Certification Companion Guide:
§ 170.401 Information Blocking
Updated on 03-11-2024
This Certification Companion Guide (CCG) is an informative document designed to assist with health IT product certification. The CCG is not a substitute for the requirements or other provisions specified in regulations. It extracts portions of ONC final rules’ preambles and includes subsequent clarifying interpretations specific to 45 CFR 170.401 or notes. Please consult the ONC Regulatory Activities page for links to all ONC final rules that include Certification Program provisions. The full text of information blocking regulatory provisions is codified in 45 CFR part 171, which is available online from the Code of Federal Regulations website (eCFR.gov). ONC has published over 50 frequently asked questions (FAQs) on information blocking topics. The Information Blocking topic page of HealthIT.gov links to these FAQs and other informational resources specific to information blocking and relevant to all actors subject to 45 CFR part 171 as well as other persons interested in learning more about information blocking. Other regulatory resources cited in this CCG can be found where indicated. The CCG is for public use and should not be sold or redistributed.
| Version # | Description of Change | Version Date |
|---|---|---|
| 1.0 | Initial Publication | 06-15-2020 |
| 1.1 | Updated compliance dates per the Interim Final Rule (IFR), Information Blocking and the ONC Health IT Certification Program: Extension of Compliance Dates and Timeframes in Response to the COVID-19 Public Health Emergency. | 11-02-2020 |
| 1.2 | Updated to provide additional clarity on the Attestations Condition and Maintenance of Certification requirements. | 03-12-2021 |
| 1.3 | Included information on the ONC Information Blocking Frequently Asked Questions resource | 10-18-2021 |
| 1.4 | Updated compliance date per the Interim Final Rule (IFR), Information Blocking and the ONC Health IT Certification Program: Extension of Compliance Dates and Timeframes in Response to the COVID-19 Public Health Emergency. | 05-04-2022 |
| 1.5 | Updated to reflect regulatory changes as outlined in Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule. Streamlined content by removing select sections within 45 CFR part 171 within the CCG and instead reference existing Information Blocking resources. | 03-11-2024 |
§ 170.401 Information blocking.
- Condition of Certification requirement. A health IT developer must not take any action that constitutes information blocking as defined in 42 U.S.C. 300jj-52 and § 171.103 on or after April 5, 2021.
- [Reserved]
None.
Attestation Requirements
Outlined below is a summary of the attestation requirements for the Information Blocking Condition of Certification (45 CFR 170.401). This attestation is a part of the Attestations Condition and Maintenance of Certification requirements available for developers to attest semiannually (beginning on April 1, 2022) alongside the other attestation requirements in 45 CFR § 170.406. For additional details related to the attestation requirements, please refer to the Attestations Condition and Maintenance of Certification CCG.
- A health IT developer must not take any action that constitutes information blocking on or after April 5, 2021.
Certification Requirements
Applicability of Condition: The Condition of Certification applies to all health IT developers participating in the ONC Health IT Certification Program (“Certified Health IT developers”). A Certified Health IT Developer is responsible for ensuring that all of its health IT and related actions and behaviors do not constitute information blocking or inhibit the appropriate access, exchange, and use of electronic health information (EHI).
Condition Explanations and Clarifications
Clarifications:
- The Condition of Certification prohibits any health IT developer who has at least one health IT product certified under the ONC Health IT Certification Program (Certification Program) from taking any action that constitutes information blocking as defined by section 3022(a) of the Public Health Service Act (PHSA) and in 45 CFR 171.103.
- The Condition of Certification is not limited only to certified health IT.
- For the Information Blocking and Assurances Conditions and Maintenance of Certification requirements, a health IT developer is also responsible to ensure that all of its health IT and related actions and behaviors do not constitute information blocking as defined in PHSA section 3022 and 45 CFR 171.103, or inhibit the appropriate access, exchange, and use of EHI. (Sections 170.401 and 170.402 implement, consistent with other requirements in Title XXX, PHSA section 3001(c)(5)(D)(i) and (ii) as added by the 21st Century Cures Act.)
- A developer’s health IT product suite that a hospital, clinician office practice, or other healthcare provider uses (and colloquially references) as its “EHR system” will typically include a wide variety of functions, services, components, and combinations thereof. Even where such a health IT product suite meets the definition of “Certified EHR Technology” for purposes of participation in the Promoting Interoperability Programs, there is no guarantee that every part of the overall product suite will meet the requirements of at least one certification criterion adopted by the Secretary of the Department of Health and Human Services (Secretary). In fact, typically only a subset of the functions, services, components, and combinations thereof within the overall product suite will meet the requirements of at least one certification criterion adopted by the Secretary and be Health IT Modules certified under the Certification Program. The Condition of Certification will apply to all of the Certified Health IT Modules within a developer’s product suite(s) so long as at least one Health IT Module is certified under the Certification Program at the time the developer engages in a practice that is the subject of an information blocking claim. (85 FR 25796)
- The Condition of Certification references the “information blocking” definition in 45 CFR 171.103. Information blocking exceptions can be found in subparts B, C, and D of 45 CFR part 171. Certain terms, such as “actor” and “practice,” have been defined for purposes of the information blocking regulations (45 CFR part 171) in § 171.102.
- Actors are encouraged to review their current, anticipated, or potential practices against the full text of relevant sections within 45 CFR part 171. Additional information specific to definitions, exceptions, and other provisions codified in 45 CFR part 171 is available in the ONC final rules that have established and, as applicable, revised them.
- Actors who wish to avail themselves of any of the voluntary exceptions to the information blocking definition that are set forth in subparts B, C, and D of 45 CFR part 171 should specifically review the full text of each such exception.
- ONC publishes on HealthIT.gov information resources specific to information blocking, including Information Blocking Frequently Asked Questions (FAQs), that also may be helpful in understanding the information blocking regulations in 45 CFR part 171. Questions and informal feedback about information blocking policy can be submitted to ONC through the Health IT Feedback and Inquiry Portal on ONC’s website, HealthIT.gov.