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Challenges & Opportunities in Emerging Digital Health Technologies

ISPE

Given the proliferation and confusion of various digital health terms, this article includes a compiled glossary of core DHT terms and definitions (see Table 1). Table 1: Terms and definitions for DHTs. Description. Artificial intelligence (AI)/machine. learning (ML).

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Challenges & Opportunities in Emerging Digital Health Technologies

ISPE

Given the proliferation and confusion of various digital health terms, this article includes a compiled glossary of core DHT terms and definitions (see Table 1). Table 1: Terms and definitions for DHTs. Description. Artificial intelligence (AI)/machine. learning (ML).

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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the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. While the final guidance includes the same definition of “signal” as that used in the draft guidance—i.e.,

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