---
type: source
title: "Current Challenges and the Way Forwards for Regulatory Databases of Artificial Intelligence as a Medical Device"
author: "npj Digital Medicine authors (2026)"
url: https://www.nature.com/articles/s41746-026-02407-w
date: 2026-01-01
domain: health
secondary_domains: [ai-alignment]
format: journal-article
status: processed
processed_by: vida
processed_date: 2026-04-02
priority: medium
tags: [FDA, clinical-AI, regulatory-databases, post-market-surveillance, MAUDE, global-regulation, belief-5]
flagged_for_theseus: ["Global regulatory database inadequacy for AI medical devices — same surveillance vacuum in US, EU, UK simultaneously"]
extraction_model: "anthropic/claude-sonnet-4.5"
---

## Content

Published in *npj Digital Medicine*, volume 9, article 235 (2026). Perspective article examining current challenges in using regulatory databases to monitor AI as a medical device (AIaMD) and proposing a roadmap for improvement.

**Four key challenges identified:**

1. **Quality and availability of input data** — regulatory databases (including MAUDE) were designed for hardware devices and lack fields for capturing AI-specific failure information. The underlying issue is fundamental, not fixable with surface-level updates.

2. **Attribution problems** — when a patient is harmed in a clinical encounter involving an AI tool, the reporting mechanism doesn't capture whether the AI contributed, what the AI recommended, or how the clinician interacted with the output. The "contribution" of AI to harm is systematically unidentifiable from existing reports.

3. **Global fragmentation** — No two major regulatory databases (FDA MAUDE, EUDAMED, UK MHRA) use compatible classification systems for AI devices. Cross-national surveillance is structurally impossible with current infrastructure.

4. **Passive reporting bias** — MAUDE and all major regulatory databases rely on manufacturer and facility self-reporting. For AI, this creates particularly severe bias: manufacturers have incentive to minimize reported AI-specific failures; clinicians and facilities often lack the technical expertise to identify AI contributions to harm.

**Authors' call to action:**
"Global stakeholders must come together and align efforts to develop a clear roadmap to accelerate safe innovation and improve outcomes for patients worldwide." This call is published in the same quarter as FDA expanded enforcement discretion (January 2026) and EU rolled back high-risk AI requirements (December 2025) — the opposite direction from the authors' recommendation.

**Companion 2026 paper:** "Innovating global regulatory frameworks for generative AI in medical devices is an urgent priority" (npj Digital Medicine 2026) — similar urgency argument for generative AI specifically.

## Agent Notes

**Why this matters:** This is the academic establishment's response to the regulatory rollback — calling for MORE rigorous international coordination at exactly the moment the major regulatory bodies are relaxing requirements. The temporal juxtaposition is the key signal: the expert community is saying "we need a global roadmap" while FDA and EU Commission are saying "get out of the way."

**What surprised me:** The "global fragmentation" finding. The US, EU, and UK each have their own regulatory databases (MAUDE, EUDAMED, MHRA Yellow Card system) — but they don't use compatible AI classification systems. So even if all three systems were improved individually, cross-national surveillance for global AI deployment (where the same tool operates in all three jurisdictions simultaneously) would still be impossible.

**What I expected but didn't find:** Evidence that the expert community's recommendations are being incorporated into any active regulatory process. The paper calls for stakeholder coordination; no evidence of active international coordination on AI adverse event reporting standards.

**KB connections:**
- Babic framework paper (archived this session) — specific MAUDE data
- Petrie-Flom EU AI Act analysis (already archived) — EU side of the fragmentation
- Lords inquiry (already archived) — UK side, adoption-focused framing
- Belief 5 (clinical AI creates novel safety risks) — surveillance vacuum as the mechanism that prevents detection

**Extraction hints:**
1. "Regulatory databases in all three major AI market jurisdictions (US MAUDE, EU EUDAMED, UK MHRA) lack compatible AI classification systems, making cross-national surveillance of globally deployed clinical AI tools structurally impossible under current infrastructure"
2. "Expert calls for coordinated global AI medical device surveillance infrastructure (npj Digital Medicine 2026) are being published simultaneously with regulatory rollbacks in the EU (Dec 2025) and US (Jan 2026) — the opposite of the recommended direction"

**Context:** This is a Perspective in npj Digital Medicine — a high-status format for policy/research agenda-setting. The 2026 publication date means it is directly responding to the current regulatory moment.

## Curator Notes

PRIMARY CONNECTION: Babic framework paper on MAUDE; EU AI Act rollback; FDA CDS guidance expansion
WHY ARCHIVED: Provides the global framing for the surveillance vacuum — it's not just a US MAUDE problem, it's a structurally fragmented global AI device monitoring system at exactly the moment AI device deployment is accelerating.
EXTRACTION HINT: Most valuable as context for a multi-source claim about the "total safety gap" in clinical AI. Does not stand alone — pair with Babic, FDA CDS guidance, and EU rollback sources.
