ECRI Targets Hidden AI Failures with New Patient Safety Reporting Channel

Global patient safety nonprofit ECRI is widening its national problem-reporting network to explicitly capture errors, malfunctions, and near misses linked to artificial intelligence (AI) tools and AI-enabled devices used in patient care. The move aims to close a critical data gap as hospitals and health systems rapidly deploy AI for diagnosis, triage, documentation, and patient communication.

A New Channel for Tracking AI-Related Harm

For decades, ECRI has collected confidential reports on medical device issues and health IT problems from frontline clinicians and healthcare organizations, investigating them and sharing lessons learned back to the reporting sites and the wider industry. With the latest expansion, its Problem Reporting Network now includes a dedicated pathway for incidents where an AI-enabled tool may have contributed to an error, produced an incorrect output, or introduced new risks into care delivery.

ECRI is urging healthcare providers, health systems, and clinicians across the United States to submit reports whenever they suspect an AI application played a role in a safety event—whether the error reached a patient or was caught beforehand as a near miss. Reports can cover a broad range of technologies, including diagnostic algorithms, clinical decision-support tools, radiology image analysis systems, risk prediction models, and AI-driven chatbots used in patient engagement.

Underreported AI Problems in Clinical Practice

The expansion reflects growing concern that AI-related safety issues are significantly underreported compared with more traditional device failures. In a recent ECRI survey of 124 quality, safety, risk, and compliance leaders, nearly one‑third said they had encountered an AI output they believed was incorrect or misleading within the past year. About 9% said an AI error had reached a patient or affected a care decision. ECRI argues that without formal reporting mechanisms, many of these incidents remain invisible to oversight bodies and technology developers.

ECRI has previously warned that adverse events involving AI-enabled medical devices and applications are often missed because staff may not realize when AI is running in the background, or they may attribute problems solely to human error or workflow issues. The organization’s guidance emphasizes the need to recognize reportable AI events, identify which products incorporate AI, and conduct risk assessments specific to AI-enabled devices.

Examples of AI Errors ECRI Wants Reported

The expanded reporting network is designed to capture a spectrum of AI-related safety concerns, including:

• Incorrect or misleading outputs that influence diagnostic or treatment decisions, such as misclassification of imaging findings or inaccurate risk scores.
• False positives and false negatives in AI-driven diagnostic tools, even when performance metrics appear acceptable, if they contribute to missed or unnecessary care.
• Algorithmic bias leading to poorer performance for specific patient groups, including women and racial or ethnic minorities.
• Unexpected behavior or unsafe recommendations from AI chatbots or virtual assistants used in clinical or patient-facing workflows.
• System malfunctions or integration failures where AI components interact incorrectly with electronic health records or medical devices, causing delays, data loss, or wrong information displays.

All reports submitted to ECRI are kept confidential, and the service is free to participating organizations and clinicians. ECRI triages and investigates reports, may notify manufacturers when appropriate, and incorporates findings into its safety alerts, guidance documents, and member resources.

AI Risks Already Top ECRI’s Safety Agendas

The expanded reporting network aligns with ECRI’s broader assessment that AI-related risks are now among the most pressing patient safety challenges. In its annual list of Top 10 Health Technology Hazards for 2026, ECRI ranked the misuse of AI chatbots in healthcare as the number‑one hazard, warning that poorly governed or inadequately supervised chatbots can provide inaccurate or unsafe guidance to patients and clinicians.

ECRI’s 2026 Top Patient Safety Concerns report similarly identified “Navigating the AI Diagnostic Dilemma” as the leading safety concern, citing a growing risk of missed, delayed, or incorrect diagnoses when AI tools are deployed without robust validation, governance, and clinical oversight. The organization recommends structured logging of when AI informs diagnostic decisions, maintenance of detailed audit trails, and clear processes for clinicians to override AI outputs when they conflict with clinical judgment.

How the Expanded Network Fits into Broader Oversight

Regulatory agencies such as the U.S. Food and Drug Administration maintain databases of adverse events and cleared AI-enabled medical devices, but ECRI’s reporting network offers a complementary channel focused specifically on patient safety and practical implementation issues. ECRI encourages organizations to report AI-related events not only to regulatory databases but also to its own system, where incidents can be analyzed in the context of broader patterns of health technology hazards.

Reports submitted through the expanded AI pathway will feed into ECRI’s internal databases and may prompt targeted safety alerts, practice recommendations, or deeper investigations of specific products or use cases. Over time, ECRI expects that richer reporting will help quantify how often clinical AI tools produce incorrect or misleading outputs, what types of workflows are most vulnerable, and which controls are effective at preventing harm.

Call to Action for Clinicians and Health Systems

With AI adoption accelerating across radiology, pathology, emergency triage, scheduling, and patient messaging, ECRI’s message to healthcare organizations is direct: treat AI incidents as reportable patient safety events and submit them through established channels, including ECRI’s expanded network. The organization urges hospitals to educate frontline staff on how to spot potential AI errors, document them consistently, and escalate concerns for review.

By systematically capturing AI-related problems—from subtle misclassifications to major diagnostic failures—ECRI aims to give clinicians and technology developers clearer visibility into real‑world risks, ultimately shaping safer AI deployment across the healthcare system.