Attached is Volume 1, Issue 7 of the IHE Radiology Global Regulatory Monitoring Report. The purpose of this report is to help keep you informed of recent and emerging governmental policy activity affecting radiology.

As an international organization, IHE Radiology monitors activity across the United States, Canada, Europe, Japan, and Australia. The report also continues to follow important international developments that may affect diagnostic imaging, interoperability, artificial intelligence, and radiation safety. Issue 7 covers activity from June 30 through August 29, 2026.

United States: Important developments include continued activity involving the new Diagnostic Imaging Reference in USCDI Version 7, updated FHIR standards for prior authorization and other payer-provider exchanges, and the availability of new standards through ONC’s 2026 Standards Version Advancement Process. The two CMS CY 2027 Proposed Rules remain open for comment, with the OPPS/ASC comment period closing August 31 and the Medicare Physician Fee Schedule comment period closing September 14.

Canada: Health Canada’s consultation on recognized medical-device standards, including imaging-related standards, remains open.

Europe: Implementation of the AI Act continues, while European Commission initiatives are expanding real-world testing and deployment of AI-based image screening.

Japan: Japan is considering changes involving medical radiation management while also beginning a national initiative to modernize hospital information systems and move toward cloud-based, standards-oriented infrastructure.

Australia: Australia announced an important new national interoperability baseline using AU Core and AUCDI for FHIR connections to My Health Record. The Therapeutic Goods Administration also opened a consultation on making more information about the safety, quality, and performance of medical devices publicly available.

The report also continues to follow World Health Assembly resolutions addressing access to diagnostic imaging through teleradiology, as well as radiation safety and medical exposure.

Several additional Canadian, European, U.S., Australian, and Japanese comment and implementation deadlines are identified in the report’s Regulatory Early Warning Dashboard.

Best regards,

Mike Bohl
IHE Radiology Planning Committee Co-chair

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Integrating the Healthcare Enterprise (IHE)

IHE is an initiative by healthcare professionals and industry to improve the way computer systems in healthcare share information. IHE promotes the coordinated use of established standards such as DICOM and HL7 to address specific clinical needs in support of optimal patient care. Systems developed in accordance with IHE communicate with one another better, are easier to implement, and enable care providers to use information more effectively.  For more information on IHE Radiology specifically and how you can use and/or become involved in the development of future interoperability initiatives go to https://www.ihe.net/ihe_domains/radiology/.