The latest policies, articles, white papers, and more.
Two years in, Rubrum Advising’s North Star remains clear: helping patients access meaningful, high-impact care by aligning innovation with the clinical knowledge, regulatory frameworks, and policy trends that deliver it.
Rubrum Advising, a boutique firm rooted in clinical practice and dedicated to developing healthcare market access, regulatory and policy strategies that demonstrate the value of groundbreaking innovations to payers and providers, today announced the launch of a new government affairs and advocacy practice.
The Alliance for Screening Measurement Modernization (ASMM) brings together organizations from across the healthcare sector to explore a broader framework for the timely integration of evidence into currently endorsed national health screening policies.
In the U.S., a significant barrier to ensuring high quality health care is our very complex regulatory environment. As the pace of innovation continues increasing rapidly, it is critical that our policy infrastructure evolves to meet the moment.
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.
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