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Security, Privacy and Information Governance

Tag: HHS

$4 Million Judgment Awarded to Office for Civil Rights for HIPAA Violation

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A U.S. Department of Health and Human Services (HHS) Administrative Law Judge (ALJ) has ruled that the University of Texas MD Anderson Cancer Center violated the Health Insurance Portability and Accountability Act of 1996 (HIPAA) in its failure to encrypt its electronic devices and ordered MD Anderson to pay $4,348,000 in civil monetary penalties  to the Office for Civil Rights (OCR). This is the second summary judgment ordered in favor of the OCR in its history, and the fourth largest amount recovered by OCR for HIPAA violations.

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Continued Special Privacy Treatment for Substance Use Disorder Information

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The Senate Health, Education, Labor and Pensions Committee recently passed the Opioid Crisis Response Act of 2018 (OCRA) – a bipartisan package of more than 40 proposals designed to help families and entire communities affected by the nation-wide opioid crisis.

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New FDA Guidance on Waiver of Informed Consent for Minimal Risk Investigations

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The FDA recently issued new guidance that allows institutional review boards (IRBs) to waive or alter the FDA’s informed consent requirements for certain minimal risk clinical investigations without objection from the FDA.

The statutory basis for the guidance comes from amendments made by the 21st Century Cures Act from late in 2016 (P.L 144-255). This guidance, which took effect on July 25, 2017, is the first step for the FDA on this issue.  The FDA intends to implement subsequent regulations to permit IRB waiver or alterations of informed consent requirements for minimal risk clinical investigations.

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