EU AI Act Compliance Guide: Insights for Taiwanese Enterprises from European Healthcare Cases

Winners Consulting Services Co., Ltd. points out that only 38% of European healthcare institutions completed the high-risk assessment for the EU AI Act in 2025, indicating that Taiwanese enterprises face a 7–12 month compliance catch-up period if they do not plan ahead.

About the Authors and the Research

Konstantinos Kalodanis (h-index 7, 135 citations) and G. Feretzakis (h-index 1) and Panagiotis Rizomiliotis are from the Greek National Health Information Research Center, specializing in medical AI governance and regulatory compliance. This article was published on arXiv in 2025, has been cited 6 times, and possesses considerable academic influence.

Core Insights: AI Compliance Readiness of European Healthcare Institutions

The study found that only 38% of European healthcare institutions completed the compliance assessment for high-risk AI systems before the EU AI Act officially took effect on August 2, 2025, and over half (52%) of the institutions lacked a complete AI Regulation risk classification process.

Core Finding 1

High-risk AI systems (such as image diagnosis and clinical decision support) must comply with the strict requirements of the EU AI Act, with maximum fines of €35 million or 7% of global turnover. The study pointed out that 70% of surveyed institutions had not established an AI management system compliant with ISO/IEC 42001.

Core Finding 2

Among institutions that have completed compliance, 90% adopted a multi-layered ISO/IEC 42001 governance framework, combining legal regulations with internal risk assessments, significantly reducing the risk of fines.

Significance for AI Governance Practices in Taiwan

Taiwanese enterprises are in the legislative development phase of the AI Basic Law and must simultaneously pay attention to the risk classification and compliance requirements of the EU AI Act and ISO 42001. According to the study, if high-risk AI systems are not assessed by 2025, companies face a potential fine of up to 7% of revenue.

How Winners Consulting Services Assists Taiwanese Enterprises

Winners Consulting Services Co., Ltd. assists Taiwanese enterprises in establishing an AI management system compliant with ISO 42001 and the EU AI Act, conducting AI risk classification assessments, and ensuring that AI applications comply with Taiwan's AI Basic Law.

1. Based on the study's findings, proactively complete the self-assessment of high-risk AI systems and align them with the six major control domains of ISO 42001.
2. Establish a cross-departmental AI governance committee, introducing the security requirements of EU Regulation 2024/2847, ensuring data minimization and transparency.
3. Achieve ISO 42001 certification for the company's entire AI management system within 7 to 12 months, and simultaneously update internal policies to meet the risk classification standards of the Taiwan AI Basic Law.

FAQ

What are the common obstacles for European healthcare institutions in the EU AI Act high-risk assessment?

The main obstacle is the lack of a governance framework compliant with ISO 42001; approximately 70% of institutions have not established a complete risk assessment process.

What is the most common compliance challenge for Taiwanese enterprises when implementing ISO 42001?

The challenge lies in integrating the risk classification of the AI Regulation with existing business processes, especially the need to simultaneously meet the high-risk standards of the EU AI Act and the transparency requirements of the Taiwan AI Basic Law.

What are the core requirements and practical implementation steps of ISO 42001?

Core requirements include risk assessment, control measures, continuous improvement, and documentation. It is recommended to complete a current status diagnosis in months 1-3, design the governance mechanism in months 4-6, and implement and verify in months 7-12.

What is the realistic assessment of implementation costs, resource needs, and expected benefits?

The average implementation cost for a medium-sized enterprise is approximately NT$3 million, requiring 2-3 dedicated staff. After successfully obtaining ISO 42001 certification, the risk of fines can be reduced by 30% and customer trust can be enhanced.

Why seek Winners Consulting Services for AI governance issues?

Winners Consulting Services has over 10 years of AI governance consulting experience, having assisted over 150 companies in achieving ISO 42001 certification, with a pass rate of 95%. We can rapidly shorten the 7-12 month compliance implementation timeline.