Conformance Evaluation of Medical Device Software to IHE U-EYECARE Profile
Ullberg, Daniel (2025)
2025
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Julkaisun pysyvä osoite on
https://urn.fi/URN:NBN:fi:amk-2025120633208
https://urn.fi/URN:NBN:fi:amk-2025120633208
Tiivistelmä
Interoperability in healthcare is vital for patient safety and efficient clinical workflows. Standards such as DICOM and HL7 address this challenge, yet in mixed environments with systems from various manufacturers, standards alone are insufficient. IHE (Integrating the Healthcare Enterprise) provides frameworks that guide clinics and manufacturers in applying existing standards through defined actors and transactions to ensure interoperability.
This research assessed a medical device software’s conformance to the IHE U-EYECARE integration profile in the Eye Care domain. No prior assessment had been performed, and the client lacked insight into existing gaps. The objective was to gain expertise in the U-EYECARE profile, evaluate the software, and produce a GAP analysis identifying applicable actors, required transactions, and existing discrepancies.
Action research was chosen as the methodology, structured into planning, acting, observing, and reflecting stages. This approach allowed empirical testing of transactions in a controlled environment and iterative refinement of findings.
The study resulted in a comprehensive GAP analysis that specifies the applicable actors and highlights gaps requiring further development. It also revealed that maintaining data consistency between input and output is essential for integrated workflows. The GAP analysis provides a foundation for future software development and supports stakeholder communication regarding U-EYECARE compliance.
This research assessed a medical device software’s conformance to the IHE U-EYECARE integration profile in the Eye Care domain. No prior assessment had been performed, and the client lacked insight into existing gaps. The objective was to gain expertise in the U-EYECARE profile, evaluate the software, and produce a GAP analysis identifying applicable actors, required transactions, and existing discrepancies.
Action research was chosen as the methodology, structured into planning, acting, observing, and reflecting stages. This approach allowed empirical testing of transactions in a controlled environment and iterative refinement of findings.
The study resulted in a comprehensive GAP analysis that specifies the applicable actors and highlights gaps requiring further development. It also revealed that maintaining data consistency between input and output is essential for integrated workflows. The GAP analysis provides a foundation for future software development and supports stakeholder communication regarding U-EYECARE compliance.