News & Analysis as of

Department of Health and Human Services (HHS) Healthcare ONC

Ballard Spahr LLP

2024 HIPAA Developments

Ballard Spahr LLP on

Over the course of the past few months, the Office of Civil Rights (OCR) and the Office of the National Coordinator for Health Information Technology (ONC), both of which are divisions of the U.S. Department of Health and...more

McDermott+

HHS Institutes Information Blocking Disincentives for Healthcare Providers

McDermott+ on

The long-awaited final reg is upon us! The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) released a final regulation earlier this week...more

McDermott Will & Emery

Special Report: Understanding ONC’s Health AI Transparency and Risk Management Regulatory Framework

McDermott Will & Emery on

The Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) final rule, issued by the US Department of Health and Human Services (HHS) Office of...more

Fenwick & West LLP

New Federal Requirements for AI and IT System Implementation in Healthcare

Fenwick & West LLP on

On October 30, 2023, the Biden administration issued Executive Order 14110 on the Safe, Secure and Trustworthy Development and Use of Artificial Intelligence (the “Executive Order”). As detailed in our previously published...more

McDermott+

Baby Steps Toward Implementing a Regulatory Framework for AI in Healthcare

McDermott+ on

A few weeks ago, Regs & Eggs highlighted the major issues that McDermott+Consulting is monitoring this year – and the implementation of the president’s executive order (EO) on artificial intelligence (AI) was definitely part...more

Snell & Wilmer

HHS Establishes Certification Requirements for Artificial Intelligence and Machine Learning Software Developers

Snell & Wilmer on

As the impact of artificial intelligence on various sectors of the U.S. economy grew in 2023, so did the involvement of regulators and policymakers. One of the most recent — and substantive — regulatory standards is the...more

Fox Rothschild LLP

Groundbreaking U.S. Artificial Intelligence (AI) Rule May Mean A Healthier New Year In 2025 and Beyond

Fox Rothschild LLP on

Exactly 12 days before Christmas, the U.S. Department of Health and Human Services’ Office of the National Coordinator (ONC) gave the health industry a unique gift buried in a 900+ page rule adoption. The gift? The first...more

Quarles & Brady LLP

HHS Finalizes AI Transparency Rule

Quarles & Brady LLP on

On December 13, the U.S. Department of Health and Human Services (HHS) through the Office of the National Coordinator for Health Information Technology (ONC) finalized its Health Data, Technology, and Interoperability:...more

Manatt, Phelps & Phillips, LLP

HHS Finalizes Regulation of Certain AI

This week, the U.S. Department of Health and Human Services (HHS) took its first step in actually regulating the use of artificial intelligence (AI) in health care. Through its Office of the National Coordinator for Health...more

Akin Gump Strauss Hauer & Feld LLP

President Biden's AI EO: Key Takeaways for Health Care & Life Sciences

Key Points - President Biden’s eagerly-awaited executive order (EO) on artificial intelligence (AI) tasks the Department of Health & Human Services (HHS) with promoting responsible AI innovation, development and use,...more

Bass, Berry & Sims PLC

HHS Proposes Rule to Establish Disincentives for Healthcare Providers That Engage in Information Blocking

Bass, Berry & Sims PLC on

In 2020, when the U.S. Department of Health and Human Services (HHS) published its Final Rule to implement the information blocking prohibitions of the 21st Century Cures Act, HHS left healthcare providers wondering what...more

Davis Wright Tremaine LLP

HHS Proposes Information Blocking Disincentives for Health Care Providers

While health care providers have been required to comply with the 21st Century Cures Act Information Blocking Rule (the Rule) since April 5, 2021, as of yet there is no enforcement mechanism in place with respect to the Rule...more

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

HHS OCR/ONC Announce Latest Version of Security Risk Assessment Tool

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) and the Office of the National Coordinator for Health Information Technology (ONC) have released version 3.4 of their Security Risk Assessment...more

Troutman Pepper

Enforcement of Information Blocking Penalties in Health Care IT Begins

Troutman Pepper on

On September 1, the Department of Health and Human Services Office of Inspector General (HHS-OIG) will begin enforcing information blocking penalties against certain health care information technology (IT) actors as published...more

McDermott Will & Emery

Inside the ONC’s Plans to Regulate Health AI: Proposal on Predictive Decision Support Interventions

McDermott Will & Emery on

The Department of Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) published a notice of proposed rulemaking on April 18, 2023, titled “Health Data, Technology, and...more

Pullman & Comley - Connecticut Health Law

ONC Releases New Guidance FAQs on Information Blocking

Recently, the Office of the National Coordinator for Health IT (ONC) issued a new series of helpful FAQs related to its information blocking regulations. The new FAQs cover a wide range of topics, including the content and...more

Faegre Drinker Biddle & Reath LLP

A Recap of National Health IT Week

National Health IT Week wrapped up on Friday. This may have been the most eventful week in the ten year history of the event, which is organized by the Health Information Management Systems Society (HIMSS). Below are a few...more

Womble Bond Dickinson

Is Your HIPAA Compliance Program Ready for the FTC?

Womble Bond Dickinson on

Everyone in healthcare knows that the next round of HIPAA audits is coming. Covered entities and business associates have long been advised to review and update their HIPAA security risk analyses, have business associate...more

King & Spalding

Also In The News - Health Headlines - October 2015 #2

King & Spalding on

HHS Publishes Final Federal Health IT Strategic Plan 2015-2020 – On September 21, 2015, the Office of the National Coordinator for Health Information Technology (ONC) of HHS laid out the federal government’s final version of...more

Robinson & Cole LLP

HHS/Office of the National Coordinator issues report that health information sharing is being blocked to gain a competitive edge

Robinson & Cole LLP on

In a scathing report released last Friday, the Department of Health and Human Services Office of the National Coordinator (ONC) accused hospitals and software vendors of preventing the sharing of health information in order...more

Mintz - Health Care Viewpoints

Health Care Update - July 2014 #3

In This Issue: - First Guidance following Hobby Lobby released - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Congressional and State Initiatives ...more

Obermayer Rebmann Maxwell & Hippel LLP

News from the Health Law Gurus™

News from the Health Law Gurus™ is a weekly summary of notable health law news from around the country with helpful links to related content. Burwell Confirmed as HHS Secretary—Last week, the Senate approved of the...more

Mintz - Health Care Viewpoints

The ONC’s Health IT Vision Plan: A Building Under Construction

The HHS Office of the National Coordinator (ONC) released its report “Connecting Health and Care for the Nation: A 10-Year Vision to Achieve an Interoperable Health IT Infrastructure” (the “Vision Plan”) last week to help...more

Foley & Lardner LLP

Finally…FDASIA Health IT Regulation Report Released

Foley & Lardner LLP on

The U.S. Food and Drug Administration (FDA), along with HHS’ Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC, together with FDA and ONC, the...more

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