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
Carreyrou Captivates Lab Institute With Inside Look at Theranos Fall
From - G2 Compliance Advisor
The tale could be headed to movie theaters around the nation soon. It is a gripping story of a Steve Jobs–wannabe—a young Stanford dropout with…
Mindset Shift Moves Labs from Transactions to Insights
From - Laboratory Industry Report
How do you plan for the future in a rapidly changing environment? That is the big task that laboratories are being asked to do. There is no roadmap, yet their financial livelihood is dependent upon…
Labs Need to Take Elevated Role in Health Care
From - Diagnostic Testing & Emerging Technologies
Labs need to take a more prominent role in the broader health care ecosystem—from being a recognized member of patient care teams to being a leading player in…
Investigative Journalist Wins Kellison Award
From - National Intelligence Report
John Carreyrou, the Pulitzer prize-winning journalist who exposed Theranos as a fraud, was presented with…
FDA Biological Products Agency Issues New Recommendations for Emergency Weather Response
From - National Intelligence Report
With another hurricane season wreaking havoc, the FDA's Center for Biologics Evaluation and Research (CBER), which regulates…
Latest Legal Challenge to ACA May Mean a Hot Mess for Insurance Markets
From - Laboratory Industry Report
After a series of setbacks, Republicans challenging the constitutionality of the Affordable Care Act (ACA) and its individual mandate are…
Point-of-Care Test Can Increase Access to Toxoplasma Testing
From - Diagnostic Testing & Emerging Technologies
A novel fingerstick test may improve access to Toxoplasma gondii testing for pregnant women, according to…
Case of the Month: Anthem Settles Massive HIPAA Breach Case for Record $16 Million
From - G2 Compliance Advisor
Pop Quiz: What's the highest amount a health care entity ever paid to the HHS Office for Civil Rights (OCR) to settle a HIPAA violation…