ULG’s Language Solutions Blog

Simplifying Section 1557 of the Affordable Care Act (ACA)

Section 1557 of the Affordable Care Act (ACA) prohibits healthcare providers from discriminating against individuals on the basis of race, color, national origin, sex, age, or disability. There are specific language access requirements within Section 1557 to ...

Topics: Compliance, Healthcare Translation, Telehealth


Are you prepared for open enrollment? Get your translations started today

We know preparing for 2021 open enrollment season while meeting all the necessary language access requirements can feel like a moving target. As health insurers are facing increasing compliance standards while under tight CMS deadlines, here are some things ...

Topics: Best Practices, Translation, Compliance


Everything ISO Covers That You Weren’t Aware Of

Since 1947, the International Organization for Standardization (ISO) has been creating quality control standards to ensure the safety of products and services worldwide. With more than 22,000 quality standards in industries ranging from healthcare to food and ...

Topics: Featured, Localization, Strategy, Tips & Tricks, Translation, Compliance


Conference Connections: ULG to attend European UDI Forum

  Eileen Kerry, out of ULG’s Galway Office, will represent ULG at this forum, exploring current and future regulations for how medical devices are labeled. This is the only European conference dedicated to global UDI compliance and wider industry ...

Topics: healthcare, Compliance, MDR


GDPR Enforcement: Are you prepared for an audit or a "dawn raid?"

  It’s nearly the one-year mark for the Global Data Protection Regulation (GDPR) and we’re starting to see enforcement already. Most notably, of course, is the $57 million fine to Google for violations. Even companies who are very stringent about data privacy ...

Topics: Featured, Strategy, Technology, Compliance, GDPR


Understanding the Medical Device Regulation: What is a Notified Body and What Function Does it Serve?

  Almost two years after its initial publication, many medical device companies are still in the process of adapting to the new EU Medical Device Regulation (MDR). Although this regulation was released in May 2017, the transition process will last through ...

Topics: Featured, Localization, Strategy, Tips & Tricks, Translation, Compliance, MDR


21 CFR Part 11: Helping Med Device Companies Abide by the FDA’s Electronic Records Regulation

With the medical industry constantly expanding and sharing knowledge and products worldwide, having a physical file room to house all paperwork and records is no longer a viable option. Medical device manufacturers and pharmaceutical companies usually ...

Topics: Featured, Localization, Strategy, Translation, Compliance


New Roles of Economic Operators Under the MDR

  When the European Union passed the Medical Device Regulation (MDR) back in April 2017, economic operators involved in the importation and distribution of medical devices became subject to new regulatory changes that would affect their ability to conduct ...

Topics: Featured, Localization, Strategy, Translation, Compliance, MDR


Why a Secure Translation Workflow is Necessary

  The bulk of translation projects are conducted on computers and through the Internet. The client must transfer the original document and any supplementary materials to the translator at the start of the project, and the translator will need to transfer ...

Topics: Featured, Strategy, Compliance


A Beginner's Guide to ISO Identification of Medicinal Products

The International Organization for Standardization (ISO) is the world’s leading quality control organization that sets standards related to manufacturing, product labeling, and safety. Many companies choose to follow ISO standards to foster trust with ...

Topics: Featured, Strategy, Compliance


Regulating Big Data: SC 42 and Artificial Intelligence

  According to the International Data Corporation (IDC), 40% of digital transformation initiatives will use Artificial Intelligence (AI) services by 2019 and 75% of enterprise applications will use AI by 2021. The IDC also estimates that spending for AI ...

Topics: Featured, Technology, Translation, Compliance


Why is ISO 13485 Important in the Language Industry?

Since 1947, the International Organization for Standardization (ISO) has created thousands of quality control parameters for a variety of industries to ensure that global companies produce the safest consumer goods, including food, medicine, and vehicles. ...

Topics: Featured, Localization, Translation, Compliance