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See below the Saul Ewing LLP Health Law Practice Group 2023 predictions from various members of our practice group! Our colleagues help interested parties in the health care delivery system with transactional, regulatory, compliance and litigation issues at the Federal and state level. We are...
On January 6, 2023, the Biden Administration released an interim Guidance on the Consideration of Greenhouse Gas Emissions and Climate Change to assist federal agencies to “better assess and disclose climate impacts” of their policies. See NEPA Guidance on Consideration of Greenhouse Gas Emissions...

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...

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...

Two federal programs administered by the United States Environmental Protection Agency (the “EPA”) provide financial assistance in the form of grants and rebates to public and non-profit entities seeking to replace their existing buses and trucks into clean vehicles. The most recent program was...

​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”)...

The Inflation Reduction Act (the “IRA”), signed into law on August 16, 2022, appropriates nearly $27 billion to provide financial assistance to certain entities in their efforts to reduce greenhouse gases. This “Greenhouse Gas Reduction Fund” (the “Fund”) is available to a wide range of recipients...

On August 23, 2022, the Office for Civil Rights (OCR) within the U.S. Department of Health and Human Services (HHS) announced a $300,640 settlement and a Corrective Action Plan ("CAP") with New England Dermatology P.C., d/b/a New England Dermatology and Laser Center ("NEDLC") to resolve allegations...

On July 27, 2022, Florida Governor Ron DeSantis announced legislative proposals and initiatives that would prevent State Board of Administration (SBA) fund managers from considering environmental social and governance (ESG) factors when investing the state’s money. Instead, the proposed legislation...

On July 15, 2022, the Office for Civil Rights (OCR) within the U.S. Department of Health and Human Services (HHS) announced the resolution of eleven investigations as part of its Health Insurance Portability and Accountability Act (HIPAA) Right of Access Initiative (the "Initiative"). OCR created...

On August 4, 2022, the New Jersey Department of Environmental Protection (“NJDEP”) filed suit against Monsanto Co., Pharmacia LLC and Solutia, Inc., seeking to hold them liable for PCB contamination throughout New Jersey. ( Complaint). While the suit also addresses contamination at Monsanto’s...

On June 29, 2022, the U.S. Department of Health and Human Services Office for Civil Rights released two guidance documents addressing (1) disclosures under the HIPAA Privacy Rule relating to reproductive health care (“Disclosure Guidance”), and (2) the privacy and security of reproductive health...

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