Health Care Law News and Insights

The intersection of software, technology and health care and the proliferation of software as a medical device in the health care arena has become common place and has spurred significant innovations. The term Software as a Medical Device (SaMD) is defined by the International Medical Device Regulators Forum as "software intended to be used...

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Throughout the COVID-19 public health emergency (PHE), the Centers for Medicare & Medicaid Services (CMS) used a combination of emergency authority waivers, regulations, enforcement discretion, guidance, and reliance on new legislation to provide broad flexibilities under the Medicare and Medicaid programs. With the expiration of the PHE on May 11,...

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n this post, we summarize noteworthy False Claims Act (FCA) decisions so far from 2023. Each of the three circuit court opinions discussed here ruled in favor of the defendants on different aspects of the FCA: the Sixth Circuit addressed falsity predicated on an Anti-Kickback Statute violation, the Second Circuit...

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