21st Century Cures Act: What Life Sciences Companies Need To KnowDaniel A. Kracov
The Cures Act deadline is coming on April 5th, but with everything that SNFs have going on how can they meet this deadline. We've put together a guide to help them get compliant and engage their patients and family members in a meaningful way.
Many experts, including multiple FDA insiders, have complained about the progressive decay of scientific standards at the agency. This has only gotten worse since 2016, with the passage of the 21st Century Cures Act, which gives the FDA enormous leeway in what kinds of studies it demands of co...
President Obama signed in a law, known as the 21st Century Cures Act, on December 13, 2016. The goal of the Cures Act is to decrease the administrative burdens, encourage innovation, and to enhance America’s healthcare field. Lobbying over this bill has been strong between the two politica...
The FDA hasapprovedseveral stem cell-based products. Thanks to the 21st Century Cures Act, the FDA established clear guidelines for which stem-cell treatments it oversees in 2017. This includes bone marrow transplantation to treat certain cancers, as well as blood and immune system disorders. ...
Additionally, HHS said it plans to leverage the 21st Century Cures Act to enhance innovation and promote access and use of electronic health information. The Cures Act includes provisions that can: promote the development and use of upgraded health IT capabilities; establish transparent expectations ...
The 21st Century Cures Act, passed by Congress in late 2016, actually promotes real-world evidence. The practice offers a way for a medtech company to prove safety and efficacy without necessarily having to conduct a clinical trial. But there are also worries that it exposes a device company...
In 2016, President Obama took a major step to solveinformation blockingby signing the 21st Century Cures Act, which requires EHR systems to provide a patient-facing API to maintain their federal certification. In 2020, the Centers for Medicaid & Medicare Services (CMS) issued a rule requiring ...
This facet of the 21stCentury Cures Act is important because it includes not just patient data access—which in some cases could start and end with a copy of one’s health records—but also clinical notes. In essence, the Cures Act is putting into action widespread OpenNotes, ...
The push for interoperability has been further emphasized by recent regulatory requirements such as the21st Century Cures Act, which mandates easier access toelectronic health informationfor patients and providers. Healthcare CIOs are pivotal in aligning their systems with these regulations to ensure...