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Enhanced Adverse Event Reporting in Patient Support Services
Synergizing AI detection with human oversight
Amber Doner, Sr. Director, Quality & Compliance, Patient Support Services, IQVIA
May 20, 2025

Adverse Event (AE) reporting is crucial in ensuring patient safety and regulatory compliance in healthcare. In Patient Support Services (PSS) programs, AEs must be identified, documented, and reported promptly. However, human error is inevitable, and AEs can be missed. Understanding the behavior of AE processes, rather than attempting to eliminate human error entirely, is vital for identifying gaps and mitigating risks.

This blog explores the importance of monitoring AE reporting through compliance measures and process control charts, documenting missed reports, and integrating feedback loops to strengthen both human and artificial intelligence-driven AE detection. It highlights how human error serves as a critical feedback mechanism for AI models, improving the overall AE monitoring program.

The role of aggregating compliance measures

To ensure compliance, PSS programs must aggregate data from multiple sources to monitor AE reporting and detect process inefficiencies. Missed AEs—those not identified or reported within contractual timelines—are valuable indicators of where human error occurs. These incidents highlight potential process gaps and serve as an early warning for future compliance risks. Documenting these missed reports is essential, as it provides critical feedback for both human process improvement and AI model refinement.

Given that human error can’t be fully eliminated, the focus must be on identifying where these errors are most likely to occur and understanding their causes. By analyzing aggregated compliance data, organizations can address key risks and implement targeted interventions.

Process control charts for monitoring AE reporting

Process control charts offer a visual tool for tracking AE reporting performance over time. These charts help detect when the AE reporting process begins to fall outside acceptable limits, signaling when intervention is needed.

Missed AE reports, for instance, may indicate process breakdowns related to inadequate staff training or inefficient workflows. By regularly analyzing these reports, organizations can spot trends that suggest emerging issues, allowing them to take corrective action before the situation worsens.

Human error and AI model feedback

AI and machine learning (ML) models are increasingly being integrated into AE detection. However, these models are only as strong as the data they receive, and human error plays a crucial role in refining AI capabilities. When AEs are missed due to human error, these incidents should be fed back into AI models to improve their detection algorithms.

By learning from human mistakes, AI systems can continuously adapt, becoming more adept at recognizing patterns that humans may overlook. Thus, human oversight and error correction are essential to both training AI models and enhancing their accuracy over time.

Designing a strong AE monitoring program

A comprehensive AE monitoring program must include:

  • Clear reporting protocols: All staff must understand AE reporting procedures and timelines.
  • Ongoing training: Continuous training should focus on common errors and ways to avoid them.
  • Feedback loops: Missed AEs and human errors should be documented and used to refine AI models and improve process workflows.
  • Process control tools: Monitoring tools like control charts help identify deviations and flag when processes may be at risk of failure.
Communication channels and feedback integration

In a PSS program, AEs are reported through multiple channels—phone, email, patient portals, and social media. Monitoring these channels effectively is vital, as each presents opportunities for human error. By integrating AI into these channels, potential AEs can be flagged for review, but human oversight is still required to catch nuances AI may miss.

These feedback loops not only improve AI systems but also enhance staff training and process adjustments, leading to stronger compliance programs.

Conclusion

Adverse event reporting in Patient Support Services programs is a crucial aspect of both regulatory compliance and patient safety. While human error can never be entirely eliminated, understanding the behavior of AE processes helps organizations identify the most significant gaps and risks in their reporting systems. Aggregating compliance measures and utilizing process control charts are vital for monitoring these processes, flagging when they deviate from expected norms.

Leveraging missed AE reports, rather than seeing them solely as failures, offers a valuable opportunity to provide feedback to both human teams and AI models, strengthening overall detection capabilities. The strength of AI in identifying AEs will rely heavily on this feedback loop, allowing the system to continuously learn from human error.

By designing a comprehensive AE monitoring program that integrates human oversight with AI-driven detection, PSS programs can ensure more accurate and timely AE reporting. Ultimately, this approach not only enhances compliance but also improves patient safety by ensuring that no potential AE goes unrecognized.

Want to learn more about how AI is transforming Patient Support? Connect with us to explore innovative strategies and technologies that are revolutionizing patient care to drive optimal health and well-being.

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