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FDA Authorizes Marketing for First Combination Flu and COVID-19 At-Home Test Outside of Emergency Use

On October 7, 2024, FDA granted marketing authorization for the over‑the‑counter combination flu and COVID-19 combination test, Healgen Rapid Check COVID-19/Flu A&B Antigen Test. Although other at‑home combination tests...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

Health Care Providers and the State of Liability Protections in the COVID-19 Era

- As the COVID-19 pandemic continues, the clamor for liability protections for the nation’s health care providers continues. - Although there are serious political divisions, the COVID Phase 4 relief legislation may...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

HHS OCR to Exercise Enforcement Discretion to Allow Business Associates to Share PHI for Public Health and Health Oversight...

On April 2, 2020, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced that the agency will exercise enforcement discretion with respect to certain uses and disclosures of protected...more

The Health Care Industry and the CARES Act: Insight and Next Steps

While the United States now leads the world with the number of reported cases of COVID-19, the Coronavirus Aid, Relief, and Economic Security (CARES) Act (or “the Act”) takes major, though perhaps still incomplete, steps...more

Privacy Versus Pandemic: Health Privacy Considerations in Response to COVID-19

As COVID-19 continues to spread, health care providers, health plans and employers are facing difficult privacy questions as they attempt to balance privacy concerns against the need to protect patients, employees and...more

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