| Mintz

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 …

21st Century Cures Act Requires FDA to Expand the Role of Real World Evidence

… 21st Century Cures Act Requires FDA to Expand the Role of Real World Evidence …

Jan

12

2017

Part I: Introduction to the 21st Century Cures Act

… Part I: Introduction to the 21st Century Cures Act Topics 21st Century Cures Act Webinar Series This …

Closing the Orphan Drug Act Loophole

… for drug pricing reform, whether that’s ultimately Cures 2.0 or a separate bill . If this reform legislation … Drug Orphan Drug Act Orphan Drug Program Orphan Drug Rule 21st Century Cures 21st Century Cures Act Cures Act Food & Drug …

Health Care: A Clearer Vision in 2020? Don’t Bet On It

… the prospects for a bill. We are also keeping an eye on the Cures 2.0 effort, which was launched in late 2019 by … (D-CO) and Fred Upton (R-MI), both champions of the 2016 21st Century Cures Act that focused on research, regulation, and …

FDA 2018 Year in Review (and a Few Thoughts on 2019)

… in late 2017 to align with the changes required by the 21st Century Cures Act , which was signed into law in December 2016. In …

Building a Health App? Part 3: What You Need to Know About FDA’s Regulation of Mobile Apps

… discretion because they pose a low risk to patients. 21 st Century Cures Act As a result of the 21st Century Cures Act (the “Act”), the definition of …

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

… as we previously reported, the December 2016 bipartisan 21st Century Cures Act ("Cures Act") included a new accelerated approval …

GAO Report: Medicare Reimbursement Policies Impede Telehealth Adoption

… Medicare telehealth reimbursement barriers. In the 21 st Century Cures Act, Congress called for expanding the use of … climate. April 26, 2017 Blog Health Care 115th Congress 21st Century Cures Act CMS CMS Innovation Center GAO report …

Briefings on HIPAA: Inside the 21st Century ONC Cures Act

… Briefings on HIPAA: Inside the 21st Century ONC Cures Act Mintz Of Counsel Kate Stewart was quoted in an …