Tag Archives: proposes

HIV self-test app connects users to care, FDA proposes De Novo update, and more digital health news briefs

De Novo rule proposal published for review. The FDA has published a new proposal for revisions to the De Novo regulatory pathway for devices without a predicate. The rule, which is currently available for public comment, aims to provide additional structure, clarity and transparency to the process, and outlines how the agency processes and gauges… Read More »

Trump Administration proposes using ACA subsidies to buy non-Obamacare health insurance

The Centers for Medicare and Medicaid Services today has released proposed waivers that include the ability for states to provide financial assistance for different types of health insurance, not just qualified health plans under the Affordable Care Act. States could choose to expand the availability of plans and could provide subsidies to a defined contribution,… Read More »