§170.406 Attestations

Version 1.0 Updated on 06-15-2020
Revision History
Version # Description of Change Version Date
1.0

Initial Publication

06-15-2020
Regulation Text
Regulation Text

§170.406 Attestations —

  1. Condition of Certification requirement. A health IT developer, or its authorized representative that is capable of binding the health IT developer, must provide the Secretary an attestation of compliance with the following Conditions and Maintenance of Certification requirements:
    1. Section 170.401;
    2. Section 170.402, but only for § 170.402(a)(4) and (b)(2) if the health IT developer certified a Health IT Module(s) that is part of a health IT product which can store electronic health information;
    3. Section 170.403;
    4. Section 170.404 if the health IT developer has a Health IT Module(s) certified to any of the certification criteria adopted in § 170.315(g)(7) through (10); and such health IT developer must also ensure that health IT allows for health information to be exchanged, accessed, and used, in the manner described in § 170.404; and
    5. Section 170.405 if a health IT developer has a Health IT Module(s) certified to any one or more 2015 Edition certification criteria in 
      § 170.315(b), (c)(1) through (3), (e)(1), (f), (g)(7) through (10), and (h).
  2. Maintenance of Certification requirement.
    1. A health IT developer, or its authorized representative that is capable of binding the health IT developer, must provide the attestation specified in paragraph (a) of this section semiannually for any Health IT Modules that have or have had an active certification at any time under the ONC Health IT Certification Program during the prior six months.
    2. [Reserved].
Standard(s) Referenced
Standards Referenced

None

Certification Companion Guide: Attestations

This Certification Companion Guide (CCG) is an informative document designed to assist health IT developers meet the Condition(s) and Maintenance of Certification requirements. The CCG is not a substitute for the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule (ONC Cures Act Final Rule). It extracts key portions of the ONC Cures Act Final Rule’s preamble and includes subsequent clarifying interpretations. To access the full context of regulatory intent, please consult the ONC Cures Act Final Rule or other included regulatory references. The CCG is for public use and should not be sold or redistributed.

Attestation Requirements

The health IT developer must provide an attestation of compliance with the Conditions and Maintenance of Certification requirements 170.401, 170.402, 170.403, 170.404, and 170.405. For additional details related to the attestation requirements of each Condition and Maintenance of Certification specific to 170.401 through 170.405 please refer to the specific Condition’s CCG.

Certification Requirements

Applicability: Applies to all health IT developers of certified health IT.

Condition Explanations and Clarifications

Applies to Entire Criterion

Clarifications:

  • Health IT developers will attest twice a year to compliance with the Condition(s) and Maintenance of Certification requirements (except for the EHR reporting criteria submission requirement, which would be separately implemented through future rulemaking).
    • 170.401 Information blocking
    • 170.402 Assurances
    • 170.403 Communications
    • 170.404 Application programming interfaces
    • 170.405 Real world testing
  • Health IT developers will be able to submit their attestations within a designated 30-day window twice a year for purposes of compliance.
    • The first attestation window will begin on April 1, 2021. This attestation period will cover the time period from the effective date of the final rule through March 31, 2021. This irregular time period is due to the publication of the final rule.
    • Subsequently, a regular 6-month period will commence with the attestation window for the 6-month period opening on October 1, 2021 (attesting for the period of April 1 through September 30).
  • Attestations will be submitted to ONC-Authorized Certification Bodies (ONC-ACBs), and ONC will then make the attestations publicly available through the Certified Health IT Product List (CHPL).
    • ONC will provide a web-based form and method for health IT developers to submit attestations in an efficient manner for ONC-ACBs’ review.
    • ONC will provide a method for health IT developers to indicate their compliance, noncompliance, or the inapplicability of each Condition and Maintenance of Certification as it applies to all or each of their Health IT Modules certified under the Program.
  • All attestations must be approved and submitted by an officer, employee, or other representative the health IT developer has authorized to make a binding attestation(s) on behalf of the health IT developer.

Paragraph (a) Condition of Certification Requirement

Clarifications:

  •  No additional clarifications.

Paragraph (b) Maintenance of Certification Requirement

Clarifications:

  • No additional clarifications.

Content last reviewed on June 15, 2020
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