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Merge pull request #73 from onc-healthit/inquiries-aug-2024
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Anonymized Inquiries as of August 2024
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imkacarlson committed Aug 23, 2024
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8 changes: 8 additions & 0 deletions docs/404-conditions-maintenance.md
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- Regarding the recommendation by commenters that the scope of “all data elements” include the data elements of the standard adopted in § 170.213 and FHIR® resources referenced by the implementation specification adopted in § 170.215(b), ONC notes that both the standard and implementation specification are included in the interpretation of “all data elements of a patient's electronic health record to the extent permissible under applicable privacy laws” above. We note that this specific interpretation does not extend beyond the API Condition and Maintenance of Certification requirements finalized in § 170.404 and cannot be inferred to reduce the scope or applicability of other Cures Act Conditions of Certification or the <a target = "_blank" href = "https://www.ecfr.gov/cgi-bin/text-idx?SID=034c12732e5cb9328303ecdf94ecde87&mc=true&tpl=/ecfrbrowse/Title45/45cfr171_main_02.tpl">information blocking provisions</a> which include a larger scope of data.

!!! note ""
[Health IT Feedback and Inquiry Portal Q&A: Applies to Entire Criterion 170.404](inquiry-portal/404-inquiries.md#applies-to-entire-criterion)

### API Condition Of Certification Requirements
#### API Condition Of Certification General Requirements
???+ quote "**Regulation text at § 170.404(A)(1)**"
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- Any fee that is not covered by an exception would be suspect under the <a target = "blank" href = "https://www.ecfr.gov/cgi-bin/text-idx?SID=034c12732e5cb9328303ecdf94ecde87&mc=true&tpl=/ecfrbrowse/Title45/45cfr171_main_02.tpl">information blocking provisions</a> and would equally not be permitted by this API Condition of Certification requirement.
- Health IT developers are permitted to offer discounts to customers, as long as the discounted fees do not constitute information blocking and otherwise conform to applicable ONC certification requirements as well as all other applicable laws.

!!! note ""
[Health IT Feedback and Inquiry Portal Q&A: Paragraph (a)(3)(i): API Fees - General Conditions](inquiry-portal/404-inquiries.md#paragraph-a3i-api-fees-general-conditions)

#### API Fees – Permitted Fee (Development, Deployment, Upgrades)
???+ quote "**Regulation text at § 170.404(A)(3)(II)**"
(ii) *Permitted fee—development, deployment, and upgrades*. A Certified API Developer is permitted to charge fees to an API Information Source to recover the costs reasonably incurred by the Certified API Developer to develop, deploy, and upgrade certified API technology.
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* Application developer affirmations to health IT developers regarding the ability of their applications to secure a refresh token, a client secret, or both, must be treated in a good faith manner consistent with the provisions established in the openness and pro-competitive conditions at § 170.404(a)(4).
* The technical requirements to support patient authorization of apps to access their data in § 170.315(g)(10)-certified API technology are described in § 170.315(g)(10)(v)(A) and require conformance to the HL7® SMART App Launch Implementation Guide using the OAuth 2.0 framework. Certified Health IT Developers must make these patient authorization capabilities available in their § 170.315(g)(10)-certified APIs according to the general access requirements at § 170.404(a)(1), and openness and pro-competitive conditions at § 170.404(a)(4). Under these collective Program requirements, any individual can authorize apps of their choice to receive their health data without any additional or out-of-band steps, or any other preconditions.

!!! note ""
[Health IT Feedback and Inquiry Portal Q&A: Paragraph (a)(4): API Openness And Pro-Competitive Conditions](inquiry-portal/404-inquiries.md#paragraph-a4-api-openness-and-pro-competitive-conditions)

### API Maintenance Of Certification Requirements
#### Authenticity Verification and Registration for Production Use
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