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
- Updates on changes to regulations
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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
FDA Grants Approval for 23andMe DTC Genetic Test
From - National Intelligence Report
23andMe and the U.S. Food and Drug Administration (FDA) announced last week that the agency allowed marketing of 23andMe's Personal Genome Service Genetic Health Risk (GHR) tests for…
Making Laboratory Safety as Simple as ABC
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
When it comes to safety in the laboratory, there are several rules, regulations, and guidelines to keep track of from multiple organizations. If your responsibilities for lab safety are…
Testing Guidelines at a Glance
From - Diagnostic Testing & Emerging Technologies
Two recent testing guidelines were released that address carrier screenings for pregnant women and a rare disease lacking a…
Key Coverage Determinations and Product Developments
From - Laboratory Industry Report
Although several companies secured favorable diagnostic coverage determinations in March, the big winner was Vermillion, manufacturer of the…
CMS Exercises Enforcement Discretion for PAMA Reporting
From - G2 Compliance Advisor
As we previously reported, the Centers for Medicare & Medicaid Services (CMS) has indicated that laboratories had sought relief from the March 31 deadline for reporting applicable information under the…
Role of Healthcare AI in the Lab: Today & Tomorrow
By Jason Bhan, MD, Co-Founder, Chief Medical Officer at Prognos bio
Laboratories have traditionally directed their information technology (IT) focus to support their main business of testing. The IT infrastructure they have invested in allows them to…
Draft Legislation Proposes New Category for LDTs
From - National Intelligence Report
House of Representatives members Larry Bucshon, M.D. (R-IN) and Diana DeGette (D-CO) are looking for feedback on a discussion draft of legislation called the…
Survey Says New Pathologists Need “Soft” Skills for Success
From - Laboratory Industry Report
Like any other professional, new pathology graduates need a combination of technical and "soft" skills to succeed. If you think that sounds like…
Strategic Alliances, Partnerships & Collaborations Analysis – April 2017
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Mergers, Acquisitions & Asset Sales Analysis – April 2017
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