TAG:
HIPAA
February 9, 2026, Intelligence: Late-Breaking Lab News
Texas Attorney General Ken Paxton filed a lawsuit against Epic Systems, intensifying scrutiny of how pediatric medical records are controlled and the broader power of dominant electronic health record (EHR) vendors. The suit alleges Epic unlawfully monopolizes the EHR…
Top Stories in 2025 Played Out in Courts, Capitol Hill
CEO SUMMARY: The biggest story of the year for clinical laboratories came in a huge court victory, as a federal judge vacated the FDA’s final rule on laboratory developed tests. Labs breathed a sigh of relief after the court decision, as the FDA rule had promised to incr…
Profitable Collaboration with Pharma Companies
CEO SUMMARY: Drug discovery efforts by pharmaceutical companies often need a boost from anatomic pathology practices and clinical laboratories. Forward-thinking lab leaders and pathologists can take advantage of their data and expertise to partner with pharma, setting the …
Clinical Labs Battle Complex Claims Denials
CEO SUMMARY: While the number of denials is not going up, the reasons that private payers deny claims are becoming more complex and time-consuming to appeal. After reviewing noteworthy trends among payers, learn a three-level approach to appeals that may lead to greater su…
For AI Regulation, Look to Data Laws, FDA Action
CEO SUMMARY: AI is creating legal uncertainty for clinical labs, especially around data privacy and FDA oversight of AI tools in diagnostics. Few court cases exist yet that interpret AI use within clinical settings, but labs must watch how HIPAA and state laws wield influence. Vendor soft…
How Labs, Pathologists Should Prepare for Payer Audits
PAYER AUDITS ARE ON THE RISE, AND CLINICAL LABORATORIES AND PATHOLOGY PRACTICES THAT ARE NOT ADEQUATELY PREPARED could face millions of dollars in unexpected recoupment demands. That’s the word from Jane Pine Wood, JD, a healthcare attorney with McDonald Hop…
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…
CURRENT ISSUE
Volume XXXIII, No. 7 – May 26, 2026
Momentum is building on Capitol Hill to pass the RESULTS Act, which would stave off drastic 15% reimbursement cuts under PAMA. Advocates seek lobbying help from clinical labs and anatomic pathology practices. Also, The Dark Report examines Roche’s deal to acquire PathAI.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
Lab leaders rely on THE DARK REPORT for actionable intelligence on important developments in the business of laboratory testing. Maximize the money you make-and the money you keep! Best of all, it is released every three weeks!
Sign up for TDR Insider
Join the Dark Intelligence Group FREE and get TDR Insider FREE!
Never miss a single update on the issues that matter to you and your business.