The Connected Enterprise: Plain Language and Healthcare

This is the second piece in the Lionbridge Connected Enterprise Series, a discussion on life science companies’ efforts to standardize metrics and governance for language services across the entire enterprise. We’ll talk about approaches to connecting previously siloed departments and optimizing use of language service providers (LSPs) as well as common pitfalls during the process. 

Plain language should be straightforward, right? Surely writing something short and simple is easier than thinking up long sentences full of fancy words?

You’d think it would be that simple, but in reality—well, it’s complicated. Sometimes plain language comes naturally, like when we’re messaging a friend or family member. You don’t need subordinate clauses to arrange a birthday party.

But some subjects aren’t simple, and it can be hard to explain them to people who aren’t experts. We’ve all experienced it: You consult the user manual for some new gadget, come across confusing terminology and features, and you end up tossing it aside in frustration.

In the field of healthcare, the stakes are much higher. Innovative treatments may offer hope to many, but if you’re not an expert – and most people aren’t – the science behind them can be mystifying.

That creates an enormous challenge for life sciences professionals. A person receiving a COVID shot doesn’t need to know every detail of what an mRNA vaccine is, but they need to have confidence that it will protect them and that the risk to them is small.

Likewise, a patient participating in a clinical trial needs to understand exactly what they’re consenting to. And once a drug or device is approved for the market, people need to know if it’s right for their needs and, if so, how to use it safely.

Human Habits are Hard to Break

These are serious obligations, and they force manufacturers to take readability seriously. But providing accurate information in accessible language isn’t as straightforward as it sounds.

Human factors play a part. Professionals tend to slip into professional jargon without noticing. Experts get used to communicating with other experts. Unconscious bias can creep in, resulting in content that strays from the facts and influences the decisions of patients.

There are structural and institutional problems, too. Authorities recognize the importance of readability, but they’ve struggled to address the challenges involved in a comprehensive way.

The FDA has issued a lot of guidance on plain language, but most of it remains unenforced by statute. In the EU, there are legal requirements, but they’re fragmentary and in some respects incomplete. For example, EU law requires that lay summaries of trials be published but offers only guidelines and suggestions on how they should be written and presented.

Similarly, the Medical Device Regulation mandates a Summary of Safety and Clinical Performance with a separate summary for lay persons. Here, again, manufacturers are told what to do, but they’re given little guidance on exactly how to do it.

Unsurprisingly, this has resulted in confusion and uncertainty. How do you define plain language? How do you measure it or test it?

But the news isn’t all bad. The gaps left by regulators are being filled. The European Forum for Good Clinical Practice (EFGCP), of which Lionbridge is a contributing member, works to uphold ethical standards and patient welfare. Its work on transparency and health literacy principles is informed by patient advocates as well as subject matter experts, and its consultations with the European Commission may lead to greater clarity in future regulations.

Plain Language Management Support

In the meantime, help is at hand. Over the last decade, language service providers have developed sophisticated technologies capable of much more than just translation. Sophisticated AI systems can provide deep insights into your patient-facing content, going far beyond traditional readability scores. These tools can even target specific aspects of language covered by health literacy guidelines, like the use of passive voice and medical terminology.

Ultimately, effective readability solutions depend on expertise as well as technology. Authoring and editing patient-facing content requires a unique blend of skills, deep regulatory experience and a comprehensive understanding of best practices in health literacy.

And as a company organizes its linguistic management, these requirements and tools offer an opportunity to streamline language services for faster, better quality translations and localizations in the future.

Making healthcare content clear and accessible is a task that comes with challenges, but it plays a vital role in satisfying regulators, maintaining public trust and, above all, keeping patients safe and healthy. That makes it worth the effort.

Not sure where to start when it comes to wrangling new regulations, multiple departments, and varied geographies? Get Mark Aiello’s overview of the process and reach out to our team today for guidance from experts.