In this issue:

Federal healthcare law enforcement is turning its eye to new areas of healthcare activity, including COVID-19 testing and opioid prescribing. In other news, the state of California has terminated its contract with PerkinElmer to run the state COVID-19 testing lab, even as numerous questions about the lab’s compliance with health regulations remain.

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In this issue of The Dark Report, learn how the latest clinical laboratory trends will be showcased in the upcoming Executive War College. Also, read how the Valencia Branch Lab has remained open despite dozens of deficiencies; how IoT technology helps labs track specimen collection; and details on physician settlements for allegedly offering kickbacks for lab test referrals.

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Artificial intelligence is making strides in the clinical laboratory and pathology laboratory industry. In Europe and the United States, the first AI-powered solutions that automate digital pathology image analysis for primary diagnosis are obtaining regulatory clearance. This is highlighted by the investment by Sonic Healthcare in a thriving AI business. Also, AI is being used in lab coding, billing and collections.

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In just three weeks, two major LIS vendors announced significant deals, raising important questions about what these moves mean for clinical laboratory directors and pathologists. These acquisitions may trigger significant shifts in the LIS products labs can buy, and demonstrate the value of healthcare data. Also, two large private practice pathology groups decide to sell to larger pathology superlabs.

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XIFIN’s acquisition of pharmacy technology company OmniSYS is the latest evidence that retail pharmacies are preparing to become a new front door to healthcare for consumers. Also, there is more consolidation within the IVD industry.

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This issue includes the annual Top 10 Lab Stories of the year, this year ranging from COVID-19 to ransomware attacks on labs to the Theranos trial. These stories are useful to use in strategic planning by lab directors and pathologists. Also in this issue, there’s a reprieve on PAMA fee cuts as Congress postpones the 2021 cuts for a year.

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Two distinctly different bills have surfaced in Congress, each with the potential to have substantial impact on how laboratory-developed tests (LDTs) are regulated by agencies of the federal government. Also, an attorney with decades of experience in advising clinical labs on CLIA matters analyzes the lessons to be learned for lab directors in the Elizabeth Holmes trial.

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In this issue:

There are many important lessons for the clinical lab industry to learn from the federal fraud trial of Elizabeth Holmes, and The Dark Report studies them in depth. Also, a live Executive War College highlighted clinical laboratory and pathology trends for the coming months and years.

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In this issue:

The former Theranos lab director, pathologist Adam Rosendorff MD, has been in the news, as Elizabeth Holmes’ defense demonstrates the risks associated with lab oversight. Also, Walgreens has announced it will build 1,000 primary care clinics by 2027, showing how the traditional model of primary care is changing.

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