Request for Information: Diagnostic Imaging Interoperability Standards and Certification
Published Date: 1/30/2026
Proposed Rule
Summary
The government wants your ideas on new rules to make sharing medical images, like X-rays and MRIs, easier and faster for doctors and patients. This could change how health tech companies build their software and might lead to new certification rules. If you have thoughts, send them by March 16, 2026, so your voice counts in shaping the future of medical imaging tech!
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
Shift from CDs to electronic image access
HHS is asking whether adopting standards and certification for diagnostic images would make it easier for doctors and patients to access X-rays, MRIs, and other images electronically instead of using physical media like CDs and DVDs. The RFI states that better electronic access could improve care, reduce duplicative imaging tests, and reduce costs for patients and providers.
Possible new certification for health IT vendors
The RFI seeks input on whether ONC should adopt diagnostic imaging technical standards and certification criteria under the ONC Health IT Certification Program and whether systems like PACS and VNAs could be certified. Any future rulemaking to add imaging certification requirements would directly affect health IT developers who build or maintain imaging and EHR software.
Full-resolution image access and patient apps
The RFI asks whether providers and patient-facing apps need access to full-resolution diagnostic images (e.g., full DICOM files) or if lower-resolution reference images are sufficient, and whether image data elements should be added to USCDI or VDT certification criteria. If adopted, such requirements could affect clinicians' ability to make diagnoses and patients' access to usable images through apps.
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Key Dates
Department and Agencies
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