Exec Chat: CES 2020: For FDA's Amy Abernethy, It's About Data, But Also Community Engagement
Amy Abernethy, FDA's principal deputy commissioner, sat down with Medtech Insight during CES 2020 to discuss the agency's progress on the Technology Modernization Action Plan, the pre-certification program for digital health products, and the FDA's plans for 2020.
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Agency heads say the new plan will siphon and aggregate more data that could help the regulatory body make better and faster regulatory decisions.
CES 2020: Panel Discusses Health Care In 2040 – Empowered Consumer, Digital Transformation, Data Sharing, Open Source
An expert panel at CES 2020 discussed Deloitte's vision for health care in 2040, with the empowered consumer managing their own health, enabled by a new ecosystem of secure, open access to data and "nudges" to change behaviors. Consulting firm Deloitte foresees outside disruptors dismantling the traditional health-care system, but panelists from Johnson & Johnson and Anthem flexed their muscles.
A short, seven-page draft guidance from the US agency lists submissions that must be sent to the FDA in an electronic format.