Tag Archives: HIPAA

$5.5 Million HIPAA Settlement Emphasizes Importance of Audit Controls of Access by OHCA Affiliates

On February 16, 2017, the Office for Civil Rights (OCR) announced a $5.5 million settlement with South Broward Hospital District d/b/a Memorial Healthcare System (Healthcare System), to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  The Healthcare System is a nonprofit corporation that operates several hospitals, an urgent care center, a nursing home, and ancillary health care facilities throughout south Florida.  The Healthcare System is also affiliated with physician offices through an Organized Health Care Arrangement (OHCA).…

21st Century Cures Act – Implications for Investigators and Research Sites

Below is a summary of some of the key provisions relevant to investigators and research sites included in the recently enacted, bipartisan 21st Century Cures Act, including human subjects protections and the privacy and security of health information used in clinical research.  Among other requirements, the Act:

*requires the Department of Health and Human Services (HHS) to harmonize the U.S. Food and Drug Administration (FDA) Human Subjects Regulations with the HHS Human Subject Regulations (the Common Rule), which should help streamline research that falls under both sets of regulations;…

OCR’s HIPAA Guidance on Cloud Computing

On October 6, 2016, the Office for Civil Rights (OCR) released HIPAA guidance on cloud computing (Guidance).  The Guidance was intended to help covered entities and business associates understand their HIPAA obligations in cloud computing arrangements, and clarify the HIPAA obligations of cloud service providers (CSPs). The Guidance noted in part that:

  • CSPs that create, receive, maintain or transmit electronic protected health information (ePHI) are classified as “business associates” under HIPAA. If a covered entity or business associate uses a CSP to perform any of these functions, it must enter
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