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
AACC Calls for Lab Professionals to Support Value-Based Care
From - Laboratory Industry Report
Laboratory professionals have a central role to play in supporting the transition to value-based care, according to…
Employment Law Update for HR Managers
By Mike O'Brien bio
This is my periodic update prepared for interested HR professionals trying to deal with the complex American employment laws…
GAO Faults U.S. Handling of Zika Outbreak; IDs Challenges to Test Development
From - National Intelligence Report
The US. Government Accountability Office (GAO) found that the U.S. Department of Health and Human Services was "reactive" in its handling of the…
Medical Necessity Requirement Bites Anatomic Pathologists
By Robert Mazer bio
The DOJ has announced two separate settlements involving claims for allegedly unnecessary special stains…
Signs Point to Expansion of Provider-Initiated Personal Genomic Testing
From - Diagnostic Testing & Emerging Technologies
Since 2013 when the U.S. Food and Drug Administration (FDA) effectively stopped direct-to-consumer personal genomic testing, there has been pent up demand among healthy individuals for…
FDA Watch: Congress Kills Trump Plan to ‘Recalibrate’ User Fees
From - Laboratory Industry Report
Instead of the budget cuts the President asked for, the newly approved federal government spending plan increases FDA funding by…
How Much Time Does OSHA Have to Cite Labs for Recordkeeping Violations?
From - G2 Compliance Advisor
OSHA Recordkeeping Regulations (Section 1904.33) require labs and other employers to retain accurate illness and injury records) for 5 years…
Phone-Based Genetic Counseling Supports Healthy Genome Sequencing
From - Diagnostic Testing & Emerging Technologies
Also at the ACMG meeting, researchers from Illumina (San Diego, Calif.) reported on a pilot project conducted at the San Diego Blood Bank where…