The 21st Century Cures Act (Cures Act) was signed into law in 2016, in part to promote interoperability of health information technology (health IT) and reduce information blocking (HealthIT.gov, 2023a). This was not the first legislation introduced by the U.S. Congress ta...
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...
such as seminal work by Masys et al1and Cimino et al,2to nearly ubiquitous components of electronic health records. This success has been associated with several factors, including regulatory pressures—eg, the Meaningful Use program and the 21st Century Cures Act—and recent changes to health ...
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。
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, 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. ...
The 21st Century Cures Act focuses on medical research and FDA regulation to bring effective innovations to patients and providers.
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...
FDA's support of the recent passage of the 21st Century Cures Act is indicative of the agency's desire to streamline the medical device regulatory process. Notably, the Cures Act creates a breakthrough pathway for devices that treat life-threatening conditions or impact small populations. The ...
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 January 1, 2020.