This recommended practice defines a technology architecture and interoperability framework supporting clinical trial activities conducted in participant-at-home environments including remote patient monitoring, digital health technologies, telehealth platforms, and distributed clinical research infrastructure with elements of decentralization. It specifies reference models and requirements for technology architectures, device ecosystem interoperability, secure acquisition and transmission of clinical research data, digital endpoint measurement infrastructure, remote safety monitoring systems, and orchestration across decentralized trial platforms. The recommended practice also addresses security, privacy, and data governance for distributed research environments. The recommended practice focuses on enabling technology systems and data infrastructure and does not define clinical practice guidelines or regulatory policy. It further establishes expectations for lifecycle management, cross platform interoperability, and consistent representation of participant-at-home system interactions, including alignment with foundational clinical research and data exchange standards to support reliable, scalable, and regulatory grade home based clinical trial operations.
- Standard Committee
- EMB/Stds Com - Standards Committee
- Status
- Active PAR
- PAR Approval
- 2026-06-04
Working Group Details
- Society
- IEEE Engineering in Medicine and Biology Society
- Standard Committee
- EMB/Stds Com - Standards Committee
- Working Group
-
HBCT WG - Home-Based Clinical Trials
- IEEE Program Manager
- Christian Orlando
Contact Christian Orlando - Working Group Chair
- Isaac Rodriguez-Chavez
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