News & Analysis as of

Compliance Health Insurance Portability and Accountability Act (HIPAA) Regulatory Requirements

Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations. ... more +
Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations.  In response to many corporate scandals evidencing rampant unethical business practices, many nations, including the United States, began passing strict regulatory frameworks aimed at curbing these abuses. Notable pieces of legislation in this area include the U.S. Foreign Corrupt Practices Act (FCPA), Sarbanes-Oxley (SOX), and the U.K. Bribery Act, to name a few. The foregoing statutes and the severe penalties often associated with them form the basis of many modern institutional compliance programs. less -
Woods Rogers

Federal Court Strikes Down HIPAA Reproductive Health Privacy Rule Lifting Compliance Requirements for Regulated Entities

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In a sweeping decision published in June, a federal court in Texas struck down most of the HIPAA Rule to Support Reproductive Health Care Privacy (Reproductive Health Rule) enacted in 2024 under the Biden administration to...more

McDermott Will & Emery

Partnering with Legal at the Critical AI/Healthcare Crossroads

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The intersection of AI and healthcare is outpacing the development of laws and regulations governing the technology. Even in the early days of AI transformation, this is creating uncertainty for healthcare organizations....more

Ropes & Gray LLP

Navigating TRAIGA: Texas’s New AI Compliance Framework

Ropes & Gray LLP on

On June 22, 2025, Texas enacted the Texas Responsible Artificial Intelligence Governance Act (“TRAIGA”), putting it at the forefront of state-level AI regulation in the United States. TRAIGA becomes effective January 1, 2026....more

Foley & Lardner LLP

The Intersection of AI, Digital Health, and the TCPA: What You Need to Know

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Artificial intelligence (AI) is widely transforming digital health, including by automating certain patient communications. However, as health care companies consider deploying AI-driven chatbots, texting platforms, and...more

Baker Donelson

DOJ Bulk Data Rule: Key Takeaways for Healthcare and Life Sciences

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The Data Security Program (DSP), implemented by the Department of Justice's National Security Division (DOJ/NSD) under Executive Order 14117 (Preventing Access to Americans' Bulk Sensitive Personal Data and United States...more

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

Foley & Lardner LLP

HIPAA Compliance for AI in Digital Health: What Privacy Officers Need to Know

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Artificial intelligence (AI) is rapidly reshaping the digital health sector, driving advances in patient engagement, diagnostics, and operational efficiency. However, for Privacy Officers, AI’s integration into digital health...more

Perkins Coie

HHS Proposal To Strengthen HIPAA Security Rule

Perkins Coie on

Earlier this year, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) adopted a new proposal to strengthen the Health Insurance Portability and Accountability Act (HIPAA) security standards...more

Bodman

Resolutions for Healthcare Providers: Part 2 of 2 – Compliance Plans, Risk Assessments, and Improved Workflows

Bodman on

As the new year continues, it is useful to review your practice’s processes and policies to ensure that the practice operates with efficiency and remains compliant with ever-changing healthcare regulations....more

Buchalter

Significant New HIPAA Obligations on Their Way for 2025

Buchalter on

The Department of Health & Human Services (HHS) issued proposed changes to the HIPAA Security Rule (“Proposed Rule”) on January 6, 2025, and is accepting comments from the public until March 7, 2025. The Proposed Rule...more

Husch Blackwell LLP

Compliance with the HIPAA Privacy Rule to Support Reproductive Healthcare Privacy

Husch Blackwell LLP on

On April 22, 2024, the Health and Human Services’ Office for Civil Rights (OCR) issued the HIPAA Privacy Rule to Support Reproductive Health Care Privacy Final Rule. The final rule limits the sharing of protected health...more

Foley & Lardner LLP

New York’s Proposed Health Information Privacy Act Takes Aim at Digital Health Companies

Foley & Lardner LLP on

The New York Health Information Privacy Act (NYHIPA), if enacted, could create a chilling effect on patient access and engagement to readily available digital health care services relied upon by New Yorkers. Digital health...more

Epstein Becker & Green

Recent Developments in Health Care Cybersecurity and Oversight: 2024 Wrap Up and 2025 Outlook

Epstein Becker & Green on

As Cyberattacks targeting the health care sector have continued to intensify over the past year, including ransomware attacks that have resulted in major data breaches impacting health care organizations, the protection of...more

Warner Norcross + Judd

Holy Smokes: Is Your Tobacco Surcharge Program Compliant?

Warner Norcross + Judd on

A “tobacco surcharge” is part of many employers’ wellness programs, where the employer charges tobacco users higher health insurance premiums than non-tobacco users. A typical tobacco surcharge program will ask an employee if...more

Ankura

Is there room for AI in the ICU? Guiding Principles and Compliance Considerations

Ankura on

Artificial Intelligence (AI) offers unprecedented opportunities to enhance patient care, streamline clinical documentation, and support medical decision-making processes. More and more healthcare professionals find themselves...more

Health Care Compliance Association (HCCA)

Recognized Security Practices ‘Saved’ Covered Entity $60K of $300K Fine, But Which Ones Remain a Mystery

Covered entities (CEs) and business associates (BAs) may receive a “discount” for having recognized security practices (RSPs) in place when the HHS Office for Civil Rights (OCR) calculates financial penalties for Security...more

Akerman LLP - Health Law Rx

New York Focuses on Healthcare Cybersecurity: Recent Regulatory and Enforcement Activities

The healthcare sector has seen an alarming uptick in cybersecurity incidents, including ransomware attacks, in recent years. In response to these cybersecurity threats, New York State is ramping-up efforts to protect patient...more

Health Care Compliance Association (HCCA)

2nd Settlement Triggered by 2017 Ransomware Attack Costs WA Practice $100K; ‘Not a Breach’

Let’s review for a moment. It’s not a HIPAA violation to be a victim of ransomware. It’s not a HIPAA violation to pay a ransom. It’s up to the covered entity (CE) to determine if a security or privacy incident is a...more

Health Care Compliance Association (HCCA)

[Webinar] The Metrics of Selecting Effective Metrics - September 11th, 12:00 pm - 1:30 pm CT

Learning Objectives: - Assess and identify how to select metrics that matter in measuring the effectiveness and progress of a compliance program - Align metrics with regulatory requirements and how they apply to one's...more

Society of Corporate Compliance and Ethics...

[Event] Regional Compliance & Ethics Conference - May 3rd, Lewis Center, OH

Looking for compliance education and networking in your area? SCCE & HCCA’s Regional Compliance & Ethics Conferences bring compliance practitioners from all disciplines together for convenient, local compliance education....more

Health Care Compliance Association (HCCA)

[Event] Regional Compliance & Ethics Conference - May 3rd, Lewis Center, OH

Looking for compliance education and networking in your area? SCCE & HCCA’s Regional Compliance & Ethics Conferences bring compliance practitioners from all disciplines together for convenient, local compliance education....more

Health Care Compliance Association (HCCA)

[Event] Regional Compliance & Ethics Conference - February 22nd - 23rd, Anchorage, AK

Looking for compliance education and networking in your area? SCCE & HCCA’s Regional Compliance & Ethics Conferences bring compliance practitioners from all disciplines together for convenient, local compliance education....more

Society of Corporate Compliance and Ethics...

[Event] Regional Compliance & Ethics Conference - February 22nd - 23rd, Anchorage, AK

Looking for compliance education and networking in your area? SCCE & HCCA’s Regional Compliance & Ethics Conferences bring compliance practitioners from all disciplines together for convenient, local compliance education....more

Health Care Compliance Association (HCCA)

As AI-Assisted Research Advances, Experts Share Worries, Oversight Strategies; Collaboration Urged

At Cornell University, institutional review board (IRB) members meet with the chief information security officer and a liaison to the general counsel’s office. Their regular attendance has been “really critical,” said IRB...more

Health Care Compliance Association (HCCA)

[Event] 28th Annual Compliance Institute - April 14th - 17th, Nashville, TN

Get ready to be inspired with game-changing insights and industry connections! For over two and a half decades, healthcare compliance professionals have gathered at HCCA’s Compliance Institute (CI) to share ideas, learn...more

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