News & Analysis as of

Health Technology Department of Health and Human Services (HHS)

Manatt, Phelps & Phillips, LLP

[Webinar] Understanding Recent Developments in Health Care Privacy Laws - July 24th, 10:00 am - 11:00 am PST

This year, the federal government has made significant changes to longstanding health care privacy rules, while state lawmakers continue to enact privacy restrictions on consumer health data. These reforms modify legal...more

Robinson+Cole Health Law Diagnosis

Forecasting the Integration of AI into Health Care Compliance Programs

Health care entities maintain compliance programs in order to comply with the myriad changing laws and regulations that apply to the health care industry. Although laws and regulations specific to the use of artificial...more

NAVEX

Addressing Cybersecurity Expectations in Healthcare

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2024 is shaping up to be a very active year for regulatory and enforcement developments in the healthcare industry – developments that concern not just hospitals and nursing facilities, but many non-healthcare companies as...more

Akin Gump Strauss Hauer & Feld LLP

ONC Steps into AI Regulation by Imposing Requirements for ‘Predictive Decision Support Interventions’; Also Updates Information...

On December 13, 2023, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) published a wide-ranging final rule, Health Data, Technology, and...more

Alston & Bird

Health Care Week in Review: Biden Administration Issued Final Rule on Fees for IDR Process Under NSA; W&M Democrats Release Report...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Hogan Lovells

Providers & payers sign U.S. pledge to develop AI responsibly, as HHS finalizes Health IT rule

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The U.S. Biden administration announced Thursday that 28 health care providers and payers have signed the White House’s voluntary commitment aimed at ensuring the safe development of artificial intelligence (AI), adding to...more

Alston & Bird

Biden Executive Order on Artificial Intelligence Highlights Breadth, Challenges, and More Activity to Come

Alston & Bird on

On October 30, 2023, President Joe Biden signed the Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (EO). The wide-ranging EO covers many sectors of the economy and...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - October 2023 #4

News Briefs - 2024 FDA Guidance Likely to Include AI, Cybersecurity - The Food and Drug Administration is ramping up production of medtech guidance, adding 18 draft documents to the list of priorities for its 2024 financial...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

ArentFox Schiff

OIG Finalizes Rule Authorizing Civil Monetary Penalties Against Information Blocking Violators

ArentFox Schiff on

A final rule published on July 3, 2023, empowers the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) to impose civil monetary penalties (CMP) of up to $1 million for unlawful acts of...more

Davis Wright Tremaine LLP

Information Blocking Enforcement Is Here – Are You Ready?

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) announced its final rule (the Enforcement Rule) implementing the information blocking penalties created by the 21st Century Cures Act...more

Akerman LLP - Health Law Rx

OIG Issues Information Blocking Penalties Final Rule: Health IT Developers and Health Information Exchanges/Networks Have a...

On June 27, 2023, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued its long-anticipated final rule amending the OIG’s civil monetary penalty (CMP) regulations as they relate to...more

Holland & Knight LLP

Information Blocking Enforcement Penalties Begin Sept. 1, 2023

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The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently posted the final rule establishing civil monetary penalties (CMPs) for information blocking (IB Enforcement Rule). The Rule...more

Mintz - Health Care Viewpoints

OIG, HHS Publish Information Blocking CMP Final Rule, Enforcement Priorities

Though there has been much speculation and commentary among industry stakeholders, the Office of Inspector General (OIG) and the Office of the National Coordinator for Health Information Technology (ONC) have not yet begun...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

Holland & Knight LLP

ONC Proposes Updates to Information Blocking Regulations

Holland & Knight LLP on

The U.S. Department of Health and Human Services' (HHS) Office of the National Coordinator for Health Information Technology (ONC) on April 11, 2023, released a Notice of Proposed Rule Making called the Health Data,...more

Fenwick & West LLP

Increased Regulatory Scrutiny on Health Technology Companies’ Use of Advertising Technologies

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The proliferation of health apps and connected devices that allow individuals to track their health conditions, treatment, medications, fitness, fertility, sleep, mental health, diet and other vital areas has led to increased...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 20, Number 3. In This Month's E-News: March 2023

Report on Research Compliance Volume 20, Number 3. February 23, 2023 - The Office of Management and Budget (OMB) is planning to revise the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for...more

Foley & Lardner LLP

‘Move fast and break things’ is a bad idea for health tech startups

Foley & Lardner LLP on

It may seem counterintuitive, but one of the reasons some entrepreneurs are drawn to healthcare are the regulations. No industry outside of defense is as heavily scrutinized, and for good reason: When you deal with people...more

Kerr Russell

Telemedicine in Michigan: 2021

Kerr Russell on

The COVID-19 pandemic continues to demonstrate the importance and effectiveness of telemedicine as a means of providing patients with access to safe and quality medical care through the use of technology... Originally...more

BakerHostetler

[Podcast] Let it Flow: Breaking Down Information Blocking

BakerHostetler on

Partner Vimala Devassy and Associate Kyle Gregory discuss how recent regulations issued by the U.S. Department of Health and Human Services (HHS) represent the latest effort to break down these barriers to interoperability...more

K&L Gates LLP

White Paper: OIG Finalizes New and Revises Existing AKS Safe Harbors and Creates New CMP Law Exception

K&L Gates LLP on

On 2 December 2020, the Office of Inspector General (OIG) in the U.S. Department of Health & Human Services (HHS) issued a long-awaited final rule (the Final Rule or Rule). The Final Rule adds multiple new safe harbors,...more

BakerHostetler

The HHS Regulatory Sprint Removes Some Stark and AKS Hurdles for Donating Healthcare Technology

BakerHostetler on

This is the second in a series of client alerts on the collaborative effort between the Department of Health and Human Services Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS), which...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 12. In This Month's E-News: December 2020

Report on Research Compliance 17, no. 12 (December 2020) - Finalizing a document issued last year, on Nov. 9 the Food and Drug Administration issued “Enhancing the Diversity of Clinical Trial Populations—Eligibility...more

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