TAG:
McDonald Hopkins
LDT Oversight May Fall to Congress, CLIA
By Robert Michel | From the Volume XXXII, No. 7 – May 12, 2025 Issue
CEO SUMMARY: After a federal court struck down the FDA’s final rule on laboratory developed tests, attention has shifted to Congress and CLIA as likely paths forward for oversight. A lack of bipartisan momentum makes new legislation unlikely in the near term. Experts sug…
With LDT Rule Vacated, Labs Await FDA Retort
By Robert Michel | From the Volume XXXII, No. 6 – April 21, 2025 Issue
CEO SUMMARY: In a major win for clinical laboratories, a federal judge vacated the FDA’s final rule on LDTs, writing in his decision that the agency overstepped its authority. For now, labs can develop and modify LDTs without FDA oversight, but future action in some form…
Why Labs Should Comply with FDA’s Final Rule on LDTs
By Robert Michel | From the Volume XXXII, No. 3 – February 17, 2025 Issue
CEO SUMMARY: Even as lawsuits challenging the Laboratory Developed Test (LDT rule) issued by the federal Food and Drug Administration (FDA) progress in federal court, clinical labs performing LDTs face an interesting decision. Should they invest the staff time and money to comply with the…
Two Different LDT Lawsuits Combined in Federal Court
By Robert Michel | From the Volume XXXI, No. 16 – November 25, 2024 Issue
CEO SUMMARY: Different lawsuits challenging the FDA’s LDT rule were filed in recent months by the American Clinical Laboratory Association and the Association for Molecular Pathology. Both lawsuits were filed in the U.S. District Court for the Southern …
Assessing the Clinical Service & Revenue Issues of the LDT Rule
By Robert Michel | From the Volume XXXI, No. 12 – September 3, 2024 Issue
BARRING INTERVENTION BY FEDERAL COURTS OR THE U.S. Congress, clinical labo…
What Labs with LDTs Must Do to Comply with FDA’s LDT Rule
By Robert Michel | From the Volume XXXI, No. 10 – July 22, 2024 Issue
CEO SUMMARY: Until the recently filed court challenge to the Food and Drug Administration’s LDT rule succeeds or Congress intervenes with new legislation, those clinical laboratories performing laboratory developed tests (LDTs) must comply with the requirements of the new rule. This com…
LDT Rule Is Now a Fact! What Will Be Consequences?
By R. Lewis Dark | From the Volume XXXI, No. 8 – June 10, 2024 Issue
TODAY, THE NEW RULE FOR REGULATION OF LABORATORY DEVELOPED TESTS …
Proposed Electronic Signature Rule Has Compliance Risks
By Scott Wallask | From the Volume XXX, No. 9 – June 19, 2023 Issue
CEO SUMMARY: Proposed HHS rule aims to define and standardize physician electronic signatures. For clinical laboratories, this is important because lab test claims require a signed requisition form. Given …
Expert Lists Strategies to Cope with Cyber Attacks
By Robert Michel | From the Volume XXIX, No. 1 – January 10, 2022 Issue
CEO SUMMARY: Class action lawsuits filed by patients whose protected health information (PHI) was breached during a cyber attack may be one additional unwelcome consequence for clinical laboratories and anatomic pathology groups hit by a ransomware or cyber attack. This is what happ…
All Labs Are Threatened by Encryption, Ransomware
By Robert Michel | From the Volume XXVIII, No. 12 – September 7, 2021 Issue
CEO SUMMARY: Cybercrime—in the form of encryption attacks followed by ransom demands—is now a threat to every clinical laboratory and anatomic pathology group in the United States. Experts recommend that all labs elevate the attention they pay to their incident response teams ta…
CURRENT ISSUE

Volume XXXII, No. 7 – May 12, 2025
Economic, Tech changes drive lab concerns, The Dark Report provides insights from the Executive War College speakers about how clinical labs can use business strategies and tactics to handle the new tariffs, future regulations, and artificial intelligence (AI). Also, this issue provides guidance on how labs and pathologists should prepare for payer audits.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
Lab leaders rely on THE DARK REPORT for actionable intelligence on important developments in the business of laboratory testing. Maximize the money you make-and the money you keep! Best of all, it is released every three weeks!
Sign up for TDR Insider
Join the Dark Intelligence Group FREE and get TDR Insider FREE!
Never miss a single update on the issues that matter to you and your business.
Topics
- Anatomic Pathology
- Clinical Chemistry
- Clinical Laboratory
- Clinical Laboratory Trends
- Digital Pathology
- Genetic Testing
- In Vitro Diagnostics
- IVD/Lab Informatics
- Lab Intelligence
- Lab Marketplace
- Lab Risk & Compliance
- Laboratory Automation
- Laboratory Billing
- Laboratory Compliance
- Laboratory Equipment
- Laboratory Information Systems
- Laboratory Management
- Lean Six Sigma
- Managed Care Contracts
- Molecular Diagnostics
- Pathology Trends
- People
- Uncategorized
The Dark Report
1000 N West Street, Suite 1200 Wilmington, Delaware, United States, 19801
Phone: 512-264-7103
Email: info@darkreport.com
© 2025 The Dark Report. All rights reserved. Part of the LabX Media Group