Global News

EC Backs Down from May 2022 Deadline in Favor of Progressive IVDR Implementation Rollout

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...]


White House Rolls Out Plan to Increase Nationwide Rapid, Point-of-Care COVID-19 Testing

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

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...]


Why Falling Demand for COVID-19 Testing May Be a Mixed Blessing

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 Clears the Way for Over-the-Counter Sale of COVID-19 Home Test Kits

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...]


OIG Warns Medicare Beneficiaries Not to Fall for COVID-19 Scams

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

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

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

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

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...]