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
Breast Tissue Density Reporting Should Cover All Women
A recent study suggests that the US should standardize breast density reporting and require that all women receive notification.
How to Save Clinical Labs from Future Pandemic Challenges
A recent AMP report offers recommendations to policymakers to prevent problems in future public health emergencies.
MD Malpractice Premiums Rising at Rapid Rate: AMA Report
Malpractice premium costs are climbing at rates not seen since the turn of the century, according to a new AMA report.
Medicaid Fraud Enforcement Trends: Fewer Cases, Higher Penalties
MFCU enforcement activity has rebounded from recent declines but still hasn’t reached pre-pandemic levels, according to a recent OIG report.
2022 Laboratory and Pathology Coding, Billing, and Reimbursement Update
This free webinar addresses annual billing changes and critical developments currently facing laboratory medicine.
NIPS Tests Are under Fire Again—This Time from the FDA
With increasing media coverage about problems with genetic non-invasive prenatal screening, the agency warns of risks of false results.
The Sun Is Setting on the Controversial SUNSET Rule
While HHS hasn’t yet officially withdrawn SUNSET, recent indications are that it’s only a matter of time.
OCR Cracks Down on Right of Access Foot Dragging
Thanks to recent federal enforcement initiatives, prompt response to patient PHI requests should be a growing priority for HIPAA compliance.
Regulatory Roundup: New laws, regulations, cases, and enforcement actions affecting labs and the lab industry
This month’s roundup includes the continued court battle between BGI and Illumina, an FCA lawsuit, and the latest version of OSHA’s COVID-19 rule.
Ellume Faces Lawsuit for Not Refunding Costs of Recalled COVID-19 Tests
Company involved in recent Class 1 recalls of COVID-19 rapid tests now faces further fallout by not refunding customers for faulty tests.