How Does Terra Handle Translation Projects Containing ePHI
02/04/2024

How Does Terra Handle Translation Projects Containing ePHI?

We believe that every person, regardless of their background or native language, has the right to comprehend their medical information, which may require translation services.  

When it comes to the handling of electronically Protected Health Information, the utmost care must be taken in order to adhere to HIPAA regulations regarding privacy and security measures. Here’s how the Terra team handles translation projects containing ePHI

First Things First 

Before kicking off a translation project containing ePHI, we typically have a call with the client to better understand their needs, expectations, and special considerations. If they have concerns about cybersecurity measures or want to learn more about the HIPAA-compliant team that will handle their projects, we will walk them through our training program and introduce them to the strong culture of compliance we promote. 

Receiving a Project 

Once everyone is on the same page and the client is ready to send their first project, they usually do it through a secure file transfer platform (of their preference) where they upload the files containing ePHI that require translation. Our team also receives an email from the client where the details of this project are included, such as language pair, word count, and deadline. 

Assigning the Project 

Next, we move on to assigning the project to a Terra account manager (AM) trained in HIPAA compliance. The AM opens the assignment email, analyzes the request, and downloads the files that need translation from the client’s platform to their encrypted devices. From there, they upload them to Terra’s secure storage platform. Then, the AM shares the project details with a project manager (PM) who is in charge of uploading the project to a secure translation tool, including only the vital instructions and information the translator needs to perform their job, and assigns it to a linguist selected from a list of already approved vendors.  

The linguists working on these projects are both experts in the healthcare field and are also trained in HIPAA compliance. To test their knowledge, they must pass an internal test to demonstrate their ability to properly handle the documents with the utmost care.

Translating & Editing 

When we’re ready to move on to the translating and editing stage, our trusted HIPAA-compliant linguist receives a notification about the assigned project and proceeds to translate it within the secure translation tool. The access this translator has to the project files is controlled, limited to view-only, and removed once the project is completed. 

Every person involved in the process has unique and non-transferable credentials. This helps us track everything and keep a record of the management of the project.

After the translation is performed, the next step is editing and an editor reviews the final version, making sure there are no spelling, grammar, or formatting errors.  

While the use of a CAT tool during the translation process supposes the use of a translation memory (TM) as well, our team has an established process to make sure that segments containing ePHI are not stored in the project TM

Final Delivery 

After editing steps are finalized, the project is ready and the PM in charge delivers the files to the client through the client’s secure platform. The final files are uploaded to our own secure storage platform for a set period of time in case they are needed in the near future, and after that period is over, the files are deleted.  

The Takeaway 

Terra ensures a secure and compliant ePHI translation process, prioritizing confidentiality and integrity. Clients can trust their sensitive healthcare information is safe thanks to Terra’s commitment to maintaining the highest standards in handling electronically Protected Health Information. 

Communication Matters: Translating After-Visit Summaries for Patient Understanding
05/03/2024

Communication Matters: Translating After-Visit Summaries for Patient Understanding

Today, increasing language access in the U.S. healthcare industry is more important than ever. About 29.6 million people are identified as having limited English proficiency (LEP). Because of this, the translation of many patients’ after-visit summaries when attending a medical appointment becomes crucial.  

What is an AVS and why is it important?  

An after-visit summary (AVS) serves as a post-appointment document for patients that summarizes their health status and outlines future care steps, including self-management tasks. This document is so important to have because it enhances care and health outcomes for both adult and pediatric patients and makes life easier for their families or caregivers. The AVS includes treatment decisions for acute and chronic conditions, while for pediatric patients, it aids in tracking growth, development, immunizations, and specific instructions related to diagnoses. It’s a valuable tool for guiding self-care outside clinical settings, planning future appointments, and sharing crucial information with other healthcare providers. 

The critical role of AVS translations  

To better understand the important role translation plays in the realm of AVS documents, let’s look at a helpful example. An adult needs to start taking a statin medication (a group of medicines that help lower your cholesterol) and the explanation in their AVS is in a language they don’t speak, or they are not proficient in. In this case, the patient will likely not realize what they need to do next, and their cholesterol will go unchecked. Any type of misunderstanding will interfere with the patient’s current condition.  

Patients have the right to understand their health status and the instructions they must follow to take care of themselves, or in the case of parents, to take care of their children’s health. Having access to an AVS in their native language decreases the risk of them making a mistake when taking medication or missing their next medical appointment.   

How accessible language increases patient comprehension  

Understanding their medical condition can feel overwhelming for patients, which is why a compassionate approach is always necessary when it comes to communication. The message conveyed, irrespective of language, should be clear and accurate. That way, patients can easily grasp the necessary steps for recovery. Translating such documents requires tailoring the language, style, and tone to suit the recipient. Utilizing straightforward language aids in effective communication, fostering trust and respect between patients and their healthcare providers. 

For instance, while translating medication prescriptions and instructions it’s best to add the generic drug name to help patients locate their medicine easily at their local pharmacy. This thoughtful approach enhances comprehension and ensures better adherence to treatment. 

Another effective approach involves adapting complex medical terms and clarifying acronyms to ensure patients comprehend instructions for properly taking their prescribed medication. For example, rather than directly translating abbreviations like “4 puffs Q4 PRN for wheezing or cough” in EN>ES, it’s preferable to break it down into easy-to-understand steps.  

Providing instructions like “4 descargas cada 4 horas, cuando sea necesario en caso de sibilancia o tos” in Spanish, which translates to “4 puffs every 4 hours, when necessary, in case of wheezing or cough,” helps patients grasp the information more clearly and accurately. 

Conclusion  

To recap—an AVS holds significant importance in the medical field, particularly for vulnerable groups facing communication barriers, like those with Limited English Proficiency (LEP)

Clear communication serves as the cornerstone for establishing trust and respect between healthcare providers and patients. This, in turn, leads to enhanced care, improved health outcomes, and a more positive healthcare journey overall. Advocating for increased language access is pivotal in shaping a healthcare system that is more inclusive and centered around the needs of the patient. It’s a step toward creating a healthcare environment that prioritizes every individual’s understanding and comfort, fostering a more equitable and patient-focused approach. 

14/02/2024

Protecting ePHI in Translation: The Role of a HIPAA Privacy Officer  

In the complex landscape of healthcare, safeguarding sensitive patient information is paramount. Amidst the intricate process of translating documents containing Electronic Protected Health Information (ePHI), the pivotal role of a HIPAA Privacy Officer becomes evident. In this article, we’ll delve into the significance of this key figure in ensuring HIPAA compliance and preserving the integrity of patient data during translation processes

What a HIPAA Privacy Officer Does 

Matías Giannoni, Ph.D., works as a HIPAA Privacy Officer at Terra to ensure that everyone involved in handling ePHI knows the rules, regulations and policies really well and, more importantly, if in doubt, that they feel confident reaching out to him before taking any step or action that might be in violation of the rules or, worse, compromising information. “So, it is not just a matter of ticking a few boxes but being tangentially involved in operations to make sure all processes are compliant and secure,” Giannoni explained. 

The key responsibilities of working as a HIPAA Privacy Officer include: 

  • Making sure all the processes internally are compliant and everyone knows exactly what they have to do in order to minimize risks to almost zero 
  • Overseeing the annual training of team members handling ePHI to keep up to date with the latest developments 
  • Assessing new technologies to optimize our operations while remaining in compliance 
  • Acting as a liaison to the IT Department and prioritizing cybersecurity by taking all the steps to be at the cutting edge of information security technologies  
  • Being the first point of contact in case of any breach and the one in charge of communicating any situation with external stakeholders 

Working with Total HIPAA 

While Giannoni has strong experience working in heavily regulated environments with obscure and sometimes confusing regulations, Terra also relies on an external organization for additional consulting and guidance. When it comes to collaborating with Total HIPAA, Giannoni shared that they have been key partners in organizing our processes, conducting a thorough internal audit, and training our team. There are many things in which their expertise has proven to be invaluable. “Sometimes a certain technology is compliant with regulations, but it can be improved with a more advanced technology as regulations sometimes are defined with reference to technologies that existed at the point a certain legislation was put in place, and Total HIPAA advises us on those points where we can do even better than the minimum standards.” 

The Most Important Aspect of Protecting Patient Privacy 

The human aspect, both in terms of where the main failures can come from as well as in terms of the consequences cannot be overlooked. “When I think about this task, I am not thinking about potential fines or breaches of contract. Having access to all this sensible information, I am constantly obsessed about the fact that I would never like to see such sensitive information out in the open or in the hands of a heartless ransomware hacker,” Giannoni said, “That thought keeps me constantly alert.” 

To make sure that all staff members handling ePHI are trained on HIPAA policies and procedures, they receive Total HIPAA’s thorough training and evaluation annually. According to Giannoni, all of our team members scored high in their training and demonstrated a very strong culture of compliance. “Nevertheless, I often test their knowledge in our operational meetings to make sure they remember it correctly,” he shared.  

The Takeaway 

In safeguarding ePHI, the role of a HIPAA Privacy Officer stands as a crucial pillar in ensuring compliance and fortifying the security of patient data during translation processes. All patients deserve privacy while navigating medical care, which is why at Terra, we go to great lengths to remain compliant.  

Building a Digital Fortress for ePHI A Three-Layer Defense System
16/01/2024

Building a Digital Fortress for ePHI: A Three-Layer Defense System

In a world defined by seamless connectivity and digital advancement, safeguarding electronic Protected Health Information (ePHI) stands as a paramount responsibility, especially within the realm of healthcare. As technology intertwines with the sanctity of personal health data, the stakes are high and demand a robust defense system.  

At Terra, we’re strongly committed to the protection of the data that our clients entrust us to translate. To help us achieve our privacy goals, we partner with Total HIPAA and continuously take steps in the various aspects that pertain to our business operations. This helps us ensure that our processes are always compliant with HIPAA’s Security and Privacy Rules. Let’s take a closer look at the three layers of our defense system.  

Layer # 1: IT Infrastructure 

Our IT Department understands cybersecurity is crucial to protect ePHI and considers it a top priority. Because of this, this department takes the following actions to ensure adequate protection of this information: 

Device protection  

All devices owned by Terra are administered and monitored through Microsoft Azure tools, which include observing for potential threats as well as tracking local user activity. Additionally, all of our connections are SSL (Security Socket Layer) encrypted and we are currently working on expanding our corporate VPN to all users for additional security. As a bonus, any activity logs generated by these tools can be analyzed on demand.  

Software and hardware monitoring 

We continuously monitor both software and hardware through Microsoft Intune, as well as the configuration and subsequent deployment of proprietary security policies. In order to provide maximum security to our clients, Terra hosts all information on our own secure on-premises server in Milwaukee, Wisconsin. This ensures that the information stays within our secure environments, enabling us to have more control over the management of information. 

Security 

To help enhance security, Terra utilizes Microsoft Defender for Endpoint to ensure security through MFA for all Active Directory users. Our team also has limited access to protected health information. They can only view what is necessary and individual access to ePHI is constantly logged. Additionally, all our devices containing protected health information are encrypted and have strong password protection. We frequently update these passwords to maintain their strength.  

When it comes to our internal and external communication, as well as the sharing and management of files, knowledge bases, and content in general, we use Office 365 Suite for seamless collaboration across the organization.  

Layer # 2: Our Team 

Just as crucial as the IT infrastructure, having a team of people behind it who know how to use the tools is as important—if not more. Here’s how we make sure our team has the tools, resources and knowledge to remain compliant: 

All team members with access to protected health information, from leaders to project managers, are trained on the HIPAA compliant procedures and processes in place so they can handle ePHI securely from initial reception to final client delivery. This includes HIPAA concepts, standards, and security and privacy measures. Every member that passes all the courses also receives an official certification from Total HIPAA and is required to sign a confidentiality agreement that protects patient privacy. We promote and encourage a culture of compliance. Because of this, every year, our team participates in additional training.  

Documents that contain ePHI and require translation services are carefully assigned to linguists who are both experts in the healthcare field and are also trained in HIPAA compliance. To evaluate their knowledge, we created an internal test that they must pass to demonstrate their ability to properly handle the documents with the utmost care. These linguists are not able to download the ePHI to their own devices and always work within secure environments. 

Layer # 3: Our Privacy Officer 

Having the right team in place makes all the difference. Our Privacy Officer, Matías Giannoni, oversees the development, implementation, maintenance and adherence to the procedure regarding the safe handling of ePHI in compliance with HIPAA regulations. Matías acts as a liaison to the IT Department to ensure privacy and security practices are implemented. He guides the training of our team, addresses any concerns individuals may have, and promptly analyzes if actions should be taken.  

A Commitment to Risk Assessment, Mitigation and Continuous Improvement  

Maintaining confidentiality, document control, and client trust are vital to Terra. This commitment is illustrated by the entire Terra team executing risk assessments on a yearly basis under the most stringent guidelines and practices to preserve the security of all private information entrusted to us.  

Our journey towards maintaining privacy is always evolving as HIPAA regulations are subject to change. As a result, we continuously improve our policies and procedures to stay up to date. 

The Importance of Language Access Surrounding Vaccine Distribution
07/04/2021

The Importance of Language Access Surrounding Vaccine Distribution

Vaccines can save lives and the massive importance of vaccine distribution has been magnified by the coronavirus pandemic. When it comes to public health issues, language access is undeniably important. This is especially true for vaccine distribution. In order to make sure proper language access occurs, it’s important to take medical translation seriously. 

Why Language Access Matters

Language barriers can become even harder to break through once you begin to involve complex scientific and medical terms. This lack of understanding can lead to devastating results. During the coronavirus pandemic, researchers found that communities with high populations of non-English speakers had more cases of COVID-19 than English-speaking communities and, as a result, higher amounts of COVID-19-related deaths. Coronavirus incidence rates were as much as 14.3% greater in communities with high populations of non-English speakers. Some experts worry that this is because of language barriers that make it hard to understand the public service announcements that share essential public health guidelines surrounding social distancing, masks, and other strategies for avoiding contracting the virus. 

A Disservice to Vaccine Distribution

In order to properly, and safely, distribute vaccines, the proper distribution of information is necessary. Language barriers can discourage consumers from feeling comfortable getting a vaccine and understanding what the risks are, as well as how to get one if they do want one. 

Language barriers are leading to low vaccination levels for Hispanics in North Carolina. Even though Hispanics make up 10% of North Carolina’s population, only about 2.5% of all coronavirus vaccines administered in the state have gone to Hispanic recipients. Enrolling to receive a vaccine online may be causing problems for non-English speakers who can’t understand the website and the enrollment process. Even though many health departments offer phone assistance in Spanish, a lack of staffing can lead to long wait times and a lack of assistance. A properly translated website could easily increase access to vaccines for the Hispanic community in North Carolina. 

How Human Translation Can Help

When it comes to translating medical information around complex topics like vaccines and their distribution, there seems to be some confusion as to why unsupervised machine translation tools cannot get the job done. As advanced as that technology is becoming, terms and phrases that are more nuanced often end up literally getting lost in translation. For example, recent mistranslation-related events in Virginia caused mass confusion. After utilizing Google to generate a translation of the Virginia Department of Health’s website, their Spanish readers were under the impression that the COVID-19 vaccine was “not necessary.” Why? Because the website showed a translation of “the vaccine is not required” as “la vacuna no es necesaria”, which in Spanish means “the vaccine is not necessary.” 

It’s easy to see how this faulty translation caused misunderstandings that can have a life or death impact. Working with a human translator can help avoid any misunderstandings caused by syntax choices. Translators not only take word choice into account, but cultural and historical influences that can impact how a translated work is perceived.

Translation of Summary of Benefits and Coverage 101
18/11/2020

Translation of Summary of Benefits and Coverage 101

All professionals in the medical industry should have their consumers’ best needs at heart, this includes insurance companies. Generally, they do, which is why so much importance is placed on the translation of the Summary of Benefits and Coverage (SBC) in the medical industry. 

The role of a SBC is to ensure that consumers are aware of the health benefits and coverage available to them through their healthcare plan. In fact, the Affordable Care Act (ACA) typically requires that any group of health plans or health insurance companies provide a summary of benefits and coverage that can accurately describe the benefits and coverage available under the plan. While that definition will give you a quick glimpse at why SBCs are so important, let’s dive a bit deeper into this complicated topic and how medical translation comes into play.

What is an SBC?

Alongside helping consumers understand their health plan’s features and offerings, an SBC also covers the costs associated with the plan. An SBC can cover very complicated topics, such as cost-sharing rules or limits and exceptions to coverage, in a way that is easy for the average consumer to understand. One way that a health insurance or plan company can do this is by providing consumers with a “Uniform Glossary” designed to clearly explain any medical or insurance-related terms that may apply to a plan. Not only are all plans required by the ACA to provide a SBC to their consumers, but they must follow a uniform template that is customized to reflect the terms of a specific plan. 

Why do SBCs matter? 

It is of the utmost importance that consumers have access to an SBC. Not only does this access help them understand their plan features and the costs associated with it once they’re enrolled, but they can use the SBC to answer some of their general questions regarding a health plan before they choose to enroll in it. This knowledge helps consumers make informed decisions about their health and finances. 

Why does an SBC need to be translated into other languages?

Because we live in an increasingly global world, health plans and insurance providers must keep diversity in mind. A minimum of 350 languages are spoken in homes throughout the United States. While providing SBCs in each of those languages wouldn’t be possible or even necessary as many of these languages are spoken by bilingual citizens, compliance regulations dictate which languages providers must accommodate. Vital plan information must be available in the 15 non-English languages most commonly spoken in a state or languages spoken by at least 10 percent of a county’s population. The ACA, and other related statutes and regulations, currently have strict language requirements. For example, qualified health plan insurers that have been registered for at least one year are required to provide oral and written translation services to consumers in a minimum of 150 languages.

It is important to remember that the translation of the Summary of Benefits and Coverage is not just a matter of compliance, but of inclusion. Providing resources for a growing and diverse population should always be a priority.

Why the Translation of Medical Insurance Claims Matters
20/08/2020

Why the Translation of Medical Insurance Claims Matters

If an apple a day keeps the doctor away, can it also keep the medical insurance claims away? Nobody enjoys paperwork, but medical insurance claims are a vital part of the healthcare system. If patients don’t want to pay out of pocket, and medical providers want to receive swift payment, it’s important that everyone works together to properly file these forms. There is one major roadblock insurance companies can encounter. This process can be disrupted without the proper translation of medical insurance claims. 

What is a medical insurance claim form? 

Medical insurance claim forms are necessary when a patient needs to request reimbursement or direct payment for any medical services they’ve obtained. Basically, they are of the utmost importance for making sure medical service providers get paid. In order for these payments to come from insurance companies, either the patient or the provider must submit the proper medical insurance claims. There are two options for submitting a medical insurance claim. The first option is generally the most convenient. The medical services provider will directly submit the claim for the patient to the insurance company electronically. Another option is for patients to personally fill out a health insurance claim form and send in the paperwork. Most insurance companies offer electronic forms that patients can download and submit online. This process more commonly occurs if the health service provider is not in a patient’s health insurance network and therefore can’t file a claim on their behalf. 

What information does it contain?

The importance of the translation of medical insurance claims

The stakes are high when it comes to the translation of medical insurance claims. If a claim form is not in the native language of the claimant, there is always the possibility of misrepresentation on the insured’s part. Or, potentially, the misunderstanding on the insurance company’s part. Claim forms can be considered critical documents for health coverage access. Not providing translated claim forms in different languages can limit the ability of LEP speakers to properly complete their forms for claim processing. Mistakes can be made and misunderstandings can occur. Once the claim is filled out by the LEP speaker, the insurance company could require translation services to process it properly.

Insurance companies must comply with regulations regarding insurance forms, as many are considered to be critical documents. Critical documents that help obtain health insurance coverage or access to health care services can be required by state or federal law to be provided to the following people: qualified individuals, applicants, qualified employers, qualified employees, or enrollees. In most states, the top 15 languages spoken by the LEP populations of that state must be translated. 

Generally, it’s vital that insurance companies act in good faith at all times in regard to the insurance policies they write. Insurance policies are contracts. Insurance companies must do their best to uphold these contracts, including providing the necessary translation of medical insurance claims to guarantee patients’ access to healthcare coverage.

The Translation of Discharge Information 101
12/05/2020

The Translation of Discharge Information 101

If only an apple a day kept the doctor away. Dealing with any type of medical issue, big or small, can add stress and discomfort to a patient’s life. Even worse though is when a patient can’t understand their discharge information, which is a vital part of physician-patient communication. Patients who have a poor understanding of their discharge instructions may be negatively affected after leaving the hospital. This information is imperative for adequately managing their diagnosis, medications, and follow-up appointments. Oftentimes, non-English speaking patients (or those without high literacy levels) are the ones who struggle with understanding discharge information. The proper translation of discharge information can help provide patients with the best possible level of care. 

The Dangers of Misunderstood Discharge Information

When a patient can’t understand their discharge information, confusion and less than desired medical results can ensue. Even worse, this lack of understanding can lead to death. In 2015, a patient in Houston, Texas, was discharged from a hospital and experienced a stroke. According to the lawsuit against the hospital, the stroke was caused because the hospital did not translate the patient’s discharge instructions into a language that the patient’s caretaker could read. Not only did this lack of proper communication harm the patient, but if the hospital loses the lawsuit, they can expect to pay more than $200,000. One way or the other, both parties have been harmed. Because of Section 1557 of the Affordable Care Act (ACA), healthcare providers are forbidden from discriminating against patients because of their “national origin.” Which means healthcare providers generally have to provide proper translation for patients with Limited English Proficiency (LEP).

The Lack of Translation of Discharge Information

How common is a lack of proper linguistic access to discharge information for non-English speakers? More than it should be. A study by the University of California, San Francisco learned that patients with limited English proficiency demonstrated a weaker understanding of their discharge information regarding medications than their English-speaking counterparts. It was also found that only about half of hospitals translate discharge instructions properly. 

Some hospitals only provide privileged access to discharge materials in languages aside from English. They may translate standard discharge instructions for a few common illnesses, but the materials aren’t personalized for each patient. Which means the discharge materials aren’t addressing those patients’ individual needs, such as medication dosing or accounting for a combination of health conditions. While some hospital staff interpreters will provide patients with oral discharge information, they don’t necessarily offer written instructions the patient can reference at home. Only professional translators should handle written translation as they specialize in that skill; it is not something an interpreter is trained for. 

Why the Translation of Discharge Information is So Difficult

Generic discharge information handouts are not the solution and neither is oral instructions. Medical facilities should provide access to written hospital discharge instructions in the language spoken and read by the patient. Most hospitals have a written translation policy for select hospital documents like consent forms, but discharge instructions are not guaranteed at every hospital. 

Machine translation is another flawed solution. Machine translation options, such as Google Translate, that may be available to medical professionals can lead to errors. Complicated instructions and medical jargon can be difficult to translate properly using machine translation. Only a skilled medical translator who is familiar with both languages can safely translate this type of medical information. 

It is possible for hospitals to partner with a translation service provider. While they won’t work from the hospital premises, hospitals and translation service providers can come to an agreement that guarantees quick turnarounds. Time is generally the most pressing challenge in translating discharge information, as a patient can’t wait for their discharge information, so it’s important to arrange a translation timeline that works for both parties.

The Importance of Language Access During the COVID-19 Pandemic
31/03/2020

The Importance of Language Access During the COVID-19 Pandemic

During this challenging time, one small source of comfort is knowing that we are all in this together. The COVID-19 pandemic is affecting communities from around the world and we must work across borders to beat this pandemic. Knowledge plays an indisputably significant role in overcoming the health and financial challenges arising from COVID-19. In order to share the knowledge that will help us progress past COVID-19, it is more pressing than ever before that we break down language barriers. This is why it’s important: 

To Enact Proper Safety Measures

Our current landscape is changing rapidly right now and it is important that both individuals and business owners have access to the latest safety information and regulations in their native languages. In regions where many languages are spoken, this is especially necessary. For example, in Orange County, CA, confusion occurred when new ordinances regarding social distancing and business regulations were announced. A poorly worded message was partly to blame for the mass confusion, but a language barrier was another reason there was a lack of understanding across the Orange County community.

Orange County officials attempted to remedy the situation by introducing updates in more languages, but the initial confusion caused fear and concern. Access to adequately translated materials is vital for everyone to do their part in maintaining safety regulations and slowing the spread of COVID-19 translated materials is critical. As the United States generally has a population that speaks many languages, the Federal Emergency Management Agency (FEMA) has a Language Action Plan that they recommend for scenarios like this. The plan suggests providing access to vital information in 19 different languages to confront a crisis properly.

To Make Progress Together

Alongside the countless individuals working to slow the spread of COVID-19, many researchers aim to find a vaccine or medication for treatment. As always, medical researchers must have access to the latest advancements. The translation of medical research is of the utmost importance for increasing our ability to work towards vaccines and treatments more efficiently. 

Typically, English is considered the go-to language for the medical community, but increased language access to COVID-19 research could help us make progress quicker. With proper translation, researchers can share updates on the outcomes of social distancing, expected health care costs, disease trends, the best treatments and care plans, and risk factors. Patients will also require access to translated materials such as pharmaceutical packaging and instructions for use. 

To Strengthen Communities

It is clear now, more than ever before, how essentially a strong sense of community is. If members of a community do not feel like they have access to the resources they need and are not being assisted, this could damage the strength of a community. Working together can only happen if we all feel united and valued. Proper language access during the COVID-19 pandemic is an indispensable step toward strengthening the bond of a community.

The Translation of Instructions for Use (IFU): A Breakdown 
09/03/2020

The Translation of Instructions for Use (IFU): A Breakdown 

Every member of the medical profession should first and foremost prioritize patient safety. One such way to be successful at protecting patient safety is to dedicate resources to the proper translation of “instructions for use” (IFU). Essentially, the term IFU refers to the patient labeling found on many prescription medicines and medical devices. The manufacturer of the drug develops the patient label. But the FDA (a United States government agency) is in charge of approving it. IFUs are especially important when a medication has complicated dosing instructions and the patient may need help using the product properly.

As we live in an increasingly global world, medical device manufacturers and pharmaceutical companies will require assistance translating IFUs into other languages. Quality translation improves patient safety and helps get medical devices and medications approved for distribution throughout various regions. 

Why IFUs Matter

From a consumer standpoint, IFUs are of the utmost importance. The information included in an IFU helps provide the proper use of a medication or device, as well as any necessary precautions. The FDA requires that medication guides, such as IFUs, come with certain medical products. Usually, they do so when they’ve determined that: 

  • The consumer requires specific information to prevent serious adverse effects.
  • A patient has the right to be aware of serious side effects before deciding to use this product.
  • Proper usage of the product is essential to its effectiveness.

Medication guides, including IFUs, must be given to consumers each time the medication is dispensed. It is worth noting that not all medications will provide an IFU. If a consumer ever has questions about a medication, it is best that they consult a healthcare provider or pharmacist. 

Where Translation Helps

Now, looking from a business standpoint, European regulations can provide an example of the importance of translating IFUs. The translation of an IFU is necessary for sale in Europe. Medical products in Europe must have a CE Mark. This mark guarantees that the safety and authenticity of a product are verified and translated properly. 

A CE Mark allows a manufacturer to sell a product throughout the EU. In order to obtain that mark, all materials (such as an IFU) are translated into each of the 24 official languages of the European Union. In Europe in particular, all products must have a CE Mark, which enables manufacturers and traders to commercialize them in the European Economic Area (EEA). 

The Future of IFUs

The standards for medical professionals and products evolve and adapt over time. The digital age is, of course, affecting patient safety regulations. Those who wish to market their products in the European Union should prepare for the emergence of the eIFU (electronic information for use) in 2020. The new eIFU requirements aim to increase medical device safety and effectiveness by providing users with the most current information. An eIFU can include video and audio files, which will make it easier to demonstrate how to operate and handle medical devices. eIFUs will allow companies to bring revisions or changes to the market faster. This extra content will require translation services to ensure all consumers can understand a video or audio file. 

New regulations will be in place in 2020 that medical device manufacturers in the European Union need to prepare for. Manufacturers should be prepping for the change now, including getting ahead on any translation needs.