Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Lab Industry Advisor Subscriptions Include
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
Medical Device Executives Nailed with Fraud Charges
The three Magellan Diagnostics executives are accused of FDA violations, as well as wire fraud and conspiracy.
Theranos’ Holmes Won’t Avoid Jail While Her Appeal Is Pending
On Monday, federal Judge Edward Davila denied the disgraced Theranos CEO’s motion to remain free while she appeals her conviction.
Grassley’s Bill Aiming to Amend FCA Passes Senate
The bipartisan bill was recently reintroduced to amend the FCA in response to a landmark 2016 Supreme Court ruling.
Almost Half of Healthcare Workers Burnt Out during Pandemic
A recent study revealed burnout rates of 49.9 percent among healthcare professionals during the early stages of the COVID-19 pandemic.
Lab Institute Virtual Event: Dealing with a Difficult Economy
Our June virtual event will offer a variety of solutions and strategies for dealing with key issues labs face during times of economic strife.
Reintroduction of SALSA Revives Labs’ Hopes for PAMA Relief
New legislation would force CMS to change the way it calculates Medicare prices for lab tests.
FTC Orders Illumina to Unwind Grail Acquisition
On Friday, the US federal trade commission ordered Illumina to divest Grail, which it acquired for $8 billion in August 2021.
Texas Lab Settles Kickback Allegations for $5.9M
Last week saw three key settlements, including a lab accused of paying kickbacks for test referrals and billing for unnecessary drug tests.
DOJ Increases FCA Penalties
The U.S. Department of Justice recently announced inflationary increases to civil monetary penalties under the False Claims Act.
OTC COVID-19/Influenza Test Approval Comes Too Late to Save Lucira Health
No company better embodies the vicissitudes of running a COVID-19-focused diagnostics business during the pandemic period than Lucira Health.