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FDA’s Proposed Rule on Laboratory Developed Tests: One Small Change to Regulatory Language That Would Mark a Giant Leap in Lab...

On October 3rd, the Food and Drug Administration (FDA) published its widely anticipated proposed rule on the regulation of laboratory developed tests (LDTs). Last year, Congress failed to pass the Verifying Accurate,...more

Comment Deadline Extended for the HIPAA Proposed Privacy Rule

On March 9, 2021, the U.S. Department of Health and Human Services Office for Civil Rights announced that the public comment period for the HIPAA proposed privacy rule would be extended until May 6, 2021. The rulemaking was...more

Pending Proposed Rule Would Make Far-Reaching Changes to HIPAA Privacy Regime

On January 21, 2020, the far-reaching HIPAA Privacy Proposed Rule, initially released on December 10, 2020, was published in the Federal Register. Despite speculation that the publication timeline would be altered when the...more

Pending Proposed Rule Would Make Far-Reaching Changes to HIPAA Privacy Regime

Today, the far-reaching HIPAA Privacy Proposed Rule, initially released on December 10, 2020, was posted for public inspection on the Federal Register website. The rule is scheduled to be published in the Federal Register on...more

CMS Proposes New Hospital Reporting Requirements and Signals Major Shift in Hospital Rate-Setting Methods

- Tucked into a massive Medicare payment rule is a proposal to fundamentally change how CMS sets hospital payment rates. - Recognizing that a hospital’s chargemaster rarely reflects true market costs, CMS seeks to use...more

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