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Effective June 25, 2024, the U.S. Department of Health & Human Services’ Office for Civil Rights (HHS) issued a Final Rule modifying the HIPAA Privacy Rule to enhance reproductive health care privacy. This change follows the...more
Report on Research Compliance 21, no. 9 (September, 2024) - Based on their review of public data on ClinicalTrials.gov, a bipartisan quartet of U.S. representatives has asked the Food and Drug Administration (FDA) to...more
In the wake of the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization and subsequent state abortion bans, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services issued a...more
The Department of Health and Human Services issued a final rule amending the HIPAA privacy rules (“2024 Privacy Rule”). The 2024 Privacy Rule limits the use or disclosure of an individual’s PHI in connection with reproductive...more
The HIPAA Privacy, Security, and Breach Notification Rules apply to healthcare providers who engage in certain electronic transactions, healthcare clearinghouses, and health plans, including employee group health plans with...more
On March 18, 2024, the Office for Civil Rights ("OCR") at the U.S. Department of Health and Human Services ("HHS") published updated guidance on the use of online tracking technologies by HIPAA covered entities and business...more
On March 18, 2024, the Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) issued revised guidance on the use of tracking technologies by HIPAA-covered entities and business associates....more
The long-anticipated final rule addressing substance use disorder (SUD) records at 42 C.F.R. Part 2, commonly referred to as Part 2, is here. The final rule is a joint undertaking by the U.S. Department of Health and Human...more
Last week, the Substance Abuse and Mental Health Services Administration (SAMHSA) within the US Department of Health and Human Services (HHS) issued a long-awaited final reg that aims to better align 42 CFR Part 2. This...more
Substance Use Disorder (SUD) programs and HIPAA-regulated entities seeking to streamline their privacy and security practices and workflows received welcome news from the U.S. Department of Health & Human Services (HHS) last...more
Why is everyone talking about provider disclosures to law enforcement of late? The Senate Finance Committee authored a letter to Xavier Becerra, Secretary of the U.S. Department of Health and Human Services (HHS), outlining...more
On November 20, 2023, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced a settlement with Saint Joseph’s Medical Center for potential violations of the Health Insurance...more
On Monday, November 6, 2023, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) released its General Compliance Program Guidance (“GCPG”) for the general healthcare compliance community and...more
We are pleased to present our annual End of Year Plan Sponsor “To Do” Lists. This year, we present our “To Do” Lists in four separate Employee Benefits Updates. This Part 1 covers year-end health and welfare plan issues....more
On July 20, 2023, the Department of Health and Human Services (DHHS) through the Office of Civil Rights (OCR) and the Federal Trade Commission (FTC) issued a joint letter to hospitals and telehealth providers alerting them to...more
The No Surprises Act (the NSA) bans “gag clauses” that prevent disclosure of price or quality information in agreements between health plans and certain service providers. In addition, the NSA requires plan sponsors to attest...more
Regulatory enforcement and large litigation relating to the use of third party trackers on companies’ websites and applications have been on the rise. Tracking often occurs without the companies’ knowledge or consent. Third...more
On December 1, 2022, the Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) issued a Bulletin to highlight the obligations of HIPAA-covered entities and business associates when using...more
Proposed changes to the federal substance use disorder law will increase provider efficiency and alignment with the Health Insurance Portability and Accountability Act (HIPAA). In a move that seeks to decrease administrative...more
In the wake of the Supreme Court’s decision to overturn Roe v. Wade, which interpreted a right to abortion in the Constitution through the 14th Amendment, the Department of Health and Human Services (HHS) Office of Civil...more
On June 29, in response to the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, the U.S. Department of Health & Human Services Office for Civil Rights (HHS OCR) issued guidance on when entities...more
On December 10, 2020, the Department of Health and Human Services, Office for Civil Rights (OCR) issued a Notice of Proposed Rulemaking (NPRM) to revise the HIPAA Privacy Rule. The proposed revisions to the Privacy Rule seek...more
The U.S. Department of Health and Human Services (HHS) recently released a final rule further amending 42 CFR Part 2 regulations (Part 2) to allow greater sharing of patient records related to substance use disorder (SUD)...more
On June 12, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) issued timely HIPAA guidance (Guidance) regarding solicitations of blood and plasma donations from recovered COVID-19 patients....more