TAG:
HIPAA
HHS Revises HIPAA Privacy, Security Rule
CEO SUMMARY: Officials at the Department of Health and Human Services (HHS) are proposing significant changes in what observers are calling a major revision to HIPAA’s requirements for protected health information (PHI) and cybersecurity. HHS issued a statement that the objective of the…
Epic Sued for Antitrust Violations by Small, Start-up Company
IT’S BEING CALLED A “DAVID VERSUS GOLIATH” SPAT. Last month, Particle Health of New York City filed an …
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…
Change Healthcare Hit by Major Cyberattack
CEO SUMMARY: It was a classic ransomware attack against Change Healthcare, the business unit of Optum that is itself a division of UnitedHealth Group. On Feb. 21, this cyberattack shut down critical systems at Change Healthcare, such as those involved in accepting and forwarding prescript…
European Lab’s Data Breach Has Lessons for U.S. Clinical Labs
IN WHAT COULD BE A CAUTIONARY TALE FOR CLINICAL LABORATORIES, a cybersecurity researcher has reported the discovery of a medical laboratory database that publicly exposed COVID-19 test records containing people’s personal data, including their names, passport numbers, appointment details, and test …
Cyberattack Victims Sue Enzo Biochem and Labcorp
CEO SUMMARY: It’s the latest reminder that clinical laboratories and anatomic pathology groups are at risk for two threats. One threat is a cyberattack that shuts down a lab’s IT system while stealing patient data. The other threat involves lawsui…
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 …
Draft Rule Standardizes Electronic Signatures
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…
March 6, 2023, Intelligence: Late-Breaking Lab News
Since Congress did not include new regulations for laboratory-developed tests (LDTs) in a year-end spending budget, it appears the Food and Drug Administration (FDA) will take steps of its own to increase the agency’s oversight of LDTs. “We are moving forward with rulemaking,” said Eliza…
Labs Must Audit Their Cybersecurity Measures
CEO SUMMARY: While clinical laboratory managers and pathologists are aware of the risks of a data breach, they often assume that related protection measures are working as needed. That is a mistake. With the cost of healthcare data breaches on the rise, it is vitally important for l…
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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