Reliable Business Intelligence News About Clinical Laboratories, Pathology Groups, & Laboratory
Diagnostics Since 1995
The most complete archive of clinical and pathology lab industry news available, including issues from 1997 to the present.
A new federal rule has been proposed that will require healthcare providers, including clinical laboratories and pathology groups, to report cyberattacks and ransom paid in a swift timeframe. Also, the FDA’s new LDT federal rule is about to go into effect. The Dark Report further takes a look at an innovation program at an Arizona lab.
Laboratory managers will want to note that The Dark Report itself was targeted by the fraudsters who hit Change Health in a cyberattack. Also, one lab has some innovative methods of combatting the chronic staffing shortage, including hiring college graduates and students.
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
An expert attorney analyzes the most recent cases of EKRA violations, showing how many labs could be in violation themselves. Also, a major cyberattack on Change Healthcare, owned by UnitedHealth Group, creates disruptions to providers around the country. Other news includes a look at the worldwide pathologist shortage.
A “perfect storm” of new developments in the clinical laboratory and pathology group industry is coming, and The Dark Report is analyzing these changes as well as preparing to present the details to attendees at the annual Executive War College. Also, HHS has published an important final rule for health IT Interoperability.
The Dark Report takes a deep dive into the comments submitted on the FDA’s draft LDT rule, questioning the FDA’s transparency in publishing the comments. Also included is a report on a letter about LDT oversight issued jointly by the FDA and CMS. In addition, a major data breach at a European lab has lessons for American clinical labs.
The Dark Report notes that British Columbia cervical cancer screenings will now be made via self-collected HPV testing, rather than Pap smears, in an effort to overcome medical personnel shortages. Also, a new deal between Google Cloud and Epic Systems aims to help hospitals move their EHR data to the cloud.
This issue examines the top 10 stories from 2023, which show no immediate threats to the clinical laboratory industry, but which were mostly about developments where the consequences will influence laboratory operations in coming years. In other news, a convicted fraudster earns an eight-year prison sentence for violating EKRA.
In this issue, The Dark Report discusses the impact of artificial intelligence-powered solutions. The Dark Report suggests that it is timely for lab managers at all levels of the organization to begin learning about the field of artificial intelligence. In addition to this topic, discover how labs should be prepared for data to dominate diagnostics, understand that CLIA lab directors must monitor delegated duties, and stay informed about the latest regulatory and IVD updates.
In this issue, Clinisys CEO Michael Simpson explains new developments in digital technologies that will expand the value and role of lab test data. Also, recent cases of healthcare fraud are examined, and whole genome sequencing for newborns is shown to be gaining favor with physicians and payers alike.
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Volume XXXII, No. 10 – July 14, 2025
This issue is strong on different flavors of enforcement that clinical laboratories, whether they want to or not, will need to contend with. Lab stakeholders provide insights that medical labs need to brace for more action to counter pending test reimbursement rate cuts under PAMA. Also, this issue provides the legal and regulatory landscape for clinical labs’ use of AI and how it evolves with the technology. AI is creating legal uncertainty for clinical labs, especially around data privacy and FDA oversight of AI tools in diagnostics.
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