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Healthcare › Department of Health and Human Services (HHS) › Office for Human Research Protections (OHRP)

Health Care Compliance Association (HCCA)

Amid Seeming Error, HHS Finalizes Klote’s Termination As Director of Crippled OHRP; She Issues a Warning

Health Care Compliance Association (HCCA) on

In the end, the final termination letter arrived in the mail on July 18. For nearly three months—about half of the length of time she was director of the HHS Office for Human Research Protections (OHRP)—Molly Klote, M.D.,...more

McDermott Will & Schulte

FDA, OHRP Issue Joint Guidance on Collection of Tissue Biopsies in Clinical Trials

McDermott Will & Schulte on

On January 6, 2025, the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) released a joint draft guidance document: Considerations for...more

Davis Wright Tremaine LLP

Is AI Development "Research" Under HIPAA?

Davis Wright Tremaine LLP on

Continued advancement in artificial intelligence offers great promise to improve health care. But AI feeds on tremendous amounts of data, and using protected health information (PHI) to develop or improve AI often involves...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 19, Number 11. In This Month’s E-News: November 2022

Health Care Compliance Association (HCCA) on

NIH is unable to “ensure grants have appropriate cybersecurity provisions” and should make nearly a half-dozen changes, according to auditors for the HHS Office of Inspector General (OIG). Yet, NIH said it had already made...more

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