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New CISA Draft Rule Mandates Rapid Reporting of Cyberattacks
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…
February 5, 2024, Intelligence: Late-Breaking Lab News
In Australia last December, a clinical lab company was taken to court by the Office of the Australian Information Commissioner (OAIC), which deals with privacy issues. The government agency alleges that Australian Clinical Labs (ACL) had “serious and systemic” fa…
CURRENT ISSUE
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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