in All Things Localization, Life Sciences, Technology

This week the Harvard Business Review addressed the need for increased thought leadership in regulatory submissions for the tech world pertaining to cloud computing, artificial intelligence, blockchain, and smart robotics. As the author highlights, these technologies are so disruptive that the question is not only how they should be regulated, but if governments and regulatory bodies even have the capabilities to do so. Furthermore, governments and regulatory bodies will require expert tech translations for regulatory submissions to streamline any new measures introduced for the tech world.

If you search online for information about regulatory documents, Google will likely return you a list of results about required submissions from across the life sciences sector, whether or not your search terms name any part of the industry. It is with good reason that the global healthcare industry is regulated to a degree that eclipses other fields, given the challenges of protecting consumers while working to grow their access to healthcare solutions. Though it can be easy to view regulatory processes as laborious constraints, there is no available alternative today for the vast array of documents and communications required to validate the use of new products in treatment. On the other hand, the resulting standards concerning, for instance, Common Technical Documents (CTD/eCTD) submissions for medical devices can also be viewed as organizing principles for complexities that would otherwise be intractable. Possibly a more interesting question than whether or not this will progress toward simplicity is whether or not other industries could soon experience a credible need for such extensive documentation and intensive regulatory oversight – particularly in emerging sectors where consumer protection presents completely new questions.

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We covered previously how AI is making headlines not only for its incredible capabilities but also for the troubling biases that developers have struggled to prevent within their algorithms, for instance. It is not difficult to picture a future where products are required to undergo testing and documentation for consumer protection criteria and threats like demographic biases, transparency issues, or lacking protections for user privacy. Seen another way, new AI and 5G applications could eventually be required to undergo something like the digital tech equivalent of a clinical trial to evaluate their potential dangers or determine their eligible designations as products.

In another category, the question of how products like these need to be ‘labelled’ – a crucial regulatory question for many common products entering new markets – has yet to be realistically addressed due to the intangible, digital nature of the technologies themselves. If conventional packaging decals and the legal and user agreements governing apps and customer portals are different approaches to the same thing, they may not even be applicable solutions to the massive challenge of bridging communication gaps vital to ensuring the safety and ethical nature of future technical ecosystems. Categorizing products into official classes may become more important to consumer protections, and these requirements are likely to vary by country and region.

All of this is hypothetical, but more in its particulars then in its general likelihood to occur. As AI integrates with life, we will see paradigm-shifting solutions to problems in all sectors of the economy and society that will require the same level of testing and documentation as public health solutions and clinical research do now. These concerns tend to be seen domestically, but the global nature of network technologies means that localizing these types of products for overseas markets and regulatory environments could soon involve linguistic and regulatory hurdles akin to those faced in the life sciences today.  As always, the ability to adapt to local criteria will be just as vital as the ability to translate information accurately, and both will be crucial.

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As well as applying technology to help our customers manage their multilingual content needs, CSOFT works with technology providers to help bridge all of their content needs entering new markets. With a global network of linguists and subject matter experts specializing in areas such as technical and legal translations, CSOFT can help companies innovating in new areas reach global consumers and audiences for their brands through targeted localization solutions. Visit us at to learn more!

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