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

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. 


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

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

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

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

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

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 

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.

Translation of Informed Consent Forms: An Introduction

Translation of Informed Consent Forms: An Introduction

Clinical trials are undoubtedly important. Without them, little scientific or medical progress would be possible. But even more essential than the trials themselves, is the welfare of the human participants. They are an integral part of the clinical trial process. Their rights and wellness should always be a priority. One way to ensure all participants are fairly treated is through the proper translation of informed consent forms. 

What is an Informed Consent Form?

An informed consent form is a requirement, not an option. A human can not partake in the research process during a clinical trial without signing one. These forms obtain a participant’s consent to participate and inform them of their rights. A participant should expect to find the following information on an informed consent form in a clearly described and understandable way.

  • A summary of the procedure or study.
  • The purpose of it.
  • The duration and schedule.
  • Expected procedures.
  • Potential benefits and risks.
  • Alternatives to participating.
  • The rights and responsibilities of those involved (the participant, study administrators, sponsors, etc.).

The requirements of an informed consent form ensure that a subject’s participation is voluntary. Informing participants about all aspects of the trial is required both ethically and legally. 

Informed consent forms consist of two parts. One part is the information sheet that includes the aspects outlined above. The second part is the certificate of consent. Participants receive a copy of their informed consent form and information sheet. 

Where Does Translation Come In to Play?

Ensuring all research participants are properly informed of what a medical study entails is vital, or else you risk violating a participant’s rights. Being prepared to overcome language barriers can be necessary to ensure no violations occur. A language barrier or poor translation efforts can derail a clinical trial. A barrier can also harm a participant. Particularly if they do not understand what they are agreeing to.   

The proper translation of informed consent forms is a more pressing need than ever before due to the increase in medical research conducted in developing countries. These locales are often chosen as the site of clinical trials because they offer reduced costs. As well as access to affected populations who may benefit from the trial. For some, these trials are the only access to medical care they have. 

What is at Risk?

These trials can lead to new treatments, vaccines, and medications. But they can also violate the ethical rights of the at-risk populations found in developing countries. These violations can occur in first-world countries too. Particularly, in locations like the United States, where different cultures and languages frequently mix. Working with a seasoned translation expert can help avoid these violations and contribute to the success of a clinical trial.

It is not appropriate to exclude a participant due to their inability to read or understand a particular language. Doing so violates the governing principles of human subject research. Respect for persons, beneficence, and justice. Researchers must communicate directly with a subject or provide a trustworthy alternative to ensure they understand their rights, risks, and what their participation will entail. 

The Translation of Medical Documents into Spanish & Its Challenges

The Translation of Medical Documents into Spanish & Its Challenges

When it comes to languages, Spanish is a global powerhouse. Over 442,000,000 people around the world speak Spanish. There are 20 states and territories that consider it the majority language. In these territories, Spanish is the language children learn in school. And the language of official documents. In the United States, the Spanish language is also prevalent. Despite not being the official language. Spanish is the most predominant language spoken by immigrants and U.S.-born Limited English Proficiency (LEP) individuals. With 64% of the total LEP population speaking Spanish. Considering these vast numbers and the regulations regarding health care accessibility for everyone, it comes as no surprise that there is a growing need for the translation of medical documents into Spanish. The needs for medical translation are various, but when translating from English to Spanish and vice versa, medical translators must be prepared to solve a number of challenges that may arise. These are a few of them:

Medication and Drug Names

One of the first missteps in translating medical documents into Spanish is confusing medication and drug names. Names can easily be mixed up because drug and medication names used locally are different than internationally. Both brand and generic drugs can have names specific to the country in which they are sold. For example, acetaminophen is a name used in the United States for what is internationally known as paracetamol.

Mistranslating names can lead to dire consequences. Especially when it comes to dosing. Scarily, the FDA estimates more than one million people each year experience physical harm from medication misuse. This is why translating a medical text requires a specialized translator trained to deal with medical vocabulary.

Units of Measurement

Even without the need for translation, measurement mistakes are easy to make. Parent medication administration error rates are an example of this issue. More than 40% of parent administrators make dosing errors involving oral liquid medications. Units of measure conversions can be difficult, so linguists have to be very careful when translating them. In some scenarios, conversions are necessary. Other times, it is okay to leave the unit of measurement as is. In general, medicine and science utilize the metric system as it is more accurate. Hispanic countries also use the metric system, but U.S. citizens more commonly use non-metric units. It is of the utmost importance that medical translators are aware of whom the target audience is (general population or scientists, for example) and the system used in particular countries. This helps them determine whether conversions are necessary or not.

The Translation of Medical Documents into Spanish & Its Challenges - UNITS OF MEASUREMENT map

New Terminology

The medical field is ever-changing. Progress is a good thing, except when it causes misunderstandings. Occasionally, there is not a recognized translation for a certain term. It is challenging for bilingual dictionaries to keep up with new concepts, technology, research, and medical terms. Many bilingual English-Spanish medical dictionaries are direct translations of English. They don’t always take into account the actual terminology used in the target language. 

Translators also have to be wary of what is known as “false friends”. These are words that sound very similar and appear to be the equivalent of two words in different languages. The word “severe” is an example of a false friend. Severo is a term in Spanish that means ‘strict, tough, harsh in treatment or punishment’ and describes the character of a person. But this word is easily confused with “severe”. A word that can have many meanings, such as grave, intense, or strong. Such as severe pain, a severe blow to the head, or a severe problem. The English word “condition” serves as another example. In Spanish, the word for condition can vary depending on the usage intended. When the word “condition” refers to a defective state of health, it is translated as enfermedad. When it refers to a particular state someone or something is in, it is translated as estado or situación. But at first glance, the Spanish word condición sounds like the proper word.

How Medical Translators Can Improve Accuracy

It is important that the medical translator keeps in mind the limitations of scientific and medical dictionaries. Some may find it necessary to purchase additional medical dictionaries to create a comprehensive knowledge base. Furthermore, skilled medical translators must read the latest journals and scientific papers to properly understand the current medical landscape, as well as recognize and translate new terms.

Localization of Medical Software: A Global Need

Localization of Medical Software: A Global Need

Safety first. When it comes to patient welfare, safety is always the goal. This is why the localization of medical software is a topic worth discussing. In the context of medical software, localization refers to adapting the strings of text in computer software to different languages, regional peculiarities, and technical requirements of a target locale. Medical software influences a patient’s health. A fault or bug in the code can put a patient at risk. But risks can also stem from a lack of proper translation of the languages used for medical device software. With more than 1.5 million medical devices available in homes, medical offices, and hospitals, there is ample need for the localization of medical software.

Where Medical Device Regulations Come Into Play

Medical software aids in decisions that affect patient care. It is vital that manufacturers build their software to meet medical device standards. Meeting those standards is not mandated, but will help ensure companies build software safely. Developing software with medical device standards will save you time and money if at a point your software is considered a medical device. Tackling these standards up front instead of at a later date will be most beneficial.

What is Medical Device Software?

Some software programs are already considered medical devices, which come with their own set of regulations. The International Medical Device Regulators Forum (IMDRF) defines software that is a medical device as, “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” Medical device regulators from across the globe came together as a part of IMDRF to determine the framework and principles that enable stakeholders such as regulators to protect patients and promote safe innovation.

Medical device software has to meet strict manufacturing standards that help ensure quality. These standards vary by country. In the United States, the FDA and HIPPA set these standards. In Europe and Canada, the standards are set by the ISO and IEC commissions.

What is Not Medical Device Software?

Not all software programs utilized in making medical devices are regulated by medical device standards. For example, software that controls a medical device isn’t considered to be an actual medical device. Other examples include software that relies on data from a medical device, but which does not have a medical purpose. Software used to enable medical workflow such as scheduling patient visits. And the software used to monitor the performance and functioning of a medical device.

Why the Localization of Medical Software Matters

Even if the software is not seen as a medical device, the localization of medical software is of vital importance. Not only on the safe side, but on the business side as well. In order to market a medical device and its accessories in a foreign market, companies must remain compliant with any international and local regulations. Instruction for use, packaging, labeling, and manuals must be presented in the national language of each country it is registered.

Typically, user interface translation is one of the key areas of translating medical device software, as any language confusion while using medical software can have perilous results. The FDA and the European Medical Device Directive are extending their purview to medical software. This is to ensure that medical software functions correctly. As well as to help users and health care providers know how to use the software in its intended way in each territory.