After many years of existence, Electronic Health Record Systems (EHRS) adoption in both hospital and primary care centers is close to 100% in some European countries. Millions of personal health records, containing valuable clinical information, are ready to be used in more and more health processes.
Pharmaceutical Clinical Trials are one of this health related processes which have very high expectations in the use of EHRS data. Clinical Trial Management Systems (CTMS) and Clinical Data Systems (CDS) would improve their processes by accessing this EHRS data. Nevertheless, legal and technical aspects are making difficult this use.
Focusing on technical issues, there exist standards for representing both the EHR information (such as HL7 CDA, CEN/ISO 13606 or openEHR), and standards for clinical trial studies (such as CDIS CDASH and CDISC ODM). But there is a lack of interoperability between them all, and an imprecise way for the definition of the data sets to be shared.
This paper will present an ICT infrastructure to enable the semantic interoperability of EHRS and CTMS by means of scalable and standardised Virtual Health Records (VHR) and by a clear definition of the data to be exchanged. The infrastructure focuses on generic methods in order to simplify and standardise the way in which clinical research systems acquire data from heterogeneous EHRS.
A VHR mediator system connects both sides through a hub where processes are able to transfer data in both senses. Data structures will be described through CDISC ODM and CDISC CDASH in the form of computable semantic concept definitions. The presented model will include methodology, processes, architecture and existing software components.
Advantages of this model are: (1) It is independent of existing standards, software and architecture of EHRS. (2) Allows reach level 3 making EHR and CR systems fully interoperable. (3) Allows fast solution development adaptable to fit different scenarios.
A model like this can be keystone in the way to reach fully collaboration between health and clinical research domains, assuring data quality and improving processes.
CDISC International Interchange Conference
18th & 19th April 2012, Stockholm