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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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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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The Digital Transformation of Patients – Update from Rock Health and Stanford

Health Populi

The coronavirus pandemic accelerated digital transformation of organizations, including health care providers.

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For Ryan Health, telehealth seeds planted during the pandemic have flourished

Healthcare IT News - Telehealth

Ryan Health is a federally qualified health center based in Manhattan that has been providing comprehensive and affordable primary and specialty care to New York’s diverse and underserved communities since 1967. As an FQHC, 75% of patients are enrolled in Medicaid or Medicare; another 7% are uninsured.

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Essential Telemedicine Terms Clinicians Should Know

Enzyme Health

CMS is the federal agency that administers HIPAA standards and develops Medicaid and Medicare reimbursement policies for telemedicine. HIPAA : HIPAA, or the Health Insurance Portability and Accountability Act , is a healthcare compliance law providing data security and privacy for the safeguarding of patient medical information.

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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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