The Changing Regulatory Landscape DURING AND AFTER COVID-19

On August 19th, three of the nation’s top experts explored the balance between speed and safety during an evolving pandemic; when the country needs effective solutions that work now. The experts examined the following questions:

How is the FDA challenging the status quo in the regulatory space?
What standards do we need in order to make the 100M+ wearables in the country useful?
Does the nation need a national data platform?
What do we know about you and where you’ve been?
What’s the balance between “good enough” in a crisis, and responsible innovation?

Eric Topol is the Founder and Director of the Scripps Research Translational Institute, Professor, Molecular Medicine, and Executive Vice-President of Scripps Research. As a researcher, he has published over 1,200 peer-reviewed articles, with more than 250,000 citations, elected to the National Academy of Medicine, and is one of the top 10 most cited researchers in medicine. His principal scientific focus has been on the genomic and digital tools to individualize medicine.

Bakul Patel, MSEE, MBA, is the Director for Digital Health, at the Center for Devices and Radiological Health (CDRH), at the Food and Drug Administration (FDA). Mr. Patel is responsible for leading, executing and coordinating scientific efforts related to digital health, software and emerging technologies. In 2003, Mr. Patel created the now ubiquitous term, “software as a medical device” (SaMD) and led efforts to harmonize its definition globally. Mr. Patel is currently leading the effort for the agency in developing an innovative software precertification program to reimagine a pragmatic regulatory approach for Digital health that aims for patients and providers to have timely access to safe and effective digital health products.

Moderated by Aenor Sawyer, Chief Health Innovation Officer, Translational Research Institute for Space Health; Director UCSF Skeletal Health Service; Director UCSF SpaceHealth;  NODE.Health Executive Board Member

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Digital Medicine in the Emergency Department Webinar Summary: COVID Solutions, Clinical Decision Tools, and Improved Public Health Intervention

The Emergency Department (ED) is the entryway to the healthcare system for one-third of Americans every year. Digital tools can be used to improve healthcare before, during, and after an ED visit. On May 20th, NODE.health hosted a webinar, moderated by Dr. Rosner, a Physician and digital health researcher, with three Emergency Physicians on how digital health can be used in the context of COVID-19 to improve clinical decision making, and address public health issues. This article is a summary of the webinar.

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