View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
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.
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
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.
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
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
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
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
National Survey of Digital Health Companies
ICR Summary 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.
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
Agency Contact:
Catherine Howard 202 768-2368 catherine.howard@hhs.gov
Common Form ICR:
No
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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