36 model for other jurisdictions.1 It went into effect across all EU Member States on August 1, 2024, and the enforcement of the majority of its provisions will begin on August 2, 2026. It applies to any AI System which is defined as “a machine-based system designed to operate with varying levels of autonomy, that may exhibit adaptiveness after deployment and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments.” The EU AI Act applies to providers, developers, importers, and users/deployers who place or put into service AI systems in the EU market, irrespective of where they are established or located, but does not apply to AI systems used solely for scientific research, development, and testing. The EU AI Act features a risk-based approach to regulation which requires an initial assessment of the risks each AI system can generate. The EU AI Act completely bans certain AI practices that present an unacceptable risk to fundamental rights, such as those that manipulate human behavior or exploit individuals’ vulnerabilities (e.g., age or disabilities). High-Risk AI systems are the most highly regulated and include AI systems used in critical infrastructures, in medical devices and safety products, and in ways that affect access to educational and employment opportunities. The EU AI Act imposes a wide range of obligations on entities using high-risk AI systems, including implementation of a risk management program, data training and data governance, technical documentation, recordkeeping, transparency, human oversight, and cybersecurity. High-risk AI systems also must be registered in an EU database before such AI systems are released in the EU market, thus the assessment of whether an AI system is high-risk must be done in advance. Limited-risk AI systems, such as chatbots, must merely ensure that users are provided notice that they are interacting with an AI system. There are no restrictions on minimal-risk AI systems, such as spam filters or video games. Penalties for non-compliance include a maximum financial penalty of up to EUR 35 million or seven percent (7%) of worldwide annual turnover, whichever is greater. 1 Council Regulation (EU) 2024/1689 (amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139, and (EU) 2019/2144, and Directives 2014/90/ EU, (EU) 2016/797, and (EU) 2020/1828 (Artificial Intelligence Act)) (June 13, 2024), https:// eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R1689.
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