News & Analysis as of

Disclosure Requirements Department of Health and Human Services (HHS)

Lathrop GPM

Administration Issues Cross-Agency Guidance Targeting Health Care Pricing and Focusing on Hospitals and Health Plans

Lathrop GPM on

On May 22, 2025, the U.S. Department of Health and Human Services, Department of Treasury and Department of Labor (the “Agencies”) announced new steps intended to “strengthen healthcare price transparency.” ...more

Holland & Knight LLP

New York Budget Omits Changes to State's "Disclosure of Material Transactions" Law

Holland & Knight LLP on

In a prior blog post, we summarized proposed legislation included in New York Gov. Kathy Hochul's state fiscal year (FY) 2025-2026 budget that would have subjected "material transactions" to additional disclosure and...more

Robinson+Cole Data Privacy + Security Insider

Insight Into DOGE’s Access to HHS’ Systems

Becker’s Hospital Review reports that the Department of Government Efficiency (DOGE) “has access to sensitive information in 19 HHS databases and systems,” according to a court filing obtained by Wired. HHS provided the...more

Foster Garvey PC

Hospital Price Transparency: What Hospitals Need to Know About Trump's Executive Order

Foster Garvey PC on

On February 28, 2025, President Trump issued Executive Order 14221 (“EO”), which requires the Federal government to “promote universal access to clear and accurate health care prices” and “increase enforcement of price...more

MoFo Life Sciences

HHS Secretary to FDA: Consider Elimination of GRAS Self-affirmation Pathway

MoFo Life Sciences on

On March 10, the U.S. Department of Health and Human Services (HHS) issued a press release emphasizing “radical transparency to make sure all Americans know what is in their food” and announcing that HHS Secretary Robert F....more

McDermott+

Breaking Down the New No Surprises Act FAQs Post-TMA III

McDermott+ on

On January 14, 2025, the US Departments of Labor, Health and Human Services (HHS), and the Treasury (collectively, the Departments), along with the Office of Personnel Management (OPM), jointly issued Part 69 of a series of...more

Vedder Price

Trump Administration Issues Executive Order Mandating Implementation and Enforcement of Health Care Pricing Transparency

Vedder Price on

On February 25, 2025, President Donald J. Trump signed an executive order titled “Making America Healthy Again by Empowering Patients with Clear, Accurate, and Actionable Healthcare Pricing Information” (the “2025 Order”)...more

Wiley Rein LLP

Trump Prioritizes Health Care Pricing Transparency in New Executive Order

Wiley Rein LLP on

On Tuesday, February 25, 2025, President Trump issued an Executive Order (EO), “Making America Healthy Again By Empowering Patients with Clear, Accurate, and Actionable Healthcare Pricing Information.” The EO aims to improve...more

Akin Gump Strauss Hauer & Feld LLP

Making America Healthy Again By Empowering Patients With Clear, Accurate, and Actionable Healthcare Pricing Information (Trump EO...

The EO announces a policy of the United States to put patients first and ensure they have the necessary information to make well-informed healthcare decisions. The order builds upon Executive Order 13877 (Improving Price and...more

Bass, Berry & Sims PLC

Athira Pharma Inc. Agrees to Settle False Claims Act Allegations

Bass, Berry & Sims PLC on

On January 6, the Department of Justice (DOJ) announced that Athira Pharma Inc., a Washington-based biopharmaceutical company, agreed to pay over $4 million to settle allegations it violated the False Claims Act (FCA). The...more

Harris Beach Murtha PLLC

"No Surprises Act" Ruling Favors Regulators, Insurers

Federal regulators recently won a large legal victory when the Fifth Circuit Court of Appeals upheld several provisions of the rule regulating Qualified Payment Amount (“QPA”) calculations under the No Surprises Act (the...more

Davis Wright Tremaine LLP

Whether Naughty or Nice, Compliance Deadline for HIPAA Reproductive Care Privacy Is Coming to Town

We just want to provide a friendly reminder that, before key staff depart for the holidays, HIPAA covered entities and business associates should finalize their compliance with the 2024 HIPAA amendments related to...more

Health Care Compliance Association (HCCA)

Disclosure of Full Record to Employer Results in $35K Fine, Broad CAP; Echoes of 2017 HIV Case

It’s not immediately obvious why someone would want to disclose a health care test result as part of a job application. But one such request spurred a Pennsylvania entity to provide a lot more than that: it sent her whole...more

Proskauer - Health Care Law Brief

No Surprises Here!  Fifth Circuit Upholds QPA Calculations and Disclosure Requirements, but Sides with Providers on Payment...

The Fifth Circuit Court of Appeals has handed down a significant decision in response to a challenge from health care providers to the implementing regulations of the No Surprises Act (“NSA”). The Court upheld the...more

Harris Beach Murtha PLLC

“No Surprises Act” Ruling Favors Regulators, Insurers

Share Federal regulators recently won a large legal victory when the Fifth Circuit Court of Appeals upheld several provisions of the rule regulating Qualified Payment Amount (“QPA”) calculations under the No Surprises Act...more

Stevens & Lee

Compliance Deadlines Approaching for HIPAA Final Rule Supporting Reproductive Health Care Privacy

Stevens & Lee on

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

Health Care Compliance Association (HCCA)

In This Month’s E-News: September 2024

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

Bass, Berry & Sims PLC

New Reproductive Health Care Privacy Final Rule: Key Compliance Steps and Dates

Bass, Berry & Sims PLC on

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

Holland & Hart - The Benefits Dial

P-R-I-V-A-C-Y is Priceless to Me: The 2024 Privacy Rule

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

Holland & Hart LLP

Avoiding HIPAA Penalties: A Checklist for Covered Entities

Holland & Hart LLP on

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

Moore & Van Allen PLLC

New OCR Guidance on Tracking Technologies

Moore & Van Allen PLLC on

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

Gardner Law

Amidst Legal Fight, HHS Revises Online Tracking Guidance

Gardner Law on

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

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 2, March 2024

HHS Cybersecurity Performance Goals and the Healthcare Industry - The healthcare industry is a major target for cyberattacks because of all of the personal information collected from patients. Recognizing that the healthcare...more

Davis Wright Tremaine LLP

Old Rule, New Tricks: HHS Finalizes Most Substantial Changes to Substance Use Disorder Confidentiality Rule in Decades

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

McDermott+

SAMHSA Issues Final Reg Aligning 42 CFR Part 2 With HIPAA

McDermott+ on

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

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