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Updated OCR guidance does not solve HIPAA’s tracker uncertainty

The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) updated its guidance concerning compliance obligations for HIPAA covered entities and business associates using online tracking...more

A closer look: Remote monitoring terms in Clinical Trial Agreements require careful review

Sponsors of clinical trials in the United States have a regulatory responsibility under 21 CFR Part 312.50 to monitor the progress of clinical studies. Historically, Sponsors performed in-person monitoring visits of every...more

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