Clinic Government IT Lab Testing 
Permanente Medicine
MAY 20, 2025
” Related AI scribes story: Analysis: AI scribes save physicians time, improve patient interactions and work satisfaction Dr. Nguyen also highlighted the potential to utilize artificial intelligence and Kaiser Permanente’s extensive medical database to develop predictive analytic models aimed at enhancing patient care.
FDA Law Blog
OCTOBER 10, 2022
Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Interpretation of Statutory Criteria Under the Final Guidance.
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FDA Law Blog
JANUARY 6, 2022
In general, EKRA prohibits, knowingly and willfully, soliciting, receiving, paying or offering kickbacks in exchange for referring to, inducing a referral to, or using the services of a recovery home, clinical treatment facility, or laboratory. S&G Labs’ pay structure was important to the Court’s decision regarding the EKRA issue.
FDA Law Blog
JANUARY 6, 2022
In general, EKRA prohibits, knowingly and willfully, soliciting, receiving, paying or offering kickbacks in exchange for referring to, inducing a referral to, or using the services of a recovery home, clinical treatment facility, or laboratory. S&G Labs’ pay structure was important to the Court’s decision regarding the EKRA issue.
FDA Law Blog
AUGUST 3, 2022
Mullen — Happy Birthday Laboratory Developed Tests (LDTs). Of course, FDA’s August 3, 1992 statement that it could regulate LDTs came long after laboratories began offering diagnostic tests. It came 16 years after Congress passed the Medical Device Amendments of 1976, without saying a word about FDA authority over laboratory testing.
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