected attributes, and AI systems used for emotion recognition purposes.
These systems must adhere to stringent requirements to ensure they do not pose unacceptable risks or operate in a manner that protects individuals' rights and safety. The classification emphasises the importance of high standards and accountability in deploying AI in sensitive and impactful areas.
The European Commission has the power to amend the above-mentioned categories of high-risk AI systems including to modify any existing use cases or add new ones (Article 7(1) of the EU AI Act).
Where an AI system falls into one of the two categories above-mentioned but does not pose significant risk of harm to health, safety or fundamental rights, the operators of such AI systems are relieved from the requirements imposed for high-risk AI systems (except for the EU database registration). However, to benefit from such exemption, a thorough assessment must be documented and strict conditions must be met (however these conditions are currently difficult to interpret, and further guidelines from the Commission are expected).
Laws specifically addressing AI have not yet been introduced in Hong Kong.
The Ethical AI Framework identifies certain categories of AI application as ‘likely to result in high risk’, for which CIO/IT Board approval is required, namely:
- AI application has a high degree of autonomy;
- AI application is used in a complex environment;
- sensitive personal data is used in the AI application;
- personal data is processed on a large scale and/or are combined data sets, taking into account certain factors;
- the AI application can result in a potentially sensitive impact on human beings;
- the AI application involves the evaluation or scoring of individuals;
- automated/complex decision-making by the AI application with significant impact and legal consequences without human intervention; and
- the AI application involves systemic observation or monitoring.
The GenAI Guideline proposes a four-tier risk classification system, in which applications of generative AI in critical infrastructure contexts (e.g., healthcare diagnostics, autonomous vehicles) are classified as high-risk.
The Model Framework and Guidance indicate that AI systems have a higher risk profile if they are likely to have a significant impact on individuals.
Under the SFC Circular, the SFC generally considers using an AI language model for providing investment recommendations, investment advice or investment research to investors or clients as high-risk use cases, given that problematic output may lead licensed corporations to recommend unsuitable financial products or misinform investors. Licensed corporations are expected to adopt extra risk mitigation measures for high-risk use cases, including model validation, human-in-the-loop review, and ongoing monitoring.
Article 6 of the EU AI Act sets out classification rules for high-risk AI systems, stating that high-risk AI systems fall within two categories: (i) safety components of products or products themselves regulated by existing EU product safety laws (listed in Annex I, e.g., medical devices, automotive AI); or (ii) used in specified areas (listed in Annex III), namely:
- Critical infrastructure: AI systems used as safety components in the management or operation of critical digital infrastructure, road traffic, or the supply of water, gas, heating or electricity.
- Education and vocational training: AI systems that determine access to education or training or otherwise impact a person's future opportunities and career development and AI systems used for monitoring and detecting prohibited behaviour during tests.
- Employment and worker management: AI systems used in hiring (including the placement of targeted job advertisements), performance evaluation, promotion or termination decisions.
- Access to essential private and public services: AI systems that evaluate eligibility for essential public services, such as social security and healthcare as well as AI systems for evaluating and classifying emergency calls and dispatching emergency services. Additionally, AI systems used to evaluate creditworthiness or during the risk assessment and pricing of life and health insurance.
- Law enforcement: AI systems used by law enforcement for risk assessments, predicting criminal activities (the risk of individuals becoming victims of crime, risk of (re-)offending or otherwise during criminal investigations), for polygraphs (i.e. 'lie detectors' or similar tools), and assessing reliability of evidence.
- Border control and migration: AI systems used to assess visa applications, asylum claims, and border security including for polygraphs (i.e. 'lie detectors' or similar tools) and for detecting, recognising or identifying individuals in migration contexts.
- Judicial and democratic processes: AI systems assisting judicial authorities with researching and interpreting facts and the law and applying the law to a set of facts. As well as AI systems used for influencing the outcome of elections or referendum or voting behaviour.
- Biometric identification and categorisation: AI systems that perform remote biometric identification are used to categorise individuals based on biometric data or other sensitive or protected attributes, and AI systems used for emotion recognition purposes.
These systems must adhere to stringent requirements to ensure they do not pose unacceptable risks or operate in a manner that protects individuals' rights and safety. The classification emphasises the importance of high standards and accountability in deploying AI in sensitive and impactful areas.
The European Commission has the power to amend the above-mentioned categories of high-risk AI systems including to modify any existing use cases or add new ones (Article 7(1) of the EU AI Act).
Where an AI system falls into one of the two categories above-mentioned but does not pose significant risk of harm to health, safety or fundamental rights, the operators of such AI systems are relieved from the requirements imposed for high-risk AI systems (except for the EU database registration). However, to benefit from such exemption, a thorough assessment must be documented and strict conditions must be met (however these conditions are currently difficult to interpret, and further guidelines from the Commission are expected).
India does not have a universal risk categorisation framework under law.
The India AI Governance Guidelines recommend India-focused risk classifications keeping the unique aspects of India and sector-specific use cases in context. It also highlights the need to protect vulnerable groups (such as women and children) from risks of AI.
The RBI’s FREE-AI framework recommends that regulated financial institutions adopt a Board-approved AI policy that risk-tiers their AI use cases by materiality, complexity and degree of autonomy, with more stringent controls applied proportionately to higher-risk applications. The report provides illustrative examples across the risk spectrum, ranging from lower-risk internal uses (such as chatbots and back-office automation) to higher-risk applications (such as credit scoring and automated underwriting) where greater oversight and validation are expected. The FREE-AI framework is a forward-looking recommendation and is not binding law.
Article 6 of the EU AI Act sets out classification rules for high-risk AI systems, stating that high-risk AI systems fall within two categories: (i) safety components of products or products themselves regulated by existing EU product safety laws (listed in Annex I, e.g., medical devices, automotive AI); or (ii) used in specified areas (listed in Annex III), namely:
- Critical infrastructure: AI systems used as safety components in the management or operation of critical digital infrastructure, road traffic, or the supply of water, gas, heating or electricity.
- Education and vocational training: AI systems that determine access to education or training or otherwise impact a person's future opportunities and career development and AI systems used for monitoring and detecting prohibited behaviour during tests.
- Employment and worker management: AI systems used in hiring (including the placement of targeted job advertisements), performance evaluation, promotion or termination decisions.
- Access to essential private and public services: AI systems that evaluate eligibility for essential public services, such as social security and healthcare as well as AI systems for evaluating and classifying emergency calls and dispatching emergency services. Additionally, AI systems used to evaluate creditworthiness or during the risk assessment and pricing of life and health insurance.
- Law enforcement: AI systems used by law enforcement for risk assessments, predicting criminal activities (the risk of individuals becoming victims of crime, risk of (re-)offending or otherwise during criminal investigations), for polygraphs (i.e. 'lie detectors' or similar tools), and assessing reliability of evidence.
- Border control and migration: AI systems used to assess visa applications, asylum claims, and border security including for polygraphs (i.e. 'lie detectors' or similar tools) and for detecting, recognising or identifying individuals in migration contexts.
- Judicial and democratic processes: AI systems assisting judicial authorities with researching and interpreting facts and the law and applying the law to a set of facts. As well as AI systems used for influencing the outcome of elections or referendum or voting behaviour.
- Biometric identification and categorisation: AI systems that perform remote biometric identification are used to categorise individuals based on biometric data or other sensitive or protected attributes, and AI systems used for emotion recognition purposes.
These systems must adhere to stringent requirements to ensure they do not pose unacceptable risks or operate in a manner that protects individuals' rights and safety. The classification emphasises the importance of high standards and accountability in deploying AI in sensitive and impactful areas.
The European Commission has the power to amend the above-mentioned categories of high-risk AI systems including to modify any existing use cases or add new ones (Article 7(1) of the EU AI Act).
Where an AI system falls into one of the two categories above-mentioned but does not pose significant risk of harm to health, safety or fundamental rights, the operators of such AI systems are relieved from the requirements imposed for high-risk AI systems (except for the EU database registration). However, to benefit from such exemption, a thorough assessment must be documented and strict conditions must be met (however these conditions are currently difficult to interpret, and further guidelines from the Commission are expected).
There is currently no statutory ‘risk‑tiering’ or ‘high‑risk’ AI classification regime in Israel.
The 2023 AI Policy Paper endorses a risk‑proportionate approach, and the PPA’s draft guidance frames obligations through existing privacy principles and risk assessments rather than categorical risk tiers.
The Financial Sector Report employs a risk-based method, dividing AI systems into two main categories: low- to medium-risk and high-risk, based on the EU AI Act's four-tier structure. Systems involved in credit scoring, insurance pricing and managing investment portfolios are specifically classified as high-risk, requiring greater transparency, real-time human supervision, AI governance and disclosure standards.
Article 6 of the EU AI Act sets out classification rules for high-risk AI systems, stating that high-risk AI systems fall within two categories: (i) safety components of products or products themselves regulated by existing EU product safety laws (listed in Annex I, e.g., medical devices, automotive AI); or (ii) used in specified areas (listed in Annex III), namely:
- Critical infrastructure: AI systems used as safety components in the management or operation of critical digital infrastructure, road traffic, or the supply of water, gas, heating or electricity.
- Education and vocational training: AI systems that determine access to education or training or otherwise impact a person's future opportunities and career development and AI systems used for monitoring and detecting prohibited behaviour during tests.
- Employment and worker management: AI systems used in hiring (including the placement of targeted job advertisements), performance evaluation, promotion or termination decisions.
- Access to essential private and public services: AI systems that evaluate eligibility for essential public services, such as social security and healthcare as well as AI systems for evaluating and classifying emergency calls and dispatching emergency services. Additionally, AI systems used to evaluate creditworthiness or during the risk assessment and pricing of life and health insurance.
- Law enforcement: AI systems used by law enforcement for risk assessments, predicting criminal activities (the risk of individuals becoming victims of crime, risk of (re-)offending or otherwise during criminal investigations), for polygraphs (i.e. 'lie detectors' or similar tools), and assessing reliability of evidence.
- Border control and migration: AI systems used to assess visa applications, asylum claims, and border security including for polygraphs (i.e. 'lie detectors' or similar tools) and for detecting, recognising or identifying individuals in migration contexts.
- Judicial and democratic processes: AI systems assisting judicial authorities with researching and interpreting facts and the law and applying the law to a set of facts. As well as AI systems used for influencing the outcome of elections or referendum or voting behaviour.
- Biometric identification and categorisation: AI systems that perform remote biometric identification are used to categorise individuals based on biometric data or other sensitive or protected attributes, and AI systems used for emotion recognition purposes.
These systems must adhere to stringent requirements to ensure they do not pose unacceptable risks or operate in a manner that protects individuals' rights and safety. The classification emphasises the importance of high standards and accountability in deploying AI in sensitive and impactful areas.
The European Commission has the power to amend the above-mentioned categories of high-risk AI systems including to modify any existing use cases or add new ones (Article 7(1) of the EU AI Act).
Where an AI system falls into one of the two categories above-mentioned but does not pose significant risk of harm to health, safety or fundamental rights, the operators of such AI systems are relieved from the requirements imposed for high-risk AI systems (except for the EU database registration). However, to benefit from such exemption, a thorough assessment must be documented and strict conditions must be met (however these conditions are currently difficult to interpret, and further guidelines from the Commission are expected).
Currently, there are no laws in Japan that specifically address this point.
Article 6 of the EU AI Act sets out classification rules for high-risk AI systems, stating that high-risk AI systems fall within two categories: (i) safety components of products or products themselves regulated by existing EU product safety laws (listed in Annex I, e.g., medical devices, automotive AI); or (ii) used in specified areas (listed in Annex III), namely:
- Critical infrastructure: AI systems used as safety components in the management or operation of critical digital infrastructure, road traffic, or the supply of water, gas, heating or electricity.
- Education and vocational training: AI systems that determine access to education or training or otherwise impact a person's future opportunities and career development and AI systems used for monitoring and detecting prohibited behaviour during tests.
- Employment and worker management: AI systems used in hiring (including the placement of targeted job advertisements), performance evaluation, promotion or termination decisions.
- Access to essential private and public services: AI systems that evaluate eligibility for essential public services, such as social security and healthcare as well as AI systems for evaluating and classifying emergency calls and dispatching emergency services. Additionally, AI systems used to evaluate creditworthiness or during the risk assessment and pricing of life and health insurance.
- Law enforcement: AI systems used by law enforcement for risk assessments, predicting criminal activities (the risk of individuals becoming victims of crime, risk of (re-)offending or otherwise during criminal investigations), for polygraphs (i.e. 'lie detectors' or similar tools), and assessing reliability of evidence.
- Border control and migration: AI systems used to assess visa applications, asylum claims, and border security including for polygraphs (i.e. 'lie detectors' or similar tools) and for detecting, recognising or identifying individuals in migration contexts.
- Judicial and democratic processes: AI systems assisting judicial authorities with researching and interpreting facts and the law and applying the law to a set of facts. As well as AI systems used for influencing the outcome of elections or referendum or voting behaviour.
- Biometric identification and categorisation: AI systems that perform remote biometric identification are used to categorise individuals based on biometric data or other sensitive or protected attributes, and AI systems used for emotion recognition purposes.
These systems must adhere to stringent requirements to ensure they do not pose unacceptable risks or operate in a manner that protects individuals' rights and safety. The classification emphasises the importance of high standards and accountability in deploying AI in sensitive and impactful areas.
The European Commission has the power to amend the above-mentioned categories of high-risk AI systems including to modify any existing use cases or add new ones (Article 7(1) of the EU AI Act).
Where an AI system falls into one of the two categories above-mentioned but does not pose significant risk of harm to health, safety or fundamental rights, the operators of such AI systems are relieved from the requirements imposed for high-risk AI systems (except for the EU database registration). However, to benefit from such exemption, a thorough assessment must be documented and strict conditions must be met (however these conditions are currently difficult to interpret, and further guidelines from the Commission are expected).
High-risk AI in Latvia
The annotation to the Law on the Artificial Intelligence Centre states that Latvia lacks the competencies and capabilities related to the management of AI risks, both in terms of monitoring prohibited and high-risk uses of AI and in protecting against the malicious use of AI. As a solution, the creation of a supportive environment for the development, testing, and implementation of safe and trustworthy AI solutions is proposed, including the establishment of a regulatory sandbox to facilitate simplified innovation deployment. It is also planned to strengthen sectoral competencies, foster cooperation with international partners, and develop methodologies and tools for risk management, as well as provide support to supervisory authorities. The Centre will serve as a platform for coordinating strategic projects and providing consultations, thereby promoting understanding and management of AI-related risks in Latvia. The Centre is already established, the supervising council has also been appointed and currently the head of the Centre is being sought.
Article 6 of the EU AI Act sets out classification rules for high-risk AI systems, stating that high-risk AI systems fall within two categories: (i) safety components of products or products themselves regulated by existing EU product safety laws (listed in Annex I, e.g., medical devices, automotive AI); or (ii) used in specified areas (listed in Annex III), namely:
- Critical infrastructure: AI systems used as safety components in the management or operation of critical digital infrastructure, road traffic, or the supply of water, gas, heating or electricity.
- Education and vocational training: AI systems that determine access to education or training or otherwise impact a person's future opportunities and career development and AI systems used for monitoring and detecting prohibited behaviour during tests.
- Employment and worker management: AI systems used in hiring (including the placement of targeted job advertisements), performance evaluation, promotion or termination decisions.
- Access to essential private and public services: AI systems that evaluate eligibility for essential public services, such as social security and healthcare as well as AI systems for evaluating and classifying emergency calls and dispatching emergency services. Additionally, AI systems used to evaluate creditworthiness or during the risk assessment and pricing of life and health insurance.
- Law enforcement: AI systems used by law enforcement for risk assessments, predicting criminal activities (the risk of individuals becoming victims of crime, risk of (re-)offending or otherwise during criminal investigations), for polygraphs (i.e. 'lie detectors' or similar tools), and assessing reliability of evidence.
- Border control and migration: AI systems used to assess visa applications, asylum claims, and border security including for polygraphs (i.e. 'lie detectors' or similar tools) and for detecting, recognising or identifying individuals in migration contexts.
- Judicial and democratic processes: AI systems assisting judicial authorities with researching and interpreting facts and the law and applying the law to a set of facts. As well as AI systems used for influencing the outcome of elections or referendum or voting behaviour.
- Biometric identification and categorisation: AI systems that perform remote biometric identification are used to categorise individuals based on biometric data or other sensitive or protected attributes, and AI systems used for emotion recognition purposes.
These systems must adhere to stringent requirements to ensure they do not pose unacceptable risks or operate in a manner that protects individuals' rights and safety. The classification emphasises the importance of high standards and accountability in deploying AI in sensitive and impactful areas.
The European Commission has the power to amend the above-mentioned categories of high-risk AI systems including to modify any existing use cases or add new ones (Article 7(1) of the EU AI Act).
Where an AI system falls into one of the two categories above-mentioned but does not pose significant risk of harm to health, safety or fundamental rights, the operators of such AI systems are relieved from the requirements imposed for high-risk AI systems (except for the EU database registration). However, to benefit from such exemption, a thorough assessment must be documented and strict conditions must be met (however these conditions are currently difficult to interpret, and further guidelines from the Commission are expected).
Article 6 of the EU AI Act sets out classification rules for high-risk AI systems, stating that high-risk AI systems fall within two categories: (i) safety components of products or products themselves regulated by existing EU product safety laws (listed in Annex I, e.g., medical devices, automotive AI); or (ii) used in specified areas (listed in Annex III), namely:
- Critical infrastructure: AI systems used as safety components in the management or operation of critical digital infrastructure, road traffic, or the supply of water, gas, heating or electricity.
- Education and vocational training: AI systems that determine access to education or training or otherwise impact a person's future opportunities and career development and AI systems used for monitoring and detecting prohibited behaviour during tests.
- Employment and worker management: AI systems used in hiring (including the placement of targeted job advertisements), performance evaluation, promotion or termination decisions.
- Access to essential private and public services: AI systems that evaluate eligibility for essential public services, such as social security and healthcare as well as AI systems for evaluating and classifying emergency calls and dispatching emergency services. Additionally, AI systems used to evaluate creditworthiness or during the risk assessment and pricing of life and health insurance.
- Law enforcement: AI systems used by law enforcement for risk assessments, predicting criminal activities (the risk of individuals becoming victims of crime, risk of (re-)offending or otherwise during criminal investigations), for polygraphs (i.e. 'lie detectors' or similar tools), and assessing reliability of evidence.
- Border control and migration: AI systems used to assess visa applications, asylum claims, and border security including for polygraphs (i.e. 'lie detectors' or similar tools) and for detecting, recognising or identifying individuals in migration contexts.
- Judicial and democratic processes: AI systems assisting judicial authorities with researching and interpreting facts and the law and applying the law to a set of facts. As well as AI systems used for influencing the outcome of elections or referendum or voting behaviour.
- Biometric identification and categorisation: AI systems that perform remote biometric identification are used to categorise individuals based on biometric data or other sensitive or protected attributes, and AI systems used for emotion recognition purposes.
These systems must adhere to stringent requirements to ensure they do not pose unacceptable risks or operate in a manner that protects individuals' rights and safety. The classification emphasises the importance of high standards and accountability in deploying AI in sensitive and impactful areas.
The European Commission has the power to amend the above-mentioned categories of high-risk AI systems including to modify any existing use cases or add new ones (Article 7(1) of the EU AI Act).
Where an AI system falls into one of the two categories above-mentioned but does not pose significant risk of harm to health, safety or fundamental rights, the operators of such AI systems are relieved from the requirements imposed for high-risk AI systems (except for the EU database registration). However, to benefit from such exemption, a thorough assessment must be documented and strict conditions must be met (however these conditions are currently difficult to interpret, and further guidelines from the Commission are expected).
Article 6 of the EU AI Act sets out classification rules for high-risk AI systems, stating that high-risk AI systems fall within two categories: (i) safety components of products or products themselves regulated by existing EU product safety laws (listed in Annex I, e.g., medical devices, automotive AI); or (ii) used in specified areas (listed in Annex III), namely:
- Critical infrastructure: AI systems used as safety components in the management or operation of critical digital infrastructure, road traffic, or the supply of water, gas, heating or electricity.
- Education and vocational training: AI systems that determine access to education or training or otherwise impact a person's future opportunities and career development and AI systems used for monitoring and detecting prohibited behaviour during tests.
- Employment and worker management: AI systems used in hiring (including the placement of targeted job advertisements), performance evaluation, promotion or termination decisions.
- Access to essential private and public services: AI systems that evaluate eligibility for essential public services, such as social security and healthcare as well as AI systems for evaluating and classifying emergency calls and dispatching emergency services. Additionally, AI systems used to evaluate creditworthiness or during the risk assessment and pricing of life and health insurance.
- Law enforcement: AI systems used by law enforcement for risk assessments, predicting criminal activities (the risk of individuals becoming victims of crime, risk of (re-)offending or otherwise during criminal investigations), for polygraphs (i.e. 'lie detectors' or similar tools), and assessing reliability of evidence.
- Border control and migration: AI systems used to assess visa applications, asylum claims, and border security including for polygraphs (i.e. 'lie detectors' or similar tools) and for detecting, recognising or identifying individuals in migration contexts.
- Judicial and democratic processes: AI systems assisting judicial authorities with researching and interpreting facts and the law and applying the law to a set of facts. As well as AI systems used for influencing the outcome of elections or referendum or voting behaviour.
- Biometric identification and categorisation: AI systems that perform remote biometric identification are used to categorise individuals based on biometric data or other sensitive or protected attributes, and AI systems used for emotion recognition purposes.
These systems must adhere to stringent requirements to ensure they do not pose unacceptable risks or operate in a manner that protects individuals' rights and safety. The classification emphasises the importance of high standards and accountability in deploying AI in sensitive and impactful areas.
The European Commission has the power to amend the above-mentioned categories of high-risk AI systems including to modify any existing use cases or add new ones (Article 7(1) of the EU AI Act).
Where an AI system falls into one of the two categories above-mentioned but does not pose significant risk of harm to health, safety or fundamental rights, the operators of such AI systems are relieved from the requirements imposed for high-risk AI systems (except for the EU database registration). However, to benefit from such exemption, a thorough assessment must be documented and strict conditions must be met (however these conditions are currently difficult to interpret, and further guidelines from the Commission are expected).
High-risk AI in Malta
Malta has not adopted additional substantive requirements for high-risk AI systems beyond those established under the EU AI Act.
Laws specifically addressing AI have not been introduced in Mauritius yet.
Laws specifically addressing AI have not been introduced in Mexico yet. Article 10 of the AI Bill establishes that the following AI systems used for the following purposes are considered to be high-risk:
- Real-time or delayed remote biometric identification of persons in private spaces.
- Management of water, electricity and gas supply.
- The allocation and determination of access to educational establishments and the assessment of students.
- The selection and recruitment of employees, as well as the assignment of tasks and the monitoring and evaluation of their performance and conduct.
- The assessment of individuals for access to benefits, services and social programmes.
- The assessment of the economic solvency of persons, or to establish their credit rating.
- The definition of priorities for the care of persons or groups of persons in emergency or disaster situations.
- The use to determine the risk of a person or persons committing or reoffending.
- The use at any stage of the investigation and interpretation of facts that could constitute an offence during criminal proceedings.
- The use for personalised or individualised management of migration, asylum and border control.
- Influencing the political-electoral preferences of citizens, supplanting the voice or image of candidates or political leaders without explicitly and undeniably doing so.
Article 12 of the AI Bill specifies the obligations on providers of high-risk AI systems, including the following:
- To have a quality management system in place.
- To develop and disseminate the technical documentation of the AI system.
- When under their control; to retain log files automatically generated by their AI systems.
- To ensure that AI systems are subject to human assessment and control procedures determined by the competent authority before being placed on the market or put into service.
Laws specifically addressing AI have not been introduced in Morocco yet, so no AI uses are expressly specified as being high-risk.
Article 6 of the EU AI Act sets out classification rules for high-risk AI systems, stating that high-risk AI systems fall within two categories: (i) safety components of products or products themselves regulated by existing EU product safety laws (listed in Annex I, e.g., medical devices, automotive AI); or (ii) used in specified areas (listed in Annex III), namely:
- Critical infrastructure: AI systems used as safety components in the management or operation of critical digital infrastructure, road traffic, or the supply of water, gas, heating or electricity.
- Education and vocational training: AI systems that determine access to education or training or otherwise impact a person's future opportunities and career development and AI systems used for monitoring and detecting prohibited behaviour during tests.
- Employment and worker management: AI systems used in hiring (including the placement of targeted job advertisements), performance evaluation, promotion or termination decisions.
- Access to essential private and public services: AI systems that evaluate eligibility for essential public services, such as social security and healthcare as well as AI systems for evaluating and classifying emergency calls and dispatching emergency services. Additionally, AI systems used to evaluate creditworthiness or during the risk assessment and pricing of life and health insurance.
- Law enforcement: AI systems used by law enforcement for risk assessments, predicting criminal activities (the risk of individuals becoming victims of crime, risk of (re-)offending or otherwise during criminal investigations), for polygraphs (i.e. 'lie detectors' or similar tools), and assessing reliability of evidence.
- Border control and migration: AI systems used to assess visa applications, asylum claims, and border security including for polygraphs (i.e. 'lie detectors' or similar tools) and for detecting, recognising or identifying individuals in migration contexts.
- Judicial and democratic processes: AI systems assisting judicial authorities with researching and interpreting facts and the law and applying the law to a set of facts. As well as AI systems used for influencing the outcome of elections or referendum or voting behaviour.
- Biometric identification and categorisation: AI systems that perform remote biometric identification are used to categorise individuals based on biometric data or other sensitive or protected attributes, and AI systems used for emotion recognition purposes.
These systems must adhere to stringent requirements to ensure they do not pose unacceptable risks or operate in a manner that protects individuals' rights and safety. The classification emphasises the importance of high standards and accountability in deploying AI in sensitive and impactful areas.
The European Commission has the power to amend the above-mentioned categories of high-risk AI systems including to modify any existing use cases or add new ones (Article 7(1) of the EU AI Act).
Where an AI system falls into one of the two categories above-mentioned but does not pose significant risk of harm to health, safety or fundamental rights, the operators of such AI systems are relieved from the requirements imposed for high-risk AI systems (except for the EU database registration). However, to benefit from such exemption, a thorough assessment must be documented and strict conditions must be met (however these conditions are currently difficult to interpret, and further guidelines from the Commission are expected).
As mentioned in the Prohibited Activities section, laws specifically addressing AI have not been introduced in New Zealand yet, so no AI uses are expressly classified as high-risk by statute. However, several frameworks identify higher-risk use cases. The non-binding OPC AI Guidance identifies the use of AI tools for automated decision-making as being higher-risk, given the potential for the use to have direct impacts on outcomes for individuals. The Biometrics Code effectively treats certain biometric uses as high-risk by imposing ‘safe limits’ on highly intrusive practices, as discussed in the Prohibited Activities section. The OPC’s 2025 Annual Report called for Privacy Act modernisation to introduce stronger protections for automated decision-making, including addressing inaccuracy, discrimination and explainability, though no amendments have been proposed by legislators. Finally, the use of AI in the public sector is receiving increasing attention, particularly in automated decision-making in regulatory contexts.
A standalone AI law has not yet been enacted in Nigeria, so there are no statutory provisions on high-risk AI.
The content on High-risk AI in the European Union applies in Norway.
The AI Regulation expressly identifies certain AI systems as high-risk. AI systems are considered high-risk where their use poses a risk to human life, dignity, liberty, physical safety or other fundamental rights. Such systems may be used subject to specific conditions and controls.
High-risk uses include:
- AI systems used to manage critical national assets supporting essential services, such as energy, telecommunications, health, transport, water and banking.
- AI systems used in educational processes involving children and adolescents, including access to educational institutions, assessment of learning outcomes, assessment of the level of education received, or identification of prohibited conduct during examinations or educational activities, unless the system performs only a complementary function and does not replace human pedagogical evaluation.
- AI systems used to determine recruitment, assessment, hiring, dismissal or working conditions of workers or job applicants.
- AI systems used to determine access to, assessment, prioritisation or termination of social programme benefits and/or household targeting.
- AI systems used to determine individuals’ creditworthiness, except where the AI system is used for financial fraud detection.
- AI systems used to determine access to health services or complementary services affecting individuals’ life and wellbeing.
- AI systems that support assessment, diagnostic suggestions, management or prognosis of individuals’ health status where this may have a significant impact on their physical or mental wellbeing, emergency triage, or the evaluation of sensitive personal data, including data recorded in electronic health records.
- AI systems used to infer the emotions of a natural person in workplace or educational settings, except where the AI system is intended to be installed or placed on the market for medical or safety reasons.
- Any other use that poses a risk to human life, physical safety, fundamental rights, liberty or dignity, where the system’s performance involves a high probability of stigmatisation, discrimination or cultural bias, or a high level of complexity for human oversight.
Article 6 of the EU AI Act sets out classification rules for high-risk AI systems, stating that high-risk AI systems fall within two categories: (i) safety components of products or products themselves regulated by existing EU product safety laws (listed in Annex I, e.g., medical devices, automotive AI); or (ii) used in specified areas (listed in Annex III), namely:
- Critical infrastructure: AI systems used as safety components in the management or operation of critical digital infrastructure, road traffic, or the supply of water, gas, heating or electricity.
- Education and vocational training: AI systems that determine access to education or training or otherwise impact a person's future opportunities and career development and AI systems used for monitoring and detecting prohibited behaviour during tests.
- Employment and worker management: AI systems used in hiring (including the placement of targeted job advertisements), performance evaluation, promotion or termination decisions.
- Access to essential private and public services: AI systems that evaluate eligibility for essential public services, such as social security and healthcare as well as AI systems for evaluating and classifying emergency calls and dispatching emergency services. Additionally, AI systems used to evaluate creditworthiness or during the risk assessment and pricing of life and health insurance.
- Law enforcement: AI systems used by law enforcement for risk assessments, predicting criminal activities (the risk of individuals becoming victims of crime, risk of (re-)offending or otherwise during criminal investigations), for polygraphs (i.e. 'lie detectors' or similar tools), and assessing reliability of evidence.
- Border control and migration: AI systems used to assess visa applications, asylum claims, and border security including for polygraphs (i.e. 'lie detectors' or similar tools) and for detecting, recognising or identifying individuals in migration contexts.
- Judicial and democratic processes: AI systems assisting judicial authorities with researching and interpreting facts and the law and applying the law to a set of facts. As well as AI systems used for influencing the outcome of elections or referendum or voting behaviour.
- Biometric identification and categorisation: AI systems that perform remote biometric identification are used to categorise individuals based on biometric data or other sensitive or protected attributes, and AI systems used for emotion recognition purposes.
These systems must adhere to stringent requirements to ensure they do not pose unacceptable risks or operate in a manner that protects individuals' rights and safety. The classification emphasises the importance of high standards and accountability in deploying AI in sensitive and impactful areas.
The European Commission has the power to amend the above-mentioned categories of high-risk AI systems including to modify any existing use cases or add new ones (Article 7(1) of the EU AI Act).
Where an AI system falls into one of the two categories above-mentioned but does not pose significant risk of harm to health, safety or fundamental rights, the operators of such AI systems are relieved from the requirements imposed for high-risk AI systems (except for the EU database registration). However, to benefit from such exemption, a thorough assessment must be documented and strict conditions must be met (however these conditions are currently difficult to interpret, and further guidelines from the Commission are expected).
Article 6 of the EU AI Act sets out classification rules for high-risk AI systems, stating that high-risk AI systems fall within two categories: (i) safety components of products or products themselves regulated by existing EU product safety laws (listed in Annex I, e.g., medical devices, automotive AI); or (ii) used in specified areas (listed in Annex III), namely:
- Critical infrastructure: AI systems used as safety components in the management or operation of critical digital infrastructure, road traffic, or the supply of water, gas, heating or electricity.
- Education and vocational training: AI systems that determine access to education or training or otherwise impact a person's future opportunities and career development and AI systems used for monitoring and detecting prohibited behaviour during tests.
- Employment and worker management: AI systems used in hiring (including the placement of targeted job advertisements), performance evaluation, promotion or termination decisions.
- Access to essential private and public services: AI systems that evaluate eligibility for essential public services, such as social security and healthcare as well as AI systems for evaluating and classifying emergency calls and dispatching emergency services. Additionally, AI systems used to evaluate creditworthiness or during the risk assessment and pricing of life and health insurance.
- Law enforcement: AI systems used by law enforcement for risk assessments, predicting criminal activities (the risk of individuals becoming victims of crime, risk of (re-)offending or otherwise during criminal investigations), for polygraphs (i.e. 'lie detectors' or similar tools), and assessing reliability of evidence.
- Border control and migration: AI systems used to assess visa applications, asylum claims, and border security including for polygraphs (i.e. 'lie detectors' or similar tools) and for detecting, recognising or identifying individuals in migration contexts.
- Judicial and democratic processes: AI systems assisting judicial authorities with researching and interpreting facts and the law and applying the law to a set of facts. As well as AI systems used for influencing the outcome of elections or referendum or voting behaviour.
- Biometric identification and categorisation: AI systems that perform remote biometric identification are used to categorise individuals based on biometric data or other sensitive or protected attributes, and AI systems used for emotion recognition purposes.
These systems must adhere to stringent requirements to ensure they do not pose unacceptable risks or operate in a manner that protects individuals' rights and safety. The classification emphasises the importance of high standards and accountability in deploying AI in sensitive and impactful areas.
The European Commission has the power to amend the above-mentioned categories of high-risk AI systems including to modify any existing use cases or add new ones (Article 7(1) of the EU AI Act).
Where an AI system falls into one of the two categories above-mentioned but does not pose significant risk of harm to health, safety or fundamental rights, the operators of such AI systems are relieved from the requirements imposed for high-risk AI systems (except for the EU database registration). However, to benefit from such exemption, a thorough assessment must be documented and strict conditions must be met (however these conditions are currently difficult to interpret, and further guidelines from the Commission are expected).
Article 6 of the EU AI Act sets out classification rules for high-risk AI systems, stating that high-risk AI systems fall within two categories: (i) safety components of products or products themselves regulated by existing EU product safety laws (listed in Annex I, e.g., medical devices, automotive AI); or (ii) used in specified areas (listed in Annex III), namely:
- Critical infrastructure: AI systems used as safety components in the management or operation of critical digital infrastructure, road traffic, or the supply of water, gas, heating or electricity.
- Education and vocational training: AI systems that determine access to education or training or otherwise impact a person's future opportunities and career development and AI systems used for monitoring and detecting prohibited behaviour during tests.
- Employment and worker management: AI systems used in hiring (including the placement of targeted job advertisements), performance evaluation, promotion or termination decisions.
- Access to essential private and public services: AI systems that evaluate eligibility for essential public services, such as social security and healthcare as well as AI systems for evaluating and classifying emergency calls and dispatching emergency services. Additionally, AI systems used to evaluate creditworthiness or during the risk assessment and pricing of life and health insurance.
- Law enforcement: AI systems used by law enforcement for risk assessments, predicting criminal activities (the risk of individuals becoming victims of crime, risk of (re-)offending or otherwise during criminal investigations), for polygraphs (i.e. 'lie detectors' or similar tools), and assessing reliability of evidence.
- Border control and migration: AI systems used to assess visa applications, asylum claims, and border security including for polygraphs (i.e. 'lie detectors' or similar tools) and for detecting, recognising or identifying individuals in migration contexts.
- Judicial and democratic processes: AI systems assisting judicial authorities with researching and interpreting facts and the law and applying the law to a set of facts. As well as AI systems used for influencing the outcome of elections or referendum or voting behaviour.
- Biometric identification and categorisation: AI systems that perform remote biometric identification are used to categorise individuals based on biometric data or other sensitive or protected attributes, and AI systems used for emotion recognition purposes.
These systems must adhere to stringent requirements to ensure they do not pose unacceptable risks or operate in a manner that protects individuals' rights and safety. The classification emphasises the importance of high standards and accountability in deploying AI in sensitive and impactful areas.
The European Commission has the power to amend the above-mentioned categories of high-risk AI systems including to modify any existing use cases or add new ones (Article 7(1) of the EU AI Act).
Where an AI system falls into one of the two categories above-mentioned but does not pose significant risk of harm to health, safety or fundamental rights, the operators of such AI systems are relieved from the requirements imposed for high-risk AI systems (except for the EU database registration). However, to benefit from such exemption, a thorough assessment must be documented and strict conditions must be met (however these conditions are currently difficult to interpret, and further guidelines from the Commission are expected).
There is no statutory cross-sector risk taxonomy for AI systems.
The SDAIA AI Ethics Principles establish a four‑tier risk classification framework (no risk, limited, high, and unacceptable risk). Under the guidelines, high‑risk systems that pose a threat to fundamental rights are required to undergo conformity assessments and comply with applicable legal requirements.
Organisations are expected to integrate AI risk assessments into existing regulatory compliance frameworks to ensure comprehensive oversight, including:
- Data protection impact assessments (personal data processing, lawful basis, cross-border transfer)
- Model risk assessments (accuracy, reliability, and performance limitations)
- Bias and fairness assessments (discriminatory outcomes, dataset integrity)
- Cybersecurity and resilience testing (system vulnerabilities, adversarial risk)
- Governance and accountability reviews (human oversight, decision ownership)
- Third-party and outsourcing risk assessments (vendor reliance, outsourcing risks)
Laws specifically addressing AI have not yet been introduced in Singapore.
The Model Framework for GenAI cites as examples of high-risk AI use cases: (i) use for medical diagnosis or (ii) use with national security or societal implications.
The Model Framework for Agentic AI recommends defining significant checkpoints or action boundaries that require human approval, especially before sensitive actions are executed, including high-stakes actions and decisions such as editing of sensitive data, final decisions in high-risk domains (such as healthcare or legal), and actions that may trigger liability.
Article 6 of the EU AI Act sets out classification rules for high-risk AI systems, stating that high-risk AI systems fall within two categories: (i) safety components of products or products themselves regulated by existing EU product safety laws (listed in Annex I, e.g., medical devices, automotive AI); or (ii) used in specified areas (listed in Annex III), namely:
- Critical infrastructure: AI systems used as safety components in the management or operation of critical digital infrastructure, road traffic, or the supply of water, gas, heating or electricity.
- Education and vocational training: AI systems that determine access to education or training or otherwise impact a person's future opportunities and career development and AI systems used for monitoring and detecting prohibited behaviour during tests.
- Employment and worker management: AI systems used in hiring (including the placement of targeted job advertisements), performance evaluation, promotion or termination decisions.
- Access to essential private and public services: AI systems that evaluate eligibility for essential public services, such as social security and healthcare as well as AI systems for evaluating and classifying emergency calls and dispatching emergency services. Additionally, AI systems used to evaluate creditworthiness or during the risk assessment and pricing of life and health insurance.
- Law enforcement: AI systems used by law enforcement for risk assessments, predicting criminal activities (the risk of individuals becoming victims of crime, risk of (re-)offending or otherwise during criminal investigations), for polygraphs (i.e. 'lie detectors' or similar tools), and assessing reliability of evidence.
- Border control and migration: AI systems used to assess visa applications, asylum claims, and border security including for polygraphs (i.e. 'lie detectors' or similar tools) and for detecting, recognising or identifying individuals in migration contexts.
- Judicial and democratic processes: AI systems assisting judicial authorities with researching and interpreting facts and the law and applying the law to a set of facts. As well as AI systems used for influencing the outcome of elections or referendum or voting behaviour.
- Biometric identification and categorisation: AI systems that perform remote biometric identification are used to categorise individuals based on biometric data or other sensitive or protected attributes, and AI systems used for emotion recognition purposes.
These systems must adhere to stringent requirements to ensure they do not pose unacceptable risks or operate in a manner that protects individuals' rights and safety. The classification emphasises the importance of high standards and accountability in deploying AI in sensitive and impactful areas.
The European Commission has the power to amend the above-mentioned categories of high-risk AI systems including to modify any existing use cases or add new ones (Article 7(1) of the EU AI Act).
Where an AI system falls into one of the two categories above-mentioned but does not pose significant risk of harm to health, safety or fundamental rights, the operators of such AI systems are relieved from the requirements imposed for high-risk AI systems (except for the EU database registration). However, to benefit from such exemption, a thorough assessment must be documented and strict conditions must be met (however these conditions are currently difficult to interpret, and further guidelines from the Commission are expected).
High-risk AI in the Slovak Republic
High-risk AI systems are regulated primarily through the framework established by the EU AI Act. The Slovak authorities are responsible for supervising compliance with obligations applicable to providers and deployers of such systems. The Office for Digital Integrity acts as the general market surveillance authority, while designated sectoral regulators exercise supervision in specific sectors.
The proposed legislation specifically enables the establishment of AI regulatory sandboxes and testing environments. Public authorities may create experimental environments for the development, validation, testing and pilot deployment of AI systems before they are placed on the market or put into service. The Office for Digital Integrity may also establish and coordinate national AI regulatory sandboxes, including those prioritising access for small and medium-sized enterprises (SMEs) and start-ups.
In addition, the draft law provides detailed powers for supervisory authorities to conduct inspections, investigate complaints and oversee real-world testing activities for AI systems.
Article 6 of the EU AI Act sets out classification rules for high-risk AI systems, stating that high-risk AI systems fall within two categories: (i) safety components of products or products themselves regulated by existing EU product safety laws (listed in Annex I, e.g., medical devices, automotive AI); or (ii) used in specified areas (listed in Annex III), namely:
- Critical infrastructure: AI systems used as safety components in the management or operation of critical digital infrastructure, road traffic, or the supply of water, gas, heating or electricity.
- Education and vocational training: AI systems that determine access to education or training or otherwise impact a person's future opportunities and career development and AI systems used for monitoring and detecting prohibited behaviour during tests.
- Employment and worker management: AI systems used in hiring (including the placement of targeted job advertisements), performance evaluation, promotion or termination decisions.
- Access to essential private and public services: AI systems that evaluate eligibility for essential public services, such as social security and healthcare as well as AI systems for evaluating and classifying emergency calls and dispatching emergency services. Additionally, AI systems used to evaluate creditworthiness or during the risk assessment and pricing of life and health insurance.
- Law enforcement: AI systems used by law enforcement for risk assessments, predicting criminal activities (the risk of individuals becoming victims of crime, risk of (re-)offending or otherwise during criminal investigations), for polygraphs (i.e. 'lie detectors' or similar tools), and assessing reliability of evidence.
- Border control and migration: AI systems used to assess visa applications, asylum claims, and border security including for polygraphs (i.e. 'lie detectors' or similar tools) and for detecting, recognising or identifying individuals in migration contexts.
- Judicial and democratic processes: AI systems assisting judicial authorities with researching and interpreting facts and the law and applying the law to a set of facts. As well as AI systems used for influencing the outcome of elections or referendum or voting behaviour.
- Biometric identification and categorisation: AI systems that perform remote biometric identification are used to categorise individuals based on biometric data or other sensitive or protected attributes, and AI systems used for emotion recognition purposes.
These systems must adhere to stringent requirements to ensure they do not pose unacceptable risks or operate in a manner that protects individuals' rights and safety. The classification emphasises the importance of high standards and accountability in deploying AI in sensitive and impactful areas.
The European Commission has the power to amend the above-mentioned categories of high-risk AI systems including to modify any existing use cases or add new ones (Article 7(1) of the EU AI Act).
Where an AI system falls into one of the two categories above-mentioned but does not pose significant risk of harm to health, safety or fundamental rights, the operators of such AI systems are relieved from the requirements imposed for high-risk AI systems (except for the EU database registration). However, to benefit from such exemption, a thorough assessment must be documented and strict conditions must be met (however these conditions are currently difficult to interpret, and further guidelines from the Commission are expected).
Laws specifically addressing AI have not been introduced in South Africa, so no AI uses are expressly classified as high-risk by statute.
The AI Act outlines several key obligations for AI business operators who aim to provide high-impact AI systems or products or services utilising such technology.
- High-Impact AI Definition: ‘High-Impact AI’ systems are those that significantly influence or pose risks to the safety and fundamental rights of individuals. These are typically employed in critical decision-making or assessments with substantial impact on someone’s rights and responsibilities. The AI Act (Article 2, Item 4) lists specific domains including: energy supply, drinking water production, healthcare systems, medical devices and digital medical products, nuclear safety, use of biometric information for investigation or arrests, recruitment and loan assessments that materially affect individuals’ rights and obligations, and key operation of transportation means, facilities, and systems. Additional domains may be designated by Enforcement
- Preliminary Review Obligation: AI business operators must assess whether their AI technology qualifies as high-impact before deployment. They may seek confirmation from the Minister of MSIT if there is uncertainty regarding the classification of their AI system (Article 33).
- Advance Notification Obligation: AI business operators intending to deploy products or services using high-impact AI are obligated to inform users in advance (Article 31, Paragraph (1)). Non-compliance may result in an administrative fine of up to KRW 30 million (Article 43, Paragraph (1), Item 1).
- Safety and Reliability Measures: A comprehensive framework of safety and reliability measures must be implemented by operators offering high-impact AI systems to ensure these systems operate as intended without undue risk (Article 34).
- Impact Assessment Obligation: AI business operators must use their efforts to assess the potential impact of their high-impact AI on individuals’ fundamental rights. Public institutions, including national and local government entities, must prioritise AI solutions that have undergone such assessments (Article 35).
- Right to Explanation: Individuals affected by AI systems including high-impact AI have the right to request clear explanations of the logic and principles behind AI-generated outcomes, to the extent that this is technically and reasonably feasible (Article 3, Paragraph (2)).
Article 6 of the EU AI Act sets out classification rules for high-risk AI systems, stating that high-risk AI systems fall within two categories: (i) safety components of products or products themselves regulated by existing EU product safety laws (listed in Annex I, e.g., medical devices, automotive AI); or (ii) used in specified areas (listed in Annex III), namely:
- Critical infrastructure: AI systems used as safety components in the management or operation of critical digital infrastructure, road traffic, or the supply of water, gas, heating or electricity.
- Education and vocational training: AI systems that determine access to education or training or otherwise impact a person's future opportunities and career development and AI systems used for monitoring and detecting prohibited behaviour during tests.
- Employment and worker management: AI systems used in hiring (including the placement of targeted job advertisements), performance evaluation, promotion or termination decisions.
- Access to essential private and public services: AI systems that evaluate eligibility for essential public services, such as social security and healthcare as well as AI systems for evaluating and classifying emergency calls and dispatching emergency services. Additionally, AI systems used to evaluate creditworthiness or during the risk assessment and pricing of life and health insurance.
- Law enforcement: AI systems used by law enforcement for risk assessments, predicting criminal activities (the risk of individuals becoming victims of crime, risk of (re-)offending or otherwise during criminal investigations), for polygraphs (i.e. 'lie detectors' or similar tools), and assessing reliability of evidence.
- Border control and migration: AI systems used to assess visa applications, asylum claims, and border security including for polygraphs (i.e. 'lie detectors' or similar tools) and for detecting, recognising or identifying individuals in migration contexts.
- Judicial and democratic processes: AI systems assisting judicial authorities with researching and interpreting facts and the law and applying the law to a set of facts. As well as AI systems used for influencing the outcome of elections or referendum or voting behaviour.
- Biometric identification and categorisation: AI systems that perform remote biometric identification are used to categorise individuals based on biometric data or other sensitive or protected attributes, and AI systems used for emotion recognition purposes.
These systems must adhere to stringent requirements to ensure they do not pose unacceptable risks or operate in a manner that protects individuals' rights and safety. The classification emphasises the importance of high standards and accountability in deploying AI in sensitive and impactful areas.
The European Commission has the power to amend the above-mentioned categories of high-risk AI systems including to modify any existing use cases or add new ones (Article 7(1) of the EU AI Act).
Where an AI system falls into one of the two categories above-mentioned but does not pose significant risk of harm to health, safety or fundamental rights, the operators of such AI systems are relieved from the requirements imposed for high-risk AI systems (except for the EU database registration). However, to benefit from such exemption, a thorough assessment must be documented and strict conditions must be met (however these conditions are currently difficult to interpret, and further guidelines from the Commission are expected).
Article 6 of the EU AI Act sets out classification rules for high-risk AI systems, stating that high-risk AI systems fall within two categories: (i) safety components of products or products themselves regulated by existing EU product safety laws (listed in Annex I, e.g., medical devices, automotive AI); or (ii) used in specified areas (listed in Annex III), namely:
- Critical infrastructure: AI systems used as safety components in the management or operation of critical digital infrastructure, road traffic, or the supply of water, gas, heating or electricity.
- Education and vocational training: AI systems that determine access to education or training or otherwise impact a person's future opportunities and career development and AI systems used for monitoring and detecting prohibited behaviour during tests.
- Employment and worker management: AI systems used in hiring (including the placement of targeted job advertisements), performance evaluation, promotion or termination decisions.
- Access to essential private and public services: AI systems that evaluate eligibility for essential public services, such as social security and healthcare as well as AI systems for evaluating and classifying emergency calls and dispatching emergency services. Additionally, AI systems used to evaluate creditworthiness or during the risk assessment and pricing of life and health insurance.
- Law enforcement: AI systems used by law enforcement for risk assessments, predicting criminal activities (the risk of individuals becoming victims of crime, risk of (re-)offending or otherwise during criminal investigations), for polygraphs (i.e. 'lie detectors' or similar tools), and assessing reliability of evidence.
- Border control and migration: AI systems used to assess visa applications, asylum claims, and border security including for polygraphs (i.e. 'lie detectors' or similar tools) and for detecting, recognising or identifying individuals in migration contexts.
- Judicial and democratic processes: AI systems assisting judicial authorities with researching and interpreting facts and the law and applying the law to a set of facts. As well as AI systems used for influencing the outcome of elections or referendum or voting behaviour.
- Biometric identification and categorisation: AI systems that perform remote biometric identification are used to categorise individuals based on biometric data or other sensitive or protected attributes, and AI systems used for emotion recognition purposes.
These systems must adhere to stringent requirements to ensure they do not pose unacceptable risks or operate in a manner that protects individuals' rights and safety. The classification emphasises the importance of high standards and accountability in deploying AI in sensitive and impactful areas.
The European Commission has the power to amend the above-mentioned categories of high-risk AI systems including to modify any existing use cases or add new ones (Article 7(1) of the EU AI Act).
Where an AI system falls into one of the two categories above-mentioned but does not pose significant risk of harm to health, safety or fundamental rights, the operators of such AI systems are relieved from the requirements imposed for high-risk AI systems (except for the EU database registration). However, to benefit from such exemption, a thorough assessment must be documented and strict conditions must be met (however these conditions are currently difficult to interpret, and further guidelines from the Commission are expected).
There are currently no high-risk AI use cases specifically prescribed under Thai law. However, in addition to the authorisation above, the Draft AI Law Principles (2025) also contemplates a risk management framework for a provider / deployer of high-risks AI systems. The BOT AI Guideline (2025), issued by the Bank of Thailand (BOT), also addresses the nature of the AI system usage and risk management for AI systems deployed in financial services.
Laws specifically addressing AI have not been enacted in Türkiye yet; therefore, there is currently no regulation related to high-risk use.
There is no unified federal law or emirate level law in the UAE that has a primary focus on regulating AI (and therefore no classification of AI into unacceptable risk, high risk, limited risk and minimal risk).
The DIFC’s Data Protection Regulations do not classify AI Systems into unacceptable risk, high risk, limited risk and minimal risk.
Sector regulators are looking at high risks posed by AI in their sectors and the Financial Conduct Authority (FCA), the Office of Communications (Ofcom) and the Medicines and Healthcare products Regulatory Agency (MHRA) are increasingly embedding AI principles into their existing frameworks. Use of AI is likely to trigger the need for a data protection impact assessment where personal data is involved in the design, development and/or deployment.
Unlike in the EU, the risk categorisation of AI technologies in the US is not defined by a single, harmonised legislative or regulatory taxonomy. Whether a specific AI technology or use is considered ‘high-risk’ will depend on, and will matter only if, jurisdiction-specific laws or rules include a relevant definition. As originally enacted, the Colorado AI Act was the only legislation that adopted a risk stratification system categorising certain uses of AI as ‘high-risk’. However, amendments enacted in May 2026 (SB 189) removed this risk-based framework before it took effect, replacing it with narrower transparency requirements for automated decision-making technology that take effect on 1 January 2027.