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href="https://ai-act-law.eu/chapter/3/">Chapter 3 (Art. 6-49)<div class="menu-item-description">High-risk AI systems</div></a> <ul class="sub-menu"> <li id="menu-item-1356" class="section menu-item menu-item-type-custom menu-item-object-custom menu-item-1356"><a>Section 1<div class="menu-item-description">Classification of AI systems as high-risk</div></a></li> <li id="menu-item-1354" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1354"><a href="https://ai-act-law.eu/article/6/">Art. 6<div class="menu-item-description">Classification rules for high-risk AI systems</div></a></li> <li id="menu-item-1355" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1355"><a href="https://ai-act-law.eu/article/7/">Art. 7<div class="menu-item-description">Amendments to Annex III</div></a></li> <li id="menu-item-1357" class="section menu-item menu-item-type-custom menu-item-object-custom menu-item-1357"><a>Section 2<div class="menu-item-description">Requirements for high-risk AI systems</div></a></li> <li id="menu-item-1358" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1358"><a href="https://ai-act-law.eu/article/8/">Art. 8<div class="menu-item-description">Compliance with the requirements</div></a></li> <li id="menu-item-1359" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1359"><a href="https://ai-act-law.eu/article/9/">Art. 9<div class="menu-item-description">Risk management system</div></a></li> <li id="menu-item-1361" class="menu-item menu-item-type-post_type menu-item-object-article current-menu-item menu-item-1361"><a href="https://ai-act-law.eu/article/10/" aria-current="page">Art. 10<div class="menu-item-description">Data and data governance</div></a></li> <li id="menu-item-1372" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1372"><a href="https://ai-act-law.eu/article/11/">Art. 11<div class="menu-item-description">Technical documentation</div></a></li> <li id="menu-item-1377" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1377"><a href="https://ai-act-law.eu/article/12/">Art. 12<div class="menu-item-description">Record-keeping</div></a></li> <li id="menu-item-1378" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1378"><a href="https://ai-act-law.eu/article/13/">Art. 13<div class="menu-item-description">Transparency and provision of information to deployers</div></a></li> <li id="menu-item-1379" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1379"><a href="https://ai-act-law.eu/article/14/">Art. 14<div class="menu-item-description">Human oversight</div></a></li> <li id="menu-item-1380" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1380"><a href="https://ai-act-law.eu/article/15/">Art. 15<div class="menu-item-description">Accuracy, robustness and cybersecurity</div></a></li> <li id="menu-item-1498" class="section menu-item menu-item-type-custom menu-item-object-custom menu-item-1498"><a>Section 3<div class="menu-item-description">Obligations of providers and deployers of high-risk AI systems and other parties</div></a></li> <li id="menu-item-1381" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1381"><a href="https://ai-act-law.eu/article/16/">Art. 16<div class="menu-item-description">Obligations of providers of high-risk AI systems</div></a></li> <li id="menu-item-1382" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1382"><a href="https://ai-act-law.eu/article/17/">Art. 17<div class="menu-item-description">Quality management system</div></a></li> <li id="menu-item-1383" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1383"><a href="https://ai-act-law.eu/article/18/">Art. 18<div class="menu-item-description">Documentation keeping</div></a></li> <li id="menu-item-1384" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1384"><a href="https://ai-act-law.eu/article/19/">Art. 19<div class="menu-item-description">Automatically generated logs</div></a></li> <li id="menu-item-1386" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1386"><a href="https://ai-act-law.eu/article/20/">Art. 20<div class="menu-item-description">Corrective actions and duty of information</div></a></li> <li id="menu-item-1387" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1387"><a href="https://ai-act-law.eu/article/21/">Art. 21<div class="menu-item-description">Cooperation with competent authorities</div></a></li> <li id="menu-item-1388" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1388"><a href="https://ai-act-law.eu/article/22/">Art. 22<div class="menu-item-description">Authorised representatives of providers of high-risk AI systems</div></a></li> <li id="menu-item-1389" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1389"><a href="https://ai-act-law.eu/article/23/">Art. 23<div class="menu-item-description">Obligations of importers</div></a></li> <li id="menu-item-1390" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1390"><a href="https://ai-act-law.eu/article/24/">Art. 24<div class="menu-item-description">Obligations of distributors</div></a></li> <li id="menu-item-1391" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1391"><a href="https://ai-act-law.eu/article/25/">Art. 25<div class="menu-item-description">Responsibilities along the AI value chain</div></a></li> <li id="menu-item-1392" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1392"><a href="https://ai-act-law.eu/article/26/">Art. 26<div class="menu-item-description">Obligations of deployers of high-risk AI systems</div></a></li> <li id="menu-item-1393" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1393"><a href="https://ai-act-law.eu/article/27/">Art. 27<div class="menu-item-description">Fundamental rights impact assessment for high-risk AI systems</div></a></li> <li id="menu-item-1499" class="section menu-item menu-item-type-custom menu-item-object-custom menu-item-1499"><a>Section 4<div class="menu-item-description">Notifying authorities and notified bodies</div></a></li> <li id="menu-item-1394" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1394"><a href="https://ai-act-law.eu/article/28/">Art. 28<div class="menu-item-description">Notifying authorities</div></a></li> <li id="menu-item-1395" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1395"><a href="https://ai-act-law.eu/article/29/">Art. 29<div class="menu-item-description">Application of a conformity assessment body for notification</div></a></li> <li id="menu-item-1397" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1397"><a href="https://ai-act-law.eu/article/30/">Art. 30<div class="menu-item-description">Notification procedure</div></a></li> <li id="menu-item-1398" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1398"><a href="https://ai-act-law.eu/article/31/">Art. 31<div class="menu-item-description">Requirements relating to notified bodies</div></a></li> <li id="menu-item-1399" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1399"><a href="https://ai-act-law.eu/article/32/">Art. 32<div class="menu-item-description">Presumption of conformity with requirements relating to notified bodies</div></a></li> <li id="menu-item-1400" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1400"><a href="https://ai-act-law.eu/article/33/">Art. 33<div class="menu-item-description">Subsidiaries of notified bodies and subcontracting</div></a></li> <li id="menu-item-1401" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1401"><a href="https://ai-act-law.eu/article/34/">Art. 34<div class="menu-item-description">Operational obligations of notified bodies</div></a></li> <li id="menu-item-1402" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1402"><a href="https://ai-act-law.eu/article/35/">Art. 35<div class="menu-item-description">Identification numbers and lists of notified bodies</div></a></li> <li id="menu-item-1403" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1403"><a href="https://ai-act-law.eu/article/36/">Art. 36<div class="menu-item-description">Changes to notifications</div></a></li> <li id="menu-item-1404" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1404"><a href="https://ai-act-law.eu/article/37/">Art. 37<div class="menu-item-description">Challenge to the competence of notified bodies</div></a></li> <li id="menu-item-1405" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1405"><a href="https://ai-act-law.eu/article/38/">Art. 38<div class="menu-item-description">Coordination of notified bodies</div></a></li> <li id="menu-item-1406" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1406"><a href="https://ai-act-law.eu/article/39/">Art. 39<div class="menu-item-description">Conformity assessment bodies of third countries</div></a></li> <li id="menu-item-1500" class="section menu-item menu-item-type-custom menu-item-object-custom menu-item-1500"><a>Section 5<div class="menu-item-description">Standards, conformity assessment, certificates, registration</div></a></li> <li id="menu-item-1408" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1408"><a href="https://ai-act-law.eu/article/40/">Art. 40<div class="menu-item-description">Harmonised standards and standardisation deliverables</div></a></li> <li id="menu-item-1409" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1409"><a href="https://ai-act-law.eu/article/41/">Art. 41<div class="menu-item-description">Common specifications</div></a></li> <li id="menu-item-1410" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1410"><a href="https://ai-act-law.eu/article/42/">Art. 42<div class="menu-item-description">Presumption of conformity with certain requirements</div></a></li> <li id="menu-item-1411" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1411"><a href="https://ai-act-law.eu/article/43/">Art. 43<div class="menu-item-description">Conformity assessment</div></a></li> <li id="menu-item-1412" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1412"><a href="https://ai-act-law.eu/article/44/">Art. 44<div class="menu-item-description">Certificates</div></a></li> <li id="menu-item-1413" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1413"><a href="https://ai-act-law.eu/article/45/">Art. 45<div class="menu-item-description">Information obligations of notified bodies</div></a></li> <li id="menu-item-1414" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1414"><a href="https://ai-act-law.eu/article/46/">Art. 46<div class="menu-item-description">Derogation from conformity assessment procedure</div></a></li> <li id="menu-item-1415" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1415"><a href="https://ai-act-law.eu/article/47/">Art. 47<div class="menu-item-description">EU declaration of conformity</div></a></li> <li id="menu-item-1416" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1416"><a href="https://ai-act-law.eu/article/48/">Art. 48<div class="menu-item-description">CE marking</div></a></li> <li id="menu-item-1417" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1417"><a href="https://ai-act-law.eu/article/49/">Art. 49<div class="menu-item-description">Registration</div></a></li> </ul> </li> <li id="menu-item-1418" class="menu-item menu-item-type-post_type menu-item-object-chapter menu-item-has-children menu-item-1418"><a href="https://ai-act-law.eu/chapter/4/">Chapter 4 (Art. 50)<div class="menu-item-description">Transparency obligations for providers and deployers of certain AI systems</div></a> <ul class="sub-menu"> <li id="menu-item-1424" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1424"><a href="https://ai-act-law.eu/article/50/">Art. 50<div class="menu-item-description">Transparency obligations for providers and deployers of certain AI systems</div></a></li> </ul> </li> <li id="menu-item-1419" class="menu-item menu-item-type-post_type menu-item-object-chapter menu-item-has-children menu-item-1419"><a href="https://ai-act-law.eu/chapter/5/">Chapter 5 (Art. 51-56)<div class="menu-item-description">General-purpose AI models</div></a> <ul class="sub-menu"> <li id="menu-item-1501" class="section menu-item menu-item-type-custom menu-item-object-custom menu-item-1501"><a>Section 1<div class="menu-item-description">Classification rules</div></a></li> <li id="menu-item-1425" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1425"><a href="https://ai-act-law.eu/article/51/">Art. 51<div class="menu-item-description">Classification of general-purpose AI models as general-purpose AI models with systemic risk</div></a></li> <li id="menu-item-1426" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1426"><a href="https://ai-act-law.eu/article/52/">Art. 52<div class="menu-item-description">Procedure</div></a></li> <li id="menu-item-1502" class="section menu-item menu-item-type-custom menu-item-object-custom menu-item-1502"><a>Section 2<div class="menu-item-description">Obligations for providers of general-purpose AI models</div></a></li> <li id="menu-item-1427" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1427"><a href="https://ai-act-law.eu/article/53/">Art. 53<div class="menu-item-description">Obligations for providers of general-purpose AI models</div></a></li> <li id="menu-item-1428" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1428"><a href="https://ai-act-law.eu/article/54/">Art. 54<div class="menu-item-description">Authorised representatives of providers of general-purpose AI models</div></a></li> <li id="menu-item-1503" class="section menu-item menu-item-type-custom menu-item-object-custom menu-item-1503"><a>Section 3<div class="menu-item-description">Obligations of providers of general-purpose AI models with systemic risk</div></a></li> <li id="menu-item-1429" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1429"><a href="https://ai-act-law.eu/article/55/">Art. 55<div class="menu-item-description">Obligations of providers of general-purpose AI models with systemic risk</div></a></li> <li id="menu-item-2537" class="section menu-item menu-item-type-custom menu-item-object-custom menu-item-2537"><a>Section 4<div class="menu-item-description">Codes of practice</div></a></li> <li id="menu-item-1430" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1430"><a href="https://ai-act-law.eu/article/56/">Art. 56<div class="menu-item-description">Codes of practice</div></a></li> </ul> </li> <li id="menu-item-1420" class="menu-item menu-item-type-post_type menu-item-object-chapter menu-item-has-children menu-item-1420"><a href="https://ai-act-law.eu/chapter/6/">Chapter 6 (Art. 57-63)<div class="menu-item-description">Measures in support of innovation</div></a> <ul class="sub-menu"> <li id="menu-item-1431" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1431"><a href="https://ai-act-law.eu/article/57/">Art. 57<div class="menu-item-description">AI regulatory sandboxes</div></a></li> <li id="menu-item-1432" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1432"><a href="https://ai-act-law.eu/article/58/">Art. 58<div class="menu-item-description">Detailed arrangements for, and functioning of, AI regulatory sandboxes</div></a></li> <li id="menu-item-1433" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1433"><a href="https://ai-act-law.eu/article/59/">Art. 59<div class="menu-item-description">Further processing of personal data for developing certain AI systems in the public interest in the AI regulatory sandbox</div></a></li> <li id="menu-item-1443" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1443"><a href="https://ai-act-law.eu/article/60/">Art. 60<div class="menu-item-description">Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes</div></a></li> <li id="menu-item-1434" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1434"><a href="https://ai-act-law.eu/article/61/">Art. 61<div class="menu-item-description">Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes</div></a></li> <li id="menu-item-1435" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1435"><a href="https://ai-act-law.eu/article/62/">Art. 62<div class="menu-item-description">Measures for providers and deployers, in particular SMEs, including start-ups</div></a></li> <li id="menu-item-1436" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1436"><a href="https://ai-act-law.eu/article/63/">Art. 63<div class="menu-item-description">Derogations for specific operators</div></a></li> </ul> </li> <li id="menu-item-1421" class="menu-item menu-item-type-post_type menu-item-object-chapter menu-item-has-children menu-item-1421"><a href="https://ai-act-law.eu/chapter/7/">Chapter 7 (Art. 64-70)<div class="menu-item-description">Governance</div></a> <ul class="sub-menu"> <li id="menu-item-1504" class="section menu-item menu-item-type-custom menu-item-object-custom menu-item-1504"><a>Section 1<div class="menu-item-description">Governance at Union level</div></a></li> <li id="menu-item-1437" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1437"><a href="https://ai-act-law.eu/article/64/">Art. 64<div class="menu-item-description">AI Office</div></a></li> <li id="menu-item-1438" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1438"><a href="https://ai-act-law.eu/article/65/">Art. 65<div class="menu-item-description">Establishment and structure of the European Artificial Intelligence Board</div></a></li> <li id="menu-item-1439" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1439"><a href="https://ai-act-law.eu/article/66/">Art. 66<div class="menu-item-description">Tasks of the Board</div></a></li> <li id="menu-item-1440" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1440"><a href="https://ai-act-law.eu/article/67/">Art. 67<div class="menu-item-description">Advisory forum</div></a></li> <li id="menu-item-1441" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1441"><a href="https://ai-act-law.eu/article/68/">Art. 68<div class="menu-item-description">Scientific panel of independent experts</div></a></li> <li id="menu-item-1442" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1442"><a href="https://ai-act-law.eu/article/69/">Art. 69<div class="menu-item-description">Access to the pool of experts by the Member States</div></a></li> <li id="menu-item-1505" class="section menu-item menu-item-type-custom menu-item-object-custom menu-item-1505"><a>Section 2<div class="menu-item-description">National competent authorities</div></a></li> <li id="menu-item-1444" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1444"><a href="https://ai-act-law.eu/article/70/">Art. 70<div class="menu-item-description">Designation of national competent authorities and single points of contact</div></a></li> </ul> </li> <li id="menu-item-1422" class="menu-item menu-item-type-post_type menu-item-object-chapter menu-item-has-children menu-item-1422"><a href="https://ai-act-law.eu/chapter/8/">Chapter 8 (Art. 71)<div class="menu-item-description">EU database for high-risk AI systems</div></a> <ul class="sub-menu"> <li id="menu-item-1445" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1445"><a href="https://ai-act-law.eu/article/71/">Art. 71<div class="menu-item-description">EU database for high-risk AI systems listed in Annex III</div></a></li> </ul> </li> <li id="menu-item-1423" class="menu-item menu-item-type-post_type menu-item-object-chapter menu-item-has-children menu-item-1423"><a href="https://ai-act-law.eu/chapter/9/">Chapter 9 (Art. 72-94)<div class="menu-item-description">Post-market monitoring, information sharing and market surveillance</div></a> <ul class="sub-menu"> <li id="menu-item-1506" class="section menu-item menu-item-type-custom menu-item-object-custom menu-item-1506"><a>Section 1<div class="menu-item-description">Post-market monitoring</div></a></li> <li id="menu-item-1446" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1446"><a href="https://ai-act-law.eu/article/72/">Art. 72<div class="menu-item-description">Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems</div></a></li> <li id="menu-item-1507" class="section menu-item menu-item-type-custom menu-item-object-custom menu-item-1507"><a>Section 2<div class="menu-item-description">Sharing of information on serious incidents</div></a></li> <li id="menu-item-1447" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1447"><a href="https://ai-act-law.eu/article/73/">Art. 73<div class="menu-item-description">Reporting of serious incidents</div></a></li> <li id="menu-item-1508" class="section menu-item menu-item-type-custom menu-item-object-custom menu-item-1508"><a>Section 3<div class="menu-item-description">Enforcement</div></a></li> <li id="menu-item-1448" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1448"><a href="https://ai-act-law.eu/article/74/">Art. 74<div class="menu-item-description">Market surveillance and control of AI systems in the Union market</div></a></li> <li id="menu-item-1449" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1449"><a href="https://ai-act-law.eu/article/75/">Art. 75<div class="menu-item-description">Mutual assistance, market surveillance and control of general-purpose AI systems</div></a></li> <li id="menu-item-1450" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1450"><a href="https://ai-act-law.eu/article/76/">Art. 76<div class="menu-item-description">Supervision of testing in real world conditions by market surveillance authorities</div></a></li> <li id="menu-item-1451" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1451"><a href="https://ai-act-law.eu/article/77/">Art. 77<div class="menu-item-description">Powers of authorities protecting fundamental rights</div></a></li> <li id="menu-item-1452" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1452"><a href="https://ai-act-law.eu/article/78/">Art. 78<div class="menu-item-description">Confidentiality</div></a></li> <li id="menu-item-1453" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1453"><a href="https://ai-act-law.eu/article/79/">Art. 79<div class="menu-item-description">Procedure at national level for dealing with AI systems presenting a risk</div></a></li> <li id="menu-item-1463" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1463"><a href="https://ai-act-law.eu/article/80/">Art. 80<div class="menu-item-description">Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III</div></a></li> <li id="menu-item-1454" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1454"><a href="https://ai-act-law.eu/article/81/">Art. 81<div class="menu-item-description">Union safeguard procedure</div></a></li> <li id="menu-item-1455" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1455"><a href="https://ai-act-law.eu/article/82/">Art. 82<div class="menu-item-description">Compliant AI systems which present a risk</div></a></li> <li id="menu-item-1456" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1456"><a href="https://ai-act-law.eu/article/83/">Art. 83<div class="menu-item-description">Formal non-compliance</div></a></li> <li id="menu-item-1457" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1457"><a href="https://ai-act-law.eu/article/84/">Art. 84<div class="menu-item-description">Union AI testing support structures</div></a></li> <li id="menu-item-1509" class="section menu-item menu-item-type-custom menu-item-object-custom menu-item-1509"><a>Section 4<div class="menu-item-description">Remedies</div></a></li> <li id="menu-item-1458" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1458"><a href="https://ai-act-law.eu/article/85/">Art. 85<div class="menu-item-description">Right to lodge a complaint with a market surveillance authority</div></a></li> <li id="menu-item-1459" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1459"><a href="https://ai-act-law.eu/article/86/">Art. 86<div class="menu-item-description">Right to explanation of individual decision-making</div></a></li> <li id="menu-item-1460" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1460"><a href="https://ai-act-law.eu/article/87/">Art. 87<div class="menu-item-description">Reporting of infringements and protection of reporting persons</div></a></li> <li id="menu-item-1510" class="section menu-item menu-item-type-custom menu-item-object-custom menu-item-1510"><a>Section 5<div class="menu-item-description">Supervision, investigation, enforcement and monitoring in respect of providers of general-purpose AI models</div></a></li> <li id="menu-item-1461" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1461"><a href="https://ai-act-law.eu/article/88/">Art. 88<div class="menu-item-description">Enforcement of the obligations of providers of general-purpose AI models</div></a></li> <li id="menu-item-1462" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1462"><a href="https://ai-act-law.eu/article/89/">Art. 89<div class="menu-item-description">Monitoring actions</div></a></li> <li id="menu-item-1464" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1464"><a href="https://ai-act-law.eu/article/90/">Art. 90<div class="menu-item-description">Alerts of systemic risks by the scientific panel</div></a></li> <li id="menu-item-1465" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1465"><a href="https://ai-act-law.eu/article/91/">Art. 91<div class="menu-item-description">Power to request documentation and information</div></a></li> <li id="menu-item-1466" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1466"><a href="https://ai-act-law.eu/article/92/">Art. 92<div class="menu-item-description">Power to conduct evaluations</div></a></li> <li id="menu-item-1467" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1467"><a href="https://ai-act-law.eu/article/93/">Art. 93<div class="menu-item-description">Power to request measures</div></a></li> <li id="menu-item-1468" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1468"><a href="https://ai-act-law.eu/article/94/">Art. 94<div class="menu-item-description">Procedural rights of economic operators of the general-purpose AI model</div></a></li> </ul> </li> <li id="menu-item-1477" class="menu-item menu-item-type-post_type menu-item-object-chapter menu-item-has-children menu-item-1477"><a href="https://ai-act-law.eu/chapter/10/">Chapter 10 (Art. 95-96)<div class="menu-item-description">Codes of conduct and guidelines</div></a> <ul class="sub-menu"> <li id="menu-item-1469" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1469"><a href="https://ai-act-law.eu/article/95/">Art. 95<div class="menu-item-description">Codes of conduct for voluntary application of specific 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class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1482"><a href="https://ai-act-law.eu/article/104/">Art. 104<div class="menu-item-description">Amendment to Regulation (EU) No 168/2013</div></a></li> <li id="menu-item-1483" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1483"><a href="https://ai-act-law.eu/article/105/">Art. 105<div class="menu-item-description">Amendment to Directive 2014/90/EU</div></a></li> <li id="menu-item-1484" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1484"><a href="https://ai-act-law.eu/article/106/">Art. 106<div class="menu-item-description">Amendment to Directive (EU) 2016/797</div></a></li> <li id="menu-item-1485" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1485"><a href="https://ai-act-law.eu/article/107/">Art. 107<div class="menu-item-description">Amendment to Regulation (EU) 2018/858</div></a></li> <li id="menu-item-1486" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1486"><a href="https://ai-act-law.eu/article/108/">Art. 108<div class="menu-item-description">Amendments to Regulation (EU) 2018/1139</div></a></li> <li id="menu-item-1478" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1478"><a href="https://ai-act-law.eu/article/109/">Art. 109<div class="menu-item-description">Amendment to Regulation (EU) 2019/2144</div></a></li> <li id="menu-item-1488" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1488"><a href="https://ai-act-law.eu/article/110/">Art. 110<div class="menu-item-description">Amendment to Directive (EU) 2020/1828</div></a></li> <li id="menu-item-1489" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1489"><a href="https://ai-act-law.eu/article/111/">Art. 111<div class="menu-item-description">AI systems already placed on the market or put into service and general-purpose AI 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id="content" class="site-content"> <div id="primary" class="content-area"> <main id="main" class="site-main" role="main"> <article id="post-58" class="article-en-order-number-10 post-58 article type-article status-publish hentry"> <header class="entry-header"> <h1 class="entry-title"><span class="dsgvo-number">Art. 10 AI Act </span><span class="dsgvo-title">Data and data governance</span></h1> </header><!-- .entry-header --> <div class="entry-content"> <ol> <li>High-risk AI systems which make use of techniques involving the training of AI models with data shall be developed on the basis of training, validation and testing data sets that meet the quality criteria referred to in paragraphs 2 to 5 whenever such data sets are used.</li> <li><sup>1</sup>Training, validation and testing data sets shall be subject to data governance and management practices appropriate for the intended purpose of the high-risk AI system. <sup>2</sup>Those practices shall concern in particular: <ol> <li>the relevant design choices;</li> <li>data collection processes and the origin of data, and in the case of personal data, the original purpose of the data collection;</li> <li>relevant data-preparation processing operations, such as annotation, labelling, cleaning, updating, enrichment and aggregation;</li> <li>the formulation of assumptions, in particular with respect to the information that the data are supposed to measure and represent;</li> <li>an assessment of the availability, quantity and suitability of the data sets that are needed;</li> <li>examination in view of possible biases that are likely to affect the health and safety of persons, have a negative impact on fundamental rights or lead to discrimination prohibited under Union law, especially where data outputs influence inputs for future operations;</li> <li>appropriate measures to detect, prevent and mitigate possible biases identified according to point (f);</li> <li>the identification of relevant data gaps or shortcomings that prevent compliance with this Regulation, and how those gaps and shortcomings can be addressed.</li> </ol> </li> <li><sup>1</sup>Training, validation and testing data sets shall be relevant, sufficiently representative, and to the best extent possible, free of errors and complete in view of the intended purpose. <sup>2</sup>They shall have the appropriate statistical properties, including, where applicable, as regards the persons or groups of persons in relation to whom the high-risk AI system is intended to be used. <sup>3</sup>Those characteristics of the data sets may be met at the level of individual data sets or at the level of a combination thereof.</li> <li>Data sets shall take into account, to the extent required by the intended purpose, the characteristics or elements that are particular to the specific geographical, contextual, behavioural or functional setting within which the high-risk AI system is intended to be used.</li> <li><sup>1</sup>To the extent that it is strictly necessary for the purpose of ensuring bias detection and correction in relation to the high-risk AI systems in accordance with paragraph (2), points (f) and (g) of this Article, the providers of such systems may exceptionally process special categories of personal data, subject to appropriate safeguards for the fundamental rights and freedoms of natural persons. <sup>2</sup>In addition to the provisions set out in <a href="https://gdpr-info.eu/" target="_blank" rel="noopener">Regulations (EU) 2016/679</a> and <a href="https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32018R1725" target="_blank" rel="noopener">(EU) 2018/1725</a> and <a href="https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32016L0680" target="_blank" rel="noopener">Directive (EU) 2016/680</a>, all the following conditions must be met in order for such processing to occur: <ol> <li>the bias detection and correction cannot be effectively fulfilled by processing other data, including synthetic or anonymised data;</li> <li>the special categories of personal data are subject to technical limitations on the re-use of the personal data, and state-of-the-art security and privacy-preserving measures, including pseudonymisation;</li> <li>the special categories of personal data are subject to measures to ensure that the personal data processed are secured, protected, subject to suitable safeguards, including strict controls and documentation of the access, to avoid misuse and ensure that only authorised persons have access to those personal data with appropriate confidentiality obligations;</li> <li>the special categories of personal data are not to be transmitted, transferred or otherwise accessed by other parties;</li> <li>the special categories of personal data are deleted once the bias has been corrected or the personal data has reached the end of its retention period, whichever comes first;</li> <li>the records of processing activities pursuant to <a href="https://gdpr-info.eu/" target="_blank" rel="noopener">Regulations (EU) 2016/679</a> and <a href="https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32018R1725" target="_blank" rel="noopener">(EU) 2018/1725</a> and <a href="https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32016L0680" target="_blank" rel="noopener">Directive (EU) 2016/680</a> include the reasons why the processing of special categories of personal data was strictly necessary to detect and correct biases, and why that objective could not be achieved by processing other data.</li> </ol> </li> <li>For the development of high-risk AI systems not using techniques involving the training of AI models, paragraphs 2 to 5 apply only to the testing data sets.</li> </ol> <div class="empfehlung-erwaegungsgruende"> <h2>Suitable Recitals</h2> <span><a href="https://ai-act-law.eu/recital/67/">(<span class="bold-number">67</span>) Data governance and management practices</a></span> <span><a href="https://ai-act-law.eu/recital/68/">(<span class="bold-number">68</span>) Access to high-quality data</a></span> <span><a href="https://ai-act-law.eu/recital/70/">(<span class="bold-number">70</span>) Processing of special categories of personal data</a></span> </div> <div class="page-navigation"> <div class="alignleft"> <a href="https://ai-act-law.eu/article/9/" title="Art. 9 AI Act - Risk management system"> <span class="previous-page">←</span>Art. 9 AI Act </a> </div> <div class="alignright"> <a href="https://ai-act-law.eu/article/11/" title="Art. 11 AI Act - Technical documentation"> Art. 11 AI Act<span class="next-page">→</span> </a> </div> </div><!-- .page-navigation --> <div class="link-to-overview"> <a class="btn btn-primary" role="button" href="https://ai-act-law.eu" rel="home">AI Act</a> <span class="link-description">Table of contents</span> </div> <div class="feedback hidden-print"> <span class="feedback-title"><a 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