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.
An attorney widely experienced in clinical laboratory regulation has prepared guidelines for complying with the FDA’s new LDT rule, and The Dark Report offers them in their entirety to readers. Also, a House of Representatives bill includes language calling for the FDA to suspend its rule.
The Dark Report examines the new trend of do-it-yourself lab testing, powered by investor-led lab companies that offer lab tests without a doctor’s order. Also, a company is offering its new system that automates microtomy to pathology labs to save time and alleviate the shortage of histotechs, among other benefits the company claims.
The Dark Report examines all angles of the FDA’s new rule regulating laboratory-developed tests, from an exclusive inside look at the ACLA’s lawsuit against it, to expert attorneys analyzing the details, to how managed care payers regard the new rule. Also in this issue is a look back at how regulators have impacted the clinical lab industry in the past.
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.
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Volume XXXI, No. 10 – July 22, 2024
An attorney widely experienced in clinical laboratory regulation has prepared guidelines for complying with the FDA’s new LDT rule, and The Dark Report offers them in their entirety to readers. Also, a House of Representatives bill includes language calling for the FDA to suspend its rule.
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