ISPE
OCTOBER 27, 2022
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).
ISPE
OCTOBER 27, 2022
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).
The FDA Law Blog
OCTOBER 10, 2022
The CDS Guidance interprets the Cures Act’s definition of “medical software” that is excluded from the statutory “device” definition, as it relates to CDS software. While the final guidance includes the same definition of “signal” as that used in the draft guidance—i.e.,
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