# AI Risk Mitigation — legal context bundle > Curated from overview.legal on 2026-08-22. Canonical page: https://overview.legal/topics/risk-mitigation-measures-ai > Sources are cited per item. Verify against the official texts before relying on them. Risk management systems include specific measures to mitigate identified risks. This concept deserves dedicated coverage as it encompasses the practical implementation of risk reduction strategies beyond general risk assessment. ## Overview ## Legal Framework Article 9 of the AI Act establishes the core obligation for providers of high-risk AI systems to implement a risk management system as a fundamental component of their compliance architecture. The risk management system must be designed as a continuous, iterative process that runs throughout the entire lifecycle of an AI system — from development through deployment and post-market monitoring. The framework requires providers to identify, analyze, and mitigate known and reasonably foreseeable risks that their AI systems may pose to health, safety, and fundamental rights. Critically, risk mitigation measures must be proportionate to the nature, scope, context, and purpose of the system, as well as to the severity and probability of potential harm. This proportionality principle mirrors the risk-based approach familiar from GDPR Article 9 processing conditions and Article 35 data protection impact assessments, where the adequacy of safeguards is measured against the objective risk landscape. Recital 138 reinforces that risk mitigation is not a one-time exercise but must be embedded within regulatory sandboxes and controlled testing environments before systems reach the market. Recital 164 extends the supervisory dimension, granting the AI Office investigative powers to evaluate whether general-purpose AI model providers have implemented adequate mitigation measures, including through independent expert assessments. The doctrinal analysis underscores that risk determination requires an objective assessment combining the probability of harm with the severity of its impact on rights and freedoms. This dual-factor analysis — probability multiplied by severity — sets the baseline for calibrating mitigation intensity. ## Key Developments The EDPB's SPE Programme report on AI Privacy Risks and Mitigations for Large Language Models, authored by Isabel Barberá, establishes a comprehensive risk management methodology specifically tailored to LLM systems. This represents one of the first concrete attempts to operationalize the AI Act's risk management requirements for a specific technology category, providing a structured approach to identifying and mitigating privacy-specific risks in generative AI. In January 2026, the EDPB and EDPS jointly called for stronger safeguards to protect fundamental rights during AI Act implementation, signaling that supervisory authorities will scrutinize whether mitigation measures are substantive rather than procedural box-ticking. This positions risk mitigation as an area where enforcement bodies expect demonstrable, documented effectiveness — not merely the existence of a risk management policy. ## Practical Guidance - **Implement a lifecycle-integrated risk management system** that begins at the design phase and continues through post-market monitoring, documenting each iteration of risk identification, assessment, and mitigation in accordance with Article 9 AI Act requirements. - **Apply a dual-factor risk assessment methodology** evaluating both the probability and severity of potential harm to fundamental rights, calibrating mitigation measures proportionately to the objective risk level rather than applying uniform controls across all systems. - **Document mitigation measure effectiveness** through testing and evaluation, ensuring that residual risks are explicitly identified and justified — supervisory authorities expect evidence that measures actually reduce risk, not merely that measures exist. - **For LLM and generative AI deployments**, adopt the structured methodology from the EDPB SPE Programme report, which addresses technology-specific risks including training data provenance, output filtering, and downstream misuse scenarios. - **Prepare for AI Office evaluations** by maintaining accessible documentation of risk management decisions, mitigation measure selection rationale, and testing results, particularly for general-purpose AI models where independent expert assessment may be requested under Recital 164. ## Legislation (full text of key provisions) ### Risk management system *Source: AI Act, aiact-art-9-en, 2024-06-12 — https://overview.legal/posts/92094* ### Recital 65 — high-risk AI risk management system *Source: AI Act, aiact-rec-65-en, 2024-06-12 — https://overview.legal/posts/93812* The risk-management system should consist of a continuous, iterative process that is planned and run throughout the entire lifecycle of a high-risk AI system. That process should be aimed at identifying and mitigating the relevant risks of AI systems on health, safety and fundamental rights. The risk-management system should be regularly reviewed and updated to ensure its continuing effectiveness, as well as justification and documentation of any significant decisions and actions taken subject to this Regulation. This process should ensure that the provider identifies risks or adverse impacts and implements mitigation measures for the known and reasonably foreseeable risks of AI systems to the health, safety and fundamental rights in light of their intended purpose and reasonably foreseeable misuse, including the possible risks arising from the interaction between the AI system and the environment within which it operates. The risk-management system should adopt the most appropriate risk-management measures in light of the state of the art in AI. When identifying the most appropriate risk-management measures, the provider should document and explain the choices made and, when relevant, involve experts and external stakeholders. In identifying the reasonably foreseeable misuse of high-risk AI systems, the provider should cover uses of AI systems which, while not directly covered by the intended purpose and provided for in the instruction for use may nevertheless be reasonably expected to result from readily predictable human behaviour in the context of the specific characteristics and use of a particular AI system. Any known or foreseeable circumstances related to the use of the high-risk AI system in accordance with its intended purpose or under conditions of reasonably foreseeable misuse, which may lead to risks to the health and safety or fundamental rights should be included in the instructions for use that are provided by the provider. This is to ensure that the deployer is aware and takes them into account when using the high-risk AI system. Identifying and implementing risk mitigation measures for foreseeable misuse under this Regulation should not require specific additional training for the high-risk AI system by the provider to address foreseeable misuse. The providers however are encouraged to consider such additional training measures to mitigate reasonable foreseeable misuses as necessary and appropriate. ### Recital 164 — AI Office monitoring and enforcement powers *Source: AI Act, aiact-rec-164-en, 2024-06-12 — https://overview.legal/posts/94010* The AI Office should be able to take the necessary actions to monitor the effective implementation of and compliance with the obligations for providers of general-purpose AI models laid down in this Regulation. The AI Office should be able to investigate possible infringements in accordance with the powers provided for in this Regulation, including by requesting documentation and information, by conducting evaluations, as well as by requesting measures from providers of general-purpose AI models. When conducting evaluations, in order to make use of independent expertise, the AI Office should be able to involve independent experts to carry out the evaluations on its behalf. Compliance with the obligations should be enforceable, inter alia, through requests to take appropriate measures, including risk mitigation measures in the case of identified systemic risks as well as restricting the making available on the market, withdrawing or recalling the model. As a safeguard, where needed beyond the procedural rights provided for in this Regulation, providers of general-purpose AI models should have the procedural rights provided for in Article 18 of Regulation (EU) 2019/1020, which should apply mutatis mutandis, without prejudice to more specific procedural rights provided for by this Regulation. ### Recital 138 — national AI regulatory sandboxes for innovation *Source: AI Act, aiact-rec-138-en, 2024-06-12 — https://overview.legal/posts/93958* AI is a rapidly developing family of technologies that requires regulatory oversight and a safe and controlled space for experimentation, while ensuring responsible innovation and integration of appropriate safeguards and risk mitigation measures. To ensure a legal framework that promotes innovation, is future-proof and resilient to disruption, Member States should ensure that their national competent authorities establish at least one AI regulatory sandbox at national level to facilitate the development and testing of innovative AI systems under strict regulatory oversight before these systems are placed on the market or otherwise put into service. Member States could also fulfil this obligation through participating in already existing regulatory sandboxes or establishing jointly a sandbox with one or more Member States’ competent authorities, insofar as this participation provides equivalent level of national coverage for the participating Member States. AI regulatory sandboxes could be established in physical, digital or hybrid form and may accommodate physical as well as digital products. Establishing authorities should also ensure that the AI regulatory sandboxes have the adequate resources for their functioning, including financial and human resources. ### Recital 116 — AI Office codes of practice development *Source: AI Act, aiact-rec-116-en, 2024-06-12 — https://overview.legal/posts/93914* The AI Office should encourage and facilitate the drawing up, review and adaptation of codes of practice, taking into account international approaches. All providers of general-purpose AI models could be invited to participate. To ensure that the codes of practice reflect the state of the art and duly take into account a diverse set of perspectives, the AI Office should collaborate with relevant national competent authorities, and could, where appropriate, consult with civil society organisations and other relevant stakeholders and experts, including the Scientific Panel, for the drawing up of such codes. Codes of practice should cover obligations for providers of general-purpose AI models and of general-purpose AI models presenting systemic risks. In addition, as regards systemic risks, codes of practice should help to establish a risk taxonomy of the type and nature of the systemic risks at Union level, including their sources. Codes of practice should also be focused on specific risk assessment and mitigation measures. ## Guidance ### SPE Programma - AI Privacy Risks & Mitigations Large Language Models (LLMs) (Isabel BARBERÁ) *Source: EDPB, ai-privacy-risks-and-mitigations-in-llms, 2025-04-21 — https://overview.legal/posts/50754 — original: https://edpb.europa.eu/system/files/2025-04/ai-privacy-risks-and-mitigations-in-llms.pdf* "The AI Privacy Risks & Mitigations Large Language Models (LLMs) report puts forward a comprehensive risk management methodology for LLM systems with a number of practical mitigation measures for common privacy risks in LLM systems. In addition, the report provides use cases examples on the appli... ## Enforcement decisions ### Italian DPA: AgID's automatic transfer of PEC addresses to INAD index unlawful *Source: Garante per la protezione dei dati personali (Italy), 2026-05-28 — https://overview.legal/posts/122875 — original: https://gdprhub.eu/index.php?title=Garante_per_la_protezione_dei_dati_personali_(Italy)_-_419/2026* Facts — The data controller for the case is a government body called the Agency for Digital Italy (AgID). AgID is tasked with driving the adoption of digital technologies in both government and the private sector. Additionally, AgID is Italy’s soon-to-be notification authority for the AI Act. The case revolves around two public online indexes of certified email addresses: the INI-PEC and the INAD. INI-PEC is the older of the two indexes and includes, among others, the email addressess of professionals (the data subjects). INAD was created by AgID in 2023 as provided by Italian law and functions as an index of “digital domiciles” (where data subjects are supposed to get certain important communications) for both professionals and other owners of a digital email address. Shortly after setting up the INAD index, AgID automatically included the addresses of professionals from the old INI-PEC index. As a result, the addresses automatically became the digital domicile for communications not related to the professional lives of the data subjects. Data subjects were given the option to opt-out of the inclusion in the INAD index. Some data subjects complained that this processing severely infringed on their privacy. As the DPA’s decision explains, it is not uncommon for professionals to give co-workers access to their professional email addresses, on the assumption that they will only be used for strictly professional communications. When the addressess became digital domiciles, third parties (such as public bodies) started using them for communications unrelated to the data subjects' personal lives - which occasionally led to unintended data disclosures. The data subjects also claimed that the controller had not informed them about the processing, which prevented them from opting out in a timely fashion. Holding — The investigation — On the duty of information — First of all, the DPA clarified that by including email addresses in the INAD index, the controller further processed personal data for a new purpose, incompatible with the original purpose of the processing (i.e.: the inclusion of email addresses in the older index). With regards to the duty of information, the controller pointed out that it contacted professional orders to inform them about the creation of the INAD index. In the context of these communications, the controller asked professional orders to inform the data subjects about this processing of personal data and about their right to opt out. The controller stated that it did not directly contact the data subjects via their email addresses, as it feared that its emails would have been mistaken as phishing or scams . The controller later launched a more effective information campaign with the help of other government bodies; however, this campaign only took place in 2025 - two years after addresses where included in the INAD index. On the controller’s identity — The DPA’s investigation also focused on a second issue, relative to the authentication procedure for digital domiciles: for a long time, a company (InfoCamere S.c.p.a.) was erroneously listed as a service provider for the INAD index. During the investigation, the controller confirmed that InfoCamere had no role in the processing of personal data. The controller also stated that it had contacted the actual service provider in order to correct the error and that the provider had done so with great delay. The DPA's conclusion — The DPA held that until 2025, the controller had failed to inform the data subjects about the inclusion of their email address in the INAD index, in violation of Articles 5(1)(a), 5(1)(b), 5(2), 12, 14 and 25 GDPR. On these grounds, the DPA fined the controller €55,000. With regards to the erroneous indication of the service provider in the authentication screen, the DPA found that the mistake was isolated and that overall, the information provided during the procedure was still sufficient to clarify that AgID was the controller. On these grounds, the DPA found that the mistake did not, in and of itself, constitute a violation of the GDPR. ## Recent developments ### Is the AI Act caging ChatGPT and other General Purpose Artificial Intelligence systems? *Source: Gaming Tech Law, 2023-03-29 — https://overview.legal/posts/6223 — original: https://www.gamingtechlaw.com/2023/03/draft-ai-act-general-purpose-artificial-intelligence/#entry-4244* > The growth of generative artificial intelligence systems has led EU lawmakers to focus on General Purpose AI in drafting the AI Act, which will set the framework governing artificial intelligence in the European Union. As previously reported, the EU Parliament has already broadened the definition of artificial intelligence for the purposes of the AI Act… ### EDPB and EDPS support streamlining AI Act implementation but call for stronger safeguards to protect fundamental rights *Source: European Data Protection Board, 2026-01-21 — https://overview.legal/posts/52417 — original: https://www.edpb.europa.eu/news/news/2026/edpb-and-edps-support-streamlining-ai-act-implementation-call-stronger-safeguards_en* Brussels, 21 January - The European Data Protection Board (EDPB) and the European Data Protection Supervisor (EDPS) have adopted a Joint Opinion on the European Commission’s Proposal for the ‘Digital Omnibus on AI’. The Proposal seeks to simplify the implementation of certain harmonised rules under the AI Act to ensure their effective application.The EDPB and the EDPS support the objective of addressing practical challenges relating to the implementation of the AI Act. Administrative simplificat ### Europe is dismantling its digital rights from within *Source: European Digital Rights, 2025-11-27 — https://overview.legal/posts/49191 — original: https://edri.org/our-work/europe-is-dismantling-its-digital-rights-from-within/* The European Commission’s new Digital Omnibus is presented as simple “streamlining”, but in practice it dismantles key safeguards in the GDPR, ePrivacy rules and the AI Act. It would make access to device data easier, weaken limits on automated decision-making and lower protections against discriminatory AI. ### Europe is undermining its own digital rights from within. *Source: European Digital Rights, 2025-11-27 — https://overview.legal/posts/52062* The new "Digital Omnibus" from the European Commission is presented as a simple "simplification," but in practice, it undermines important safeguards in the GDPR, the ePrivacy regulations, and the AI Act. It would make access to device data easier, weaken restrictions on automated decision-making, and reduce protection against discriminatory AI. The article "Europe Undermines Its Digital Rights From Within" originally appeared on European Digital Rights (EDRi). ### Why the "Digital Omnibus" threatens privacy regulations (GDPR and ePrivacy). *Source: European Digital Rights, 2025-11-19 — https://overview.legal/posts/52074* On November 19th, the European Commission published two so-called "omnibus" proposals: one revising key aspects of the General Data Protection Regulation (GDPR) and the ePrivacy rules, along with other data-related laws, and the other an amendment to the AI Act. This article focuses on the first proposal. It explains how the proposed changes could weaken fundamental rights related to data protection and the confidentiality of communications, and why the combined effect risks undermining long-standing safeguards for individuals within the EU. ## Literature ### REGULATION OF APPLIED ARTIFICIAL INTELLIGENCE IN BIOMEDICAL ENGINEERING AS A HIGH-RISK ARTIFICIAL INTELLIGENCE SYSTEM IN THE EU AI ACT *Source: AFMN Biomedicine, 2026-07-13 — https://overview.legal/posts/132435 — original: https://doi.org/10.65641/afmnai-2026-075* lt;p style= quot;text-align: justify; quot; gt; lt;span class= quot;a_GcMg font-feature-liga-off font-feature-clig-off font-feature-calt-off text-decoration-none text-strikethrough-none quot; gt;Artificial intelligence (AI) represents a global phenomenon changing all spheres of human life. Biomedical engineering is no exception, as many AI systems are applied to biomedical engineering inventions. The European Union has enacted the new EU AI Act, one of the world amp;rsquo;s first laws on AI. The ### The triple helix: markets, fundamental rights, and security in EU digital law *Source: European Law Open, 2026-07-08 — https://overview.legal/posts/132115 — original: https://doi.org/10.1017/elo.2026.10084* Abstract Digital policymaking in the European Union (EU), once seen as an internal market concern, is increasingly shaped by non-economic aims, such as the pursuit of security and the protection of fundamental rights. Recent pieces of legislation, such as the AI Act or the Cyber Resilience Act, have nominally acknowledged the relevance of such factors, but serious concerns have been raised about security considerations de facto trumping all others. In this article, we argue that, despite its pre ### General-Purpose AI under the EU AI Act: A Conceptual Allocation of Duties across the Value Chain *Source: SCRIPTed A Journal of Law Technology & Society, 2026-06-30 — https://overview.legal/posts/132370 — original: https://doi.org/10.2218/scrip.12300* This article examines how the final version of the EU Artificial Intelligence Act (“AI Act”, adopted 2024) allocates obligations across the AI value chain, with a focus on general-purpose AI (“GPAI”) or foundation models. It proposes a taxonomy of key actors – foundation model providers, fine-tuners, integrators, and deployers – and analyses the interfaces between them, including documentation tools (model cards, system cards) and logging requirements. Building on principles of control, foreseea ### Italy’s Artificial Intelligence Act and Global AI Governance: The EU Model’s Practice and Prospects *Source: Law and Economy, 2026-02-25 — https://overview.legal/posts/132619 — original: https://doi.org/10.63593/le.2788-7049.2026.03.004* The Italian Artificial Intelligence Act, enacted on September 17, 2025, represents the first comprehensive national implementation of the European Union’s AI Act. This study examines the Italian legislation through the theoretical lens of multi-level governance, analyzing its dual function as both a “bridging legislation” that translates EU framework into domestic practice and a site of significant regulatory innovation. Through detailed textual analysis and case studies, particularly in healthc ### Artificial intelligence co-regulation? The role of standards in the EU AI Act *Source: International Journal of Law and Information Technology, 2024-01-01 — https://overview.legal/posts/132440 — original: https://doi.org/10.1093/ijlit/eaae011* Abstract This article examines artificial intelligence (AI) co-regulation in the EU AI Act and the critical role of standards under this regulatory strategy. It engages with the foundation of democratic legitimacy in EU standardization, emphasizing the need for reform to keep pace with the rapid evolution of AI capabilities, as recently suggested by the European Parliament. The article highlights the challenges posed by interdisciplinarity and the lack of civil society expertise in standard-sett ## Related topics - **Artificial Intelligence** — https://overview.legal/topics/ai AI systems and their implications for data protection - **Risk Management System** — https://overview.legal/topics/risk-management-system This new topic is needed because risk management systems are a distinct and mandatory requirement under the AI Act, encompassing systematic processes for identi - **Monitoring** — https://overview.legal/topics/monitoring Systematic observation and tracking of individuals - **Supervision** — https://overview.legal/topics/toezicht Oversight and enforcement by supervisory authorities - **AI Value Chain Actors and Roles** — https://overview.legal/topics/ai-value-chain-actors The content focuses on responsibilities distributed across different actors in the AI value chain. A dedicated topic for understanding the various actors, their - **Provider Obligations for AI Systems** — https://overview.legal/topics/provider-obligations-ai The content specifically addresses obligations imposed on providers of high-risk AI systems, which is a distinct and important category of requirements that des --- Generated by overview.legal · https://overview.legal/topics/risk-mitigation-measures-ai · 2026-08-22