article thumbnail

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.

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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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

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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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.