TAG:
Food and Drug Administration
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…
Lab Stakeholders Discuss PAMA Reform
CEO SUMMARY: Medical labs need to brace for more action to counter pending test reimbursement rate cuts under PAMA. Although labs have received PAMA reprieves from Congress over the last few years, laboratory associations argue that Congress needs to vote on long-term reforms rather than …
Lab Industry Fallout from CLIAC Termination
CEO SUMMARY: Some diagnostic lab leaders and anatomic pathology practice owners may not immediately think that the elimination of a federal advisory panel should be on their radar. But the demise of the Clinical Laboratory Improvement Advisory Committee may cost labs by de…
News Briefs on Alzheimer’s Detection
FDA-cleared IVD could replace scans There has been a significant amount of activity in recent weeks as it concerns tests to detect Alzheimer’s disease. Clinical labs and neuropathologists will want to keep a cl…
June 23, 2025, Intelligence: Late-Breaking Lab News
Clinical labs that have business in clinical trials involving genetic samples should note that on June 18, the Food and Drug Administration (FDA) ordered a review of new trials that send samples to “hostile countries for genetic engineering.” The FDA mentioned China specifically. Th…
June 2, 2025, Intelligence: Late-Breaking Lab News
Our sibling publication, G2 Intelligence, reported in May about a new Department of Justice (DOJ) memorandum that indicated prosecutors will seek to exercise fairness when deciding how to pursue fraud cases against clinical laboratories and other organizations. The DOJ emphasiz…
Don’t Pass Up Chance to Steer LDTs, PAMA Reform
CLINICAL LABORATORY PROFESSIONALS HAVE RECEIVED A RARE CH…
LDT Oversight May Fall to Congress, CLIA
CEO SUMMARY: After a federal court struck down the FDA’s final rule on laboratory developed tests, attention has shifted to Congress and CLIA as likely paths forward for oversight. A lack of bipartisan momentum makes new legislation unlikely in the near term. Experts sug…
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…
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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