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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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

Healthcare Exchange Standards

So back in 2011 I wrote the first profile in IHE that was targeting ‘ease of use by lightweight application platforms such as Mobile Health Applications”. Thus it targeted use of HTTP RESTful, using JSON encoding. The Mobile Health Documents (MHD) profile was born to provide a more simple API to an XDS environment.

FHIR 40
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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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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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The The Five Biggest Areas of Opportunity for Digital Health

The Digital Health Corner

According to most recent statistics from the Office of the National Coordinator, use of EHRs has increased from 20% in 2004 to 87% in 2015. EHRs were designed as documentation centers for billing and regulatory purposes. I’d like to discuss what I believe are five areas of significant opportunity for quality technologies.