Center for Devices and Radiological Health
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HHS Publishes FDASIA Health IT Report
HHS released a draft report that includes a proposed strategy and recommendations for a health information technology (health IT) framework, which promotes product innovation while maintaining appropriate patient protections and avoiding regulatory duplication. The congressionally mandated report was developed in consultation with health IT experts and consumer representatives and proposes to clarify oversight of health IT products based on a product’s function and the potential risk to patients who use it.
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How A Small Group of Entrepreneurs Transformed Government Services
President Obama started with his own White House, recruiting Internet-savvy entrepreneurs to serve as chief technology officer (me), chief performance officer (Jeff Zients), chief information officer (Vivek Kundra) and director for social innovation (Sonal Shah), among other senior positions...
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Internal Emails Show FDA, Industry Jointly Framed 'Cures' Device Language
FDA and the largest medical device lobbying group worked together to develop proposed legislative language for most of the medical device provisions included in the House-passed 21st Century Cures bill, one of the largest FDA reform bills to pass the House in recent years, and are developing a synchronized regulatory strategy for the Senate version, according to internal emails and documents obtained by Inside Health Policy through the Freedom of Information Act...
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Mobile Health: What Should Be Regulated And What Not?
With the mHealth industry anxiously awaiting the U.S. Food and Drug Administration's final draft of guidelines for mobile medical apps (expected by this fall), the talk at that particular panel discussion focused on what should be regulated and what shouldn't. Bakul Patel, a policy adviser for the FDA's Center for Devices and Radiological Health, pointed out that the market is flooded with apps – many of them harmless, but some of them potentially dangerous and in need of regulation.
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