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
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
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
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
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
PAMA Hasn’t Reduced Part B Lab Test Costs
For the third straight year since the PAMA pricing system has been in place, overall year-over-year spending on lab tests increased in FY 2020.
Healthcare M&A Deal Volume & Size Bottom Out in First Quarter
Healthcare M&A might have bottomed out in the first quarter of 2022 in terms of both deal volume and size, according to a new report.
FDA Issues First Approval for SARS-CoV-2 Breathalyzer Test
InspectIR COVID-19 device detects the virus from breath samples in less than three minutes, offering a new screening option.
Onco Pharma Giants Team Up to Boost Access to Cancer Genomic Testing
The recently-formed Precision Cancer Consortium will make it easier for cancer patients around the world to get access to genomic testing.
CMS Highlights Threat of Healthcare Consolidation
The HHS recently published previously confidential data relating to consolidation of hospitals and nursing homes enrolled in Medicare.
EUA COVID-19 Tests to Remain on US Market After PHE Expires
The FDA has plans to ensure COVID-19 test makers won’t be left high and dry when the public health emergency ends.
FDA Aims to Address Growing Cybersecurity Threats to Medical Devices
The agency recently issued draft guidance to medical device manufacturers to help protect their products from cyberattacks.
First G2 Webinar Since LMG Takeover Sees Lively Q&A Session
April 27 webinar featuring an update on the brand and talk on recent lab industry developments sees strong engagement.
Protect Your Lab against HIPAA Right of Access Liability Risks
Key points to educate your staff on when it comes to patient requests for test records and other protected health information.
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
In this month’s key cases, Myriad Genetics shells out, Illumina wins a decisive victory, a whistleblower suit is tossed, and false billing of UDTs costs a lab at least $11.6 million.
