Navigating uncharted waters: select practical considerations in radiology AI compliance with the EU AI Act

TL;DR

This paper discusses the challenges of complying with the EU AI Act for radiology AI due to the lack of standardized guidelines.

Contribution

The paper highlights practical compliance challenges for high-risk radiology AI under the EU AI Act's flexible framework.

Findings

The EU AI Act's flexibility leads to inconsistencies in compliance for radiology AI systems.

Lack of standardized guidelines complicates meeting requirements for high-risk AI in radiology.

Non-compliance risks may impact patient safety and fundamental rights.

Abstract

Artificial intelligence (AI) is transforming traditional medicine, particularly in radiology. Its integration across patient care stages has made it increasingly ubiquitous. The European Union’s (EU) AI Act will additionally regulate AI-enabled solutions within the EU. However, without standardized guidelines, the Act’s flexibility poses practical challenges for providers and deployers, leading to inconsistencies in meeting requirements for high-risk systems like radiology AI, potentially impacting patients’ fundamental rights and safety.