News & Analysis as of

New Regulations Health Insurance Portability and Accountability Act (HIPAA)

Katten Muchin Rosenman LLP

Have You Done Your Part to Comply with Part 2 Changes?

Important changes are coming to 42 CFR Part 2 (Part 2), which deals with the confidentiality of patients’ substance use disorder (SUD) records. On April 16, 2024, the US Department of Health and Human Services (HHS) published...more

Holland & Knight LLP

U.S. Health Data Affected by New National Security Restrictions on International Data Transfers

Holland & Knight LLP on

Health Insurance Portability and Accountability Act (HIPAA)-covered entities and business associates should be familiar with restrictions on the use or disclosure of protected health information (PHI) under HIPAA rules....more

King & Spalding

OCR Proposes Updates to Strengthen the HIPAA Security Rule

King & Spalding on

On December 27, 2024, the Office for Civil Rights (OCR) at HHS issued a Notice of Proposed Rulemaking (the Proposed Rule) intended to update the Security Rule under the Health Insurance Portability and Accountability Act...more

Keating Muething & Klekamp PLL

Benefits Monthly Minute - December 2024

In the December Monthly Minute, we are wrapping up key benefits developments (including a SECURE 2.0 refresh, a look at HIPAA reproductive health care privacy, and the revised NQTL requirements) and offer action items for...more

Holland & Knight LLP

NY Department of Health Bolsters Hospital Cybersecurity Regulations

Holland & Knight LLP on

New York hospitals have less than a year to dust off their Health Insurance Portability and Accountability Act (HIPAA) compliance programs and update them to comply with more stringent and detailed state regulations. Last...more

Keating Muething & Klekamp PLL

Benefits Monthly Minute - September 2024

The September Monthly Minute highlights the DOL’s extension of existing cybersecurity guidance to health and welfare plans and also addresses the new HIPAA reproductive health privacy rule....more

Ballard Spahr LLP

Health Plan Compliance Deadlines Draw Near

Ballard Spahr LLP on

Regulations under Section 1557 of the Affordable Care Act and HIPAA will require health plans and health care providers to take action in the coming months to meet new requirements. Health plan sponsors and providers that...more

A&O Shearman

Minnesota Governor approves new Consumer Data Privacy Act

A&O Shearman on

On May 24 2024, Senate Bill 4757, a bill for an act relating to commerce containing the Minnesota Consumer Data Privacy Act (the 'Act'), was approved by the Governor of Minnesota. The Act, which becomes effective on July 31...more

Ballard Spahr LLP

HHS Aligns Part 2 Substance Use Disorder Confidentiality Requirements With HIPAA

Ballard Spahr LLP on

Newly effective regulations governing confidentiality of Substance Use Disorder (SUD) records now more closely mirror regulations implementing the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and other...more

Quarles & Brady LLP

Substance Abuse Disorder Records (42 CFR Part 2) Final Rule Is Here!

Quarles & Brady LLP on

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and Substance Abuse and Mental Health Services Administration (SAMHSA) released its anticipated Final Rule last week. The Final Rule revises...more

Bradley Arant Boult Cummings LLP

Florida Bill Proposes Safe Harbor Against Breach Suits to Businesses Maintaining Recognized Cybersecurity Programs

A recently introduced bill in the Florida Legislature would provide businesses operating in Florida, including health care providers, with a legal defense to data breach lawsuits if they maintain robust cybersecurity measures...more

Harris Beach Murtha PLLC

New York Wants Comprehensive Cybersecurity Plans for Hospitals by February 2025

Harris Beach Murtha PLLC on

New York Gov Kathy Hochul is touting her proposed statewide cybersecurity regulations for hospitals and health systems as “nation-leading,” and, if approved, those entities will have until February 2025 to comply with the new...more

Health Care Compliance Association (HCCA)

Compliance Today - January 2023. Now is the time to prepare for changes to the HIPAA Privacy Rule

According to the Office of Information and Regulatory Affairs, Office of Management and Budget, final action on the proposed rules—published in the Federal Register—to modify the HIPAA Privacy Rule is scheduled to occur in...more

Foley Hoag LLP - Security, Privacy and the...

Thirty-Three State Attorneys General Show Support for FTC’s Proposed Crackdown on “Commercial Surveillance”

On August 22, 2022, the Federal Trade Commission (“FTC”) indicated through the Advanced Notice of Proposed Rulemaking its intent to limit commercial surveillance – the common corporate practice of collecting, analyzing, and...more

Ankura

Clinical Trial Management Systems and Compliance

Ankura on

In David Fogel’s published review of 30 years of clinical trial research operations, he sums up the likelihood of study success by saying: “Clinical trials for pharmaceuticals and medical devices offer many...more

King & Spalding

FDA (Finally!) Issues Proposed Rule to Amend FDA Regulations on the Protection of Human Subjects and Institutional Review Boards

King & Spalding on

The Food and Drug Administration (FDA) recently issued a proposed rule that would extensively modify and modernize its current regulations governing the protection of human subjects and Institutional Review Boards (IRBs).1 If...more

Proskauer - Health Care Law Brief

HHS Issues HIPAA Guidance on Remote Communication Technologies for Audio-Only Telehealth

The Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”), recently issued new regulatory guidance relating to covered entities’ HIPAA-compliant use of remote communication technologies for...more

Perkins Coie

California Issues New Regulations on Notification Obligations for Medical Information Breaches

Perkins Coie on

Certain California-licensed healthcare facilities are now subject to additional breach reporting obligations pursuant to regulations (Regulations)[1] issued by the California Department of Public Health (Department) on July...more

Sheppard Mullin Richter & Hampton LLP

California Issues New Health Facility Breach Reporting Requirements

On July 1, 2021, the California Department of Public Health (“CDPH”) issued new regulations (the “Regulations”) effective immediately that more narrowly limit the circumstances under which instances of unauthorized access to...more

Foley & Lardner LLP

California Breach Regulations Applicable to Health Care Facilities Align “Breach” Definition with HIPAA, Expand Reporting...

Foley & Lardner LLP on

California clinics, health facilities, home health agencies, and licensed hospices required to report breaches to the California Department of Public Health (CDPH) under California’s Health and Safety Code Section 1280.15...more

Ankura

Using the NIST Privacy Framework to Assess Privacy Risk and Build a Privacy Program

Ankura on

Since the General Data Protection Regulation (GDPR) went into effect in 2018, over half a dozen countries have passed similar privacy regulations and another few dozen have updated or proposed new privacy regulations. In the...more

Chambliss, Bahner & Stophel, P.C.

Developing Law and Enforcement Trends on Patient Data Access Create New Risks for Radiology Providers

Recent regulatory and enforcement developments in the area of access to patient information create significant new risks for radiology providers. In particular, imaging providers should pay close attention to these...more

Health Care Compliance Association (HCCA)

[Webinar] The COVID-19 pandemic has been with us for many months – so, what’s next? - September 10th, 12:00 pm - 1:30 pm CT

Learning Objectives: - What’s next - preparing and responding to COVID-19 - CARES Act update, funding and compliance - Update and tips for navigating executive order, regulatory and legislative changes - Telehealth...more

Bradley Arant Boult Cummings LLP

SAMHSA Finalizes Revisions to Part 2 Regulations Governing Confidentiality of Substance Use Disorder Records

On July 15, 2020, the Substance Abuse and Mental Health Services Administration (SAMHSA), a branch of the U.S. Department of Health and Human Services (HHS), published its much-anticipated final rule to revise 42 C.F.R. Part...more

Proskauer - Employee Benefits & Executive...

Digging into the New HRA Regulations Part 4: Excepted Benefit HRAs

New regulations issued by the Departments of Labor, Treasury, and Health and Human Services (the “Departments”) have expanded the use of health reimbursement arrangements (“HRAs”), including permitting the use of HRAs to...more

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