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OCR Proposes Sweeping HIPAA Security Rule Amendments

Last fall at the Safeguarding Health Information: Building Assurance Through HIPAA Security 2024 conference, U.S. Department of Health & Human Services Office for Civil Rights (OCR) promised that before year’s end, it would...more

FDA Issues Guidance Addressing COVID-19 Interference with Clinical Trials

In recognition of the widespread disruptions the COVID-19 crisis is posing to planned and ongoing clinical trials at sites throughout the United States (and global clinical sites), the Food and Drug Administration (FDA)...more

The Newly Updated Common Rule is Here – And On a Collision Course With the 21st Century Cures Act

On January 18th, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a final rule updating regulations for the protection of human research subjects, the so-called “Common Rule.” The...more

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