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On April 26, 2024, the Department of Health and Human Services (HHS) published the final HIPAA Privacy Rule to Support Reproductive Health Care Privacy (Final Rule). The Final Rule became effective June 25, 2024....more
On June 28, 2024, the Supreme Court issued its opinion in Loper Bright Enterprises v. Raimondo, Secretary of Commerce and Relentless, Inc. v. Department of Commerce (Loper Bright), overturning Chevron U.S.A. Inc v. Natural...more
On April 26, 2024, the U.S. Department of Health and Human Services (HHS) and Office for Civil Rights (OCR) published Final Regulations under HIPAA’s Privacy Rule introducing greater protections for information related to...more
On April 22, 2024, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services announced final regulatory updates to the Privacy Rule under the Health Insurance Portability and Accountability Act of...more
On April 22, 2024, the Office for Civil Rights (OCR) for the United States Department of Health and Human Services issued a Final Rule amending the Privacy Rule of the Health Insurance Portability and Accountability Act...more
On April 26, 2024, almost a year after issuing a notice of proposed rulemaking to modify the Privacy Rule, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) finalized the HIPAA Privacy Rule to...more
Section 1557 of the Affordable Care Act (ACA) prohibits discrimination on the basis of race, color, national origin, sex, age or disability, or any combination thereof, in a health program or activity, any part of which is...more
The Department of Health and Human Services’ (“HHS”) Office for Civil Rights recently published a final rule (the “Final Rule“) which provides additional privacy protections related to the use and disclosure of reproductive...more
The Supreme Court’s 2022 decision in Dobbs v. Jackson Women’s Health Organization to eliminate the federal constitutional right to abortion continues to alter the legal landscape across the country. On April 26, 2024, the...more
Seyfarth Synopsis: Following years of back and forth, new final rules were published by the Department of Health and Human Services (HHS) on May 6, 2024 reinstituting the Department’s interpretation that the prohibition on...more
In a Final Rule issued on May 6, 2024, the U.S. Department of Health and Human Services (“DHHS”) finalized regulations implementing Section 1557 of the Affordable Care Act (“Section 1557”). The Final Rule updates and...more
On April 18, 2024, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) released a new Final Rule for its oft-criticized 340B Administrative Dispute Resolution (ADR)...more
Disputes between 340B Drug Pricing Program-covered entities and the drug manufacturers required to sell outpatient drugs to those entities at discounted prices will be governed by an alternative dispute resolution (ADR)...more
The US Department of Health and Human Services (HHS) issued a final rule (Final Rule) on April 26, 2024 amending the privacy regulations (Privacy Rule) promulgated under the Health Insurance Portability and Accountability Act...more
On April 22, 2024, the Office for Civil Rights (“OCR”) at the U.S. Department of Health and Human Services issued a Final Rule, entitled ‘HIPAA Privacy Rule to Support Reproductive Health Care Privacy’....more
As the federal government continues to take action in response to events impacting the healthcare landscape, stakeholders must ensure that they are staying up-to-date with health information privacy and security developments...more
In a move long anticipated by 340B Program participants, the Department of Health and Human Services (HHS) recently published its finalized 340B Administrative Dispute Resolution (ADR) rule, establishing formal processes for...more
On February 8, 2024, the U.S. Department of Health & Human Services (HHS) released a final rule modifying 42 CFR Part 2 (Part 2) provisions regarding the confidentiality of Substance Use Disorder (SUD) Patient Records. The...more
On Monday, the Department of Health and Human Services (“HHS”) announced that the prohibition against discrimination “on the basis of sex” under Section 1557 of the Affordable Care Act (“Section 1557”) once again includes...more
The U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) long-awaited administrative dispute resolution (ADR) final rule went into effect last week, on January 13, 2021. The...more
The U.S. Health Resources and Services Administration (HRSA) published a final rule (the Rule) on December 14, 2020, which outlined the requirements and procedures for the 340B pharmacy program's administrative dispute...more
Donald Trump extended two directives restricting the admission of certain immigrants and nonimmigrants to the U.S. Specifically, Presidential Proclamation (PP) 10014 restricting the admission of first-time immigrants and PP...more
Seyfarth Synopsis: A Federal Court has temporarily enjoined the Trump administration from putting into effect its recent rule that strips the Affordable Care Act of its gender identity protections....more
Under Section 1557 of the Affordable Care Act (Section 1557), "covered entities," which were defined as health programs or activities that receive "federal funding" from the U.S. Department of Health and Human Services (HHS)...more
On January 28, 2020, the Department of Health and Human Services (“HHS”) issued an announcement of financial importance to covered entities and business associates that produce copies of medical records to patients and third...more