Prospective Changes to HIPAA Rules Would Affect Clinical Labs
With new modifications to HIPAA potentially on the horizon, we hear from experts on HHS' proposal
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Articles and Reports
FDA Watch: CND Life Sciences Wins Breakthrough Device Designation for Skin-Based Neurodegenerative Test
The Syn-One assay can diagnose multiple conditions without needing a lumbar puncture
Dx Deals: Labcorp and Roche Enter into Pacts to Distribute Alzheimer’s Tests, Digitize Slides
The technology developed by Roche in recent years seems a good fit for Labcorp’s testing services
The Success of AI in Lab Billing and Coding Hinges on Good Data
Two revenue cycle management experts explain opportunities that clinical laboratories have with artificial intelligence
Dx Deals: Illumina to Acquire SomaLogic from Standard BioTools for $425M
The deal is expected to be a big boost for Illumina’s next-generation sequencing platforms
FDA Watch: Agency Launches Database of Complete Response Letters Sent to Drug Manufacturers About Initial Rejections
The early focus is on drug applications, but it could spread to the laboratory test approval process as well
CMS Clarifies CLIA Personnel Requirements in Rare Memo
Clinical labs gain flexibility in meeting regulatory standards while potentially reducing their costs
Expert Q&A: AMR Warnings Need to Be Louder, and It Just Can’t Be Up to Labs
John Osiecki of bioMérieux also discusses AI for outbreaks and regulation trends
Healthcare Fraud Takedown Reveals 4 Lessons for Clinical Labs
The $14.6 billion bust by federal prosecutors shows gaps that every laboratory should monitor
Dx Deals: QuidelOrtho Acquires LEX Diagnostics, Plans to Switch Out Respiratory Testing Platforms
The $100 million deal will take advantage of LEX VELO technology to detect influenza and SARS-CoV-2
A Look at How CLIA-Exempt States Operate and Why This Setup Exists
Washington State’s Department of Health details how its medical testing site program meets federal standards
FDA Will Not Appeal Ruling Against LDT Regulation, Giving a Big Victory to Labs
The legal strategy of the ACLA—and some political luck—prevailed in the lawsuit against LDT oversight
Expanding Test Menus: A Compliance Roadmap for FDA-Regulated Labs
Two OIG advisory opinions guide laboratories that want to work with pharma or medical device companies on expanded testing
