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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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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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UMass Memorial Health Partners with Google Cloud to Improve Healthcare with Predictive Analytics for Advanced Cardiometabolic Therapies

Digital Health Global

Access and use of patient data are protected through the implementation of Google Cloud’s reliable infrastructure and secure data storage that support HIPAA compliance, and UMass Memorial Health’s security, privacy controls, and processes. Contacts Shelly Hazlett, UMass Memorial Health, Shelly.Hazlett@umassmemorial.org

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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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

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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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

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#DHIS15 Recap: B2B2C, Mobile First, Telehealth 2.0, and more

American Well

“We want fee for value all day long” was one of several opening statements made by Optum CEO Larry Renfro at the start of the Digital Healthcare Innovation Summit on Tuesday November 3 in Boston. Renfro said that Optum doesn’t yet have a “front door” for consumers, something the company is working to develop.