LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
The latest regulatory, legal, compliance, and technology news for labs and pathology practices.
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
Here are the aspects of the proposed rule most likely to have an impact on labs and the businesses that own them.
Changes to PAMA reporting timelines and requirements, as well as payment cuts, are just some of the main takeaways labs should know about.
A total of 33 doctors have now paid settlements in relation to an alleged lab testing referrals scheme, according to the DOJ.
Research shows that AI algorithms trained with data collected from wearable devices were effective in identifying COVID-19.
The former Theranos CEO was found guilty of 10 ten counts of wire fraud and two counts of conspiracy to commit wire fraud.
Labcorp begins offering CDC’s PCR test for orthopoxviruses, including monkeypox, with plans to further expand testing capacity.
Team creates a mass spectrometry-based blood lipid test that, when combined with AI, identifies early signs of the disease.
According to a recently released report, in FY 2021, of 831 new criminal healthcare fraud investigations, 312 resulted in convictions.
Owners of now defunct Physicians Choice Laboratory Services were accused of paying kickbacks to physicians to order tests from the lab.
American Medical Association publishes its policy proposals to help ensure telehealth services are accessible and effective for everyone.