C&M Health Law

C&M Health Law

Analysis, commentary, and the latest developments in health care law and policy

Traci Vitek

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FDA’s Medical Device Safety Action Plan

Posted in Digital Health, FDA, Health IT
On April 17, 2018, the Food and Drug Administration (FDA) released its Medical Device Safety Action Plan which outlines FDA’s intended steps to address medical device safety while preserving enough space for innovation in the market. The FDA’s plan is the latest effort by the FDA on medical device safety, including a recent budget request… Continue Reading

The Freight Train Gathers Steam: An Update on the Federal Response to the Opioid Crisis

Posted in FDA, Medicaid, Medicare
Despite the Trump Administration’s declaration of a state of emergency on October 26, 2017, the federal response to the opioid crisis largely languished on the back burner—much to the chagrin of states in the trenches of the opioid epidemic. However, based on the flurry of activity over the past several weeks, the federal government response… Continue Reading