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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Keeps you up to date on the latest legal, compliance, and business developments affecting the lab industry, while offering analysis and insight to ensure your lab’s success.
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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
OIG Work Plan Monthly Review: January 2018
From - G2 Compliance Advisor
Opioid drug-related issues continue to command the lion's share of OIG Work Plan attention, including two of this month's six new items. While none of the new…
Genetic Profiling: Study Casts Doubt on Cost-Effectiveness of Leading Breast Cancer Recurrence Assay
From - Laboratory Industry Report
Among the many genetic profiling assays entering the commercial market, few have been more successful than Genomic Heath's Oncotype DX, which is now covered by most of …
Older Adults Undertested, Underdiagnosed with the Flu
From - Diagnostic Testing & Emerging Technologies
Hospitals around the nation are seeing high volumes of patients with the flu this season. A new study, published online Jan. 17 in the Journal of the American Geriatrics Society, shows that…
Innovation: AMP Issues New Guidelines for NGS Pipeline Validation
From - National Intelligence Report
Molecular next-generation sequencing (NGS) tests have spurred tremendous growth in the lab industry. But as often happens with innovation, NGS technology may be…
Case of Month: Judge Takes Back Ruling that Labs Must Independently Verify Medical Necessity
From - National Intelligence Report
Thanks for clearing that up. As if the lab industry doesn't already have enough legal agita to deal with, last June a federal D.C. District Court upheld a…
Brief Your CEO: After 36 Years, CLIA Comes Under CMS Review
From - G2 Compliance Advisor
Even as your lab makes the transition to the new, supposedly market-based PAMA Medicare Part B fee schedule for tests, big changes may be in store for another rock of…
Venture Capital Investment in Diagnostic Companies Strong in 2017
From - Diagnostic Testing & Emerging Technologies
Venture capital investments in health care innovation reached an all time high in 2017, including in diagnostics/tools (Dx/Tools) companies, according to…