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FDA and Digital Health Regulation

Health Blawg

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). Since some digital health tools will inevitably be subject to regulation while many will not, the agency has previously issued a high-level plan for streamlining its processes.

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Streamlining Healthcare Innovation: Working Together to Improve Digital Health Regulations

Mobile Health Matters

For example, the FDA created a new unit within the agency’s Center for Devices and Radiological Health , which focuses solely on digital health. Bakul Patel, the Associate Center Director for Digital Health at the FDA, envisions a Pre-Check model similar to a TSA security line at the airport.

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Moving at the speed of Eugene Borukhovich, Bayer’s Global Head of Digital Health Innovation — Harlow On Healthcare

Health Blawg

Eugene is Global Head, Digital Health Incubation and Innovation at Bayer. I spoke with Eugene as part of my ongoing series of fireside chats with healthcare innovation leaders – Harlow on Healthcare , on HealthcareNOW Radio. Eugene is Global Head, Digital Health Incubation and Innovation at Bayer.

article thumbnail

FDA and Digital Health Regulation

Health Blawg

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). Since some digital health tools will inevitably be subject to regulation while many will not, the agency has previously issued a high-level plan for streamlining its processes.

article thumbnail

FDA and Digital Health Regulation

Health Blawg

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). Since some digital health tools will inevitably be subject to regulation while many will not, the agency has previously issued a high-level plan for streamlining its processes.

article thumbnail

FDA and Digital Health Regulation

Health Blawg

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). Since some digital health tools will inevitably be subject to regulation while many will not, the agency has previously issued a high-level plan for streamlining its processes.

article thumbnail

FDA and Digital Health Regulation

Health Blawg

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). Since some digital health tools will inevitably be subject to regulation while many will not, the agency has previously issued a high-level plan for streamlining its processes.