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The HHS Office of Inspector General issued an 'unfavorable' advisory opinion in August with respect to a proposed joint venture relating to interoperative neuro monitoring. Parties considering joint ventures and those in joint ventures should review the OIG analysis to assess compliance with...
The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced a settlement on June 28, 2023 of potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules with iHealth Solutions, LLC (doing business as Advantum...
The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) recently announced two settlements with HIPAA-covered entities – one in Washington State and one in New Jersey with settlements of $240,000 and $30,000, respectively. In the Washington State settlement, hospital...
Earlier this month, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) announced two (2) different settlements, one with a HIPAA business associate for $350,000 and one with a HIPAA-covered entity pursuant to the OCR Right of Access Initiative for $15,000...
On April 12, 2023, the Office for Civil Rights (OCR) within the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (the “ Notice”) to solicit comments on its proposal to modify the HIPAA Privacy Rule. Specifically, the Privacy Rule modifications described in...
The 2021 calendar year reports from HHS OCR describe OCR’s efforts that calendar year and are instructive tools for all parties who need to comply with HIPAA to understand macro-level trends. What You Need to Know: OCR continues to receive tens of thousands HIPAA complaints each year. “Large”...
The use of artificial intelligence (AI) in health care, and specifically, as the utilization of software in medical devices continues to increase. Machine learning (ML) is a branch of AI in which computer systems automatically adapt, improve, and make predictions by applying algorithms to analyze...
On December 2, 2022, the Office for Civil Rights (“ OCR”) and the Substance Abuse and Mental Health Services Administration (“ SAMHSA”) within the U.S. Department of Health and Human Services (“ HHS”) issued a Notice of Proposed Rulemaking (“ NPRM”) to revise the Confidentiality of Substance Use...
Neither shots nor pills will immunize smaller medical, dental, chiropractic, and physical therapy practices, surgery centers, and other healthcare concerns from compliance with the looming (and burdensome) reporting obligations imposed on them if they are “reporting companies” under the federal...
Effective November 16, 2022, New Jersey will impose additional requirements when a ‘health care entity’ is sold or undergoes a change in control. The changes are the result of the enactment of S-315, on August 18, 2021. What You Need to Know: New Jersey enacted a statute that will impose additional...
Student-athletes wasted no time following the NCAA’s rule change in July 2021 permitting compensation for name, image, and likeness (“NIL”) in landing deals of all types and sizes. Now, sixteen months later, questions remain as to whether, and to what extent, institutions can be involved in the deal...
The No Surprises Act (“NSA”) is a federal law that went into effect January 1, 2022. The NSA statute was enacted as part of the Consolidated Appropriations Act, 2021 and has been implemented by three interim rule s jointly announced by the Office of Personnel Management within the Department of the...
October was National Cybersecurity Month. As part of its ongoing focus on HIPAA Security Rule awareness and compliance, the Office for Civil Rights (“OCR”) within the Department of Health and Human Services (“HHS”), published its HIPAA Security Rule Incident Procedures newsletter (the “Newsletter”)...