ONC Interim Final Rule Delays Information Blocking Requirements

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On October 30, 2020, the Office of the National Coordinator for Health Information Technology (ONC) issued an interim final rule (IFR) with comment period delaying the compliance dates for certain regulatory requirements set forth in the May 1, 2020 final rule implementing the information blocking, interoperability, and Health IT Certification Program (the Cures Act Rule). The new compliance date for the information blocking prohibition is April 5, 2021. The IFR also extends compliance dates in the ONC Health IT Certification Program, updates standards and clarifies regulatory text for certain certification criteria and makes technical corrections.

Under the IFR, the new compliance dates are as follows:

April 5, 2021:

  • Information blocking provisions, applicable to all actors, including healthcare providers (45 CFR Part 171)
  • Information Blocking Conditions and Maintenance of Certification (CoC/MoC) requirements (§ 170.401)
  • Assurances CoC/MoC requirements (§ 170.402, except for § 170.402(b)(2) as it relates to § 170.315(b)(10))
  • API CoC/MoC requirement (§ 170.404(b)(4)) - compliance for current API criteria
  • Communications CoC/MoC requirements (§ 170.403) (except for § 170.403(b)(1))

December 31, 2022:

  • 2015 Edition health IT certification criteria updates (except for § 170.315(b)(10) – electronic health information (EHI) export, which is extended until December 31, 2023)
  • New standardized API functionality (§ 170.315(g)(10))

One Calendar Year Extension

  • Submission of initial attestations (§ 170.406)
  • Submission of initial plans and results of real-world testing (§ 170.405(b)(1) and (2))

The new compliance dates are codified into the regulations, removing the need for ONC’s enforcement discretion announced in April 2020.

The press release accompanying the IFR includes a quote from the National Coordinator for Health IT, stating, “[t]o be clear, ONC is not removing the requirements advancing patient access to their health information that are outlined in the Cures Act Final Rule. Rather, we are providing additional time to allow everyone in the health care ecosystem to focus on COVID-19 response.” Thus, providers are expected to continue working toward compliance with the requirements of the Cures Act Rule.

The IFR does not provide any new information on the timing of enforcement by OIG, which is expected to begin at some point after OIG finalizes its proposed rule.

ONC’s press release is available here, and the IFR is available here.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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