Exchange of High-Frequency Medical Monitoring Data Using Fast Healthcare Interoperability Resources for Interoperable Integration Into Clinical Practice and Research: Methodological Development Study

Background Continuous patient monitoring generates vast volumes of high-frequency monitoring data, such as electrocardiogram, electroencephalography, and invasive blood pressure tracings, that are often persisted in heterogeneous, noninteroperable formats, limiting integration with electronic health records and secondary use. Although Fast Healthcare Interoperability Resources (FHIR) supports general health data exchange, native support for high-frequency medical monitoring data, including associated metadata and data quality metrics, remains limited. Objective This study aims to develop a modality-agnostic FHIR package implementing a Metadata-Proxy pattern to enable scalable, semantically precise representation of high-frequency medical monitoring data, decoupling structured clinical metadata from raw signal storage. Methods This study provides the FHIR package Time Series Integration and Data in Endpoints (TIDE), a collection of FHIR Release 4 artifacts for interoperable exchange and the standardization of high-frequency monitoring clinical data, using electroencephalography as the primary use case while remaining applicable to generic medical monitoring data. The core TIDE Observation profile separates technical metadata and analytical summaries stored directly in FHIR from high-volume raw data referenced via Endpoint resources. Quantitative results are standardized with pattern slicing, including sampling frequency, statistical summaries, and data quality metrics. Semantic interoperability was achieved through a hybrid terminology binding, using Systematized Nomenclature of Medicine Clinical Terms, Logical Observation Identifiers Names and Codes for modalities, and custom CodeSystems for technical metadata, waveform modalities, channel identifiers, and connection types not covered by standard terminologies. All profiles were authored in FHIR Shorthand and compiled with SUSHI to produce a validated Implementation Guide conformant with the FHIR Release 4 core specification. Results The resulting framework provides a modality-agnostic structure for high-frequency monitoring data, comprising 7 primary FHIR artifacts that define 16 distinct component slices for metadata and signal analysis results. Observation resources reference associated Device and Endpoint instances, encapsulate acquisition parameters, and link to full-time-series repositories. Controlled vocabularies ensure unambiguous exchange, thereby enabling downstream use in research and decision support. The architecture decouples the metadata layer from the storage layer via a standardized Endpoint extension, enabling efficient querying of signals without retrieving large amounts of raw high-frequency monitoring data. Conclusions TIDE provides a reusable, standards-compliant framework for integrating continuous high-frequency monitoring data into FHIR-based ecosystems. By separating semantically rich, queryable metadata from raw signal storage, TIDE enables longitudinal patient monitoring and automated signal quality-based triage without requiring modification of existing signal storage infrastructure.