By - FDA recently announced that it’s launching the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDHR) to advance digital health technology
In the announcement yesterday, FDA said it will work to boost the advancement of mobile devices, software-as-medical-device (SaMD), wearables when used as a medical device, and other technologies.
Additionally, through the Center, the agency will modernize digital health policies and regulatory approaches to provide access to specialized tools to boost access to safe and effective digital health technologies.
Bakul Patel, leader of regulatory and scientific efforts related to health services at FDA, will be the Center’s first director.
“Establishing the Digital Health Center of Excellence is part of the FDA’s work to ensure that the most cutting-edge digital health technologies are rapidly developed and reviewed in the U.S.,” FDA Commissioner Stephen M. Hahn, MD, said in the announcement.
Commissioner Hahn added that the announcement “marks the next stage in applying a comprehensive approach to digital health technology to realize its full potential to empower consumers to make better-informed decisions about their own health and provide new options for facilitating prevention, early diagnosis of life-threatening diseases, and management of chronic conditions outside of traditional care settings.”
The Digital Health Center of Excellence will help stakeholders provide patients with high quality digital health technologies by providing centralized expertise and serving as a resource for digital health technologirs and policies, the head of the FDA stated.
The Center will be responsible for providing advice, coordinating and supporting work being done across FDA, advancing best practices, and reimagining digital health device oversight, FDA stated.
The Center will also create a network of digital health experts and engage in collaborations with various communities to exchange knowledge and expertise regarding digital health and priorities with FDA staff.
Additional activities will help FDA’s initiative as well, the agency said. These include strategic projects to advance digital health technologies, synergies in regulatory science research in digital health, and building strategic partnerships.
“The establishment of the Digital Health Center of Excellence is part of the planned evolution of the FDA’s digital health program to amplify the digital health work that is already being done and building upon years of work at the agency,” said Jeff Shuren, MD, JD, director of CDRH.
“In the last several years, we have established partnerships internally and externally to coordinate digital health activities and to promote the consistency of regulatory policy while continuing to innovate in our regulatory approaches.”
Overall, a center of excellence is a program that is created to give a high level of expertise and related resources on a particular area of healthcare in order to provide the best patient care possible.
For years, organizations have been using centers of excellence to boost quality of care for patients. For example, Premera Blue Cross recently expanded its own center of excellence strategy in order to improve its quality of care for radiology.
Establishing a center of excellence around quality radiology practices ensures patients are on the most direct treatment path for them. It also reduces the high costs associated with misdiagnoses, the company said in a statement.But recently, healthcare stakeholders have leveraged the concept to advance health IT.
Back in July, Google Cloud and telecommunications operator, Orange, partnered to launch an Innovation Lab and a Center of Excellence to leverage data and artificial intelligence and significantly help innovation and growth.
The Center of Excellence will give Google Cloud support for Orange France and other Orange companies as they implement cloud transformation, Google said. The center will also provide training in data, artificial intelligence, and cloud services for all employees.
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September 24, 2020 at 08:30PM
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FDA Launches Center of Excellence to Advance Digital Health - HITInfrastructure.com
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