The Department of Health and Human Services (HHS) issued a notice, effective immediately, that it is exercising its enforcement discretion in how it applies HHS regulations concerning the assessment of Civil Money Penalties (CMPs) under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). HHS currently applies the same annual CMP limit across four separate tiers of violations based on the level of culpability surrounding the HIPAA violation. HHS will reduce the annual CMP limit for each of the four penalty tiers, pending further rulemaking, to better reflect the text of the Health Information Technology for Economic and Clinical Health (HITECH) Act.
The U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced a $125,000 no-fault settlement and two-year corrective action plan with Allergy Associates of Hartford, P.C. (Allergy Associates) stemming from an incident involving a physician who impermissibly released protected health information (PHI) to the media.
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.
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.
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.