Regulation — healthcare-specific

21st Century Cures Act — Information Blocking + AI transparency

Cures Act information-blocking + the ONC HTI-1 Final Rule extended AI transparency obligations to certified health-IT and, follow-on, to the hospitals that deploy it. The rule creates disclosure obligations that a hospital cannot lawfully unwind once drift is known.

What the rule actually says

"… a practice by a health care provider is information blocking if such provider knows that such practice is unreasonable and is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information …" 42 U.S.C. §300jj-52(a)(1)(B) — Information Blocking statutory basis
"Developers of certified health IT that includes Decision Support Interventions using predictive DSI must provide source attributes intelligibility … including … measures for how a specific DSI can perform on data reflective of the deployment context." ONC HTI-1 Final Rule — 45 CFR 170.315(b)(11) revised DSI criteria

What this means in plain English

Two distinct pressures:

  1. Information blocking — hospitals cannot suppress relevant AI-decision information from follow-on clinicians, patients (per patient-access rule), or other providers. Silence about known drift becomes an OIG-enforceable issue.
  2. ONC HTI-1 DSI transparency — certified health-IT developers must expose performance-in-deployment-context attributes. Hospitals become the operational consumer of that data + accountable for acting on it.

What triggers the exposure in the sample

The Snapshot documents H3 differential performance in the actual deployment context. That is exactly the "measures for how a specific DSI performs on data reflective of the deployment context" the HTI-1 rule expects to be surfaced. Failure to escalate to affected clinicians — or to record refusal to escalate — is a live information-blocking question.

What the $499 Snapshot shows against this rule

See the sample scenario walkthrough →

How does this help me?

OIG information-blocking civil monetary penalties + ONC certified-health-IT decertification chain + Medicare Promoting Interoperability Program penalties — each has its own follow-on cost.

Read: Cures Act -- what the disclosure-obligation clock actually costs to miss →

$499 Snapshot. 3 business days.

Documented deployment-context evidence — the record the HTI-1 rule contemplated hospitals would have on file.

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Snapshot credit applies to Baseline ($2,500) or Enterprise Attestation ($35-55K) upgrade within 30 days.