If you’re working in the life sciences industry, whether in clinical operations, regulatory affairs, marketing, or IT, you already know that data is king. The industry relies on vast quantities of it, including sensitive personal information such as patient records and clinical trial results. This highly sensitive data is what makes privacy a key concern: The industry is built on trust, and nothing erodes trust more rapidly than data breaches or leaks.
Localization and working across international borders adds another layer of complexity. It involves navigating a maze of growing and disparate regulations as well as increased oversight in order to maintain compliance and safeguard data transferred across borders for localization, storage, and analysis.
Data Privacy in Localization
Data protection measures are therefore essential to any localization project, whether you are in the market for medical translation services or the translation and localization of clinical trials and patient-facing applications. This is especially crucial in the regulatory space, where we are seeing an increased urgency around data privacy. In the wake of increasing concerns about data privacy violations, countries all over the world are stepping up regulatory measures and enforcement.
Crucially, implementing secure localization practices is also vital to building and maintaining patient and participant trust. Nothing erodes trust more quickly than a breach of personal information, especially with the diverse and hard-to-engage populations needed to obtain valid research data mandated by various regulations. With the rapid proliferation of digital health technologies and increased patient data collection, any system breach can do untold damage.
Global Privacy Regulations on the Rise
Clearly, the stakes are high in an industry faced with increasing regulation of the use and storage of health data, growing public awareness of data privacy, and heightened concerns around data breaches. All over the world, a growing number of increasingly complex – and often disparate – regulations are being implemented. The EU GDPR (General Data Protection Regulation) and HIPAA (Health Insurance Portability and Accountability Act) in the US are only the tip of the iceberg. In addition to federal regulations in the US, many states have adopted or are considering adopting various consumer health data protection laws. Online tracking technologies used by healthcare and digital health organizations, data transfer to countries of concern, genetic privacy protection for consumers, and the use of AI in healthcare have also come under increased regulatory scrutiny.
Adding to the complexity is near-daily news about advancements in AI capabilities and the technology’s ever-increasing use in healthcare and research settings. While these developments hold the potential for tremendous progress, they also raise numerous red flags for healthcare data security. As the landscape continues to evolve at breakneck speed, these regulations lay out strict guidelines for handling and securing data. Protecting data during localization across diverse global regulatory environments and systems in these times of accelerating change is no easy feat.
Medical Translation Services: More Than Meets The Eye
Let’s look at what actually happens when you send your life sciences content for translation. From informed consent forms to patient-facing apps, and recruitment materials to medical devices, whenever content is adapted for use with target populations of diverse languages and across geographies, it must be localized. Although translators are involved in rendering text, video, and audio resources in a given language, effective and safe localization in the life sciences requires at least five distinct types of expertise.
1. Linguistic and cultural expertise
This is perhaps the most obvious competency needed. Language experts, ideally professional translators who are native speakers of the target language, translate and culturally adapt the source text into a target language. They pay attention not only to accuracy, but also to flow, the use of the right form of address, the adaptation of examples for cultural relevance, and writing at the correct level of health literacy. Consider patient and physician recruitment materials for research: These target groups need to be addressed in a different tone of voice and at their level to ensure engagement.
2. Subject matter expertise
The second type of expertise we need for medical and life sciences localization and translation is subject matter expertise. Depending on the topic, this could be general medical expertise, knowledge of a certain therapeutic area, pharmacology, or medical devices.
3. Technical expertise
Localized content, especially if it involves sensitive data, must be appropriately managed, housed, and safeguarded. To ensure that proper processes are being followed for maximum safety and data privacy, localization teams need technical experts to help them make the right decisions.
4. Legal expertise
With so many regulations in multiple countries to keep track of, it is a good idea to consult regulatory and legal experts knowledgeable about local data protection laws. They can also help adapt data collection and storage methods to prevent a violation of the rights of data subjects, such as the right to access and the right to be forgotten.
5. Project management
With so many variables to coordinate, expert project management helps tie it all together and is vital to a secure localization process.
The Elephant in the Room: AI and Data Privacy in Localization
AI, specifically generative AI (“GenAI”), is making rapid inroads in the translation and localization industry in the form of large language models (LLMs) such as ChatGPT or DeepL. While the speed of these tools is impressive and their accuracy is improving, using them is associated with numerous limitations, pitfalls, and serious risks.
For instance, data privacy regulations such as HIPAA limit the use of AI in healthcare to methods that comply with the regulation’s data protection standards. This can be difficult to ensure as information flows to servers in various locations.
While such tools are referred to as artificial “intelligence,” they are—at best—as good as the data they were trained on, which may be flawed or biased. Hallucinations can occur, as can serious mistranslations. Another danger is a lack of consistency in referring to a condition, for example, which can be confusing to trial participants and trigger distrust. And even the most well-reviewed source text can contain errors and unclear phrasing. Human translators and editors frequently notice these issues, whereas AI tools will generally replicate and often amplify the error.
The Irreplaceable Human Touch
GenAI tends to do poorly on these tasks as opposed to human language experts, who bring cultural awareness and knowledge of linguistic intricacies such as figures of speech, dialects, regional use of language, and inappropriate terms. Its output is often less than engaging and may not be at the literacy level of the intended population. This is why, even in the age of AI, localization and translation still require a human-first approach.
In addition, life sciences GDPR compliance raises concerns on an entirely different level. While the use of GenAI may sometimes increase efficiency, it comes with unique risks relating to potential breaches and leaks of personal health information. For instance, Article 5 GDPR mandates transparency in the processing of personal data. Adhering to this and other principles, such as data minimization and consent, can be a challenge when using AI tools. There have been cases where AI models have inadvertently exposed individual patient data, and there is a risk of anonymized data being re-identified.
Putting It All Together
As we have seen, localization in the life sciences is an endeavor with high stakes around data privacy. The best solution to this dilemma is to use a human-centric approach to localization in conjunction with strong technological safeguards to maintain patient trust and regulatory compliance. Partnering with an experienced language service provider (LSP) like Vistatec, who is well-versed in secure practices, helps proactively prevent issues around data privacy in localization for your peace of mind.
Would you like to discuss this with our life sciences experts? Contact us today to discuss how we can help support your needs.
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