Standardization on for Mastering Healthcare Transformation on - Challenges and Solutions

Abstract

Background: The ongoing healthcare transforma on results in systems medicine and personalized care. This requires advanced interoperability scenarios. Objec ves: The paper aims at introducing a reference architecture model to enable the harmoniza on of exis ng and future specifi ca ons and standards. Methods: For enabling the harmoniza on of standards and specifi ca ons, they have to be correctly and formally represented using a system-theore cal, architecture-centric, ontology-based, policy-driven approach. Results: An Interoperability Reference Architecture Model has been developed and standardized at ISO TC 215 and CEN TC 251. It is used for re-engineering specifi ca ons and standards, that way enabling harmoniza on with any other specifi ca on. The proposed modeling methodology has also been introduced in several HL7 specifi ca ons. It is demonstrated by re-engineering the ISO 13606 reference model. Conclusion: The approach presented in the paper off ers a solu on for comprehensive interoperability at any interoperability level also including user domains and the individual user. That way, never-ending revision cycles and nego a on rounds for integra ng diff erent specifi ca ons in complex eHealth solu ons become obsolete.

GDPR Compliance Challenges for Interoperable Health Information Exchanges (HIEs) and Trustworthy Research Environments (TREs)

“…The cross-European scope of the SHiELD project has referenced an important body of standards work alongside the GDPR (Table 2) and reviewed in the wider context of interoperability [16]. In addition, organisational measures need to be taken in response to the legislative requirements from the GDPR.…”

“…In a foundational project (miConsent, [19]) the implementation standards in the HL7 Consent Directive, IHE BPPC [14] and APPC [20] have been evaluated. Currently, we have not yet fully evaluated for suitability in SHiELD or CHC health information exchanges the HL7 FHIR Consent Directive [15] or Consent2Share [16] frameworks. Further work is underway within SHiELD and CHC (i) critically evaluating whether or not blockchain is a security technology compatible with the GDPR's "right to erasure" (see also Section 4.3, Figure 3c).…”

“…Of the list of practicable security/ privacy standards (Table 2) some of which have reached HL7 International realm-specific Implementation Guide (IG) status for the US realm [38] and practically demonstrated e.g. in the Consent2Share project [16] which is under evaluation in our Connected Health Cities project. Cultural and legal specificities can act as a barrier for direct reuse of standards across national realms and adaptations are necessary to accommodate these and individual's needs.…”

How Do You Know When You Have Interoperability?

“…Dr. Bernd Blobel provides an outstanding discussion of interoperability and its component parts in his article "Standardization for Mastering Healthcare Transformation" [5].…”

Solving the Modeling Dilemma as a Foundation for Interoperability

“…A system-oriented, architecture-centric, ontology-based modeling approach based on ontology languages, repositories, reasoners, and query languages provides methods and tools scalable and adaptive to communities, user groups and even individuals, transferring their knowledge, experience, expectations, and intentions into machine-accessible representation and manipulation of business knowledge [1]. Such approach has been developed by the authors and standardized at ISO and CEN [3,4]. It covers all levels of ICT-related interoperability from technical interoperability through structural interoperability, syntactic interoperability, semantic interoperability and organization/ service interoperability health informatics interoperability standards usually address, but also interoperability beyond ICT-related business cases represented through domainspecific ontologies such as knowledge-based domain-domain interoperability and even skills based interoperability addressing the end-user [4].…”