News & Analysis as of

Healthcare ONC

McDermott+

McDermottPlus Check-Up: July 12, 2024

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Senate HELP Committee Holds Hearing on Medical Debt. The hearing examined the negative impacts of medical debt and explored potential solutions to address the growing issue. Senators and witnesses highlighted the disparity...more

Manatt, Phelps & Phillips, LLP

CMS and ONC Issue Final Rule on E-Prescribing

On June 17, CMS and the Office of the National Coordinator for Health Information Technology (ONC) issued a final rule implementing new standards for e-prescribing under Medicare Part D. ...more

Ballard Spahr LLP

2024 HIPAA Developments

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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

Mintz - Health Care Viewpoints

Colorado AI Systems Regulation: What Health Care Deployers and Developers Need to Know

As the first state law to regulate the results of Artificial Intelligence System (AI System) use, Colorado’s SB24-205, “Concerning Consumer Protections in Interactions with Artificial Intelligence Systems” (the Act), has...more

McDermott+

HHS Institutes Information Blocking Disincentives for Healthcare Providers

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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

Manatt, Phelps & Phillips, LLP

Manatt Health: Health AI Policy Tracker

The purpose of this quarterly tracker is to identify key federal and state health AI policy activity. Below reflects federal legislative and regulatory activity to date related to AI, and state legislative activity introduced...more

McDermott Will & Emery

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

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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

Epstein Becker & Green

ONC’s “Information Blocking Enhancements” Under the HTI-1 Rule Are in Effect

On Monday, March 11, 2024, the Office of the National Coordinator for Health Information Technology’s (ONC) Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information...more

Fenwick & West LLP

New Federal Requirements for AI and IT System Implementation in Healthcare

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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

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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

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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

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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

Robinson+Cole Health Law Diagnosis

ONC’s HTI-1 Final Rule Updates Information Blocking Regulations

On December 13, 2023, the Office of the National Coordinator for Health Information Technology (ONC) issued its final rule entitled “Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm...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

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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

Burr & Forman

HHS OCR/ONC Announce an Updated Version of Its HIPAA Security Risk Assessment Tool

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The Office of the National Coordinator for Health Information Technology (ONC) and the HHS Office for Civil Rights (OCR) have recently launched a joint HIPAA Security Risk Assessment (SRA) Tool. The tool is designed to assist...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

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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

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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

Burr & Forman

Focus on Electronic Health Information

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There have been several recent governmental actions which highlight the balance between securing electronic patient information and the need for interoperability and appropriate exchange of such information. This article will...more

Proskauer on Privacy

ONC Releases Interoperability Frameworks

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The 21st Century Cures Act directed the National Coordinator to “develop or support a trusted exchange framework, including a common agreement among health information networks nationally.” Fulfilling that mandate, the Office...more

Robinson+Cole Health Law Diagnosis

ONC Information Blocking Data Show Majority of Claims Against Health Care Providers

On February 28, 2022, the Office of the National Coordinator for Health Information Technology (ONC) issued data on information blocking claims received since April 5, 2021, the effective date of information blocking...more

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