Last month we talked about the rise of structured content in pharma driven by the need to increase content reuse, improve quality and consistency, reduce costs, and adhere to industry regulations related to readability and accessibility. That trend is being assisted and accelerated by the adoption of standards such as the Darwin Information Typing Architecture (DITA) and the use of component content management systems (CCMS) which make it easier to create, store, search, reuse, and even translate content.

The use of DITA is important because it allows for the definition of document types, the application of metadata, and the application of specializations to content that greatly facilitates the reuse of content in an automated process. In short, DITA facilitates the classifying and sorting of content at the level of granularity required by the publisher.

Dominique Trouche, CEO of WhP, explains: “DITA provides many benefits including content reuse across different documents, translating and reviewing only once, and removing the need for DTP. These all reduce costs, errors, and time requirements.” Dominique also believes that DITA’s “specialization” capability is a huge benefit since it can automate many functions such as the translation of measurements across various systems and languages and perform automated text-to-speech translation and recording in MP3.

When DITA is applied in a workflow that includes the use of a CCMS, its value becomes even more pronounced. Instead of simply storing documents or blocks of content, CCMS platforms can sort, store, and retrieve content at an extremely granular level. In life sciences this can be particularly beneficial when considering re-use opportunities such as with product disclaimers and other commonly produced industry-specific documents.

Going one step further, integrating a CCMS with a TMS is the crown jewel for content reuse and translation workflow management. However, with so many CCMS, CMS, and TMS solutions on the market, many organizations are faced with the paradox of choice, or at least find it difficult to commit to a specific solution.

According to Dominique Trouche, WhP is CCMS and CMS agnostic and can work with almost any content management platform. However, they only use one TMS. To that end, WhP has developed a firmware solution that can allow for the development of a connector for most CCMS and CMS platforms to WhP’s preferred TMS solution within one or two business days.

An example of an enhanced workflow based upon the integration of a CMS and a TMS is augmented review for medical device manufacturers. Augmented review is a better option than the traditional in-country review because only the revised content needs to be reviewed, as opposed to an entire document. This can be done by a linguist with subject matter expertise. Once changes are made to a content block, those changes can be set to automatically flow to all documents or webpages that use that specific content.

This automated approach solves the typical labor-intensive manual “find and replace” problem which first necessitates the locating of all documents and webpages where a piece of content has been used and eliminates the need for costly, time consuming, and error prone DTP work.

According to the DITA Exchange, an organization that works to help companies simplify the creation, management, delivery, and re-use of content, their Dx4 structured content management solution which runs on Microsoft SharePoint achieves the above goals and helps to fulfill compliance and regulatory requirements.

A specific example provided by the DITA Exchange is the re-use of Global Labeling content across all related documents such as Company Core Datasheet (CCDS), Company Core Safety Information (CCSI), Summary of Product Characteristics (SmPC), and United States Prescribing Information (USPI).

As the amount of life sciences content being produced and localized, as well as the volume of patient data being around the world is rapidly growing, the use of a CCMS and TMS would seem to be a no brainer for all organizations creating and translating content. But as Uncle Ben in Spider-Man says, “With great power comes great responsibilities.”

The great responsibilities in this case are specifically related to both the readability and accuracy of the content that is being translated, and also to the protection of patient and customer data that is being processed and/or translated. To ensure that these responsibilities are taken seriously, various regulatory agencies across the globe are continually updating, refining, and releasing new regulations and guidelines.

For content creation and translation, a good example of guidelines would be the Lay Summary Best Practices that were created by the Clinical Trials Expert Group (CTEG) and discussed in detail in last month’s column.

Another example would be the recently released guidance for translating Clinical Outcome Assessments (COAs). If you have been using the same procedure for translating Patient Reported Outcomes (PROs) and the various reported outcomes in COAs, you may be surprised to learn that there are several notable difference in what is accepted as best practices.

The ISOQOL Translation and Cultural Adaptation Special Interest Group (TCASIG) has released recommendations related to the translation of various COA types. These recommendations are discussed in detail in the paper Good practices for the translation, cultural adaptation, and linguistic validation of clinician-reported outcome, observer reported outcome, and performance outcome measures.

This guidance was needed because most industry guidelines had previously focused on best practices for the translation of PROs. However, as the information from PROs and the information received from Observer Reported Outcomes (ObsROs) including Clinician Reported Outcomes (ClinROs) and Performance Outcome Measures (PerfoO measures) is distinctly different in terms of the type of information that is being reported and the viewpoint and professional background of the reporters.

While the best practices for translation the COA categories is similar to those for translating PROs, there were some notable differences. For example, it is recommended that all assessment materials that have been provided to the observers, clinicians, and raters be translated. This information is needed to provide an understanding of the framework and context that the reporters had used to provide their reports.

For a more in-depth look at the recommended best practice for translating COAs, please take a look at Good practices for the translation, cultural adaptation, and linguistic validation of clinician-reported outcome, observer reported outcome, and performance outcome measures at pubmed.ncbi.nlm.nih.gov/33146755.

On the data protection and privacy front, regulations including HIPAA and GDPR, both highly relevant to the life sciences industry, are continually evolving in terms of their scope, guidance, and interpretation of their regulations. Examples include HIPAA’s easing of compliance during the COVID-19 pandemic and the allowance of the use of everyday communication tools such as FaceTime, Skype, Zoom, and Google Hangouts video by healthcare providers to provide telehealth services to their patients.

Normally the use of these types of tools would not be considered fully HIPAA compliant but have recently been allowed. It should be noted that public-facing platforms such as Facebook Live and TikTok are still not allowed.
The U.S. Congress is getting in on the healthcare data protection act and has recently introduced two bills related to the protection of healthcare data that falls outside of HIPAA protection. S.3620 is a bill to establish a commission that will study health data use and privacy protection, and S.3627, known as the “Delete Act” would call for the establishment of a centralized system that would allow individuals to request the deletion or disallow tracking of their data.

At the same time several states including California, Colorado, and Virginia have recently passed new regulations that relates to the protection of patient data that falls outside the purview of HIPAA.

Keeping up with and maintaining compliance with new regulations can be challenging for those involved with life science content creation and translation. One solution is to only work with HIPAA- and/or GDPR-compliant vendors. Typically, larger vendors will issue guidance and updates as part of the business agreement to help their customer understand the regulatory landscape and work towards maintaining compliance.

The use of machine translation continues to increase across all areas of life sciences. That said, not all that glitters is gold. Many readers may be surprised to find out that public cloud services such as Google Translate aren’t considered to be HIPAA compliant, but services such as Microsoft Translator and iTranslate Medical are promoted as HIPAA compliant by their respective companies.

Next month in The Lab we will take a deeper look at security and compliance requirements for life sciences localization providers.