Translation and Localization Resources | SimulTrans

The Importance of Translation Quality in Regulated Industries

Written by the SimulTrans Team | April 10, 2024

In today’s globalized world, where businesses operate across borders and serve diverse populations, effective communication is paramount. Nowhere is this more critical than in regulated industries such as healthcare, finance, and legal services, where accuracy and compliance are non-negotiable.

However, as organizations increasingly turn to artificial intelligence (AI) for translation needs, a pressing concern emerges: the compliance risks associated with poor AI translations.While AI translation tools have made significant strides in recent years, they still fall short in meeting the stringent requirements of regulated industries. The inherent limitations of AI, including the inability to grasp context, nuances, and idiomatic expressions, pose significant challenges in accurately translating complex and highly specialized content. In industries where precision is paramount, such as medical diagnosis, financial disclosures, or legal contracts, even minor errors in translation can have far-reaching consequences, including legal liabilities, financial losses, and compromised patient safety.

One of the primary compliance risks associated with poor AI translations lies in the misinterpretation of critical information. In regulated industries, inaccuracies or misinterpretations in translated content can lead to serious legal and financial repercussions. For instance, in the healthcare sector, mistranslated medical records or medication instructions can result in misdiagnosis, improper treatment, or patient harm, potentially exposing healthcare providers to malpractice claims and regulatory fines.

In the European Union, the regulation of medical devices is governed by the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). These regulations mandate that medical device labeling, instructions for use, and other documentation must be provided in the official languages of the Member States where the device is intended to be marketed or used. Accuracy and clarity in translations are crucial to ensure the safe and effective use of medical devices, as errors or misunderstandings could pose serious risks to patient safety. Adherence to these regulations requires meticulous attention to translation quality and compliance with linguistic requirements, underscoring the indispensable role of professional human translators in the medical device industry.

Similarly, in the financial industry, mistranslated financial statements, contracts, or regulatory documents can lead to misunderstandings, disputes, and legal liabilities. In an increasingly regulated environment, where compliance with laws and regulations such as the European Union’s General Data Protection Regulation (GDPR) or the Dodd-Frank Act in the United States is mandatory, the accuracy of translated content is critical to ensuring compliance and avoiding costly penalties.

Moreover, specific laws and regulations mandate the accuracy and quality of translations in various jurisdictions. For instance, in the European Union, where linguistic diversity is a hallmark, regulations such as Regulation (EU) No 2016/679 stipulate the right to receive information in one’s own language, emphasizing the importance of accurate translations in data protection and privacy matters. Failure to provide accurate translations of privacy policies, consent forms, or data breach notifications can result in substantial fines.

Similarly, in countries like Japan, regulations such as the Financial Instruments and Exchange Act require financial disclosures and reports to be provided in Japanese, necessitating accurate translations of financial documents to comply with regulatory requirements. Failure to adhere to these regulations can lead to legal sanctions, reputational damage, and loss of investor trust.

In light of these compliance risks, organizations operating in regulated industries must prioritize the quality and accuracy of translations. While AI translation tools offer speed and convenience, they cannot replace the nuanced understanding and expertise of professional human translators. Human translators bring a wealth of experience, cultural awareness, and linguistic proficiency to the table, enabling them to accurately translate complex content while maintaining compliance with regulatory standards.

Furthermore, human translators are adept at navigating the intricacies of specialized terminology and industry-specific jargon, ensuring that translations are precise and contextually appropriate. By leveraging the expertise of human translators, organizations can mitigate compliance risks, safeguard against legal liabilities, and uphold their commitment to providing accurate and accessible information to stakeholders.

In conclusion, the compliance risks of poor AI translations in regulated industries are substantial and multifaceted. To mitigate these risks effectively, organizations must recognize the limitations of AI translation tools and invest in professional human translators to ensure quality, accuracy, and compliance. In an era where regulatory scrutiny is heightened, the imperative of quality translations powered by human intelligence cannot be overstated.

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