Arlington, Virginia--(Newsfile Corp. - November 12, 2026) - The Association for the Advancement of Medical Instrumentation (AAMI) has published AAMI TIR115:2026, Guidance for the appropriate use of public cloud computing to enable medical device functions, a new technical information report (TIR) that helps manufacturers, cloud service providers (CSPs), regulatory professionals, and regulators keep cloud-enabled medical devices safe, effective, and compliant.

TIR115 supersedes the U.S. FDA-recognized consensus report AAMI CR510:2021, Appropriate use of public cloud computing for quality systems and medical devices.

Cloud computing has become a key part of digital health, enabling remote care, mobile medical apps, and data-intensive patient monitoring. Yet public cloud environments change frequently, often outside of the control of device manufacturers. This has created what the new document's authors call "a paradigm shift for safety and compliance," where a disconnect among users, devices, and the cloud they utilize can cause problems related to interoperability, cybersecurity, and regulatory compliance.

AAMI first sought to tackle this problem in 2021 with CR510, a first-of-its-kind consensus report that offered six practical recommendations, from identifying the intended function of cloud computing to detecting cloud resource updates and resulting adverse events. Following the success of CR510, the AAMI Standards Board approved development of a TIR to provide deeper conceptual and practical guidance.

TIR115 was developed by the AAMI Cloud Computing Working Group, which includes major device manufacturers, academic researchers, technology companies, and representatives of the FDA's Center for Devices and Radiological Health. Federal participation does not constitute government endorsement.

"Writing a standard takes way too long for this type of emerging technology," explained Philips Senior Regulatory Specialist Pat Baird, who co-chaired both the CR510 task group and the TIR115 working group.

Co-chair Randy Horton, chief solutions officer at Orthogonal, summarized their core challenge. "The key insight we arrived at was that public cloud computing has challenged the traditional notion of control in a validated state - that I, as a medical device manufacturer, control every aspect of this device or system," he said.

TIR115 explains how to design, deploy, and maintain medical devices in a cloud environment and build effective relationships with CSPs. It posits that the public cloud environment should be managed as a purchased service rather than as a component of the device, and devices can be manufactured, when feasible, to limit the impact of cloud changes on performance and safety.

Risk, the TIR stresses, depends on how a function's outputs are used. Real-time heart attack detection by a wearable defibrillator cannot rely on a cloud resource, because a lost connection could seriously harm the patient, but the same device's analysis of historical cardiac data could.

That distinction echoes a point Horton made during the TIR's development. Handing a low-level function to the cloud services provider may be safe, "But what you shouldn't do is hand over the core function."

AAMI TIR115:2026 is available now and is included in AAMI's All Standards eSubscription package.

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Source: Association for the Advancement of Medical Instrumentation