Artificial Intelligence (AI) offers boundless opportunities for innovation in the healthcare industry. However, its potential must align with regulations that ensure ethics, safety, and transparency. The new European AI Act came into force in August 2024, introducing implementation phases that will extend through August 2027. This regulation joins other critical frameworks like the Medical Device Regulation (MDR), the In Vitro Diagnostic Regulation (IVDR), and the General Data Protection Regulation (GDPR). The result? A complex regulatory landscape requiring healthcare companies to adapt rapidly.
Where do translation companies come into play? To achieve compliance with the European AI Act, having an expert partner in translation and localization can make all the difference. This blog explains why translation is a strategic ally to ensure compliance, quality, and safety in the use of AI in healthcare.
Key Implementation Dates of the European AI Act: When and How to Prepare
- Enforcement Date (August 2024):
The European AI Act formally took effect in August 2024. From this date, European companies and those planning to market products in the EU began assessing their obligations and preparing to adapt their AI systems. - Initial Obligations (February 2025):
Six months after the enforcement date, initial provisions take effect. These include classifying AI systems by risk level (high, limited, or minimal) and initiating risk management and transparency plans. - Full Enforcement (August 2027):
By August 2027, all obligations must be fully met, including transparency requirements, technical documentation, and registering “high-risk” AI systems in the EU database. - Fines and Penalties:
Non-compliance can result in significant penalties, ranging from €7.5 million (or 1.5% of global turnover) to €35 million (or 7% of global turnover).
Each phase introduces new technical and documentary requirements. For the healthcare sector, complying with the EU AI Regulation also involves addressing other significant regulations, including MDR, IVDR, and GDPR.
Navigating Interactions of the European AI Act with MDR, IVDR, and GDPR: A Regulatory Maze
In healthcare, AI-powered medical devices are classified as “high-risk” under the EU AI Regulation. This classification adds new requirements to those already mandated by healthcare laws.
- MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation):
- AI-driven devices for diagnosis or treatment must undergo stricter conformity assessments.
- Technical documentation for AI must integrate seamlessly with MDR/IVDR files, including clinical validations and risk management.
- Notified Bodies must be trained in AI to grant CE markings for high-risk medical devices.
- GDPR (General Data Protection Regulation):
- The AI Regulation introduces specific requirements for high-risk systems handling personal data but does not replace GDPR. Both apply simultaneously.
- Processing personal health data requires explicit consent and Data Protection Impact Assessments (DPIAs) when risks to patient rights are high.
- Transparency and traceability (e.g., who accessed data and decision-making processes) are critical.
This additional layer of technical and legal requirements can feel overwhelming. That’s where the expertise of a specialized translation company becomes invaluable.
Providers and Users: Responsibilities Under the AI Regulation
The EU AI Regulation distinguishes between:
- Providers (Developers):
- Responsible for creating or training AI systems.
- Must implement AI-specific Quality Management Systems (AI QMS).
- Required to ensure technical robustness and cybersecurity.
- Obligated to document design, development, clinical validation, and risk management processes.
- Users (Deployers):
- Organizations such as hospitals, clinics, and pharmaceutical companies that utilize AI tools.
- Must use AI systems as per the provider’s instructions.
- Responsible for monitoring AI operations, addressing errors or biases, and conducting impact assessments on fundamental rights, such as non-discrimination and data protection.
Many healthcare organizations act as both providers and users, particularly when developing in-house AI systems for diagnostics or big data management. This dual role amplifies compliance obligations.
Why a Translation Company is Key to Compliance
It may seem easier to use in-house AI-based translation tools, but doing so carries additional responsibilities and increases the risk of non-compliance with the AI Regulation and related frameworks like GDPR. Here’s why outsourcing to a specialized translation company is essential:
- Expertise in AI and Sectoral Regulations:
- Translation companies have leveraged AI tools like machine translation (MT) and post-editing since 2010 or earlier, making them well-versed in best practices and risk management for sensitive data.
- They comply with GDPR and the evolving requirements of the AI Regulation.
- Their expertise in MDR and IVDR ensures translations meet stringent documentation standards for medical devices.
- Transfer of Compliance Responsibility:
- When healthcare organizations use internal AI tools for translation, they bear full responsibility for data management, cybersecurity, and linguistic quality.
- By outsourcing, much of this burden shifts to the translation provider, who ensures regulatory compliance.
- Cost and Time Savings:
- Specialized companies streamline processes with proprietary software and experienced teams.
- Avoid costly fines for non-compliance while meeting tight deadlines with high-quality translations.
- Guaranteed Quality in Multilingual, Specialized Contexts:
- Translation companies combine AI technology with expert human translators, ensuring accuracy, consistency, and cultural adaptation.
- Data Security and Confidentiality:
- Professional translation companies provide clear confidentiality agreements and secure data management protocols compliant with GDPR and the AI Regulation.
- Proactive Regulatory Monitoring:
- Specialized providers stay updated on regulatory changes, ensuring seamless adaptation and compliance for their clients.
Practical Recommendations for Each Stage of Compliance
| Short-Term (Before February 2025): | Mid-Term (Until August 2027): | Long-Term (After 2027): |
| Internal Audit of AI Systems: Identify which tools or processes involve AI and classify them by risk level (high, limited, minimal). Mapping Linguistic Obligations: Assess which documents require translation or localization to meet the initial guidelines of the AI Regulation. Selecting a Translation Partner: Look for companies with expertise in medical devices and AI to establish a solid collaboration plan. | Implementing an AI QMS (Quality Management System for AI): Integrate documentation and translation processes into this system. Multilingual Training: Ensure healthcare personnel are trained in multiple languages with clear and accessible manuals and guides. Creating and Maintaining a Documentation Repository: Design a system to store all documents (in every required language), updated in line with regulatory advancements. | Continuous Monitoring of Laws and Associated Regulations: Authorities may revise the AI Regulation, so companies must remain adaptable. Internal and External Audits: Prepare multilingual reports and documentation to facilitate compliance inspections. Safe Innovation: Integrate new AI tools (e.g., large language models) within a reliable translation and localization environment. |
Ethical Innovation and Strategic Translation
The EU AI Regulation isn’t just a challenge—it’s an invitation to innovate responsibly. AI regulation aims to protect health and fundamental rights, emphasizing data quality, transparency, and human oversight.
The key to successful compliance? Comprehensive planning that includes translation and localization as integral elements. Precise, culturally adapted, and legally compliant communication is critical in a sector where every word matters.
Do You Need an Ally to Centralize and Streamline Your Translation and Localization Needs in Healthcare?
Win & Winnow provides comprehensive multilingual solutions so you can focus on innovation without worrying about the requirements of the new EU AI Regulation. Our mission is to help you comply with MDR, IVDR, GDPR, and the AI Regulation while maintaining the quality, consistency, and delivery times you need in a constantly evolving environment.
Among other services, we offer:
Complete Translation and Localization of Technical and Legal Documentation
We handle user guides, clinical manuals, protocols, contracts, and any documents regulated under MDR, IVDR, GDPR, and the new AI Regulation.
Centralized Multilingual Solutions
We unify all your translations, ensuring terminological consistency, quality standardization, and fast delivery in multiple languages.
Why Choose Win & Winnow?
- Expertise in the Healthcare Sector:
With over 20 years of experience, we understand the unique challenges of the industry and the implications of every regulation. - Focus on Responsible Innovation:
We use AI as an effective support tool, always under expert human oversight and within the applicable ethical and legal framework. - Time and Resource Savings:
Our scalable, comprehensive methodology enables us to manage large volumes of content, meeting tight deadlines without compromising quality. - Personalized Attention:
We tailor our services to your needs and create customized solutions for every project.
AI is the Future of Healthcare, but it will only be a solid future if developed responsibly, securely, and ethically. With Win & Winnow as your ally, you can confidently navigate every phase of the EU AI Regulation while keeping your focus on innovation and delivering quality care to your patients.
Contact us and discover how we can help your healthcare company meet EU requirements while unlocking the full potential of AI.
