Industry sector: Health Care
True interoperability of dispersed data amongst multiple healthcare providers (and across organizational or geographic boundaries) remains unattainable in the current tapestry of today's digital economy. ToIP architecture principles addresses the issue of breaking down silos across trust boundaries, whether across entities (organizations, nations etc) based on existing social, legal and business processes.
The FDA mandates that clinical trial data used to support approval of drugs and devices is submitted using CDISC standards. However, much of today’s research is conducted using clinical systems where data is typically exposed and shared as FHIR. This opens the door for addressing the hurdles in data interoperability due application specific/process complexities. In terms of schema design, Overlays Capture Architecture (OCA) represents a schema as a multi-dimensional object consisting of a stable schema base and interoperable overlays. Reverse engineering currently deployed single-object schemas into multiple-dimensional objects would facilitate a separation of concerns: (i.) data capture and (ii.) data usage.
Research into a globally standardized and decentralized approach to health data capture and exchange has birthed a powerful alternative architecture in OCA. This new architecture will enable easier and effective monitoring and assessment of outbreaks and healthcare policies whilst minimizing the possibilities of tampered, damaged or erroneous data in care delivery. OCA also has the potential to better support new developments in precision medicine, gene-based therapies, federated AI solutions and other social determinants of health (SDOH) initiatives.
In conjunction with the technical components described below, OCA provides a choice architecture to better enable patient-driven consent, privacy and compliance requirements across all use cases.
To address the challenge of communicating between different standards across sub-industries of the health care sector, the OCA-CDISC Focus Group will use OCA to harmonise the CDISC database models, providing a solution to semantic harmonisation between health care-specific data models and related data representation formats. This approach to semantic harmonisation will enable stakeholders to continue working with their own ontology-driven database models without the burden of being forced to produce standard transformation mappings to other standards.
The mission of the OCA-CDISC FG is to create and maintain CDISC-compliant OCA schema bases and core overlays that correspond to ... FROM HERE ... the normative HL7 FHIR Version R4 resource model.
The scope of this FG includes:
This FG uses uses the same IPR licensing selections as the Semantic Domain WG:
The objectives of the OCA-FHIR FG are to:
The OCA-FHIR FG architecture will build upon the core components of the Semantic domain.
Other candidate technologies include
Use case | Minimal mapping of FHIR r4 resources (include transitive dependencies via Referencetype properties/slots). | Comments (FHIR Profile to be identified) |
---|---|---|
Remotely accessible patient EHR | There are multiple use cases here, expect to start with Immunization and ImagingStudy | CDA not in scope. |
Consent to participate in clinical research | Consent, Contract | Handling instructions: Medical treatment and Research consent directives are not explicitly modeled in R4, might require use of Contract etc. |
Consent to participate in clinical trials | Consent, Contract | Handling instructions: Medical treatment and Research consent directives are not explicitly modeled in R4, might require use of Contract etc. |
ER Visit/specify data and credential requirements for patient identity and matching | Consent, Contract | Handling instructions: Privacy Consent directive. |