TAG:
McDonald Hopkins
With LDT Rule Vacated, Labs Await FDA Retort
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
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
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
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
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?
TODAY, THE NEW RULE FOR REGULATION OF LABORATORY DEVELOPED TESTS …
Proposed Electronic Signature Rule Has Compliance Risks
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
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
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…
All Labs Are Threatened by Ransomware Attacks
This is an excerpt of a 1,652-word article in the September 7, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Cybercrime—in the form of encryption attacks followed by ransom demands—is now a threat to…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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