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the dark report
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…
For Lab Veterans, It’s Time to Step into AI’s Shadow
READING THROUGH THE FIRST INSTALLMENT OF THE DARK REPORT’S analysis about the state of artificial intelligence (AI) in clinical laboratories, this cantankerous observer found himself thinking about ChatGPT. Do I dare to use ChatGPT? Occasionally. …
Workers Use AI More than Lab Leaders Think
CEO SUMMARY: In part one of an analysis about the state of AI in clinical laboratories, The Dark Report explores how frontline workers, especially younger ones, are using AI tools like ChatGPT far more than lab leaders. Recent reports elsewhere in the business world show e…
Economic, Tech Changes Drive Lab Concerns
CEO SUMMARY: Uncertainty around tariffs, future regulations, and artificial intelligence (AI) defined the mood at the 2025 Executive War College, where nearly 1,000 lab leaders gathered. Speakers warned of how stagnant healthcare spending could trickle down to labs. Meanwh…
Enjoy the LDT Court Victory, Yet Remain Vigilant
VICTORY IN COURT! FOR AN INDU…
With LDT Rule Vacated, Labs Await FDA Retort
CEO SUMMARY: In a major win for clinical laboratories, a federal judge vacated the FDA’s final rule on LDTs, writing in his decision that the agency overstepped its authority. For now, labs can develop and modify LDTs without FDA oversight, but future action in some form…
BD Will Sell Diagnostics Arm but Retain Vacutainer Brand
LESS THAN TWO MONTHS AFTER ANNOUNCI…
Testing at Pharmacies Enters a Murky Future
CEO SUMMARY: Five years ago, it seemed a solid prediction that retail pharmacies would establish a stronghold in primary care and offer wider access to common diagnostic testing services that clinical laboratories provide. Fast forward to 2025, and the market does not look…
Clinical Lab Test Jargon Could Spur Mistrust among Patients
LITTLE DETAILS CAN MAKE A BIG DIFFERENCE in not only how customers view a clinical laboratory, but also in ensur…
April 21, 2025, Intelligence: Late-Breaking Lab News
The administration of President Donald Trump is calling for a $40 billion cut in funding to the U.S. Department of Health and Human Services (HHS), according to a report in The Washington Post on April 16. This amount would come from HHS discretionary spending,…
CURRENT ISSUE
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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