The latest policies, articles, white papers, and more.
The dispute between the FDA and clinical laboratories over the agency’s efforts to regulate LDTs (laboratory developed tests) has focused on the question of authority: does the FDA’s authority to regulate devices include LDTs?
Advocating for the use of an evidence-development framework to facilitate early insurance coverage of gene therapies, following their accelerated FDA approval.
Practical suggestions for creating methods, rules, and guidelines to ensure that the development, testing, supervision, and use of AI in clinical decision support systems are done safely for patients.
An examination of the need to update clinical research data systems to enhance efficiency, reduce costs, and improve evidence generation for diverse patient populations.
An exploration of how private healthcare payers can actively participate in generating clinical evidence to improve coverage decisions and patient outcomes.
A discussion of several major rulings from the US Supreme Court’s 2023 to 2024 term and how they may affect federal agencies’ ability to enact health policy.
Enhancing clinician-patient interactions through targeted incentives may be a key strategy for improving healthcare quality and patient outcomes.
The FDA’s Breakthrough Device Designation faces challenges in aligning clinical evidence with Medicare reimbursement policies, slowing device access.
An outline of how current hospital safety procedures can be adapted to regulate AI technologies without compromising patient safety.
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