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Pat G. Ouellette

… Interoperability and Information Blocking Rules under the 21st Century Cures Act. Prior to joining Mintz, Pat was corporate counsel …

HHS Proposes Appropriate Disincentives for Health Care Providers That Commit Information Blocking

… Blocking November 6, 2023 | Blog | … Information Blocking, 21st Century Cures Act, Cures Act, Information Blocking Actor, …

GAO Report Sheds Light on Drug Manufacturers’ Expanded Access Programs

… provision added to the law in December 2016 as part of the 21st Century Cures Act. Specifically, language added to the Federal Food, …

FDA Provides Update on Pre-Cert Program and Launches Digital Health Center of Excellence

… of Excellence created in January 2017 and authorized by the 21st Century Cures Act . Considering its organizational placement, we …

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

Cures Act Developments: FDA Publishes CFR Amendments … Class II Devices with an Interesting Addition Since the 21st Century Cures Act became law in December 2016, we have been …

FDA Updates Digital Health Guidances to Align with 21st Century Cures Act

… FDA Updates Digital Health Guidances to Align with 21st Century Cures Act On September 26, 2019, FDA released a suite of …

QSEHRA - The 21st Century Cures Act Creates a New Health Care Plan Option for Small Employers

… QSEHRA - The 21st Century Cures Act Creates a New Health Care Plan Option for Small …

The Newly Updated Common Rule is Here – And On a Collision Course With the 21st Century Cures Act

… Common Rule is Here – And On a Collision Course With the 21st Century Cures Act On January 18 th , the U.S. Department of Health …

21st Century Cures Act & Real World Evidence: Device Policy as Foundation

21st Century Cures Act & Real World Evidence: Device Policy as Foundation …

Join Mintz and ML Strategies as We Kick-Off Our 21st Century Cures Act Webinar Series

… Join Mintz and ML Strategies as We Kick-Off Our 21st Century Cures Act Webinar Series Next Tuesday, January 12th, Mintz …

21st Century Cures Act – Med Tech Impact Webinar January 18

21st Century Cures Act – Med Tech Impact Webinar January 18 As you have seen in …