National Survey of Digital Health Companies

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Response to Datavant 11.17 Public Comment 0990-New-030D.pdf	Supplementary Document	Uploaded 2025-11-21	Available
Datavant Response - ASTP_ONC Agency Information Collection Request_ Digital Health Companies (2).pdf	Public Comments	Uploaded 2025-09-25	Available
30 Day FRN_2025-16295.pdf	Supplementary Document	Uploaded 2025-08-26	Available
30 Day FRN_2025-16295.pdf	Supplementary Document	Uploaded 2025-08-26	Repair queued
60 Day FRN_2025-09004.pdf	Supplementary Document	Uploaded 2025-08-14	Available
60 Day FRN_2025-09004.pdf	Supplementary Document	Uploaded 2025-08-14	Missing upstream
UCSF ASTP EHR API Survey Statement B Final_for ROCIS.docx	Supporting Statement B	Uploaded 2025-08-14	Available
UCSF ASTP EHR API Survey Statement B Final_for ROCIS.docx	Supporting Statement B	Uploaded 2025-08-14	Missing upstream
OMB Passback_Nov 24 25_DHC Supporting Statement A Final_for ROCIS_comments addressed.docx	Supporting Statement A	Uploaded 2025-12-02	Available
DHC Supporting Statement A Final_for ROCIS.docx	Supporting Statement A	Uploaded 2025-08-14	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
277065	National Survey of Digital Health Companies	Other-Survey	New

ICR Details

OMB Control No: 0955-0024	ICR Reference No: 202508-0955-001
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/ONC	Agency Tracking No:
Title: National Survey of Digital Health Companies
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 12/08/2025
Retrieve Notice of Action (NOA)	Date Received in OIRA: 08/26/2025
Terms of Clearance: OMB is approving this information collection request for a period of three years during which time the agency will request approval to extend or revise the collection if the agency seeks to continue the information collection activity beyond the period approved under this action.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2028	36 Months From Approved
Responses	282	0	0
Time Burden (Hours)	141	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Office of the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC) is seeking approval for a new data collection effort to field a National Survey of Digital Health Companies. This survey will help ASTP/ONC better understand companies’ adoption of various types of application programming interfaces (APIs) for electronic health record (EHR) integration, use of the HL7 Fast Healthcare Interoperability Resources (FHIR) standard, status of EHR integrations, underlying characteristics of digital health companies, perceived benefits of federal health IT policy, and needed improvements to API standards and relevant federal health IT policies. The digital health sector has rapidly grown over the past decade, fueled in large part by the implementation of EHRs and the availability of APIs that allow third-party applications to work with EHR data in various ways. It is critical to assess the digital health ecosystem’s experiences with federally regulated, standards-based application programming interfaces (APIs) for health data exchange, as mandated under the 21st Century Cures Act (42 U.S.C. § 300jj-11 and § 300jj-52). The Cures Act aims to promote secure, standardized access to and exchange of electronic health information (EHI) through certified APIs “without special effort.” This supports patient access to their medical information and allows for third-party innovation in the private sector.

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Authorizing Statute(s): US Code: 42 USC § 300jj-11 and § 300jj-52 Name of Law: 21st Century Cures Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 21785	05/21/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 41584	08/26/2025
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

table that charts list of burden

IC Title	Form No.	Form Name
National Survey of Digital Health Companies

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ICR Summary of Burden

table that charts list of burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	282	0	0	282	0	0
Annual Time Burden (Hours)	141	0	0	141	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new ICR therefore there is no change in burden hours.

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Annual Cost to Federal Government: $172,683

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 08/26/2025

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