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A practical guide to building and maintaining a clinical research compliance and ethics program.
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Read the latest news that impacts the healthcare compliance profession.
Corporate Compliance & Ethics Week 2023 kicked off with a gift for healthcare and life sciences compliance practitioners by way of the U.S. Department of...
On April 26, 2024, the U.S. Department of Health and Human Service Office for Civil Rights issued a final privacy rule to support reproductive health...
In February 2000, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published a Special Fraud Alert, “Rental of Space in...
Mergers and acquisitions (M&A) constantly occur in the healthcare industry. Organizations have varying levels of compliance involvement in the “due diligence” phase. During due diligence,...
In November 2023, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released the General Compliance Program Guidance (GCPG). The...
Organizations often struggle to navigate the fine line between research activities and quality improvement activities. This can be complicated by a lack of coordination between...
The False Claims Act (FCA) permits private individuals to bring lawsuits in the name of the United States—called qui tam—against those they believe have defrauded...
In the utilization management world, the adoption of CMS-4201-F—the new rule regulating many Medicare Advantage (MA) plan activities—was a game changer.[1] Like many new rules,...
Due diligence is a vital step in all types of mergers, acquisitions, and other transactions, including making large investments in a company (collectively referred to...
On September 14, 2023, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a proposed rule in the Federal...
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