TAG:
proposed rule
New CISA Draft Rule Mandates Rapid Reporting of Cyberattacks
By Robert Michel | From the Volume XXXI, No. 7 – May 20, 2024 Issue
CEO SUMMARY: There is another federal rule that will require compliance by clinical labs. An agency of U.S. Dept. of Homeland Security published a draft rule on April 4 that requires certain organizationsāincluding hospitals, clinical labs, and pathology groupsāto report, within 72 ho…
Yearās Top 10 Lab Stories Contain Surprises & Twists
By Robert Michel | From the Volume XXX, Number 18 – December 26, 2023 Issue
CEO SUMMARY: With the SARS-CoV-2 pandemic now in the rearview mirror of the nationās clinical labs and pathology groups, the important news stories of 2023 were mostly about developments where the consequences will influence laboratory operations in coming years. Artificial intelligence…
November 13, 2023, Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXX, Number 16 – November 13, 2023 Issue
Federal regulators recently confirmed that Dec. 4 remains the deadline for public comment on the proposed rule that the federal Food and Drug Administration (FDA) would use to regulate laboratory developed tests (LDTs). This was confirmed during a public webinar for the lab and in vi…
Draft Rule Standardizes Electronic Signatures
By Robert Michel | From the Volume XXX, No. 6 – April 17, 2023 Issue
CEO SUMMARY: Every year, payers refuse laboratory test claims on grounds that the ordering providerās signature is missing or illegibleāa situation that costs clinical labs million of dollars in…
CURRENT ISSUE
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Volume XXXI, No. 10 – July 22, 2024
An attorney widely experienced in clinical laboratory regulation has prepared guidelines for complying with the FDA’s new LDT rule, and The Dark Report offers them in their entirety to readers. Also, a House of Representatives bill includes language calling for the FDA to suspend its rule.
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