AI Compliance Officer
The EU's landmark AI Act sets new standards for transparency, human oversight, accountability, and ethical AI—with particularly strict requirements for healthcare, medical devices, and life sciences. As your AI Compliance Officer, iliomad Health Data helps your organisation meet these obligations with confidence by embedding robust AI governance, risk management, and ethical oversight directly into your operations. We work alongside your teams to ensure that innovation and regulatory compliance evolve together, enabling you to deploy AI responsibly while fully managing its risks.
Our Core Missions
The EU AI Act and international AI governance frameworks introduce transformative requirements for AI systems, throughout their whole development and deployment lifecycle . As your dedicated AI Compliance Officer, we ensure your organisation meets these obligations and standards, in a manner that is consistent with the specificities of your AI systems and your organisation's identity, through the seamless integration of these requirements into existing processes or the development of tailored new ones .
We establish and operate comprehensive AI governance frameworks precisely aligned with EU AI Act requirements, industry best practices, international governance standards and ethical principles for responsible AI development and deployment. Our governance frameworks define clear policies for AI development, deployment and use, establish appropriate oversight structures, create decision-making processes for AI-related choices, and implement the documentation and record-keeping that regulators expect. We help you build governance that is both robust and practical, enabling innovation while ensuring accountability for AI systems' impacts on individuals and society.
We provide ongoing monitoring of your AI systems for regulatory compliance, ethical alignment, and human oversight requirements, not just at the initial development and deployment stage of your AI systems,but throughout their lifecycle. Our oversight activities include regular compliance reviews, monitoring of system performance against established criteria, identification of emerging compliance issues, and coordination of remediation activities when needed. We help you maintain compliance as your AI systems evolve, as regulations are interpreted and enforced, and as best practices develop in this rapidly changing field.
We help you understand your role and compliance obligations under the EU AI Act. Whether you act as an AI provider or deployer, we support you in defining clear roles, responsibilities, and escalation paths across AI development and use. Our accountability frameworks ensure ownership of AI decisions, appropriate human oversight, and effective issue escalation, helping you meet regulatory requirements while building practical and robust AI governance.
We support organisations in demonstrating AI compliance through structured conformity assessments for their high-risk AI systems, aligned with the EU AI Act requirements for risk and quality management systems, post-market monitoring, cybersecurity resilience, registration and AI literacy. Our services enable confident deployment of AI models by combining regulatory rigor with operational practicality.
We conduct regular, comprehensive audits and performance reviews of your AI systems, ensuring they remain compliant with applicable requirements, perform as intended, and operate within acceptable risk parameters. Our audits examine compliance status, risk management effectiveness, documentation completeness, and governance implementation. We provide detailed findings and actionable recommendations, helping you identify and address issues before they become problems. Regular audits demonstrate ongoing due diligence and support continuous improvement of your AI governance.
We help organisations meet AI transparency and explainability requirements by enabling clear communication to individuals, regulators, and stakeholders. Through tailored explainability methods, disclosure mechanisms, and robust documentation, we support AI systems that are transparent, accountable, and trusted.
How iliomad Health Data Can Help You
iliomad Health Data has assisted healthcare companies in crafting AI models for various purposes, such as diagnosis, monitoring, and imaging. The experts at Iliomad can guide you in pinpointing the kind of AI model you're creating, evaluating potential risks, determining responsibilities, and formulating a strategy to develop and launch your models in a compliant manner.
FAQs
Our frequently questions
An AI Compliance Officer ensures your AI systems comply with the EU AI Act, GDPR, and other applicable regulations by overseeing risk management, documentation, and ongoing monitoring requirements. Under the EU AI Act, organizations deploying high-risk AI systems (including medical devices, clinical decision support, and diagnostic tools) must establish AI governance structures—the AI Compliance Officer fulfills this mandate.
Organizations developing or deploying AI systems in healthcare, life sciences, medical diagnostics, clinical decision support, patient risk stratification, drug discovery, or any AI classified as "high-risk" under the EU AI Act require dedicated AI compliance oversight. Most health tech companies using machine learning on patient data, MedTech companies with AI-enabled devices, and pharma companies using AI in clinical development fall into this category.
We establish AI governance frameworks, conduct conformity assessments, perform periodic AI audits and performance reviews, ensure transparency and explainability requirements are met, define accountability structures and role definitions, maintain continuous compliance oversight, and interface with regulators and notified bodies. With AI compliance experience across 66 countries, we navigate the intersection of EU AI Act, medical device regulations (MDR/IVDR), GDPR, and FDA AI/ML requirements for health applications.
A DPO focuses on data protection compliance (GDPR, privacy, data subject rights), while an AI Compliance Officer focuses on AI system compliance (EU AI Act, algorithmic accountability, risk management, performance monitoring). Many health AI companies need both roles: the DPO oversees how patient data is processed, while the AI Compliance Officer ensures the AI system itself meets safety, transparency, and regulatory requirements.
Contact us through our website form or email directly. We'll schedule an initial consultation to understand your regulatory landscape, identify immediate priorities, and propose a tailored engagement that fits your timeline and budget.
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