KPMG Law in Spain helped a leading healthcare company achieve AI regulatory compliance based on ethical and security criteria.


      • The challenge

        The company was looking to define and implement an artificial intelligence governance model that enables compliance with the EU AI Act (AIA).

      • The opportunity

        To support the company with its implementation of AI governance operating models, KPMG helped establish the required mechanisms and structures to achieve compliance with current regulations, launching operations across more than 100 AI projects.
         

        The team also identified AI systems that require CE marking (which indicates that a product meets European safety standards, a requirement for all high-risk AI systems), carried out conformity assessments and validated the high-risk classification. In addition, the team defined procedures and requirements to obtain conformity assessments for high-risk systems, offering broad-ranging support throughout the CE marking process.

      • The outcome

        Through this work, the KPMG team assessed the company’s AI governance readiness, reviewed and populated the AI inventory, and categorized system risks, providing guidance on implementing legal measures.
         

        KPMG developed a robust AI strategy for the company, advising on the implementation of control mechanisms to ensure transparency, explainability and security in the use of this technology. Associated risks such as bias and data privacy were also addressed.
         

        By adapting to new regulatory requirements such as CE marking, the company was also able to position itself as a leader in the healthcare sector for the responsible and innovative use of AI. The KPMG team assessed the company's initial level of maturity in relation to the AIA in terms of governance and regulatory adaptation and reviewed the company’s governance policies and standards using the Derisking AI by Design methodology.

         

        We help clients harness the power and potential of AI. From strategy to implementation. Small steps to solving seemingly impenetrable problems. Underpinned by trust. Find out more by getting in touch with us below.
         

        You can with AI. You can with KPMG.


      The person behind the story

      Noemí Brito

      Partner, Commercial Law & Head of Intellectual Property and New Technologies

      KPMG Abogados


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