In an increasingly interconnected world, an ever-greater number of medical documents are spanning across national borders, whether for vaccine distribution, international scientific conferences, or research articles.
Specialized medical translation is essential to ensure that knowledge is shared equally and to guarantee scientific cooperation and the safety of healthcare worldwide.
Medicine is an ultra-specialized field, spanning numerous disciplines such as physiotherapy, pharmacy and dentistry. All translation requires precision, but in the medical sector, this precision reaches critical levels: imprecise or inaccurate translations are unthinkable given the human and legal consequences they could entail.
Major events such as the COVID pandemic greatly accelerated the boom in medical translation, dramatically increasing the need to translate protocols, clinical trials and public health press articles—there was a 49% jump in demand for translation in the healthcare sector in 2020.
The Specifics of Medical Translation Expertise
At the crossroads of linguistics, science and regulation, medical translation is a demanding discipline. To guarantee high quality and safety, these specialist translators need skills that go far beyond a perfect command of the source and target language.
Essential Extra-Linguistic Training
To translate a medical document for a particular discipline, the translator must have specific medical training. Unlike standard translation, professional medical translations require cross-disciplinary, extra-linguistic expertise. Translators must have thorough knowledge of the literature, including topics such as anatomy, physiology, pathology and pharmacology.
Many of these specialist translators are therefore former doctors, chemists, dentists, engineers, nurses or pharmacists, which ensures comprehensive expertise in the various specialties (oncology, dermatology, ophthalmology, etc.).
This expertise is not accrued in order to become a doctor, but to encourage systematic doubt when consulting a document, and to always be able to defend one’s choice of words or interpretation of the text, with supporting arguments. Translators also have to actively keep their knowledge up to date with ongoing training, to stay on top of the constant advances in the industry.
Tailoring the Message to the Target Audience
Medical translators need to know by whom and for whom the text was written. The document’s tone and style and the words chosen depend on the text’s discursive type. For example, a scientific article intended for peers (informative text) will use a highly specialized, technical lexical field. On the other hand, a diagnosis or information leaflet aimed at patients (who are not used to technical terms) will require a simplified lexical field.
Distinctions Between Specialties
The term “medical translation” is broad, encompassing all health-related documents, whether they are clinical, scientific, pharmaceutical, biological or veterinary. However, differentiating between sub-domains is essential:
- Medical translation vs. translation for medical devices:
Although related, medical translations (such as a clinical report) are wildly different from medical device translations since the lexical field is not the same. A medical device is any product or equipment intended for a medical purpose. Translations in this field include labels, user instructions, data sheets and instrumentation manuals. To translate a medical device, the translator must understand how it works. Software and mobile applications for medical purposes (enabling a diagnosis to be made or health recommendations to be formulated) are also considered medical devices.
In Europe, medical devices must meet the requirements of the MDR (Medical Device Regulation).
- Medical translation vs. pharmaceutical translation:
Pharmaceutical translation focuses specifically on pharmaceutical products, marketing authorizations (MA), study protocols and pharmacovigilance. On the other hand, medical translation covers a broader spectrum, including clinical records, patient education manuals, and literature on scientific research.
Precise Terminology, Regulations and Ethics
In the healthcare sector, translation poses major challenges: errors can lead to instructions being misunderstood, dosage errors, or even serious medical complications, putting patients’ lives at risk.
Compliance with Standards and Regulations: MDR and FDA Imperatives
Medical and pharmaceutical industries are subject to increasingly stringent regulations governing all stages of the product life cycle, from development to clinical trials and post-marketing compliance. Companies must tailor their products to local standards to obtain the necessary regulatory approvals.
Not complying with these regulations may result in marketing delays, recalls and fines. To ensure safety and compliance, language service providers must comply with:
- The EU’s Medical Device Regulation (MDR). This directive establishes specific standards for the translation of labels, leaflets and device information, to ensure patient safety in the European Union.
- The requirements of the U.S. Food and Drug Administration (FDA), which provide a rigorous framework for labeling and clinical trials.
- The ISO 17100 standard on requirements for translation services, which guarantees the quality of processes, resources, qualifications and traceability.
Dual Quality Control: an ISO 17100 Requirement
In a sector where precision and reliability are absolutely essential, careful revision by a second expert translator is a non-negotiable step in the quality process. This step is a direct response to ISO 17100 requirements, which govern professional translation processes, including the review and qualification of linguistic services.
Often called a reviser, this proofreader’s crucial role involves carrying out a complete revision of the translation, comparing it to the source text. This verification is essential to identify and correct any errors or inconsistencies. The proofreader guarantees that the translation is both accurate and faithful to the source text.
For very sensitive scientific or regulatory documents, quality processes may go as far as final validation by a healthcare professional (such as a physician, pharmacist or researcher) to guarantee that the information is accurate.
The final quality control ensures that the glossary is respected, while back-translations are used to ensure that the most sensitive extracts of the publication are perfect.
This ultimate check is carried out by one of the translation agency’s project managers, a specialist in the medical sector. As well as thoroughly analyzing the source document to determine its purpose, the project manager also ensures compliance with the specific project management procedures and that strict protocols ensuring absolute data confidentiality are respected, all throughout the translation assignment.
The Challenges of Terminology and Consistency
Medical translation is made all the more complex by the polysemy of medical terms, which can have several meanings depending on the clinical context, and by the challenges of managing specific nomenclatures. Translators must be familiar with international nomenclatures such as the International Classification of Diseases (ICD) and the International Nonproprietary Names (INN) of pharmaceutical molecules.
To overcome these challenges and ensure accuracy and consistency, translators use specialized tools such as detailed glossaries, terminology databases and customer-specific translation memory software. What’s more, expert translators need to be aware of cultural variations, such as differences in hematology units (e.g., English-language authors often use g/dL, whereas French-language authors tend to use g/L).
Confidentiality, Accuracy and Reliability
Accuracy and reliability are absolutely essential in medical translations. Translators are also required to respect the confidentiality of patients’ personal medical data. This involves keeping the processed information secure, and compliance with the applicable regulations, such as the GDPR in Europe. Translators have significant responsibilities in terms of ethics, guaranteeing scientific accuracy and always referring to official sources.
Artificial Intelligence in Medical Translations: A Help or Hindrance?
Artificial intelligence’s (AI) integration into medical translation has progressed, offering the possibility of faster turnaround times and lower costs. But far from replacing humans, AI is seen as a support tool.
Advantages (and Limitations) of AI
AI technologies, such as Neural Machine Translation (NMT), can process large volumes of text faster than humans:
- In urgent situations, it means that translated documents can be made available more quickly, although their accuracy may not be totally reliable;
- It can help readers understand documents written in a language they don’t speak.
AI should only be used for content that is not very sensitive, and for which ISO 17100 compliance is not required. A machine translation does not meet the requirements of ISO 17100, even if it is corrected by a professional specialist translator, and cannot be certified as such by the language service provider who produced it.
While AI can be used for certain non-sensitive content, in the healthcare field, using it alone is not recommended—thorough human review is essential.
Human translators play a key role re-reading these AI translation outputs. This task is called post-editing and the standard process involves:
- Initial translation using AI
- Human editing by a professional medical translator to correct errors and perfect the language
- Contextual and cultural fine-tuning
- Final quality control
However, using AI should never replace the human expertise needed to ensure accurate, reliable and contextually relevant medical information.
Certain content and language pairs are not suitable for machine translation if the engines are insufficiently trained. The quality of the translation output would be too poor to be corrected. Language service providers are responsible for advising their customers on whether or not AI can be used to deliver the expected quality.
The Risks of Using AI in Medical Translation
Despite its many advantages, using machine translation in the medical field requires extreme caution, as it entails significant risks.
- Conceptual errors and lack of context
Two major problems can arise when using AI:
- Hallucinations: AI can generate convincing but incorrect content, producing misleading results or fictitious references.
- Obsolete information: an out-of-date AI model may lack translations related to the latest medical advances, such as new treatments or clinical trials (for example, a model trained up to 2021 might not include recently approved immunotherapies), which could impact patient care.
- Privacy and security issues
Using AI involves handling highly confidential information. Language service providers must guarantee that data is managed securely and in compliance with the applicable regulations.
Conclusion: A Secure Partnership Between Humans and Technology
Medical translation is a demanding specialty where the stakes are high. It requires qualified, experienced professionals, and perfect precision in terms of terminology and compliance with ISO 17100.
AI is a powerful tool to help speed up the process, but it must be used with extreme caution.
In the healthcare field, specialist human translators remain the keystone, ensuring that the medical message is not only accurate, but also ethically and culturally appropriate for patients and professionals worldwide.
At ITC Global, translation works like an efficient medical system: we are a generalist agency, able to manage all types of projects, but each assignment is entrusted to specialists in the field—just like a family doctor relies on experts to offer the best diagnosis. Our translators and project managers truly master the specifics of the medical sector to ensure perfect accuracy. And while AI can assist with certain steps, and within a strict framework of use, it is never used on its own… Only human expertise can guarantee a reliable, safe translation that meets the challenges of the healthcare sector.
