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On September 11, 2023, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced a settlement with LA Care related to potential violations of Health Insurance Portability and Accountability Act (HIPAA). LA Care is the largest publicly operated health plan in the...

In late August, the HHS Office for Civil Rights ("OCR") announced an $80,000 settlement with United Healthcare Insurance Company ("United") relating to OCR's right of access initiative (the "Initiative") which requires that patients be able to access their health information in a timely manner...

​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...

The deal reached between the President and House Speaker McCarthy on the debt limit bill includes provisions approving a natural gas pipeline project (Mountain Valley Pipeline) and eliminating any judicial review of its existing and future permits, and also includes some limited reform of the...

​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...

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...

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”)...

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