Pre-approval clinical trials cannot guarantee that drugs will not have serious side effects after they are marketed. Post-approval drug safety data studies aim to address this problem, however, their effectiveness is started to be discussed especially after recent examples of drug withdrawals. This is due to the fact that, current post market safety studies largely depend on the submission of spontaneous case reports where underreporting is a major problem. The need for a more proactive approach is apparent, where safety data from multiple sources are actively monitored, linked and analyzed. Effective integration and utilization of electronic health records (EHR) can help to improve post-market safety activities on a proactive basis. SALUS aims to facilitate this through providing functional interoperability profiles and supporting open source toolsets enabling EHR systems and clinical research systems to communicate and * The research leading to these results has received funding from the European Community’s Seventh Framework Programme (FP7/2007-2013) under grant agreement no ICT-287800, SALUS Project (Scalable, Standard based Interoperability Framework for Sustainable Proactive Post Market Safety

If Electronic Health Record systems are to provide an effective contribution to healthcare, a set of benchmarks need to be set to ensure quality control and interoperability of systems. This paper outlines the prevailing status of EHR certification in the US and the EU, compares and contrasts established schemes and poses opportunities for convergence of activity in the domain designed to advance certification endeavours generally. Several EU Member States have in the past proceeded with EHR systems quality labeling and/or certification, but these differ in scope, in legal framework under which they operate, in policies (legislation and financial incentives), in organization, and perhaps most importantly in the quality criteria used for benchmarking. Harmonization, therefore, became a must. Now, through EuroRec (with approaches ranging from self-assessment to third party certification depending on the level of confidence needed) and its Seals, the possibility to achieve this for EHR systems has started in the whole of Europe. The US HITECH Act also attempts to create incentives for all hospitals and eligible providers to adopt and use electronic information. A centerpiece of the Act is to put in place strong financial incentives to adopt and meaningfully use EHRs. The HHS/EHR Certification Programme makes use of ISO/IEC 170XX standards for accreditation, testing and certification. The approved test method addresses the functional and the interoperability requirements defined in the Final Rule criteria and standards. To date six Authorized Testing and Certification Bodies (ATCBs) are testing and certifying products in the US.

The goal of the REMINE project is to build a high performance prediction, detection and monitoring platform for managing Risks against Patient Safety (RAPS). Part of the work involves developing an ontology enabling computer-assisted RAPS decision support on the basis of the disease history of a patient as documented in a hospital information system. A requirement of the ontology is to contain a representation for what is commonly referred to by the term 'adverse event', one challenge being that distinct authoritative sources define this term in different and context-dependent ways. The presence of some common ground in all definitions is, however, obvious. Using the analytical principles underlying Basic Formal Ontology and Referent Tracking, both developed in the tradition of philosophical realism, we propose a formal representation of this common ground which combines a reference ontology consisting exclusively of representations of universals and an application ontology which consists representations of defined classes. We argue that what in most cases is referred to by means of the term 'adverse event' --when used generically --is a defined class rather than a universal. In favour of the conception of adverse events as forming a defined class are the arguments that (1) there is no definition for 'adverse event' that carves out a collection of particulars which constitutes the extension of a universal, and (2) the majority of definitions require adverse events to be (variably) the result of some observation, assessment or (absence of) expectation, thereby giving these entities a nominal or epistemological flavour.

The Belgian Federal Health Authorities are willing to redefine their eHealth vision and to reformulate their strategy in consensus with healthcare professionals and other domain experts. The National Health Insurance Institute ordered end 2007 a study to a group of experts(1), representing the majority of the eHealth stakeholders. The aim of the study was to define the strategy to be followed regarding health data exchange, data sharing, decentralised clinical data collections and Electronic Health Records. The experts issued, June 2008, a description of the current standing regarding nationally available (or to be made available) services as well as a set of priorities (structural and technological ones) for the coming years. This paper presents the experts' recommandations and some translated excerpts of their report.

If Electronic Health Record (EHR) systems are to provide an effective contribution to healthcare across Europe, a set of benchmarks need to be set to ensure the quality of such systems. This article describes the results of the EU funded QRec- project and emphasizes the need for validation of clinical archetypes to support the semantic interoperability between EHR systems and other interacting eHealth applications.