News & Analysis as of

21st Century Cures Act Enforcement Actions

King & Spalding

HHS Finalizes Disincentives for Healthcare Providers That Have Committed Information Blocking

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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

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

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

Health Care Compliance Association (HCCA)

[Event] Healthcare Privacy Compliance Academy - October 16th - 19th, San Francisco, CA

Designed for professionals with some compliance knowledge and experience, HCCA’s Healthcare Privacy Compliance Academy is ideal for practitioners who want a deeper understanding of effective compliance management in a...more

McDermott Will & Emery

[Webinar] How Not to Lose $1M: Preparing for HHS-OIG Info Blocking Enforcement - August 15th, 1:00 pm - 2:00 pm EDT

The US Department of Health and Human Services Office of Inspector General (HHS-OIG) issued a final rule to implement its authority under the 21st Century Cures Act to investigate allegations of information blocking and...more

McDermott Will & Emery

Special Report - A Million Reasons to Share: OIG’s Final Rule on Information Blocking Enforcement

McDermott Will & Emery on

On July 3, 2023, the US Department of Health and Human Services Office of Inspector General (OIG) published its long-awaited final rule implementing the 21st Century Cures Act provisions authorizing OIG to investigate claims...more

Health Care Compliance Association (HCCA)

[Virtual Event] Columbus & Indianapolis Regional Healthcare Compliance Conference - June 2nd, 8:25 am - 4:30 pm ET

General and specialty compliance education from the comfort of your home or office - HCCA’s Regional Healthcare Compliance Conferences provide practitioners with virtual compliance learning that covers a wide variety of...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - January 20th, Atlanta, GA

Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education, including updates on the latest news in regulatory...more

Health Care Compliance Association (HCCA)

[Virtual Event] San Francisco Regional Healthcare Compliance Conference - December 2nd, 8:25 am - 4:30 pm PST

General and specialty compliance training from the comfort of your home or office! HCCA’s Regional Healthcare Compliance Conferences provide practitioners with virtual compliance training that includes updates on the...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - October 28th, Louisville, KY

Looking for compliance training and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance training, including updates on the latest news in regulatory...more

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 8th - 10th, Anaheim, CA

Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - January 28th, Orlando, FL

Looking for compliance training and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance training, including updates on the latest news in regulatory...more

Health Care Compliance Association (HCCA)

[Virtual Event] Hawaii Regional Healthcare Compliance Conference - October 7th, 7:55 am - 4:00 pm HST

Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...more

Health Care Compliance Association (HCCA)

[Event] Boston Regional Healthcare Compliance Conference - September 10th, Newton, MA

Our one-day Regional Compliance Conferences provide attendees with a forum to interact with local compliance professionals, share information about your compliance successes and challenges, and create educational...more

Chambliss, Bahner & Stophel, P.C.

Developing Law and Enforcement Trends on Patient Data Access Create New Risks for Radiology Providers

Recent regulatory and enforcement developments in the area of access to patient information create significant new risks for radiology providers. In particular, imaging providers should pay close attention to these...more

Mintz - Health Care Viewpoints

Cures Act Developments: FDA Publishes CFR Amendments Exempting Class II Devices with an Interesting Addition

Since the 21st Century Cures Act became law in December 2016, we have been keeping track of the Food and Drug Administration’s actions to carry out its obligations under the relatively new law. One particular provision of the...more

Sheppard Mullin Richter & Hampton LLP

Information Blocking And The Right To Access Initiative: Why Patients Struggle to Obtain their Medical Records and what the Office...

Access to healthcare information (or lack thereof) has always been touted as one of the key factors/necessities to realizing the promise of technology in the delivery of healthcare. Despite various legislative, judicial,...more

Holland & Knight LLP

Healthcare Law Update: February 2019

Holland & Knight LLP on

CMS Regulation - CMS and ONC Unveil Proposals Transforming Interoperability and Patient Access to Data - The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health...more

McDermott Will & Emery

2018 Digital Health Data Developments – Navigating Change in 2019

Data privacy and security legislation and enforcement saw significant activity in 2018 and early 2019. McDermott’s 2018 Digital Health Year in Review: Focus on Data report – the first in a four-part series – highlights...more

Butler Snow LLP

Pro Te: Solutio Vol. 11 No. 1 – A Reflection on the First Ten Years

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It’s hard to believe a decade has passed since we delivered our first edition of Pro Te: Solutio to your door. Those years have brought enormous changes in the world and in our industry. Innovation has driven everything we...more

Mintz - Health Care Viewpoints

Bah, Humbug! HIPAA Compliance Isn’t Getting Any Easier

As we look back on 2017, one message is clear: don’t be a Scrooge when it comes to HIPAA compliance. With ever-evolving security threats and unrelenting enforcement, regulated entities must maintain a spirit of compliance...more

Mintz - Health Care Viewpoints

FDA Commissioner Announces Stem Cell Enforcement Shift, Plans to Develop Comprehensive Regenerative Medicine Policies

In a major public move that has been long-awaited by proponents of evidence-based stem cell science, FDA Commissioner Scott Gottlieb issued a lengthy statement on August 28, 2017 “on the FDA’s new policy steps and enforcement...more

Foley & Lardner LLP

Seven Key Questions in Understanding the Current Regulatory State of HCT/Ps

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Despite regulations, litigation, and significant draft guidance, the future of regulation of HCT/Ps remains up in the air. Learn what you need to know quickly with these seven questions and answers....more

BCLP

DOL Gives a Peek at Non-quantitative Treatment Limitations

BCLP on

While on this day, most people focus on the heart, we’re going to spend a little time focusing on the head. Under the Mental Health Parity and Addiction Equity Act (MHPAEA), health plans generally cannot impose more stringent...more

Mintz - Health Care Viewpoints

FDA’s Enforcement Priorities Likely to Change in 2017 and Other “Unknowable Knowns”

As we enter a new era in which executive agencies are headed by President Trump, we are also faced with many other transformative changes that will affect FDA-regulated entities in a significant and lasting way. This post...more

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