The COVID-19 pandemic has played havoc with the European Union’s (EU) plans to implement an ambitious new device regulation called the In Vitro Diagnostic Regulation (IVDR). On June 7, the European … [Read more...]
Global News
EC Backs Down from May 2022 Deadline in Favor of Progressive IVDR Implementation Rollout
October 19, 2021
COVID-19
White House Rolls Out Plan to Increase Nationwide Rapid, Point-of-Care COVID-19 Testing
September 21, 2021
Much has changed since the spring when Abbott, LabCorp, Quest and other major COVID-19 testing labs were demobilizing their coronavirus infrastructure and pivoting to normal business. The surge of new … [Read more...]
Global News
EU Shuffles IVDR Implementation Plan but Sticks to May 2022 D-Day
June 28, 2021
As you may know if your lab does business in Europe, the European Union (EU) has been planning to implement an ambitious new device regulation called the In Vitro Diagnostic Regulation (IVDR). Those … [Read more...]
Utilization
Why Falling Demand for COVID-19 Testing May Be a Mixed Blessing
April 4, 2021
We all understood that the massive spike in COVID-19 testing was unsustainable and bound to gradually peter out. But now it appears that the decline is coming steeper and faster than anybody expected. … [Read more...]
FDA
FDA Clears the Way for Over-the-Counter Sale of COVID-19 Home Test Kits
February 19, 2021
Since the pandemic began, the FDA has granted Emergency Use Authorization (EUA) for more than 250 COVID-19 diagnostic tests. Among these, nearly 30 have received clearance for at-home collection; a … [Read more...]
COVID-19
OIG Warns Medicare Beneficiaries Not to Fall for COVID-19 Scams
December 21, 2020
Pharma companies, diagnostics manufacturers, labs and other parts of the healthcare industry have done a commendable job in pivoting in response to the current public health industry. Sadly, scammers … [Read more...]
Focus On
OCR Audit Gives Providers Mixed Results for HIPAA Compliance
December 20, 2020
The Health Information Technology for Economic and Clinical Health Act (HITECH Act) requires the HHS Office for Civil Rights (OCR) to periodically audit covered entities and business associates for … [Read more...]
Special Report: Long-Awaited Kickback Relief Rules Leave Labs Out in the Cold
December 20, 2020
The final rule for value-based care kickback relief that HHS and the OIG published on Nov. 20 is slightly more favorable to labs than the proposed rule published in October 2019. But with a limited … [Read more...]
Business Trends
Labs Partner with Airlines to Offer COVID-19 Testing to Travelers
November 17, 2020
civCOVID-19 has greatly complicated air travel from country to country and even state to state. While entrance rules vary from place to place, a number of jurisdictions are allowing travelers to avoid … [Read more...]
Public Health
U.S. Needs 200 Million COVID-19 Screening Tests Per Month to Reopen Safely, Says New Report
September 17, 2020
How many COVID-19 screening tests per month will it take for the U.S. to reopen safely? One new report estimates the number as around 200 million, which is far below the 25 million tests currently … [Read more...]
