ONC's HTI-1 rule creates transparency requirements for AI and other predictive algorithms that are part of certified health IT. The disclosure baseline supports user assessment; it is not a federal approval of a model or a local decision to use it.
The CMS final rule created FHIR-based API duties for specified payers and defined categories of data to make available. The API does not guarantee that every clinical fact exists, is reconciled, or is fit for a particular use.
ASTP says exceptions are voluntary, actor knowledge standards differ, and missing an exception does not automatically establish information blocking; API success or failure cannot decide the case alone.
The published data set broadens Unique Device Identifier from implantable devices to medical devices generally, creating a wider exchange target without proving capture, mapping, or clinical use.