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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...

This month’s Friday Five explores recent decisions that reflect the precise nature of rules and definitions in the context of ERISA claims. For example, effective dates of CFR code provisions and contractually defined limitation periods can draw specific points on the timeline of a case. Similarly...

In February, 2023, the Antitrust Division of the Department of Justice (“DOJ”) announced they are withdrawing three (3) antitrust policy statements – two of which date from the 1990s – which have been relied upon by healthcare providers and their counsel guiding them through their merger and...

On February 10, 2023, the Pennsylvania Commonwealth Court issued four separate but related opinions denying property tax exemptions for four hospitals that had been purchased by the Tower Health system. [1] In each case, the court determined that the owner of the hospital did not qualify as an...

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”...

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...

On November 9, 2022, the New York Department of Financial Services (“NYDFS”) published proposed amendments (the “Proposed Amendments”) to its Cybersecurity Regulations (23 NYCRR 500), commonly referred to as Reg. 500. The comment period for these Proposed Amendments ends on January 9, 2023...

This month’s Friday Five covers cases relating to discovery in ERISA benefits cases, an appellate court strictly interpreting ERISA regulatory deadlines, a district court authorizing an ERISA breach of fiduciary duty claim based on alleged misrepresentations from an employer, another district court...

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...

This month’s Friday Five explores recent decisions that illustrate the importance of the administrative record built by a claims administrator, and the impact that the depth and thoroughness of the record will have on litigation over claims decisions. Whether reviewing claims under the de novo...

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”)...

This month’s Friday Five covers cases relating to augmentation of the administrative record following new rationales, attempted alternative ERISA causes of action, untimely ERISA claims, plans governed by ERISA even in the absence of a written plan document, and the limited weight given to residual...

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...

This month’s Friday Five covers cases relating to the interpretation of time periods for claims under life insurance and disability plans, a situation where three separate administrators handled a disability benefits claim (but came to different decisions), the Eleventh Circuit’s parsing of...

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