October 29, 2020

HHS Extends Compliance Dates for Information Blocking and Health IT Certification Requirements in 21st Century Cures Act Final Rule

Updated as of November 4, 2020 to reflect ONC’s Interim Final Rule (officially published in Federal Register on November 4, 2020)

The U.S. Department of Health and Human Services (HHS) just announced the details of their Interim Final Rule that extends the Information Blocking Rule Compliance Date to April 5, 2021 (note: ONC is an agency within HHS). To access the HHS press release, click here. This is welcome news for all Providers, HINs/HIEs, and Certified Health IT Developers who have been struggling to be ready for the original November 2, 2020 compliance date.

The HHS press release also indicated that the Interim Final Rule will include technical corrections and clarifications to the ONC Cures Act Final Rule. We will be following up with additional information regarding relevant corrections and clarifications once the Interim Final Rule is published.

Updates Regarding Official Interim Final Rule

ONC’s Interim Final Rule was published in the Federal Register, and thus made official, on November 4, 2020. From our review of the Interim Final Rule, we spotted two notable highlights not mentioned in our preliminary alert above (which was based only on the HHS press release). First, in addition to establishing the April 5, 2020, extension date discussed above, ONC specified a new date by which actors must provide all EHI in response to a request, rather than responding with only the data elements represented in the USCDI. This new date is October 6, 2022. If you have questions about EHI, USCDI, the expansion of the EHI definition over time, and/or any other key elements of the Information Blocking Rule, feel free to refer to our Information Blocking Rule Introduction and Overview and look out for forthcoming client alerts.

Second, we note one language update, as it will influence our terminology in future client alerts. In the Interim Final Rule, ONC expressed a preference to refer to April 5, 2021 as the “applicability date” for 45 CFR 171 (Information Blocking Rule) instead of the “compliance date.” To confirm, this is an update in terminology only. It does not change what actors must do to prepare for April 5, 2021.

ONC Has Posted New Guidance Resources

In addition to posting a link to the published Interim Final Rule, ONC has released a number of guidance resources on its Cures Act Final Rule website. First, ONC posted five new Fact Sheets, which serve as quick references for key Interim Final Rule details. Second, ONC posted its November 2, 2020, webinar — titled Interim Final Rule with Comment Period. Third, and most importantly, ONC posted a first round of Information Blocking FAQs. These FAQs address the following topic areas: Information Blocking – General, Actors, Electronic Health Information, Interference, Exceptions – General, Enforcement, and Reporting Claims of Information Blocking.
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