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 organizations—including hospitals, clinical labs, and pathology groups—to report, within 72 ho…
Year’s 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 nation’s 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 provider’s signature is missing or illegible—a situation that costs clinical labs million of dollars in…
CURRENT ISSUE
Volume XXXII, No. 1 – January 6, 2025
The Dark Report examines how AI is being used to predict the outcomes of FDA LDT lawsuits. Also, this issue is Part Two of a series about boosting pathology compensation in different settings, including hospitals. Two experienced pathology consultants identify the most effective approaches when negotiating Part A pathology agreements with hospitals and health systems, along with how to use data to bolster these negotiations.
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