[{"command":"settings","settings":{"pluralDelimiter":"\u0003","suppressDeprecationErrors":true,"ajaxPageState":{"libraries":"eJxLzi9K1U8pKi1IzNFLyUzMyU_XS8xKrNApSCxKTC9KLMgohskiRPRK8wpKk3IyizNSUwAiWxkF","theme":"upd","theme_token":null},"ajaxTrustedUrl":[],"user":{"uid":0,"permissionsHash":"22dcdfba032631beed6427d0f24bf0844dfb9bda62deaafe5cec74da1a30ffe0"}},"merge":true},{"command":"add_css","data":[{"rel":"stylesheet","media":"all","href":"\/core\/assets\/vendor\/jquery.ui\/themes\/base\/core.css?tj04ap"},{"rel":"stylesheet","media":"all","href":"\/core\/assets\/vendor\/jquery.ui\/themes\/base\/controlgroup.css?tj04ap"},{"rel":"stylesheet","media":"all","href":"\/core\/assets\/vendor\/jquery.ui\/themes\/base\/checkboxradio.css?tj04ap"},{"rel":"stylesheet","media":"all","href":"\/core\/assets\/vendor\/jquery.ui\/themes\/base\/resizable.css?tj04ap"},{"rel":"stylesheet","media":"all","href":"\/core\/assets\/vendor\/jquery.ui\/themes\/base\/button.css?tj04ap"},{"rel":"stylesheet","media":"all","href":"\/core\/assets\/vendor\/jquery.ui\/themes\/base\/dialog.css?tj04ap"},{"rel":"stylesheet","media":"all","href":"\/core\/misc\/components\/progress.module.css?tj04ap"},{"rel":"stylesheet","media":"all","href":"\/core\/misc\/components\/ajax-progress.module.css?tj04ap"},{"rel":"stylesheet","media":"all","href":"\/core\/assets\/vendor\/jquery.ui\/themes\/base\/theme.css?tj04ap"},{"rel":"stylesheet","media":"all","href":"\/modules\/contrib\/paragraphs\/css\/paragraphs.unpublished.css?tj04ap"}]},{"command":"add_js","selector":"body","data":[{"src":"\/core\/assets\/vendor\/jquery\/jquery.min.js?v=3.7.1"},{"src":"\/core\/assets\/vendor\/once\/once.min.js?v=1.0.1"},{"src":"\/core\/misc\/drupalSettingsLoader.js?v=10.6.3"},{"src":"\/core\/misc\/drupal.js?v=10.6.3"},{"src":"\/core\/misc\/drupal.init.js?v=10.6.3"},{"src":"\/core\/assets\/vendor\/jquery.ui\/ui\/version-min.js?v=10.6.3"},{"src":"\/core\/assets\/vendor\/jquery.ui\/ui\/data-min.js?v=10.6.3"},{"src":"\/core\/assets\/vendor\/jquery.ui\/ui\/disable-selection-min.js?v=10.6.3"},{"src":"\/core\/assets\/vendor\/jquery.ui\/ui\/jquery-patch-min.js?v=10.6.3"},{"src":"\/core\/assets\/vendor\/jquery.ui\/ui\/scroll-parent-min.js?v=10.6.3"},{"src":"\/core\/assets\/vendor\/jquery.ui\/ui\/unique-id-min.js?v=10.6.3"},{"src":"\/core\/assets\/vendor\/jquery.ui\/ui\/focusable-min.js?v=10.6.3"},{"src":"\/core\/assets\/vendor\/jquery.ui\/ui\/keycode-min.js?v=10.6.3"},{"src":"\/core\/assets\/vendor\/jquery.ui\/ui\/plugin-min.js?v=10.6.3"},{"src":"\/core\/assets\/vendor\/jquery.ui\/ui\/widget-min.js?v=10.6.3"},{"src":"\/core\/assets\/vendor\/jquery.ui\/ui\/labels-min.js?v=10.6.3"},{"src":"\/core\/assets\/vendor\/jquery.ui\/ui\/widgets\/controlgroup-min.js?v=10.6.3"},{"src":"\/core\/assets\/vendor\/jquery.ui\/ui\/form-reset-mixin-min.js?v=10.6.3"},{"src":"\/core\/assets\/vendor\/jquery.ui\/ui\/widgets\/mouse-min.js?v=10.6.3"},{"src":"\/core\/assets\/vendor\/jquery.ui\/ui\/widgets\/checkboxradio-min.js?v=10.6.3"},{"src":"\/core\/assets\/vendor\/jquery.ui\/ui\/widgets\/draggable-min.js?v=10.6.3"},{"src":"\/core\/assets\/vendor\/jquery.ui\/ui\/widgets\/resizable-min.js?v=10.6.3"},{"src":"\/core\/assets\/vendor\/jquery.ui\/ui\/widgets\/button-min.js?v=10.6.3"},{"src":"\/core\/assets\/vendor\/jquery.ui\/ui\/widgets\/dialog-min.js?v=10.6.3"},{"src":"\/core\/assets\/vendor\/tabbable\/index.umd.min.js?v=6.3.0"},{"src":"\/core\/assets\/vendor\/tua-body-scroll-lock\/tua-bsl.umd.min.js?v=10.6.3"},{"src":"\/core\/misc\/progress.js?v=10.6.3"},{"src":"\/core\/assets\/vendor\/loadjs\/loadjs.min.js?v=4.3.0"},{"src":"\/core\/misc\/debounce.js?v=10.6.3"},{"src":"\/core\/misc\/announce.js?v=10.6.3"},{"src":"\/core\/misc\/message.js?v=10.6.3"},{"src":"\/core\/misc\/ajax.js?v=10.6.3"},{"src":"\/core\/misc\/displace.js?v=10.6.3"},{"src":"\/core\/misc\/jquery.tabbable.shim.js?v=10.6.3"},{"src":"\/core\/misc\/position.js?v=10.6.3"},{"src":"\/core\/misc\/dialog\/dialog-deprecation.js?v=10.6.3"},{"src":"\/core\/misc\/dialog\/dialog.js?v=10.6.3"},{"src":"\/core\/misc\/dialog\/dialog.position.js?v=10.6.3"},{"src":"\/core\/misc\/dialog\/dialog.jquery-ui.js?v=10.6.3"},{"src":"\/core\/misc\/dialog\/dialog.ajax.js?v=10.6.3"}]},{"command":"openDialog","selector":"#drupal-modal","settings":null,"data":"\n          \u003Ca href=\u0022#\u0022\u003E\u003C\/a\u003E\n      \n  \u003Cp\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cspan\u003EThe EU Artificial Intelligence Act is a law that sets rules for AI systems used in or affecting the EU. Its main idea is simple: the greater the risk an AI system poses to people\u2019s safety, rights or access to important services, the stricter the rules. This matters for health because many clinical AI tools, including some medical devices and triage tools, are likely to face higher levels of scrutiny.\u003Cstrong\u003E \u003C\/strong\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/p\u003E\n\u003Cp\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cstrong\u003E\u003Cspan\u003E\u003Cspan\u003EBackground\u003C\/span\u003E\u003C\/span\u003E\u003C\/strong\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/p\u003E\n\u003Cp\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cspan\u003EThe Commission proposed the Artificial Intelligence Act in April 2021, and it entered into force in August 2024. Rather than applying all at once, it applies in stages to give industry, regulators, and standards bodies time to prepare.\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/p\u003E\n\u003Cp\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cstrong\u003E\u003Cspan\u003E\u003Cspan\u003EOverview\u003C\/span\u003E\u003C\/span\u003E\u003C\/strong\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/p\u003E\n\u003Cp\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cspan\u003EThe AI Act takes a risk-based approach. The more risk an AI system poses to people\u0027s safety or fundamental rights, the more obligations apply.\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/p\u003E\n\u003Cul\u003E\n\u003Cli\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cstrong\u003E\u003Cspan\u003E\u003Cspan\u003EUnacceptable risk:\u003C\/span\u003E\u003C\/span\u003E\u003C\/strong\u003E\u003Cspan\u003E\u003Cspan\u003E A list of AI uses considered too dangerous to allow at all (for example, social scoring, or manipulative AI that exploits vulnerabilities), banned outright.\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/li\u003E\n\u003Cli\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cstrong\u003E\u003Cspan\u003E\u003Cspan\u003EHigh risk:\u003C\/span\u003E\u003C\/span\u003E\u003C\/strong\u003E\u003Cspan\u003E\u003Cspan\u003E AI used in sensitive contexts such as employment, education, law enforcement, and AI that forms part of a regulated medical device, or that is used to triage patients or decide who gets access to healthcare. These systems face the heaviest ongoing obligations such as risk management, testing, documentation, human oversight, and registration.\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/li\u003E\n\u003Cli\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cstrong\u003E\u003Cspan\u003E\u003Cspan\u003ELimited risk:\u003C\/span\u003E\u003C\/span\u003E\u003C\/strong\u003E\u003Cspan\u003E\u003Cspan\u003E Systems like chatbots, which mainly face transparency duties (people must be told they are interacting with AI).\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/li\u003E\n\u003Cli\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cstrong\u003E\u003Cspan\u003E\u003Cspan\u003EMinimal risk:\u003C\/span\u003E\u003C\/span\u003E\u003C\/strong\u003E\u003Cspan\u003E\u003Cspan\u003E Most AI systems, which fall outside specific obligations.\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/li\u003E\n\u003C\/ul\u003E\n\u003Cp\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cspan\u003ESeparately, the Act regulates general-purpose AI (GPAI) models - the large foundation models that can be adapted to many tasks - with extra requirements for the most powerful models.\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/p\u003E\n\u003Cp\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cstrong\u003E\u003Cspan\u003E\u003Cspan\u003EKey provisions\u003C\/span\u003E\u003C\/span\u003E\u003C\/strong\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/p\u003E\n\u003Cul\u003E\n\u003Cli\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cstrong\u003E\u003Cspan\u003E\u003Cspan\u003EProhibited practices:\u003C\/span\u003E\u003C\/span\u003E\u003C\/strong\u003E\u003Cspan\u003E\u003Cspan\u003E Applied from February 2025.\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/li\u003E\n\u003Cli\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cstrong\u003E\u003Cspan\u003E\u003Cspan\u003EGPAI model obligations:\u003C\/span\u003E\u003C\/span\u003E\u003C\/strong\u003E\u003Cspan\u003E\u003Cspan\u003E Transparency about training data, copyright compliance, and further duties for the most capable models applied from August 2025.\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/li\u003E\n\u003Cli\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cstrong\u003E\u003Cspan\u003E\u003Cspan\u003EHigh-risk system obligations:\u003C\/span\u003E\u003C\/span\u003E\u003C\/strong\u003E\u003Cspan\u003E\u003Cspan\u003E High-risk AI systems must have a person or organisation clearly responsible for them. They must be checked to make sure they meet the rules, keep records of what they do, and be monitored by people rather than fully automated. These rules were originally planned to start in August 2026 for most high-risk AI systems, and August 2027 for AI that is part of regulated products, such as medical devices. However, the start dates have been delayed because of the European Commission\u0027s \u0022Digital Omnibus\u0022 package.\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/li\u003E\n\u003Cli\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cstrong\u003E\u003Cspan\u003E\u003Cspan\u003EMedical AI is treated as high risk:\u003C\/span\u003E\u003C\/span\u003E\u003C\/strong\u003E\u003Cspan\u003E\u003Cspan\u003E Because most AI medical devices are already classed as higher-risk products under the EU\u0027s Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR), most clinical AI tools will have to follow the AI Act as well as the medical device regulations they already meet.\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/li\u003E\n\u003Cli\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cstrong\u003E\u003Cspan\u003E\u003Cspan\u003EExtraterritorial reach:\u003C\/span\u003E\u003C\/span\u003E\u003C\/strong\u003E\u003Cspan\u003E\u003Cspan\u003E The Act applies based on impact, not headquarters location, an AI system placed on the EU market, or whose output impacts people in the EU. The AI Act applies even if the provider is based outside the EU, including in the UK.\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/li\u003E\n\u003C\/ul\u003E\n\u003Cp\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cstrong\u003E\u003Cspan\u003E\u003Cspan\u003EUK relevance\u003C\/span\u003E\u003C\/span\u003E\u003C\/strong\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/p\u003E\n\u003Cp\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cspan\u003EThe Act applies even to companies outside the EU. This means that UK companies must follow the rules if they sell AI systems in the EU or if their AI is used by people in the EU.\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/p\u003E\n\u003Cp\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cspan\u003E\u003Cspan\u003EThe EU and the UK have different ways of regulating AI. The EU has one set of detailed rules that everyone must follow. The UK uses a more flexible approach, where different regulators apply principles to guide companies. This means that UK health technology companies working in both the UK and the EU must follow two sets of rules at the same time. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) regulates AI medical devices, while EU rules apply to any activities conducted within or impacting the EU.\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/p\u003E\n\n\n      \u003Ch3 class=\u0022modal--field-link--title\u0022\u003EFurther reading\u003C\/h3\u003E\n\u003Cul class=\u0022modal--field-link--list\u0022\u003E\n  \u003Cli\u003E\u003Ca href=\u0022https:\/\/eur-lex.europa.eu\/eli\/reg\/2024\/1689\/oj\/eng\u0022\u003EAI Act Regulation (EU) 2024\/1689\u003C\/a\u003E\u003C\/li\u003E\n  \u003Cli\u003E\u003Ca href=\u0022https:\/\/ai-act-service-desk.ec.europa.eu\/en\u0022\u003EAI Act Single Information Platform\u003C\/a\u003E\u003C\/li\u003E\n  \u003Cli\u003E\u003Ca href=\u0022https:\/\/digital-strategy.ec.europa.eu\/en\/policies\/european-approach-artificial-intelligence\u0022\u003EEuropean approach to artificial intelligence\u003C\/a\u003E\u003C\/li\u003E\n\u003C\/ul\u003E\n\n    ","dialogOptions":{"width":"70%","height":"auto","dialogClass":"highlight-modal-dialog","closeOnEscape":"true","closeText":"Close text","buttons":{"button1":{"text":"Close"}},"modal":true,"title":"EU Artificial Intelligence Act","classes":{"ui-dialog":"highlight-modal-dialog"}}}]