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

Author(s): Ed Conley* and Matthias Pocs

Background: We present our current approaches to improving personal data protection in (i) large (regional/ national/international) scale health information exchanges (HIEs) and (ii) UK NHS IG toolkit and ISO 27001-compliant trustworthy research environments (TREs) for discovery science communities. In particular we examine impacts of the General Data Protection Regulation (GDPR) on these technology designs and developments and the responses we have made to control complexity.

Methods: The paper discusses multiple requirements to implement the key GDPR principles of “data protection by design” and “data protection by default”, each requiring new capabilities to embed multiple security tests and data protection tools in common deployable infrastructures. Methods are presented for consistent implementation of diverse data processing use cases.

Results: We describe how modular compositions of GDPRcompliant data processing software have been used to implement use case(s) and deliver information governance (IG) requirements transparently. Security surveillance analysis is embedded throughout the application lifecycle, namely at design, implementation and operation (runtime) phases. A solution is described to the challenge of integrating coherent research (analytic) environments for authorized researchers to access data and analytic tools without compromising security or privacy.

Conclusion: We recognise the need for wider implementation of rigorous interoperability standards concerning privacy and security management. Standards can be disseminated within low-cost commodity infrastructures that are shared across consortium partners. Comprehensive model-based approaches to information management will be fundamental to guaranteeing security and privacy in challenging areas such as ethical use of artificial intelligence in medicine. The target architecture is still in evolution but needs a number of communitycollaborative API developments to couple advanced specifications fulfilling all IG requirements.