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The purpose of this quarterly tracker is to identify key federal and state health AI policy activity. Below reflects federal legislative and regulatory activity to date related to AI, and state legislative activity introduced...more
In its two Confédération Paysanne decisions (cases C-528/161 and C-688/21), the Court of Justice of the European Union limited the exclusion of plants and products obtained by new genomic techniques (NGTs) from the...more
On February 23, 2022, the U.S. Food and Drug Administration (FDA) issued a proposed rule seeking to amend the medical device current good manufacturing practice requirements of the Quality System Regulation (QSR). Currently,...more
Along with proposed Stark Law exceptions designed to accommodate value-based care models, the Centers for Medicare & Medicaid Services (CMS or the agency) proposed additional revisions to the Stark Law regulations (the...more
On 20 November the Food and Drug Administration (FDA) published a request for comments on a proposed framework for regulating the output of digital health applications disseminated by or on behalf of drug manufacturers with...more