AdvaMed pushes CMS to implement MCIT final rule without further delay healthcaredive.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from healthcaredive.com Daily Mail and Mail on Sunday newspapers.
Key FDA Drug and Device Updates Wednesday, April 21, 2021
Over the past month, there have been a significant number of developments affecting FDA-regulated companies. This GT Alert provides an update on key FDA personnel changes; on final regulations governing software that are exempt from FDA-regulation as a result of the 21st Century Cures Act (Pub. L. 114-255); and on a new FDA policy related to drug facility inspections. In addition, there are other announcements regarding medical devices and the regulation of certain personal protection equipment (PPE).
Personnel at FDA
Dr. Patrizia Cavazzoni appointed director of the Center for Drug Evaluation and Research (CDER).
Online Healthcare Technology Market to See Major Growth by 2025 sandiegosun.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from sandiegosun.com Daily Mail and Mail on Sunday newspapers.
Post-acute facilities face hurdles in healthcare s interoperability push
Modern Healthcare Illustration / Getty Images
Landmark data-sharing regulations from HHS Office of the National Coordinator for Health Information Technology and CMS seek to tie healthcare providers and patients across the care continuum closer together but historical disparities in technology adoption between healthcare sectors could pose challenges for providers in post-acute and long-term care settings.
The information-blocking and interoperability rules, provisions of the 21st Century Cures Act, were released last year but implementation was subsequently pushed back to April 2021 due to the COVID-19 pandemic.
Under the information-blocking provisions, providers are barred from blocking patients and other providers from accessing health data unless they meet one of eight specific exceptions.
Cassie Leonard is director of congressional affairs at the College of Healthcare Information Management Executives.
Congress made the commitment to bring the U.S. health system into the modern computing age with the passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act in 2009. It then double downed on that commitment seven years later with the 21st Century Cures Act, putting the patient in the driver’s seat of where and when this new digital information travels from location to location.
The next step Congress can take to realize a fully interoperable health system that captures and exchanges patient data across health systems with 100% confidence and minimal errors would be to remove the long-standing federal funding ban on a unique patient identifier (UPI) standard.