RESUMO
This policy brief summarizes current U.S. regulatory considerations for ensuring patient safety and health care quality of genetic/genomic test information for precision medicine in the era of artificial intelligence/machine learning (AI/ML). The critical role of innovative and efficient laboratory developed tests (LDTs) in providing accurate diagnostic genetic/genomic information for U.S. patient- and family-centered healthcare decision-making is significant. However, many LDTs are not fully vetted for sufficient analytic and clinical validity via current FDA and CMS regulatory oversight pathways. The U.S. Centers for Disease Control and Prevention's Policy Analytical Framework Tool was used to identify the issue, perform a high-level policy analysis, and develop overview recommendations for a bipartisan healthcare policy reform strategy acceptable to diverse precision and systems medicine stakeholders.
RESUMO
Poor diet is the leading cause of mortality in the U.S. due to the direct relationship with diet-related chronic diseases, disproportionally affects underserved communities, and exacerbates health disparities. Evidence-based policy solutions are greatly needed to foster an equitable and climate-smart food system that improves health, nutrition and reduces chronic disease healthcare costs. To directly address epidemic levels of U.S. diet-related chronic diseases and nutritional health disparities, we conducted a policy analysis, prioritized policy options and implementation strategies, and issued final recommendations for bipartisan consideration in the 2023-24 Farm Bill Reauthorization. Actional recommendations include: sugar-sweetened beverage taxation, Supplemental Nutrition Assistance Program (SNAP) fruit and vegetable subsidy expansion, replacement of ultra-processed foods (UPF) with sustainable, diverse, climate-smart agriculture and food purchasing options, and implementing "food is medicine."