The 21st Century Cures Act has the potential to reduce racial health disparities in the criminal justice system through the Act's public health approach to addiction and mental health issues. The 21st Century Cures Act is a progressive step in the right direction; however, given the historical ...
To the Editor: In their Perspective article (June 25 issue),1 Avorn and Kesselheim argue that the 21st Century Cures Act, which is currently being debated in Congress, would lower the regulatory standards of the Food and Drug Administration (FDA) by giving it greater discretion to approve dr...
the Meaningful Use program and the 21st Century Cures Act—and recent changes to health care delivery models supporting asynchronous and virtual telehealth care. Use of patient portals is also influenced by important but relatively understudied cultural changes in people’s expectations of seamless access...
The 21st Century Cures Act, as well as the June 2018 FDA guidance on payor communications have more clearly defined guardrails to communicate this information. This paper provides insights on how to optimize this new guidance and facilitate robust and compliant conversations with decision-makers. ...
21st Century Cures Actneglected diseasesEbolaZikaincentivesThe priority review voucher program at the Food and Drug Administration (FDA) was established in 2007 to incentivize research and development (R&D) in tradiSantos Rutschman, AnaSocial Science Electronic Publishing...
Statement on Senate Passage of the 21st Century Cures ActObama, Barack H
Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the drug development and review processes for promising regenerative medicine pipeline products. A regenerative medicine therapy is eligible for RMAT design...
The 21st Century Cures Act was passed in an effort to promote innovation in healthcare and requires, among other things, the support of health information technology interoperability. The key to achieving full interoperability is the representation of health data in the FHIR format. While FHIR is...
真实世界研究(Real World Study,RWS)的概念是从2016年美国资助癌症研究和精确药物治疗的法案——《21世纪治愈法案》(21st Century Cures Act)开始兴起的,法案批准利用“真实世界证据”(Real World Evidence)取代传统临床试验进行扩大适应症的批准,可以说是当年业界的重大突破。
On March 19 CMS and ONC released the final rules for interoperability under the 21st Century Cures Act. The rules mandate payers and providers begin sharing data via application programming interfaces (APIs) as early as July 1, 2021.Download The Cures Act and Healthcare Interoperability: A call...