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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Struggling with Staying Informed? In the fast-paced world of diagnostic medicine, staying updated with the latest legal, compliance, regulatory, and industry insights is crucial. Yet, finding reliable and comprehensive information can be overwhelming and time-consuming.
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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
Genetic Testing: New Medicare Early NGS Cancer Test Coverage Policy Is Less than Meets the Eye
For Myriad Genetics, Foundation Medicine and other manufacturers of next-generation sequencing (NGS)-based test panels for early-stage cancer risk assessment, the recent announcement of CMS’ decision to provide limited Medicare coverage
Enforcement Trends: Increase in OIG Fraud Recoveries Belies Continued Decline in Enforcement Actions
OIG fraud recovery has been a solid growth business for nearly two decades. So, when the agency announced a decline in FY 2018 recovery figures, it was more than a bit surprising. But things got back to normal this year, as far as
FDA Watch: Agency Targets Sale of IVD Reagents without Premarket Approval
Distribution of diagnostics and devices without premarket approval has featured prominently on the FDA’s enforcement priority list this year. The agency has issued seven warning letters related to premarket approval in 2019 after issuing just one such warning letter in all of 2018.