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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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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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Bonus Features – December 11, 2022 – CMS holds off on good faith estimate enforcement, 61% of patients see primary care moving out of the doctor’s office, and more

Healthcare IT Today

“This exercise of enforcement discretion was necessary to allow time for providers and facilities to develop mechanisms for convening providers and facilities to request, and co-providers and co-facilities to provide, complete and accurate pricing information,” CMS said.

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The Digital Transformation of Patients – Update from Rock Health and Stanford

Health Populi

But another patient side-effect of COVID-19 has been the digital transformation of many patients , documented by data gathered by Rock Health and Stanford Center for Digital Health and analyzed in their latest report explaining how the public health crisis accelerated digital health “beyond its years,” noted in the title of the report.

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Bonus Features – December 11, 2022 – CMS holds off on good faith estimate enforcement, 61% of patients see primary care moving out of the doctor’s office, and much more

Healthcare IT Today

“This exercise of enforcement discretion was necessary to allow time for providers and facilities to develop mechanisms for convening providers and facilities to request, and co-providers and co-facilities to provide, complete and accurate pricing information,” CMS said.

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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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