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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 …
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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, …
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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 …
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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 …
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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 …
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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 …
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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 …
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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 …
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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 …
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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 …
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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 Healthcare: …
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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 …
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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 …
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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 …
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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 …
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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 …
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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 …
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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 …
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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. …
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Regulators Look to Increase Interoperability and Patient Access to Health Data

… Technology (ONC) released a proposed rule entitled  21st Century Cures Act: Interoperability, Information Blocking, and the …