Artificial Intelligence (AI) is revolutionising healthcare compliance by enhancing efficiency, accuracy, and proactive risk management. Healthcare compliance officers are increasingly leveraging AI to streamline various processes, including compliance audits, monitoring, and review of materials. However, as AI adoption accelerates, it's crucial to understand its applications, challenges, and the evolving regulatory environment, particularly the European Union's Artificial Intelligence Act (AI Act).
AI Use Cases in Healthcare Compliance
1. Compliance Audits and Monitoring
AI automates compliance processes, tracks regulatory changes in real-time, and reduces human error, making compliance more efficient and proactive. Many tools integrate AI and human expertise to streamline compliance efforts and adapt to evolving regulations.
2. Material Review and Generation
AI can streamline Medical, Legal, and Regulatory (MLR) reviews by analyzing product claims, marketing materials, and promotional content to ensure compliance with regulatory standards. It detects inconsistencies, flags potential risks, and automates documentation, enabling faster approvals while maintaining compliance with legal and regulatory guidelines.
3. Regulatory Change Monitoring
Challenges and Considerations
1. Algorithm Bias and Data Quality
AI systems can amplify bias, disrupt internal controls, and create regulatory exposure without intentional oversight. Healthcare compliance professionals must understand AI outputs to ensure ethical, legal, and successful use.
2. Over-Reliance on Automation
3. Limitations of AI Summaries in Legal and Regulatory Contexts
Another emerging challenge is AI’s role in generating summaries of complex legal documents, regulatory guidance, and industry standards. While these summaries can be useful for quick orientation, they often omit highly specific details that may carry significant compliance consequences. Compliance officers should be cautious, ensuring that stakeholders across the organisation do not rely solely on AI-generated summaries. Instead, teams should be directed to perform thorough readings of the original regulations and official guidance wherever applicable. This added diligence minimizes the risk of overlooking subtle but crucial requirements.
4. Resource Limitations for SMEs
Regulatory Implications: The EU AI Act
Strategic Recommendations
1. Due Diligence Before Adoption
2. Custom Solutions Over Off-the-Shelf Products
3. Embrace Technology with Caution
4. Mitigating Risks of AI-Generated Summaries
To address the risks of AI-generated summaries omitting critical legal or regulatory details, organisations should implement safeguards such as:
- Establishing a “dual-check” process, where AI-generated summaries are always reviewed against the original regulations by compliance officers.
- Training stakeholders to treat AI outputs as a starting point, not the final authority on compliance matters.
- Creating internal guidance protocols that explicitly require a full reading of regulatory documents and official guidance wherever applicable.
- Using AI as a supportive tool for speed and efficiency, but keeping human expertise as the ultimate decision-making authority in regulatory interpretation.
By embedding these practices, organisations can both benefit from AI’s efficiency and protect themselves against inadvertent compliance gaps.
