Information Blocking | HealthIT.gov (original) (raw)
§ 170.401 Information Blocking
Updated on 03-11-2024
| 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 Timeframesin 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 |
Regulation Text
§ 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]
Standards Referenced
None
| 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 Timeframesin 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 |
Regulation Text
§ 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]
Standards Referenced
None
Certification Companion Guide: Information Blocking
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 Certification Regulations 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.
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).
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
Content last reviewed on July 15, 2024