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Analysis PRO In-house

Lexology PRO | USA | 12 May 2021

SolarWinds hack didn’t compromise HHS healthcare data

While the SolarWinds hack affected some 18,000 computer networks and compromised an untold amount of data, the US Department of Health and Human Services has said that it was largely unscathed by the cyberattack.

Proskauer Rose LLP | USA | 5 May 2021

Recent Study Shows Lack of Compliance With CMS’ Hospital Price Transparency Rule

In a prior blog post, we discussed CMS’ Hospital Price Transparency Rule at 45 C.F.R. § 180.10 et. Seq., effective January 1, 2021 (the “Rule”)…

Cozen O'Connor | USA | 29 Apr 2021

First Candidate Enters Race Against Newly-Appointed California Attorney General

Sacramento County DA Anne Marie Schubert, a former Republican and currently registered as “No Party Preference,” announced her candidacy in the 2022…

McGuireWoods LLP | USA | 29 Apr 2021

HHS OIG Targets Ophthalmology Practices for Medicare Billing Compliance: Eight Key Takeaways

One of the most challenging billing compliance issues ophthalmology practices encounter in coding and reimbursement is understanding when services…

Skadden Arps Slate Meagher & Flom LLP | USA | 21 Apr 2021

DOJ Introduces Novel Theories of Liability and Requires Unprecedented Controls in Speaker Program Settlement

Recent settlements between the U.S. Department of Justice (DOJ) and a range of FDA-regulated drug and medical device manufacturers provide a snapshot…

Greenberg Traurig LLP | USA | 21 Apr 2021

Key FDA Drug and Device Updates

Over the past month, there have been a significant number of developments affecting FDA-regulated companies. This GT Alert provides an update on key…

Hogan Lovells | USA | 20 Apr 2021

HHS withdraws proposal to exempt 84 medical device types from FDA 510(k) process

On April 16, the U.S. Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) published a notice of withdrawal of their…

Morgan, Lewis & Bockius LLP | USA | 20 Apr 2021

Additional PREP Act Amendments Accommodate Vaccination Administration Needs

Given the significant push to vaccinate the public since the start of 2021, the increasing availability of vaccines, and the need to recruit…

Morgan, Lewis & Bockius LLP | USA | 16 Apr 2021

NRC Hosts Public Meeting on Final Changes to Fitness-for-Duty Drug Testing Requirements

The Nuclear Regulatory Commission (NRC) hosted a public meeting on April 13 to discuss and solicit stakeholder feedback on the cumulative effects of…

Kan-Tor & Acco | Israel, USA | 16 Apr 2021

Israel -United States Treaties, Agreements, and Collaborations facilitate new medical treatments

Albert Einstein, probably the world’s most renowned scientist was one of the founders of the Hebrew University in Jerusalem. His wisdom and foresight…
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