Since 1995, Reliable Business Intelligence for Clinical Laboratories, Pathology Groups and Laboratory Diagnostics

Commentary and Opinion by R. Lewis Dark

Unpacking the Surprises in the FDA LDT Rule

Commentary and Opinion by R. Lewis Dark / R. Lewis Dark

THERE ARE NOW TWO LAWSUITS IN TWO DIFFERENT COURTS CHALLENGING THE Food and Drug Administration’s Authority to regulate laboratory developed tests (LDTs). The first was filed on May 29, 2024, by the American Clinical Laboratory Association (ACLA). The second was filed on Aug. 19, 2024, by the Association for Molecular Pathology (AMP). However these lawsuits […]

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Watch Out Pathologists! They’re Coming for Histology!

Commentary and Opinion by R. Lewis Dark / R. Lewis Dark

For any lab that depends on revenue from its histology laboratory, this issue of The Dark Report has important intelligence about a serious threat to this existing business model. One of your biggest, best-financed competitors is preparing to make a foray into this market segment of lab testing. I direct you to the sidebar with

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What’s a Big Headwind for Labs? It’s the LDT Rule!

Commentary and Opinion by R. Lewis Dark / R. Lewis Dark

EXECUTIVES AT PUBLICLY-TRADED CORPORATIONS AND THE FINANCIAL ANALYSTS WHO COVER THESE COMPANIES like to use the term “headwinds” when describing problems preventing these companies from succeeding. It’s the polite euphemism that acknowledges real-world negatives without calling them by their real names, such as high customer turnover, shrinking market share, and poor economic times. I

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Is It Time for Clinical Labs to Embrace Consumers?

Commentary and Opinion by R. Lewis Dark / R. Lewis Dark

HEALTHCARE IN THIS COUNTRY HAS A WELL-DESERVED REPUTATION for being slow to incorporate new clinical knowledge, technologies, and management models into daily practice. Adoption of these innovations by hospitals, physicians, and clinical laboratories often lags behind other industries by several years. Seen in this context, today’s “new consumer” is one of those powerful developments that

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LDT Rule Is Now a Fact! What Will Be Consequences?

Commentary and Opinion by R. Lewis Dark / R. Lewis Dark

TODAY, THE NEW RULE FOR REGULATION OF LABORATORY DEVELOPED TESTS (LDTs) issued by the federal Food and Drug Administration (FDA) is an accomplished fact. In taking this action, the FDA has created a regulatory scheme that is widely viewed as disruptive and counter-productive by pathologists and clinical lab executives involved in performing LDTs in support

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Why Ransomware Attacks Are a Threat to Your Lab

Commentary and Opinion by R. Lewis Dark / R. Lewis Dark

Have you and your lab management team noticed the major shift in cybercrime that targets healthcare providers, including clinical laboratories and pathology groups? For years, cybercrime was primarily security breaches involving the theft of patients’ protected health information (PHI). This is no longer the case. Today, a growing proportion of cybercrime involves ransomware attacks.

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Artificial Intelligence and Executive War College

Commentary and Opinion by R. Lewis Dark / R. Lewis Dark

By the time you read this our 29th annual Executive War College on Diagnostics, Laboratory, and Pathology Management conference will be underway in New Orleans. As noted in previous issues of The Dark Report, three topics will be of keen interest. First is the FDA proposed rule for laboratory developed tests (LDTs). Second is private

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Are Lab Leaders Ready for Artificial Intelligence?

Commentary and Opinion by R. Lewis Dark / R. Lewis Dark

WITH ASTONISHING SWIFTNESS, ARTIFICIAL INTELLIGENCE (AI) HAS BECOME PROBABLY THE SINGLE MOST IMPORTANT TECHNOLOGY discussed in corporate boardrooms and management meetings today. This is as true for clinical labs and pathology groups as it is for Fortune 100 corporations. Almost daily, there are headlines about the inroads AI is making into different aspects of business

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Successful Ransomware Attack Misses Lab Claims

Commentary and Opinion by R. Lewis Dark / R. Lewis Dark

HAS ANYONE NOTICED THAT CYBERCRIMINALS ARE STEADILY INCREASING THE SCALE AND MAGNITUDE OF THEIR ATTACKS? The ongoing disruption from the Feb. 21 ransomware attack on Change Healthcare, owned by UnitedHealth Group, has triggered substantial financial losses and major interruptions to the cash flow of hospitals and providers throughout the United States. As you will read

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More Labs Recognize Big Changes Are Coming

Commentary and Opinion by R. Lewis Dark / R. Lewis Dark

ONE WAY TO DISCERN THE NEAR FUTURE FOR THE CLINICAL LABORATORY INDUSTRY is to recognize what is different today, compared to the recent past. One source of these insights here at The Dark Report is the many conversations we have as we finalize selecting 140 speakers and panelists to take the podium at 88 sessions

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