Localization in different industries has peculiarities that should be considered to achieve the best results. We started this series of industry articles with e-learning localization and e-commerce localization, so our team highly recommends reading them as well to understand localization diversity better. And now, let's move on to the equally exciting topic of localizing software for medical needs.

Medical software. What you need to know

Digital health is the most appropriate term to describe medical software, as it includes different subcategories like:

  • mHealth (mobile health)
  • eHealth
  • digital fitness & well-being
  • telehealth (using technologies to share medical information).

The digital health market is continuously growing and is predicted to reach $193.70bn by the end of 2024 and China is the most promising region in this industry, with an expected $53 billion in 2024.

Digital health (revenue per industry)

We can highlight the following factors that gained digital health growth:

  • There is a high level of smartphone, fitness trackers, and other mobile devices penetration into users' lives. Every day, our smartphones and fitness trackers collect information about the number of steps and our heartbeat; some models also can collect information about calorie burning, blood pressure, sleep quality, etc. All this data supports monitoring the main health indicators without human effort.
  • As a consequence of the previous factor — raised implementation of telehealth. The sharing of medical data is now easier than ever.
  • Increased digitization of everyday processes. The COVID-19 pandemic showed how effective remote processes could be. Patients sometimes prefer to get consultations remotely to save time spent on the road.
  • Development of the regulatory environment. Governments recognize the potential of digital technologies and regulate them through frameworks to raise data security while ensuring patient safety and privacy. Such steps increase patients' trust in a digital health area.
  • Resource optimization. The healthcare industry can save in the future through its optimization via digitalization. For instance, it is much easier to provide preventive care to decrease the number of chronic diseases or their complications.
  • Higher patient safety. Based on the research data, implementing electronic health records reduces medication errors by 54% and increases medical guideline adherence by 30%.

The constantly increasing popularity of digital health has led to its regulations in the legal field and brings undoubted advantages for industry and patients. But what has yet to happen in the localization field, and how can lousy localization ruin all the benefits of digital health?

Factors that gained digital health growth

Why is accurate medical software localization essential?

The enormous risks associated with people's health make us even more scrupulous in localizing digital healthcare. Below there are some of them:

  • Prescription correctness. Digital health software, such as electronic medical records (EMRs) or electronic health records (EHRs) systems, usually hosts diagnoses and prescription information. Incorrect localization can lead to the mistranslation of dosage information and, as a result, negative health consequences.
  • Risk of misinterpretations. In addition to the risk of dosage differences, both patient and doctor should have correct information about symptoms, as errors in diagnosis can occur due to misinterpretations.
  • Сorrect transcription of clinical trials. Clinical trials can embrace multinational partnerships and diverse participants. Accurate localization of trial management software ensures that the protocols, forms, and procedures will be understood correctly, facilitating the quality of such trials.

Thus, the correct medical software localization, without understatement, is vital for patients, and localization teams are responsible for making products safe. Besides high-quality translation, digital software localization implies compliance frameworks of the region to which the product will be related.

Which framework should you take into account during medical software localization?

Medical software localization involves correctly translating terms and ensuring legal compliance. Each region has its regulatory frameworks that you should consider during localization. Let's look at two areas — the EU (European Union) and the USA.

In the USA, the FDA (Food & Drugs Administration) controls the quality of digital health innovation. They regulate medical devices and software based on their intended risk to patients.

  • Low-risk: These are general wellness products intended for only general wellness use and present a low risk to the safety of users and other people. Read the entire document.
  • Moderate to high-risk: Products that require Special Control.
  • High risk: Products that require general controls and Premarket Approval (PMA.)

The EU regulates medical software under the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR).

The medical device term in the EU legal field includes "instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes..."

Like the FDA, the EU legacy splits medical devices (software) into three major groups — non-invasive, invasive, and active devices with subcategories. Read detailed descriptions for all of them in Annex VIII.

As soon as you find the best team and experts and study all legal questions, it would help if you had a tool to make localization easier and speed up time-to-market while maintaining quality. The Lingohub team knows which tools will be best for this task.

How can Lingohub help with medical software localization?

Lingohub is a translation management system that collects all the localization data and tools in one place. We protect our customers' data regarding GDPR privacy regulations and use world-class data centers, such as Amazon Web servers. Your security is our priority.

Also, Lingohub supplies a list of tools to simplify medical software localization and reduce mistakes, which is highly important in the digital health field. Let's take a look at some of them:

  • Quality checks — this tool can notify translators and localization managers about various mistakes, such as missed placeholders/HTML tags, duplications in the text, line breaks, and incorrect term usage. The Lingohub quality checks feature speeds up the time-to-market without quality reduction.
  • Term base (glossary). As mentioned above, correct terminology usage is essential to medical software localization. The Lingohub glossary provides correct suggestions for terms with additional context, like description or image. Thus, translators are highly involved in the localization process and better understand what they are working on.
  • Translation history. Once you have approved the translation, you can reuse it in the next resource files. Thus, ensuring that the same text segments are translated equally and consistently throughout the project will be kept. Also, translation history helps speed up the entire localization process and reduce the number of checks.


Medical software localization is pivotal in scaling digital health products to the global market. We at Lingohub understand how hard it can be to localize such sensitive data and are doing our best to simplify this experience for our users by providing advanced features. If you want more information about how the localization can work in your case, find the best time in our calendar and book a demo call with our team.

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