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
- 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
How the Opioid Crackdown Is Affecting Lab Enforcement & Test Utilization
From - National Intelligence Report
The alarming finding that a person is now more statistically likely to die of an opioid overdose than a motor vehicle crash comes from…
Cybersecurity: The 10 Things HHS Says You Should Be Doing to Stop Phishing, Ransomware and Other Threats
From - Lab Compliance Advisor
HHS published guidance on cybersecurity for healthcare organizations. Even though it's voluntary, the new HHS Guidance is significant to the extent it lays out the…
Study Showing PGx Testing Improves Depression Outcomes, Key to Myriad’s Reimbursement Strategy
From - Diagnostic Testing & Emerging Technologies
Pharmacogenomic testing (PGx) provides clinically meaningful improvement in response and remission rates for difficult-to-treat depression patients over standard of care, according to…
When Your Lab Has to Work through a Weather Emergency
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
I read a written Laboratory Emergency Management Plan, and at the end of the document there was a short section called…