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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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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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
CLIA: CMS Issues Guidance on How Labs Should Perform Coronavirus Testing
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CMS Increases 2020 Maximum Civil Monetary Penalties
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Congress Moves One Step Closer to Passing “Surprise Billing” Legislation
Bipartisan bill would mandate that patients receive an upfront estimate of treatment services costs, along with notification about the provider’s network status.
Enforcement Trends: OCR Continues to Crack Down on HIPAA Right of Access Violations
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ACA Update: Uncertainty Will Continue as Supreme Court Passes Up Chance for a Quick Resolution
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HIPAA: OCR Clarifies Rules for Sharing Coronavirus Patient Medical Information During Current Health Emergency
The usual HIPAA Privacy restrictions on collecting, using and disclosing personal health information (PHI) are relaxed during public health emergencies. With this in mind, the Office for Civil Rights (OCR), the HHS agency charged with enforcing the HIPAA rules,...
Special Report: FDA to Use EUA Pathway to Clear New Coronavirus Tests
The 2019 novel Wuhan coronavirus outbreak caught regulators and diagnostic test makers off guard. As the death toll mounts, the scramble is on to develop tests capable of detecting the virus. Here’s a rundown of what the FDA is doing to achieve that objective. The...
Lab Gets Chance to Prove Fraud Claims against Software Vendor at Trial
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The DX Pipeline: OraSure Subsidiary’s DNA Test Sample Collection Kit Gets FDA Greenlight
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FDA Watch: Agency to Use EUA Pathway to Clear New Coronavirus Detection Tests
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