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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 Nuts and Bolts of Locums An introductory webinar on getting started in the independent practice of emergency medicine, including a discussion on five important details that are often missed when negotiating a locums contract: What is the “bill rate” for the client? What is the margin for the...
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...
Partner Jonathan Havens will speak on "Cannabis and CBD in Food Products" at the Prime Label Consultants' Food Label Conference in Washington, D.C. Cannabidiol (CBD) remains in the news, especially since the U.S. Food and Drug Administration's January 26th announcement that existing regulatory...
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...
Partner Jonathan Havens will co-chair the 2023 FDLI Annual Conference. As the premier conference for the food and drug law community, the FDLI Annual Conference addresses complex legal, regulatory, compliance, and policy issues in all facets of the FDA-regulated industry. The conference provides in...
Saul Ewing LLP's first annual Connectors Conference: Focus on Food, Beverage & Agribusiness. This half-day event provided an opportunity to connect with and learn from leaders in the food, beverage and agribusiness sector. Our event featured a notable group of speakers, from organizations including...
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...
Work Product Protection for Patient Safety Information Charles Kelly, MS, partner, at Saul Ewing LLP, will walk attendees through two important pieces of legislation that protect healthcare workers: the Patient Safety and Quality Improvement Act of 2005, which ensures federal privilege and...
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...
In this engaging and useful session, Mr. Havens will use facts from recent food and beverage cases and recent instances of enforcement to provide practical takeaways to help the industry comply with applicable requirements and take defensible positions when developing food labels and product claims.