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Challenges & Opportunities in Emerging Digital Health Technologies

ISPE

The COVID-19 pandemic underscores the importance of DHTs through the increased reliance on telemedicine services and remote patient monitoring programs to ensure patient safety and triage scarce hospital resources. Insulin delivery is independent of insulin management system. IMDRF SaMD Risk Categorization. Framework 26. Framework 28.

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Challenges & Opportunities in Emerging Digital Health Technologies

ISPE

The COVID-19 pandemic underscores the importance of DHTs through the increased reliance on telemedicine services and remote patient monitoring programs to ensure patient safety and triage scarce hospital resources. Insulin delivery is independent of insulin management system. IMDRF SaMD Risk Categorization. Framework 26. Framework 28.

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The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

The FDA Law Blog

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Interpretation of Statutory Criteria Under the Final Guidance.

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