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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
… exchanges, and health information networks. Under the 21st Century Cures Act, health care providers determined by the HHS …
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 …
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 …
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 …
Senate Passes 21st Century Cures Act, but Can It Cure an Ailing FDA?
… Senate Passes 21st Century Cures Act, but Can It Cure an Ailing FDA? On Wednesday, the U.S. …
President Obama Signs 21st Century Cures Act; Creates Accelerated Approval Pathway for Regenerative Medicine
… President Obama Signs 21st Century Cures Act; Creates Accelerated Approval Pathway for Regenerative …
Cures Act Developments: FDA Proposes Class II Device Exemptions
… Cures Act Developments: FDA Proposes Class II Device Exemptions Since the 21st Century Cures Act became law on December 13, 2016, we have …