News & Analysis as of

21st Century Cures Act

Knobbe Martens

FDA Provides Perspective on Goals and Challenges for Regulation of Artificial Intelligence in Medical Devices, Drug Design, and...

Knobbe Martens on

A recent article authored by Haider J. Warraich, MD; Troy Tazbaz; and Robert M. Califf, MD in the Journal of the American Medical Association, reviews the history of artificial intelligence (AI) regulation by the U.S. Food...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Privacy Compliance Academy - January 27th - 30th, Orlando, FL

HCCA's Healthcare Privacy Compliance Academy is a three-and-a-half-day interactive education program with a focus on the vast body of privacy laws and regulations in place to help you protect PHI and other critical data. Our...more

Epstein Becker & Green

As the Window for Comments Closes on ONC/ASTP’s HTI-2 Proposed Rule: What’s in HTI-2 and What Does It Mean for You?

Epstein Becker & Green on

On August 5, 2024, the Office of the National Coordinator for Health Information Technology— now known as the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT (“ASTP/ONC”) within the...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - October 25th, Louisville, KY

Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education on a wide variety of current and emerging topics...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Privacy Compliance Academy - December 9th - 12th, San Diego, CA

HCCA's Healthcare Privacy Compliance Academy is a three-and-a-half-day interactive education program with a focus on the vast body of privacy laws and regulations in place to help you protect PHI and other critical data. Our...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Privacy Compliance Academy - November 18th - 21st, Boston, MA

HCCA's Healthcare Privacy Compliance Academy is a three-and-a-half-day interactive education program with a focus on the vast body of privacy laws and regulations in place to help you protect PHI and other critical data. Our...more

Burr & Forman

Healthcare Provider Disincentives for Information Blocking

Burr & Forman on

On June 31, 2024, the Department of Health and Human Services (“HHS”) published a final rule establishing penalties for healthcare providers who violate the information blocking rules implemented under the 21st Century Cures...more

McDermott Will & Emery

ASTP’s HTI-2 Proposed Rule Would Add and Expand Information Blocking Exceptions

On August 5, 2024, the US Department of Health and Human Services (HHS) Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP) published the Health Data,...more

Proskauer - Health Care Law Brief

OIG Reports that Clinical Trials Lack Diverse Subjects: What Role Can Artificial Intelligence Play?

As the largest public funder of biomedical research in the world, the National Institutes of Health (“NIH”) annually funds over $38 billion in extramural research, including about $6 billion for clinical trials. On May 28,...more

BakerHostetler

Healthcare Providers Beware: Finalized Disincentives Sharpen the Teeth of Information Blocking Rule

BakerHostetler on

On June 24, 2024, the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) at the Department of Health and Human Services (HHS) issued the 21st...more

Davis Wright Tremaine LLP

21st Century Cures Act Information Blocking Rule Finally Has Teeth With Respect to Providers

On July 1, 2024, the U.S. Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) and Office of the National Coordinator for Health Information Technology (ONC) published a final rule...more

Nelson Mullins Riley & Scarborough LLP

HHS Rule Targets Health Providers Blocking Patient Info Sharing (RIN 0955-AA05)

Healthcare providers are facing penalties for blocking access to a patient’s electronic health information under a new Biden administration rule. On June 24, the U.S. Department of Health and Human Services (HHS)...more

McDermott Will & Emery

HHS Issues Provider Information Blocking Disincentives Final Rule

On July 1, 2024, the US Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS) published a final rule in...more

King & Spalding

HHS Finalizes Disincentives for Healthcare Providers That Have Committed Information Blocking

King & Spalding on

Last week, HHS published its final rule outlining disincentives for certain healthcare providers that have committed information blocking (the Final Rule). The Final Rule also provides information related to OIG’s...more

Baker Donelson

Information Blocking: Disincentives Established for Health Care Providers

Baker Donelson on

The United States Department of Health and Human Services (HHS) has now established disincentives for certain health care providers if found by the Office of Inspector General (OIG) to have committed information blocking...more

Holland & Knight LLP

HHS Is Primed to Enforce Information Blocking Conduct

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The U.S. Department of Health and Human Services (HHS) continued its commitment to timely and full access to health records on June 24, 2024, through the finalization of its information blocking disincentives rule for...more

Holland & Knight LLP

Reproductive Healthcare Privacy Rule Brings New Requirements for All Providers

Holland & Knight LLP on

In the midst of an industry reeling from the Change Healthcare cybersecurity incident, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has issued a series of final rules requiring...more

Chambliss, Bahner & Stophel, P.C.

Supplemental vs. Special Needs Trusts: Any Difference?

Have you heard the terms “special” needs trust and “supplemental” needs trust and wondered what the difference is? The simple answer is that there’s no difference. Whether supplemental or special, these trusts serve the...more

Baker Donelson

Providers Take Note: The Common Agreement Version 2.0 Released

Baker Donelson on

The Office of the National Coordinator for Health Information Technology (ONC) released the anticipated Common Agreement Version 2.0 on April 22, 2024. Since 2016, the ONC has been working to implement the requirements of the...more

Holland & Knight LLP

Finalized HTI-1 Interoperability and Information Blocking Updates Have Taken Effect

Holland & Knight LLP on

The U.S. Department of Health and Human Services' (HHS) Office of the National Coordinator for Health Information Technology (ONC) published its Health Data, Technology, and Interoperability: Certification Program Updates,...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Privacy Compliance Academy - July 15th - 18th, Charlotte, NC

Ideal for professionals with some compliance knowledge and experience, HCCA’s Healthcare Privacy Compliance Academy offers practitioners a deeper understanding of effective compliance management in a healthcare setting. The...more

Alston & Bird

Health Care Week in Review: Congress Passed a New Continuing Resolution for FY 2024 to Avert a Government Shutdown; Biden...

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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

Gardner Law

What Does FDA Think of AI?

Gardner Law on

Speaking at CES 2024 earlier this year, U.S. Food and Drug Administration (FDA) Commissioner Robert Califf expressed significant concerns about the FDA’s ability to effectively regulate artificial intelligence (AI) in the...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Privacy Compliance Academy - May 6th - 9th, San Antonio, TX

Ideal for professionals with some compliance knowledge and experience, HCCA’s Healthcare Privacy Compliance Academy offers practitioners a deeper understanding of effective compliance management in a healthcare setting. The...more

Holland & Knight LLP

CMS Previews Changes to Medicare Advantage Capitation Rates, Parts C and D Payment Policies

Holland & Knight LLP on

The Centers for Medicare & Medicaid Services (CMS) released its Advance Notice of Methodological Changes for Calendar Year (CY) 2025 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies on Jan....more

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