Late Breaking Lab News
April 29, 2024, Intelligence: Late-Breaking Lab News
It may be that the genetic data cat is out of the bag already. Nonetheless, lawmakers in Delaware are considering a bill that—among other things—would prevent life insurance companies from buying or using genetic testing data if it was obtained from ancestry companies and not from medical records…
April 8, 2024, Intelligence: Late-Breaking Lab News
UnitedHealth Group stated that the cyberattack against Change Healthcare, a business unit of UnitedHealth’s Optum division, disrupted processing of approximately $14 billion in claims. The company discovered the cyberattack on Feb. 21 and said it d…
March 18, 2024, Intelligence: Late-Breaking Lab News
In California last month, Quest Diagnostics entered into a settlement agreement with California Attorney General Rob Bonta and nine local district attorneys. KCRA News of Sacramento reported that the “settlement resolves allegations that the company unlawfully disposed of …
February 26, 2024, Intelligence: Late-Breaking Lab News
Following an investment of $1.75 million, officials at University of Maine at Augusta (UMA) opened a new lab facility this month that allows it to double the number of medical laboratory technicians it can train, from eight to 10 to as many as 20. In its coverage of the new training …
February 5, 2024, Intelligence: Late-Breaking Lab News
In Australia last December, a clinical lab company was taken to court by the Office of the Australian Information Commissioner (OAIC), which deals with privacy issues. The government agency alleges that Australian Clinical Labs (ACL) had “serious and systemic” fa…
January 16, 2024, Intelligence: Late-Breaking Lab News
If a patient’s genetic test generates results that are actionable, will that patient move forward with treatment? That is one question asked by researchers in a study led by Vanderbilt University Medical Center that was published in the American Journal of Human Genetics. …
December 26, 2023, Intelligence: Late-Breaking Lab News
Is the world ready for a diagnostic service that performs a whole genome sequence of embryos conceived by in vitro fertilization? That’s the business plan announced on Dec. 5 by San Francisco-based Orchid Health. In covering this development, Science wrote, “Find the emb…
December 4, 2023, Intelligence: Late-Breaking Lab News
You may have thought that the long-running saga of the now-defunct Theranos had ended. But no, there is continuing litigation in the Grand Canyon State. A class action suit—In re Arizona Theranos, Inc., Litigation, Case No. 2:16-cv-2138—continues to move forward in …
November 13, 2023, Intelligence: Late-Breaking Lab News
Federal regulators recently confirmed that Dec. 4 remains the deadline for public comment on the proposed rule that the federal Food and Drug Administration (FDA) would use to regulate laboratory developed tests (LDTs). This was confirmed during a public webinar for the lab and in vi…
October 23, 2023, Intelligence: Late-Breaking Lab News
Earlier this summer, a 16-year-old completed his bachelor of science degree, along with his certification as a Medical Laboratory Scientist (MLS). The faculty at LSU Health-Shreveport reported that Isak Schmidley, MLS (ASCP)BC is the youngest graduate of its Medical Laboratory Scienc…
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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