D2.4.1 Report on Collaboration with other projects and ... Deliverable D2_4_1... · Collaboration with other projects addressing at least partially issues important for the SALUS

SALUS “Scalable, Standard based Interoperability Framework for

Sustainable Proactive Post Market Safety Studies”

SPECIFIC TARGETED RESEARCH PROJECT

PRIORITY Objective ICT-2011.5.3b) Tools and environments enabling the re-use of

electronic health records

SALUS D2.4.1

Report on Collaboration with other projects and Institutional Bodies

in Drug Surveillance

Due Date: January 31, 2013

Actual Submission Date: January 31, 2013

Project Dates: Project Start Date : February 01, 2012

Project End Date : January 31, 2015

Project Duration : 36 months

Deliverable Leader: The EuroRec Institute

Project co-funded by the European Commission within the Seventh Framework Programme (2007-2013)

Dissemination Level

PU Public X

PP Restricted to other programme participants (including the Commission Services)

RE Restricted to a group specified by the consortium (including the Commission Services)

CO Confidential, only for members of the consortium (including the Commission Services)

FP7-287800 SALUS

SALUS-FP7-287800• D2.4.1 • Version 1.0, dated January 31, 2013 Page 2 of 60

Document History:

Version Date Changes From Review

V0.1 2012.09.12 Initial Document J. Devlies All

V0.3 2012.12.12 First Draft Version for Input by the partners J. Devlies All

V0.4 2012.12.18 Agfa and Inserm contribution Dirk Colaert

Gunnar Declerck

All

V0.4b 2012.12.20 SDRC contribution Gokce Banu Laleci

Ali Anil Sinaci

All

V0.5 2012.12.21 UMC reserved sections completed Tomas Bergvall All

V0.5a 2013.01.02 Roche contribution on EFPIA Bharat Thakrar All

V0.6 2013.01.27 Prefinal version for comments Jos Devlies All

V1.0 2013.01.31 Final, comments integrated, abbreviations

updated

Gokce Banu Laleci

René Schippers

Jos Devlies

Contributors (Benef.) Jos Devlies (EuroRec), Leo Ciglenecki (EuroRec – Slovenia), Gunnar Declerck

(Inserm), Dirk Colaert (Agfa), Gokce Banu Laleci (SRDC), Mustafa Yuksel

(SRDC), Ali Anil Sinaci (SRDC), Tomas Bergvall (UMC), Bharat Thakrar (Roche),

René Schippers (ERC)

Responsible Author Jos Devlies Email [email protected]

Beneficiary EuroRec Phone +32-475-266148

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SALUS Consortium Contacts:

Beneficiary Name Phone Fax E-Mail

SRDC Gokce Banu Laleci

Erturkmen

+90-312-2101763 +90(312)2101837 [email protected]

EUROREC Georges De Moor +32-9-2101161 +32-9-3313350 [email protected]

UMC Niklas Norén +4618656060 +46 18 65 60 80 [email protected]

OFFIS Wilfried Thoben

+49-441-9722131

+49-441-9722111

[email protected]

AGFA Dirk Colaert +32-3-4448408 +32 3 444 8401 [email protected]

ERS Gerard Freriks +31 620347088 +31 847371789 [email protected]

LISPA Alberto Daprà +390239331605 +39 02 39331207 [email protected]

INSERM Marie-Christine Jaulent +33142346983 +33153109201 marie-

[email protected]

TUD Peter Schwarz +49 351 458 2715 +49 351 458 7319 Peter.Schwarz@uniklinikum-

dresden.de

ROCHE Jamie Robinson +41-61-687 9433 +41 61 68 88412 [email protected]

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EXECUTIVE SUMMARY

This deliverable reports on the collaboration initiatives of the SALUS consortium. It is the first

version of the deliverable as it reports on the activities of Year 1 of the project.

Collaboration with other projects addressing at least partially issues important for the SALUS project

too is considered as essential in order to avoid reinventing the wheel or to take (only slightly) different

options, resulting in mutually incompatible and not interoperable tools and applications.

This report start with an overview of projects that might be valuable as input, past as well as running

project. Twelve projects were scrutinised, three of them being projects yet finalised.

Though some projects are addressing medication related patient safety issues, none of them

are fully and specifically focused on longitudinal post marketed medicinal products

pharmacovigilance. They provide valuable input for SALUS, more specifically through

SALUS partners that were involved.

Some of the running projects are in an early stage at the moment SALUS has to take options,

e.g. regarding semantic interoperability issues and solution architecture. Follow-up of these

projects will identify if needed changes required within the SALUS environment.

One of the ways to improve reuse of expertise is by participating in meetings of those projects and/or

by attending conference presentations about those projects. These activities are reported in chapter 6

as well as the specific “convergence meetings” co-organised with other consortia.

Chapter 7 will, mostly in the next versions of the deliverable, document the different options that are

similar or different to the options taken in the other projects.

Another important investment to keep SALUS on track and consistent with the state of the art as well

regarding ICT (technical and semantic interoperability) as regarding the specific domain of

pharmacovigilance is the constitution of the SALUS Advisory Board. The first meeting of the

Advisory Board was organised on January 17, 2013. Chapter 8 of this deliverable reports on these

activities.

Remaining on track with international domain specific developments is another important aspect of

cooperation and collaboration, to be realised mainly through intensive contacts with International

Organisations addressing medication related decision support and safety as well as longitudinal

pharmacovigilance. This involvement is documented in Chapter 9.

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TABLE OF CONTENTS

Executive Summary ................................................................................................................................ 4 Table of contents ..................................................................................................................................... 5 1 Purpose ............................................................................................................................................. 7 2 Definitions and Reference Documents ............................................................................................. 7

2.1 Definitions and Acronyms ........................................................................................................ 7 2.2 Reference documents ................................................................................................................ 8

3 Task description ................................................................................................................................ 9 3.1 Task 2.4 Description as in the DOW ......................................................................................... 9 3.2 Partners involved in WP 2, Task 2.4 ......................................................................................... 9

4 Main tracks for collaboration and cooperation ............................................................................... 10 5 Overview of related projects ........................................................................................................... 11

5.1 Past Projects ............................................................................................................................ 11 5.1.1 EU-ADR .......................................................................................................................... 11 5.1.2 DebugIT ........................................................................................................................... 12 5.1.3 PSIP ................................................................................................................................. 14

5.2 Running Projects ..................................................................................................................... 15 5.2.1 epSOS .............................................................................................................................. 15 5.2.2 Semantic Health Net – SHN ............................................................................................ 18 5.2.3 EHR4CR .......................................................................................................................... 19 5.2.4 TRANSFoRm .................................................................................................................. 20 5.2.5 PROTECT ........................................................................................................................ 22 5.2.6 PONTE ............................................................................................................................. 24 5.2.7 OMOP .............................................................................................................................. 24 5.2.8 Eureca .............................................................................................................................. 26 5.2.9 INTEGRATE ................................................................................................................... 27 5.2.10 eTRIKS .......................................................................................................................... 28 5.2.11 OpenPHACTS................................................................................................................ 29 5.2.12 Linked2Safety ................................................................................................................ 30

5.3 Projects still to start ................................................................................................................. 31 5.3.1 EMIF ................................................................................................................................ 31

6 Involvement in other projects ......................................................................................................... 32 6.1 Attending other project’s internal meetings ............................................................................ 32

6.1.1 EHR4CR Advisory Board Meeting ................................................................................. 32 6.1.2 SemanticHealthNet Consortium Meeting, September 3 and 4, 2012 .............................. 33 6.1.3 EHR4CR Semantic Interoperability WP4 Meeting, Paris January 23-24, 2013 .............. 34

6.2 Cross project meetings ............................................................................................................ 36 6.2.1 The Basel Convergence Meeting on Secondary Use of EHR Data, November 7, 2012.. 36 6.2.2 Discipulus Consultation Meeting – Barcelona, 27 November 2012 ................................ 39 6.2.3 SALUS-EHR4CR Bilateral Convergence & Cooperation Meeting, Paris 18-21-22

January 2013 ................................................................................................................................ 40 6.2.4 Convergence Initiative Meeting, Paris 22 January 2013 ................................................. 42 6.2.5 The Brussels Convergence Conference on secondary use of EHR data, March 20-21,

2013 45 7 Concrete project to project cooperation .......................................................................................... 45

7.1 Possible Collaboration with EHR4CR Project ........................................................................ 45 7.2 Possible Collaboration with CDISC2RDF Initiative ............................................................... 45 7.3 Possible Collaboration with IHE Quality, Research and Public Health Domain (QRPH) ...... 45

8 Advisory board ............................................................................................................................... 47 8.1.1 Members of the advisory board ....................................................................................... 47

8.2 Mission of the advisory board ................................................................................................. 48 8.3 First Meeting of the Advisory Board on January 16-17, 2013 ................................................ 49

8.3.1 Invitation .......................................................................................................................... 49

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8.3.2 Introduction and Agenda of the AB meeting ................................................................... 49 8.3.3 Minutes ............................................................................................................................ 52 8.3.4 Main recommendations made by the advisory board ...................................................... 56

9 International bodies in drug surveillance ........................................................................................ 57 9.1 ID and main activities of the International Bodies .................................................................. 57

9.1.1 European Medicines Agency – EMA .............................................................................. 57 9.1.2 National Pharmacovigilance Authorities ......................................................................... 57 9.1.3 European Federation of Pharmaceutical Industries and Associations – EFPIA .............. 57

9.2 Other Cooperation and Dissemination Activities .................................................................... 58 10 SALUS Collaboration Template................................................................................................... 59

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1 PURPOSE

The purpose of this Deliverable is to report on the collaboration activities with other projects and with

International Bodies in Drug Surveillance, as described in Task 2.4 of the Description of Work.

The SALUS project is neither the first nor the only project addressing pharmacovigilance as well as

secondary use of Electronic Healthcare Records. The project management did take the option, from

the start, to align its development on what exists and has been made available by any possible third

party, for not reinventing the wheel.

The SALUS consortium made this collaboration concrete. This deliverable reports on these activities.

This first deliverable will focus on the principles and the agreements within the consortium, on

reporting facilities of such collaboration activities and on identifying the most important or interesting

projects to cooperate with.

The second and third or final deliverable will be incremental to each other.

2 DEFINITIONS AND REFERENCE DOCUMENTS

The following documents were used or referenced in the development of this document:

2.1 Definitions and Acronyms

Table 1 List of Abbreviations and Acronyms

Abbreviation/

Acronym DEFINITION

ADE Adverse Drug Event

ADR Adverse Drug Reaction

ATC Anatomic Therapeutic Classification (WHO)

BRIDG Biomedical Research Integrated Domain Group

CCD Continuity of Care Document (HL7/ASTM)

CDA HL7 Clinical Document Architecture

CDISC Clinical Data Interchange Standards Consortium

CDM Common Data Model

CDW Clinical Data Warehouse

DEBUG-IT Detecting and Eliminating Bacteria Using Information Technology

DOW Description of Work

eCRF Electronic Case Report Form

EDC Electronic Data Capture (for clinical trials)

EFPIA European Federation of Pharmaceutical Industries and Associations

EHR Electronic Health Record, Electronic Healthcare record

EHR4CR Electronic Health Record systems for clinical research

epSOS Smart Open Services for European Patients EU-ADR Exploring and Understanding Adverse Drug Reactions by Integrative Mining of Clinical

Records and Biomedical Knowledge

ETL Extract Transform Load (tool)

eTRIKS European Translational Information and Knowledge Management Services

Eureca Enabling information reuse by linking clinical research and care

HOI Health Outcome of Interest (OMOP)

IMI Innovative Medicines Initiative

LOINC Logical Observation Identifiers Names and Codes

MedDRA Medical Dictionary for Regulatory Activities

NoE Network of Excellence

OMOP Observational Medical Outcomes Partnership

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p-medicine From data sharing and integration via VPH models to personalised medicine

PARENT Cross-border patients registries initiative

PHR Personal Health Record, Patient Health Record

PONTE Efficient Patient Recruitment for Innovative Clinical Trials of Existing Drugs to Other

Indications

PCC Patient Care Coordination – IHE template

PROTECT Pharmacoepidemiological Research on Outcomes of Therapeutics by a European

Consortium

PSIP Patient Safety through Intelligent Procedures in medication

QED Query Existing Data – IHE Profile

RDF Resource Description Framework

SDO Standards Developing Organisation

SHN SemanticHealthNet

SPARQL Standard Protocol and RDF Query Language

TR Translational Research

TRANSFORM Translational Research and Patient Safety in Europe

UCUM Unified Code for Units and Measures

UMLS Unified Medical Language System

VPH Virtual Physiological Human

XCA Cross-Community Access – IHE profile

XML Extensible Markup Language

2.2 Reference documents

The following documents were used or referenced in the development of this document:

The Description of Work of the Salus project

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3 TASK DESCRIPTION

3.1 Task 2.4 Description as in the DOW

Within the scope of this task, first of all the co-operation with the Network of Excellence to be

supported on semantic interoperability and European Health Info-structure will be coordinated.

SALUS project will closely monitor the results of this Network of Excellence, and it will provide use

cases for representing the semantic interoperability requirements of proactive post market safety

studies to the Network of Excellence. We will participate to the events organized by this NoE, and we

will invite this NoE to our Advisory board.

Cooperation with the EHR4CR IMI project, PROTECT IMI Project and with the other ongoing ICT

projects targeting improving patient safety such as PONTE, PSIP, EU-ADR, DEBUG-IT,

TRANSFORM will also be coordinated in this task.

In addition to this, the collaboration with institutional bodies who are active in drug surveillance in

Europe will be coordinated in this task. Among these currently we have identified European

Medicines Agency and its local National Competent Authorities in the member states, and European

Federation of Pharmaceutical Industries and Associations (EFPIA).

SALUS partners have already close relationships with these institutional bodies, and we aim to invite

representatives of EMA and EFPIA to our advisory board and present SALUS results through our

newsletters and also through SALUS dedicated events. We aim to organize at least two such events

within the life time of SALUS project to present the progress and demonstrate results of SALUS

project.

3.2 Partners involved in WP 2, Task 2.4

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4 MAIN TRACKS FOR COLLABORATION AND

COOPERATION

Different approaches for cooperation and collaboration were implemented during the lifetime of

the project. They will be discussed one by one in this deliverable:

1. Studying objectives, methodology and results from other projects addressing secondary use

of Electronic Healthcare Record data in general and addressing more specifically

pharmacovigilance, distinguishing pre-marketing and post-marketing patient safety.

2. Through participation of Salus partners in other project’s meetings and conferences.

3. By co-organising and participation in the “Convergence Meetings” initiated by the Salus and

the EHR4CR projects.

4. By including domain experts as well as interoperability experts in the Salus Advisory Board.

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5 OVERVIEW OF RELATED PROJECTS

The Description of Work identified a number as past and/or concurrent projects targeting at least

partially similar objectives as the Salus project. The original list of project focusing on patient

safety was extended with projects addressing also more generic aspects of reuse of EHR data,

more specifically on interoperability issues.

This deliverable does not intend to provide an in depth analysis of each of the projects that can be

considered as potentially valuable source for Salus. We are only mentioning some factual data

regarding the projects, the main or high level objectives, some interesting deliverables (if

available) and a conclusion regarding possible input for the Salus project.

5.1 Past Projects

5.1.1 EU-ADR

5.1.1.1 Project facts

The full title of the project is “Exploring and Understanding Adverse Drug Reactions by

Integrative Mining of Clinical Records and Biomedical Knowledge”.

The project started in February 2008 and ended in January 2012.

The project was coordinated by the Department of Medical Informatics of the Erasmus

Medical School, Rotterdam, The Netherlands.

Web site: www.alert-project.org

5.1.1.2 High Level Objectives

The project aimed to develop an innovative computerised system to detect adverse drug

reactions (ADRs) and reporting them. EU-ADR proposes an alternative, complementary

approach towards the detection of ADR signals with the objective of overcoming some of

the limitations of spontaneous reporting databases and providing a solid basis for large-scale

monitoring of drug safety.

5.1.1.3 Interesting Work Packages and Results

When we examine the work package definitions and the final results of these work packages

(reported in the final report of EU-ADR Project), we see that in particular WP2 and WP3

are directly relevant to the work to be carried out in SALUS. The important results of these

work packages can be summarized as follows:

WP2 - Standards:

o Define a list of important adverse events that should be monitored.

o Compile validation sets of signals (drug-event combinations), to be used

throughout the project for learning and testing purposes.

o Provide a mapping between the different terminologies used in the EHR

systems.

WP3 – Signal Generation:

o Progress in establishing a common data framework that allows the extraction

of relevant data from each EHR system for subsequent text and data mining

processing.

http://www.alert-project.org/

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o Progress in developing text mining techniques that detect the selected

medical events in free-text and map these terms to corresponding standard

codes

o Progress in developing data mining algorithms that produce a prioritized set

of adverse drug reaction signals.

5.1.1.4 Possible input for Salus

The EU-ADR clearly addresses the same challenge addressed by SALUS project: secondary

use of EHRs for overcoming the deficiencies of spontaneous reports. Signal detection is one

of the main goals of the EU-ADR project and is achieved through enabling text mining,

epidemiological and other computational techniques to analyse the EHRs across different

countries.

As SALUS Project’s main aim is to establish the interoperability framework for enabling

post-market safety studies including signal detection on top of distributed heterogeneous

EHR Systems, EU-ADR Project’s final results in this respect have been analyzed in detail:

EU-ADR covers eight EHR databases, which are partners in the project. In EU-

ADR Project it has been agreed that all databases implement and use a common

platform to extract, aggregate and export data. From each database, data is extracted

and stored in three flat text files containing information about prescriptions, events,

and patients, respectively. The event file is populated with potentially adverse

events defined in the event harmonization process. The three input files are read by

a stand-alone application called Jerboa (developed in EU-ADR Project). Jerboa is

executed by the database owners in their local environment, and transforms the

input files into aggregated output files.

As explained the Jerboa application handles the extraction of data in a uniform

format in a central database. When a new database needs to be integrated, further

effort is needed to connect to the database through its proprietary interface.

The aim of SALUS project is to enhance the results of EU-ADR in terms of expanding the

number of the EHR databases it can connect to by removing the barriers of entrance into

post market safety studies thanks to SALUS standardized communication interfaces.

Defining standard interfaces for accessing EHR databases to gather ADR related

information would be a better way to enable scalability, which will be one of the goals of

SALUS project. This will be supported via the semantic interoperability platform.

EU-ADR follows an event-based approach in which some subset of events is considered for

their relation with all possible drugs. Therefore, ranked list of high-priority events have been

identified and events that are most important in pharmacovigilance are selected to prevent

unconstrained data mining. SALUS will provide a novel framework for open-ended

temporal pattern discovery on top of the electronic health records: adverse drug reaction in

SALUS will not be limited by the selected subset of events. Finally, SALUS project will

also complement EU-ADR project as SALUS also aids and speeds up spontaneous report

generation, which has not been addressed by EU-ADR project.

5.1.2 DebugIT


The full title of the project is “Detecting and Eliminating Bacteria Using Information

Technology”.

The project started in 2008 and ended in 2011.

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The project was coordinated by Agfa Healthcare. Agfa Healthcare and INSERM which are

partners in DebugIT are both partners in the SALUS project too.

Web site: http://www.debugit.eu


DebugIT aimed at developing and deploying a semantic interoperability platform to connect

different hospitals (with different IT systems).

Based on a common set of ontologies, queries are launched to the different systems, results

are converted and consolidated into the terms of the common ontology, analysed and

visualized in a dashboard.

The clinical use case in DebugIT is the resistance of bacterias.

5.1.2.3 Interesting Deliverables

D9.3 gives an overall and high level explanation of the approach and the technical

difficulties, discussions and solutions that the project encountered.

The D1.* deliverables deal with the ontology design approaches, the D2.* deliverables with

the semantic formalization and connection of the clinical systems.


The deliverables mentioned above are directly useable as input for SALUS, because also in

SALUS the project aims to connect to different systems and consolidate the data around a

common set of ontologies.

An interesting addition of SALUS to the DebugIT results is the incorporation of existing

standards (e.g. CDA documents) as external data sources.

DebugIT mostly dealt with structured clinical data, which will be also the case in SALUS.

Conceptual schema of DebugIT:

http://www.debugit.eu/

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5.1.3 PSIP


The full title of the project is “Patient Safety through Intelligent Procedures in medication”.

The project started in 2008 and ended in 2011.

The project was coordinated by the University Hospital of Lille and the University of Lille

2.

Web site: http://www.psip-project.eu/


The objectives of the project were focused on ADR prevention, identifying by data-analysis

and semantic mining situations where patient’s safety regarding the use of medicinal

products are at risk.

The project did it by providing a clinical decision support tool to assist medication selection,

administration and surveillance and by providing just-in-time and point of care information

to healthcare professionals and patients.

5.1.3.3 Interesting Deliverables


None of the SALUS partners were directly involved in the PSIP project. The project clearly

focused on direct clinical care related added value by offering decision support based on a

limited input of patient data and formalisation of ADR knowledge.

In SALUS Task 6.1, we are developing an ADE Notification Tool. That tool will enable

detection of suspected adverse event incidents so that physicians can report them on time.

PSIP project’s focus is more on ADR prevention through a decision support system (which

is based on data mining algorithms to set the rules), although the scope is slightly different

in this respect, the results of the data mining approach followed in PSIP project would be

valuable input to SALUS Task 6.1. Within the scope of this task, the results of this data

mining process has been analysed and the ADR detection rules generated by PSIP projects

are included to the set of rules we will be screening in ADR Notification process (details

will be reported in SALUS Deliverable 6.1.1).

When it comes to interoperability, which is the main focus of SALUS project, in PSIP

Project data mining of structured hospital databases and semantic mining of free-texts are

used to collect information about observed ADEs. For this purpose, PSIP proposes a data

model to which native hospital data are transformed. Then the data gathered according to

the defined model is used to identify and prevent ADEs through data mining. The common

data model described in PSIP is not standard-based. Therefore, it requires extra work for any

hospital that would like to integrate its hospital IT system with the PSIP system. The

SALUS Project aims to develop a standard-based core common data element set to extract

relevant information from clinical information systems to perform post market safety

studies. PSIP can also benefit from the standard-based common data model of the SALUS

project by describing a mapping between its data model and SALUS data model which

makes it easy to integrate new hospitals into its system. Alternatively, through SALUS

interoperability framework, the data collected from underlying hospital information systems

http://www.psip-project.eu/

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can easily transformed into the data model proposed by PSIP project so that the algorithms

and decision support system can work on them seamlessly. In other words, the PSIP

decision support system can act as a “Safety Analysis Tool” that connects to SALUS

Platform as a client.

Finally, SALUS not only addresses detection of ADEs within a hospital but also real time

screening of multiple EHRs for signal analysis, and further enables use of multiple

distributed EHRs for observational studies.

5.2 Running Projects

Quite some projects are actually addressing issues related to secondary use of EHR data and

more specifically the aspects related to interoperability, technical as well as semantic

interoperability.

The domain of implementation is different for each of these projects. Some of these projects at

least partially address medicinal product related issues in general. Only a few of the listed

projects handle Adverse Drug Events and Pharmacovigilance.

Coordination with most of these projects is important to avoid deepening of divergent options

or reinventing the wheel again. There is nevertheless a time constraint. The Salus project

cannot be put ‘on hold’, waiting for the final results of each of the concurrent projects. The

Salus consortium tries to maximise input from these project by attending – when possible –

their meetings and by co-organising the “Convergence Meetings”.

5.2.1 epSOS


The full title of the project is “Smart Open Services for European Patients - Open eHealth

Initiative for a European Large Scale Pilot of Patient Summary and Electronic Prescription”.

epSOS is an FP7 ICT Policy Support Programme (PSP) project.

The project started in July 2008 and will end in December 2013.

The coordinator of the project is Swedish Association of Local Authorities and Regions

(SALAR). As of 2012, the consortium of the epSOS project is composed of 47 beneficiaries

from 23 European countries. They include national health ministries, national competence

centres, social insurance institutions and scientific institutions as well as technical and

administrative management entities.

Web site: http://www.epsos.eu


epSOS aims at building and evaluating a service infrastructure demonstrating cross-border

interoperability between Electronic Health Record Systems in Europe. This infrastructure

enables secure access to patient health information, particularly with respect to basic patient

summaries and electronic prescriptions among different European healthcare systems. The

project has developed a solid infrastructure for sharing of patient summaries and

prescriptions by agreeing on datasets describing the accepted terms of patient summaries

and prescriptions, as well as specification of relevant interoperability standards for data

sharing.

http://www.epsos.eu/

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epSOS attempts to offer seamless healthcare to European citizens. Key goals are to improve

the quality and safety of healthcare for citizens when travelling to another European

country. Moreover, it concentrates on developing a practical eHealth framework and ICT

infrastructure that enables secure access to patient health information among different

European healthcare systems. epSOS can make a significant contribution to patient safety

by reducing the frequency of medical errors and by providing quick access to

documentation. In emergency situations, this documentation can provide the medical

personnel with life-saving information and reduce the (sometimes needless) repetition of

diagnostic procedures.

Being an ICT PSP project, the technical, legal and organizational concepts developed within

the framework of the project are subject to an extensive practical testing phase over a period

of one year. Some of the epSOS Participating Nations have already implemented and

exposed cross-border eHealth services on top of their operational EHR systems since April

2012, in the following areas identified in the first phase of the project:

Patient Summary: access to important medical data for patient treatment

Cross-border use of electronic prescriptions ("ePrescription" - or "eMedication"

systems)

In the extension phase of the project, the following services have been selected and

specified, and they will also be implemented and operated by the epSOS nations within

2013:

Health Care Encounter Report (HCER) service for reporting back encounters in

visiting country to home country of the patient

Multi-lingual patient access (PAC) to their data

Integration of the European Health Insurance Card (EHIC)

Integration of the 112 emergency services

In its final year, epSOS will focus on wide-scale deployment and testing of these cross-

border services by as many participating nations as possible.

5.2.1.3 Interesting Work Packages

The most interesting work packages from epSOS Phase 1 are as follows:

WP3.1 Definition of ePrescription Services

WP3.2 Definition of Patient Summary Services

WP3.4 Common Components Specification

WP3.5 Semantic Services

WP3.9 Development of proof of concept system for pilot phase

The most interesting work packages from epSOS Phase 2 are as follows:

WP1.4 Service definition

WP3.A Specification

WP3.B Implementation

The most relevant outcomes of these work packages for the SALUS project are as follows:

D1.4.3 Specification of the epSOS Services

D3.4.2 epSOS Common Components Specification

D3.9.1 Appendix B1/B2 epSOS Semantic Implementation Guidelines MVC/MTC

D3.A.3 epSOS Architecture and Design

The relevance of these outcomes to the SALUS project is reported in the next section.

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5.2.1.4 Possible input for SALUS

Secondary use of data is not among the use cases of the epSOS project, which originally

concentrates on secure cross-border exchange of identified patient data for clinical care

purposes. However, epSOS project will not be limited to its contractual life span; it will

continue and improve through the support of European nations, follow-up ICT PSP projects

such as eSENS and European Commission's Connecting Europe Facility (CEF) that will

support governance for the large scale deployment of interoperable eHealth services taking

into account the existing interoperability infrastructures, as identified in eHealth Action Plan

2012-20201. Therefore, more and more European countries and regions will support the

healthcare data sets that are identified by the epSOS project. In such improvement

opportunities, it is realistic to expect that secondary use of data can be of interest as well.

For these reasons, SALUS takes into account the results from the epSOS project from the

very beginning. We take the advantage that SRDC and LISPA are active beneficiaries of

both projects.

The most important input for the SALUS project is the HL7 CDA based section and entry

level templates that are identified by the epSOS project for Patient Summary (PS) and

electronic Prescription (eP) documents. epSOS document templates are based on widely

used HL7/ASTM Continuity of Care Document (CCD) and IHE Patient Care Coordination

(PCC) templates. When necessary, some further extensions or restrictions have been applied

by epSOS on top of these templates. As one of the content standards, SALUS has also

promised to support these HL7 CDA based templates, specifically to be demonstrated in

data retrieval from the Lombardy Region. While analyzing these templates, SALUS has also

taken into account the templates that are further extended or restricted by the epSOS Project.

As of December 2012, SALUS is already able to consume any valid epSOS Patient

Summary pivot document and automatically transform it to the semantic representation of

the SALUS Common Model, for further semantic processing, so that safety analysis queries

can be run on top of them.

As another important input, epSOS project has developed the Master Value Set Catalogue

(MVC) that is composed of tens of value sets from widely used international terminology

systems such as SNOMED CT, WHO ATC, LOINC, ICD-10 and UCUM as the sets of

common coded terms to be used within pivot epSOS patient documents during cross-border

data exchange. For mapping of local codes used in epSOS countries to epSOS MVC, epSOS

follows a practical approach on top of a terminology server, unlike SALUS that will support

terminology reasoning for revealing possible mappings and also other semantic

relationships such as "ingredient of". However, SALUS will take into account the MVC

content as code systems to be supported within SALUS terminology reasoning process,

since it is already a harmonization of input by semantic and clinical experts from all over the

Europe.

Last but not least, the transactions for data exchange in epSOS are also based on some well-

known IHE profiles such as Cross-Community Access (XCA). SALUS will also support

similar IHE profiles such as Query Existing Data (QED), so that SALUS can easily provide

an adapter for querying and retrieving epSOS patient documents without interrupting the

natural way of communication in epSOS.

1 eHealth Action Plan 2012-2020,

http://www.epsos.eu/fileadmin/content/pdf/COM_2012_736_EN_eHealthActionPlan.pdf

FP7-287800 SALUS


5.2.2 Semantic Health Net – SHN


The full title of the project is “Semantic Health Net”.

Semantic Health Net is a 7th Framework Network of Excellence project.

The project started in December 2011 and is expected to end in November 2014.

The project is coordinated by EuroRec.

Web site: http://www.semantichealthnet.eu


SemanticHealthNet will develop a scalable and sustainable pan-European organisational and

governance process for the semantic interoperability of clinical and biomedical knowledge,

creating an infostructure for eHealth.

The project intends to formulate recommendations to SDOs (Standard Developing

Organisations) and to the European Commission on future R&D objectives to be addressed

for defining, harmonizing and maintaining that infostructure and for supporting the

development of semantic interoperability resources.

The project will initiate a European Virtual Organisation to champion, oversee and quality

manage those resources, “establishing a Europe-wide infostructure for coherent information

and knowledge resources.”

The SHN information structure facilitating semantic interoperability based on semantic

artefacts will be validated on the basis of two use cases: chronic heart failure (CHF) and

prevention of cardiovascular diseases (as a public health issue).


WP4 Tailored and harmonised resources for EHRs/PHRs & aggregation

WP5 eHealth infostructure & tools; artefact governance; certification & testing


The infostructure designed and developed by the SHN will be available only in the later

stages of the Salus project. The domain of validation of the SHN infostructure differs

considerably as they are not really addressing medication related issues, neither ADR

related information.

Both projects are addressing the issue of semantic interoperability between data from

different origin and from different pilot sites, through an ontology based approach.

The Salus consortium will surely, in a later stage, address compatibility with the SHN

options.

http://www.semantichealthnet.eu/

FP7-287800 SALUS


5.2.3 EHR4CR


The full title of the project is “Electronic Healthcare Records for Clinical Research”.

EHR4CR is an IMI project.

The project started March 2011 and will end in February 2015.

The coordinators of the project are The EuroRec Institute and Astra Zeneca.

Web site: http://www.ehr4cr.eu


The project aims to develop a platform that will support feasibility, exploration, design and

execution of clinical studies and long-term surveillance on populations related to these

medicinal products.

The project will therefore enable analysis of heterogeneous and distributed clinical EHR

systems and integrate existing clinical trials infrastructure products (EDC systems) in order

to reduce or even avoid redundant data capture.

The project pays attention to setting up business model for exploitation of those services, to

the accreditation and certification of EHR systems capable of interfacing with the platform


WP1 Specification & Evaluation

WP4 Semantic Interoperability

WP5 Data Protection, Privacy & Security


The EHR4CR project only addresses hospital data. Salus will use hospital as well as

primary care date (at origin).

EHR4CR is also confronted with heterogeneous EHR systems, poorly structured and poorly

encoded data as well as semantic diversity. They “solved” the problem by defining a

‘minimal’ common data set and by building a CDW (Clinical Data Warehouse) at each pilot

site. This ‘minimal’ common data set has been examined in detail by SALUS project within

the scope of WP4.

In SALUS, the approach is slightly different, through the interoperability architecture we are

building, we do not mandate the source (EHRs) and target (research systems/safety analysis

algorithms) to stick to a selected common model. A common model is used to mediate the

source and target data models to one another. SALUS Semantic interoperability platform

can complement EHR4CR approach as follows: (a) SALUS Semantic interoperability

approach can be used to build the CDW for a single healthcare institute that would like to

join EHR4CR platform seamlessly (b) EHR4CR safety analysis systems can use SALUS

Semantic interoperability platform to collect safety related EHR data in the minimal

common data set they have selected from heterogeneous EHRs, although they have not built

a EHR4CR compliant CDW.

http://www.ehr4cr.eu/

FP7-287800 SALUS


Please note that these are some theoretically possible options. We have organized a two and

a half days joint meeting with EHR4CR Project, in particular with WP4 group of EHR4CR,

and identified a number of concrete collaboration opportunities. These are reported in

Section 6.2.3.

The different interpretation and/or implementation of privacy and data protection issues

mainly between the countries is another issue common to all the (research) projects using

real patient data (at the origin).

The link between the use of the patient data and providing care to that patient is even looser

in EHR4CR compared to Salus. At least one of the services provided by Salus is directly

related to providing patient care as such, the warning system for potential risks when

prescribing medicinal products to some patients.

5.2.4 TRANSFoRm


The full title of the project is “Translational Research and Patient Safety in Europe”.

TRANSFoRm is a 7th Framework ICT project.

The project started in March 2010 and is expected to end in May 2015.

The project is coordinated by King’s College London.

Web site: http://www.transformproject.eu


TRANSFoRm aims to develop the technology that facilitates a learning healthcare system.

The selected three clinical use cases will drive, evaluate and validate the approach to the

ICT challenges of embedding diagnostic decision support and clinical trial workflow into

the EHR and providing a secure infrastructure for large scale genotype-phenotype studies

using primary care data.

5.2.4.3 Interesting Tasks and Expected Outcomes

Semantic Mediator: A web-service for terminology mapping available for this and similar

projects (WT 7.2). This is an essential component of the system for semantic mediation of

data at the point of care. TRANSFoRm will not be aiming to create and manage a mapping

of minimum datasets for interoperability, but will be working with the extension of already

maintained reference terminology (via UMLS), presented as a service throughout the project

infrastructure.

Privacy Model: A generalised model for privacy based on EU data protection laws (WT

3.1, 3.2). This model will underpin the operation of the security framework and

implementation as well as the flow of data and authorization of access to data in the system.

Research Data Information Model: A standard for a computable representation of the

operational elements of a clinical study protocol (WT 6.5, 6.6). This enables an XML

document to be authored using a semantic research workbench that binds selected terms

provided by the terminology service to a data model. The document will contain all the

elements necessary to transact a study (eligibility criteria, data elements, timelines and

interventions).

http://www.transformproject.eu/

FP7-287800 SALUS


Data Federation: Middleware for transacting research workflow in distributed

heterogeneous EHR systems and data repositories (WT 7.2).


As depicted in previous sections, there are some overlapping objectives addressed by both

projects, one of which is enabling re-use of EHR data in clinical research studies. Being an

IP project, TRANSFoRm project both addresses the execution of clinical trials in

cooperation with EHRs (which is not in the scope of SALUS Project), and enabling clinical

research on primary care data. Although post-marketing safety studies are not particularly

addressed by TRANSFoRm project, the proposed interoperability approach and the security

privacy framework could be possible collaboration issues between SALUS and

TRANSFoRm projects.

TRANSFoRm project is an ongoing project started two years earlier than SALUS project,

and will run in parallel with SALUS project. Some initial results are already available from

their website. SALUS consortium particularly examined the following results:

The Report on Regulatory Requirements, Confidentiality and Data Privacy Issues,

which outlines useful background information in this field. In developing the

SALUS Data Protection Policy, the “zones” approach proposed by TRANSFoRm

project is adopted, which helps the data protection officers in user sites to

understand the applied protection measures.

The Clinical Research Information Model proposed by TRANSFoRm project is

examined. As regulated clinical research studies are not in the scope of SALUS

project, only the “Eligibility Criteria” model defined in this model is of interest to

SALUS project. In TRANSFoRm project after examining the available approaches,

a proprietary eligibility criteria model is proposed. In SALUS we will aim to exploit

the already existing approaches proposed by HL7 HQMF, BRIDG DAM and HL7

study design messages. However, our aim is to enable interoperability between

different source and target systems: TRANSFoRm eligibility model could be one of

the source models that can be considered to demonstrate the capabilities of SALUS

approach.

Some other joint objectives, or similar approaches between these projects can be

summarized as follows by indicating possible collaboration opportunities, and highlighting

the different approaches taken:

Although a final output has not been delivered about the semantic interoperability

approach of TRANSFoRm project, the proposed architecture is examined through

the available presentations of the project, and related documents. Terminology

reasoning approach seems to be based on a terminology mapping service to be

provided on top of UMLS. In SALUS project, we aim to carry out an extended

terminology reasoning approach, by integrating the available terminology resources

as ontologies, and will try to exploit the semantics defined within terminology

systems, rather than only exploiting the one to one code mappings provided by

external terminology servers.

Clinical Data Integration Model of TRANSFoRm (to be available in May 2013)

would be of interest to SALUS: through SALUS interoperability platform the

required data from SALUS enabled systems can be collected and provided to

TRANSFoRm applications through this Clinical Data Integration Model selected.

Service Oriented approach will be followed in TRANSFoRm project, a similar

approach will be followed by SALUS project, but rather than providing proprietary

service interfaces, our aim will be sticking with the existing interoperability profiles

(like IHE profiles or HL7 Service definitions) to expose EHR data for the use of

FP7-287800 SALUS


research studies to provide a more scalable approach.

5.2.5 PROTECT


The full title of the project is “Pharmaco-epidemiological Research on Outcomes of

Therapeutics”.

Protect is an IMI project The project started in September 2009 and is expected to end in August 2014.

The project is coordinated by the European Medicines Agency.

SALUS partners involved: ROCHE, UMC and INSERM (all in WP3).

Funding: The PROTECT project has received support from the Innovative Medicine

Initiative Joint Undertaking (www.imi.europa.eu) under Grant Agreement n° 115004,

resources of which are composed of financial contribution from the European Union's

Seventh Framework Programme (FP7/2007-2013) and EFPIA companies’ in kind

contribution

Web site: www.imi-protect.eu


The objective of PROTECT is to strengthen the monitoring of benefit-risk of medicines in

Europe by developing innovative methods that will enhance the early detection and

assessment of adverse drug reactions from different data sources (clinical trials, spontaneous

reporting and observational studies), and enable the integration and presentation of data on

benefits and risks.


Overview of the Work Packages

Figure 1. Work Packages of PROTECT

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Deputy Coordinator: GSK

http://www.imi-protect.eu/

FP7-287800 SALUS


WP3: “Methods for signal detection”.

The main objective of WP3 is to improve early and proactive signal detection from

spontaneous reports, electronic health records, and clinical trials.

Sub-objectives are:

Develop new methods for signal detection in Individual Case Safety Reports.

Develop Guidelines for signal detection and strengthening in Electronic Health

Records.

Implement and evaluate concept-based Adverse Drug Reaction terminologies as a

tool for improved signal detection and strengthening.

Evaluate different methods for signal detection from clinical trials.

Recommendations for good signal detection practices.

Most interesting subpackages for SALUS are:

SP6 - Novel tools for grouping ADRs (responsible: INSERM). The goal of SP6 is to

examine the impact of semantic web tools and knowledge engineering techniques

(semantic reasoning using ontology-based description of ADR terms) on signal

detection results. An ontologised version of MedDRA was realized to support

semantic reasoning, integrating Snomed-CT mapping propositions from UMLS and

other sources and manual definitions of terms.

SP10 - Signal detection in electronic health records (responsible: UMC). The goal

of SP10 is to develop and test methods of signal detection based on observational

data (primarily EHR) and evaluate the strengths and weaknesses of this data

environment for signal detection relative to current best practice. SP10 also

examines the issues around performing signal detection and signal evaluation in

observational data sets and aim to provide recommendations on this issue. The goal

is to determine if and when screening observational databases adds value to other

signal detection strategies.


SP6 will provide a report on possibilities for improving signal detection effectiveness using

knowledge engineering methods of grouping of ADRs. An ontologized version of MedDRA

(OntoADR) including mappings with Snomed-CT has been realized and is available for use

in SALUS, together with tools developed for its exploitation, in particular a tool assisting

semantic querying on MedDRA (specified as background of INSERM in SALUS).

OntoADR might be used to enable semantic querying on MedDRA in SALUS platform

components, where a MedDRA terms must be provided as input (scenario 1, part B:

enabling semi-automatic reporting of ADE, and scenario 3: Running Exploratory Analysis

Studies over EHRs for Signal Detection).

SP10 will provide a report on the use of signal detection methods applied to electronic

health records. Their results might be reused as specifications for SALUS use cases.

Please note that, SALUS project aims to show integrating the strengths of spontaneous case

safety reports and EHR systems: in other words, EHRs will not only used for direct signal

detection on top of EHRs but we will provide means to query EHRs for signal validation

and evaluation purposes too.

FP7-287800 SALUS


5.2.6 PONTE


The full title of the project is “Efficient Patient Recruitment for Innovative Clinical Trials of

Existing Drugs to other Indications”.

Protect is a 7th Framework ICT – STREP project

The project started in March 2010 and is expected to end in February 2013.

The project is coordinated by CETIC.

Web site: www.ponte-project.eu


The PONTE project intends to provide a platform that will offer intelligent automatic

identification of patients eligible to participate in well-specified clinical trials for drug

repositioning, based on a patient risk assessment.

The focus of the project is on patient recruitment for clinical trials by “enabling semantic

interoperability between clinical research and medical practice information systems”.


WP2 Requirements and use cases

WP3 Ponte Architecture

WP4 Semantic data and metadata representation


The PONTE project also reuses clinical care data from different origin, addressing the issue

of interoperability / usability of these data for clinical trials related patient recruitment. The

project addresses also the privacy and confidentiality issue of reusing data as it focuses on

patient identification and recruitment. The Salus consortium will evaluate the PONTE

options as soon as available outside the consortium.

The PONTE consortium developed an appropriate ontology. That ontology is of course

focusing on the domain of application for the validation of the PONTE developments: the

administration of thyroid hormone for patients with myocardial infarction and ST elevation.

That PONTE ontology will be examined with the intention to find opportunities for

common or similar semantic interoperability approaches.

5.2.7 OMOP


The full title of the project is “Observational Medical Outcomes Partnership”.

OMOP is a public private partnership intended to improve the drug safety monitoring. Web site: http://omop.fnih.org

http://www.ponte-project.eu/

http://omop.fnih.org/

FP7-287800 SALUS



Employing a wide variety of approaches from different scientific fields like epidemiology,

statistics, computer science etc., OMOP seeks to answer a critical challenge: what can

medical researchers learn from observational databases, can one single approach be applied

to multiple diseases? Success would mean the opportunity for the medical research

community to do more studies in less time, using fewer resources and achieving more

consistent results.

5.2.7.3 Interesting Work Packages and Outcomes

OMOP Common Data Model (CDM)

A data model was created to transform the included data sources into a common format

designed for analytical purposes. The CDM standardizes the format and the included

vocabularies map the data sources into the OMOP CDM.

OMOP Outcomes Reference Set

OMOP established an open-source library of 10 Health Outcomes of Interest (HOI)

definitions2 for use in observational studies. These ten HOIs are a subset of all conditions

that are of importance due to their historical associations with drug toxicities, their medical

significance, and/or public health implications. There is little consensus for best practice in

defining HOIs in observational databases, as observational studies for the same outcome

often use different definitions.

OMOP Methods Library

Partners of OMOP implemented several different methods built specifically for the OMOP

CDM to address the analytical problems of monitoring the health outcomes of interest. The

methods have been tested across the data sources available in the OMOP data community

and are available under the Apache public license.


The OMOP CDM might be used as the data store for the observational screening methods in

SALUS. The methods implemented on that structure will require small modifications to

conform to the SALUS architecture which will be beneficial for the Temporal Association

Screening tools.

The SALUS project can contribute back to OMOP Project by providing the necessary

interoperability infrastructure to create new data sources in conformance to OMOP CDM

model

2 Angioedema, Aplastic Anemia, Acute Liver Injury, Bleeding, GI Ulcer Hospitalization, Hip Fracture,

Hospitalization, Acute Myocardial Infarction, Mortality after Myocardial Infarction, Acute Renal Failure

FP7-287800 SALUS


5.2.8 Eureca


The full title of the project is “Enabling information re-use by linking clinical research and

care”.

Protect is a 7th Framework ICT project

The project started in February 2012 and is expected to end in August 2015.

The project is coordinated by Philips Health.

Web site: http://eurecaproject.eu


The aim of the project is to achieve semantic interoperability between clinical information

systems and clinical trial systems, using NLP technology to analyse available even free text

data. The semantic interoperability will be validated through efficient patient recruitment for

clinical trials and long term follow-up of patients beyond the end of a clinical trial, “for

better research and patient safety”.

An important goal is to develop “tools enabling the discovery of new, clinically relevant

knowledge” by data mining biomedical data and also to identify relevant clinical guidelines

for a patient.

The domain of application is oncology in general, but more especially breast cancer.

5.2.8.3 Interesting Work Packages and Aspects

WP3 Information Extraction and Data Access

WP4 Semantic Interoperability

WP5 Data Mining and Knowledge Discovery

WP7 Ethics, Legislation, Privacy and Security

EURECA plans to build (non limitative list):

- Automated recruitment of patients for trials

- Supporting update of clinical guidelines

- Supporting design of feasible ad relevant eligibility criteria, based on patient

population and previous trials

- Automated detection and reporting of side effects

- Quick overview of available information about a patient

- Longterm follow-up of patients


There is some overlap with some of the aspects of the SALUS project, more specifically

when considering “long term follow-up of patients… for better patient safety” and the

automatic detection and reporting of side effects. Other Eureca use cases are not addressed

by SALUS.

There seems to be a different approach regarding the detection and reporting of side effects

of oncology treatments, SALUS giving more importance to human element in detecting and

reporting ADEs. That difference can at least partially be declared by the domain of

application, medication in general versus applied to oncology.

http://eurecaproject.eu/

FP7-287800 SALUS


Eureca also adheres technologically to “RDF summarisation” of the large amount of

information available, e.g. regarding the maintenance of the guidelines. That approach is

also supported by SALUS.

5.2.9 INTEGRATE


The full title of the project is “Integrative Cancer Research Through Innovative Biomedical

Infrastructures”.

Protect is a 7th Framework ICT STREP project

The project started in February 2011 and is expected to end in January 2014.

The project is coordinated by Philips Health.

Web site: www.fp7-integrate.eu/


“At the centre of INTEGRATE is a shared repository of clinical, genomic and imaging data,

originating from multiple clinical trials in breast cancer”. The purpose is to build predictive

models, to identify biomarkers and to answer to research questions faster and with more

confidence.

The focus is on the screening of the patients in oncology clinical trials, extracting clinical

data for eligibility purposes from electronic health records, acquiring molecular testing data

and tracking biological samples.

The project will provide tools for researchers for central review of data across trials.

5.2.9.3 Interesting aspects

The integration of various data from multiple clinical trials addressing mainly similar

clinical conditions (breast cancer), the options regarding data accessibility and content

representation.


There is a common issue on interoperability and use of standards, but at another level. The

project is mainly centralising data yet used for clinical trials. The electronic health records

from which data (complementary data) are extracted were yet used for other clinical trials,

though mainly addressing the same clinical domain of application.

http://www.fp7-integrate.eu/

FP7-287800 SALUS


5.2.10 eTRIKS


The full title of the project is “European Translational Information and Knowledge

Management Services”.

Protect is an IMI project. The project started in October 2012 to end in September 2017.

The project is coordinated by Astra Zeneca and the Imperial College London.

Web site: www.etriks.org/


“eTRIKS address a problem faced by all translational researchers: How to maximize the

impact of the collected data while minimizing costs.” The purpose is to integrate research

data from different IMI projects, to add knowledge management tools and to offer that to the

pharmaceutical research company.

The project intends to provide a sustainable KM platform and Service to support Private /

Public Translational Research (TR) in IMI and beyond.

The project intends to be a single point of access to “curated” historic TR study data on the

cloud.

5.2.10.3 Interesting Aspects

Some keywords used by eTRIKS: cloud hosting, KM Platform, Data & Service Standards,

Analytics, Curation and Training.

The storage (cloud) and re-use of “curated” data from different “studies” for other “studies”

seems challenging regarding privacy and security related aspects.


The project is mainly addressing clinical trials data. SALUS is not addressing clinical trials

and therefore not producing clinical trial data that may be stored in the eTRIKS platform.

http://www.etriks.org/

FP7-287800 SALUS


5.2.11 OpenPHACTS


The full title of the project is “Open Pharmacological Spaces”.

Protect is an IMI project. The project started in November 2012.

The project is coordinated by Pfizer with the Universität Wien as managing entity.

Web site: www.openphacts.org/


To reduce the barriers to drug discovery in industry, academia and for small businesses, the

Open PHACTS consortium is building an Open Pharmacological Space (OPS). This will be

a freely available platform, integrating pharmacological data from a variety of information

resources and providing tools and services to question this integrated data to support

pharmacological research.

The project will provide tools to access public as well as commercial pharmacology data by

using RDF (Resource Description Framework) to encode metadata on the available data.

The Open PHACTS platform offers actually (1/2013) yet more than 800 Million triples.

5.2.11.3 Interesting Aspects

The way huge amounts of data from different databases and in different forms / formats are

made accessible in a mum of time, based on open standards.

The application is technologically based on the use of RDF and dataset descriptions.

Mappings between the difference source data are considered as crucial.

The data are stored in a “data cache”, being an RDF store.


The project addresses more the pharmaceutical research community as a whole, enabling en

easing access to all kind of “pharmacological data”. The project does not intend to address

native clinical data for pharmaceutical research.

The technological approach on how to address huge amounts of data, using metadata

directories, as in Salus, might be valuable input for the Salus project when enlarging the

data sources, as part of an exploitation phase.

http://www.openphacts.org/

FP7-287800 SALUS


5.2.12 Linked2Safety


The full title of the project is “Ensuring Patient Safety in Clinical Trials”.

Linked2Safety is an FP7 projects The project started in October 2011 and ends per September 30, 2013

The project is coordinated by Intrasoft.

Web site: www.linked2safet-project.eu/


Linked2Safety will build semantically-interlinked, secure medical and clinical information

space that will facilitate stakeholders to dynamically discover, fruitfully combine and easily

access medical resources and information contained distributed Electronic Health Records

(EHRs), ensuring integration and synthesis of patient and clinical data, respecting patients

anonymity, data ownership and privacy, as well as European and national legislation.

Linked2Safety will support sound decision making towards the effective organization and

execution of clinical trials.

Linked2Safety will validate and evaluate the Linked2Safety results by developing proof-of-

concept pilot clinical trials design studies.

5.2.12.3 Interesting aspects

The objectives as documented during the Convergence Initiative meeting of January 22,

2013 are:

- Enable patient safety through anonymisation of clinical sites and clinical data

- Build a semantically-interlinked medical information space to recruit patients

across European clinical data sets and adverse event detection

- Support effective organisation and execution of clinical trials, embedding

governance, legal and ethic requirements.


The project is, beside other areas of application, at least partially addressing similar domains

of application: pharmacovigilance and more precisely ADE detection.

It seems important to consider the Linked2Safety patient safety approach as input for the

SALUS project and vice-versa.

http://www.linked2safet-project.eu/

FP7-287800 SALUS


5.3 Projects still to start

5.3.1 EMIF


The full title of the project is “European Medical Information Framework”.

EMIF is IMI project The project will start in February 2013 and expected to end in January 2018

The project is coordinated by Janssen Pharmaceutica and managed by the Erasmus

University Medical Centre Rotterdam.

Web site:


The EMIF project intends to offer “a sustainable and scalable information framework which

has the potential to access detailed data” for clinical researchers. The project will focus on

the discovery of predictors for metabolic complications of obesity and on the discovery of

protective and precipitating factor in dementia and in Alzheimer disease.


The project has 15 Work Packages. The most interesting – at least for non partners – are

most probably:

WP1 Clinical Data Collection (and related problems)

WP11 Harmonisation and semantics

WP12 Data extraction, benchmarking, aggregation and linkage


Most options taken by the EMIF consortium will most probably only be validated too late to

have an important impact on the SALUS implementation.

The EMIF use cases are also quite different to the Salus domain of application. Medication

and even more pharmaco epidemiology isn’t in the scope of EMIF.

There might be an input from SALUS into EMIF, more especially in handling clinical data

from different origin, as for most of the listed projects. The same issues regarding legal,

organisational, technical and semantic interoperability will need to be addressed.

FP7-287800 SALUS


6 INVOLVEMENT IN OTHER PROJECTS

Involvement in other projects addressing some aspects also addressed in Salus can be fruitful for

Salus as well as for these other projects.

We are distinguishing effectively attending meeting organised by and/or within another project’s

consortium on one hand and joint meetings on the other hand.

6.1 Attending other project’s internal meetings

6.1.1 EHR4CR Advisory Board Meeting

The EHR4CR project is considered as one of the most promising projects regarding secondary

use of EHR data. It is therefore important for Salus to informed on what’s going on in that

project.

The SALUS project was represented by two partners at the first EHR4CR Advisory Board

meeting in Basel on November 7, 2012 from 09:00 to 13:00: Dr. Dirk Colaert (Agfa) as full

member and Dr. Jos Devlies (EuroRec), as observer.

SALUS and EHR4CR have both in common the re-use of EHR Data. SALUS focuses on long

term pharmacovigilance. EHR4CR has a broader focus including clinical trial protocol

feasibility studies, patient recruitment, trial execution as well as pharmacovigilance, the latter

more related to ‘early’ and ‘severe adverse events’. The EHR4CR project is expected to

address pharmacovigilance only late 2013. SALUS may therefore be of more interest to

EHR4CR than vice-versa.

Members of the EHR4CR Advisory Board are:

Gunnar Klein, Norway, National Centre for EHR Research at NTNU, president

Dirk Colaert, Belgium, Agfa

Jörg Kränzlein, Germany, ISoft (CSC)

Mitra Rocca, USA, FDA

Fergus Sweeney, United Kingdom, EMA – European Medicines Agency

Jean-Paul Deslypere, Singapore/Belgium, not present

Danielle Dupont, Switzerland, Data Mining International, not present

Minutes and Main Conclusions:

The Advisory Board discussed its role within the project, which is surely not to steer

the project.

The choice for the HL7 syntax was questioned.

The current legacy EHR systems are a major challenge requiring improved recordings

in order to realise the project vision.

The Business Modelling documentation provided to the Advisory Board was

considered as “preliminary” and need to include “physicians” as stakeholders.

The vision and mission statement for the project was discussed. Proposals for

readjustment were done.

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6.1.2 SemanticHealthNet Consortium Meeting, September 3 and 4, 2012

The SemanticHealthNet project is considered as the upmost important project focusing on the

semantic interoperability between eHealth information systems, even if the chosen domains of

piloting and implementation are not directly related to drug safety and pharmacovigilance.

Domain of collaboration: Semantic Interoperability. Realising (up to a certain level) the

“overall Semantic Interoperability” seems to be the main purpose of the project. Semantic

Interoperability is rather an enabler, a pre-requirement to realise the purpose of the Salus

project, using EHR system data in pharmacovigilance and improving the related processes.

Related to the following task within Salus:

Task 4.1 Creating the Content Models for the Functional Interoperability Profiles

Task 4.2 Creating a common set of data elements

Task 2.4 Cooperation with other projects

Description of the input from the partners into Salus3:

Semantic Health Net started with selecting two (limited) domains of application to validate

SHN options and/or developments: chronic heart failure (clinical care) and cardiovascular risk

management (public health).

Scenarios (short notes) are collected from different pilot sites in order to extract the (minimal)

data set.

Identified data elements are coded:

EN13606 detailed clinical models

Open EHR archetypes

HL7

IHTSDO Snomed CT

Different combinations of Snomed CT were possible for the same concepts.

Pharmaceutical issues or issues regarding pharmacovigilance are not addressed (yet).

Some statements noted

Interoperability is a continuous and never ending story

Interoperability is not just sharing data

ISO/CEN organised workshop and will further investigate how Contsys – HISA – 13606 can be

used together.

Salus presence:

Agfa Healthcare Dirk Colaert

ERS Gerard Freriks & René Schippers

EuroRec Jos Devlies & Georges De Moor

INSERM Christel Daniël & Nassim Douali

3 Describe possible input, possible added value for Salus from the collaboration for suggested collaboration. Describe

effective input from reported collaborations. In case of no input, please motivate the option (to be included in the

collaboration report deliverable.

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6.1.3 EHR4CR Semantic Interoperability WP4 Meeting, Paris January 23-24,

2013

6.1.3.1 Main objective of the workshop

The 4th Workshop of WP4 of the EHR4CR project mainly focused on

Semantic limitations of the actual EHR4CR protocol feasibility development and the October

2012 pilot demonstration

The semantic needs when extending the number clinical trials to be addressed by the platform

The requirements when moving to the next two scenarios: patient recruitment and trial

execution, in cooperation with WP1 of that project

The remaining problems regarding privacy and security, resulting in a unwillingness of some

EHR4CR pilot sites to provide “real data”. This was addressed in a joint workshop between

WP4 and WP5.

6.1.3.2 Agenda of the Workshop

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6.1.3.3 Some interesting statements

A detailed report of the meeting will be produced within the EHR4CR consortium and published on

the EHR4CR web site.

1. There seems to be a performance / efficiency issue at the query endpoints. Database

optimization is listed as one of the points of attention to increase efficiency. The question is

made if some “rules based querying” should be included with reference to the SALUS

project?

2. Semantic Web Technology and Tools is what we should think about (Charlie Mead)

3. “Important to have a model… but also important how that model is represented. This is

addressing the issue of metadata exchange.” (Charlie Mead)

4. Semantically equivalent >< semantically identical. Do we always need semantically identical?

5. The model promoted by CDISC is RDF. Serialise a triple store.(Landen Bain)

6. “Strip everything except semantics. There is only semantic harmonization?” (Landen Bain)

7. Metadata are essential to define something as semantically “identical”. (Landen Bain)

8. It has been discussed and agreed that the EHR4CR project can use the metadata registry that

is being developed by the SALUS project.

9. The use of the new IHE DEX profile is discussed. Please note that SALUS project is actively

contributes to this new IHE DEX Profile.

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6.1.3.4 Presence of the Salus Consortium

The Salus consortium was represented in all the meetings, mostly by members of the Salus

consortium, also participating in the EHR4CR project.

AGFA Dirk Colaert

EuroRec Jos Devlies

INSERM Christel Daniel

Marie Christine Jaulent

Gunnar Declerck

Sajjad Hussain

The Salus Advisory Board Member Kerstin Forsberg (Astra Zeneca) was also present.

6.2 Cross project meetings

6.2.1 The Basel Convergence Meeting on Secondary Use of EHR Data,

November 7, 2012

The SALUS and the EHR4CR consortia were the co-organisers of the Basel Convergence

Meeting on Secondary Use of EHR Data.

6.2.1.1 Original Invitation as published on the website of EuroRec

6.2.1.2 Purpose of the meeting

The main purpose of the meeting was to prepare a larger event on re-use of EHR data,

scheduled in Brussels, first quarter of 2013.

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The invitation clearly specified that purpose, identifying some challenges to be addressed:

1. Semantic interoperability for research use, e.g. consistent usage of terms and data

structures that are frequently needed in trials, e. g. how to use CDISC and SNOMED CT

together (and other usages, e.g. in post marketing surveillance, public health research….);

2. Data quality, how it can be defined and how to control scientifically the variable quality

of routinely collected data;

3. Metadata that can support the wide scale understanding of research data sets so that they

are correctly (re-)used by others sharing access to such data;

4. Platform architectures (conflicting designs?);

5. Privacy protection and consent for research uses of EHRs and other sources, legal

contexts (and enlarging the uses of research data for which only narrow consent might

exist);

6. Business modelling, in relation to the re-use of EHRs for research and also specifically

for interoperability.

6.2.1.3 Invited projects

The following projects were invited to attend the “Basel Convergence Meeting”:

IMI Projects

o EHR4CR http://www.ehr4cr.eu

o eTRIKS http://www.etriks.org

o EMIF to start shortly at that moment

DG Sanco Projects

o Parent http://www.patientregistries.eu

DG Connect projects

o SALUS http://www.salusproject.eu

o Eureca http://eurecaproject.eu

o Integrate http://www.fp7-integrate.eu

o p-Medicine http://p-medicine.eu/

o SemanticHealthNet http://www.semantichealthnet.eu

o TRANSFoRm http://www.transformproject.eu

o diXa http://www.dixa-fp7.eu

A table with essential information on each of the projects was distributed to the attendees. The

matrix is available on the EuroRec web site

http://www.eurorec.org/ECprojects_convergenceRoundTable_Basel2012/

The name of the file is “Matrix – Convergence Round Table – v3.xsls.

6.2.1.4 Agenda

There was no strict agenda. The different challenges were addressed one by one, each of the

represented projects being requested to comment the issue. Some challenges were added “on

the road”, resulting in the next list of issues related to mainly secondary use of EHR data. The

final list is summarised in the next slide:

http://www.ehr4cr.eu/

http://www.etriks.org/

http://www.patientregistries.eu/

http://www.salusproject.eu/

http://eurecaproject.eu/

http://www.fp7-integrate.eu/

http://p-medicine.eu/

http://www.semantichealthnet.eu/

http://www.transformproject.eu/

http://www.dixa-fp7.eu/

http://www.eurorec.org/ECprojects_convergenceRoundTable_Basel2012/

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Categorise the issues Semantic interoperability: identifying items and context in order to enable a correct and reliable

interpretation of the content

Metadata: correct and consistent identification of the nature (and status)

Quality of data entry and structuring the content

Glossaries : domain related concepts and terms

Privacy :

the main issue is the different “interpretations” of privacy : need for harmonisation

privacy enhancing techniques: how and what is needed ?

Trust

Ethics

Problem(s) awareness, promotion, education

Technical issues:

common data model, queries

Business - € related issues – added value

Metrics, evaluation (linked to quality and quality assessment)

(Generic) test data required ?

6.2.1.5 Attendees

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6.2.1.6 Minutes

Each of the represented consortia were asked to inform the other attendees on how they

experienced ‘problems’ and on how they addressed these issues within their project.

No formal decisions were taken, the purpose of the meeting being to inform each other.

6.2.1.7 Next Steps

See section 6.2.3.

6.2.2 Discipulus Consultation Meeting – Barcelona, 27 November 2012

The Discipulus project “aims to direct” the agenda and “to frame the necessary steps in the

Digital Patient”.

The Digital Patient, a VPH (Virtual Physiological Human) concept, intends to implement levels

of health prediction using patient-specific information and predictive models of physiological

systems. The Digital Patient focuses also on “understanding and explanation of the effects of

treatments”.

Possible input for the Salus project

The approach of the “Digital Patient” is rather predictive, while the Salus project addresses

more the warning for possible safety risks and the discovery of effective Adverse Events.

The “Digital Patient” analyses patient data and uses them as input for predictive models

through a Virtual Physiological reality and models. Supporting the provision of better and

individualised care is the focus.

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Salus has a double focus. It has a care improvement aspect, analysing patient data in order to

identify actual risks and to protect patients against adverse events, based on documented

patterns. Salus also collects and analyses (data mining) larger patient data sets to “detect”

expected and unexpected adverse events related to the use of medicinal products. It also offers

adverse event reporting facilities.

Both projects need to address the semantic problems addressing and using data from different

origin.

Salus presence:

Agfa Healthcare Dirk Colaert

EuroRec Jos Devlies

6.2.3 SALUS-EHR4CR Bilateral Convergence & Cooperation Meeting, Paris

18-21-22 January 2013

SALUS and EHR4CR project WP4 subgroup has organized a bilateral convergence meeting

for two and a half days on January 18, 21 and 22 for discussing possible collaboration

opportunities between the two projects especially with respect to semantic interoperability and

the use of IHE profiles. The agenda of the meeting was as follows:

Date: Friday January 18, 2013: 10:00-17:00

Title: Use cases, IHE QRPH & protocol representation

Location: AP-HP HOPITAL ROTSCHILD – Room 27 Pavillon 3

Participants: SALUS Project : Gokce Banu Laleci (SRDC), Ali Anil Sinaci (SRDC), Mustafa Yuksel

(SRDC), Gunnar Declerck (INSERM), Sajjad Hussain (INSERM)

EHR4CR Project: Christel Daniels (INSERM, AP-HP), Sajjad Hussain (INSERM),

Nicolas de St Jorre (XClinical), Landen Bain (CDISC)

Topics: o Short presentation of both SALUS & EHR4CR current status

o SALUS scenario/use-cases and achieved developments

o EHR4CR scenario/use-cases and achieved developments

o SALUS + EHR4CR: finding a list of agreed uses-case between both projects

o IHE QRPH: review of existing integration/profiles (RFD+CRD and

DCS) and identification of profiles for EHR4CR/SALUS integration

(based on the result of the internship of M.Kappoko who investigated

how far IHE profiles could address some of the EHR4CR use cases)

o Generally speaking what will be the use of CDISC ODM and CDASH (and

mappings to these resources) in EHR4CR or SALUS

o CDISC Protocol Representation Model (including the model of

eligibility criteria and activities) and needed extension

Date: Monday, January 21, 2013: 10:00-17:00

Title: Data element exchange and metadata repository

Location: INSERM – Stair D (Centre de Recherche des Cordeliers)

Participants: SALUS Project : Gokce Banu Laleci (SRDC), Gunnar Declerck (INSERM), Sajjad

Hussain (INSERM)


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Topics: o Short presentation of both SALUS & EHR4CR data elements (definition, scope

and current implementation)

o Metadata repositories (caDSR, eMERGE, ISO 11179, etc)

o IHE DEX profile

o Projectathon based on IHE QRPH

Date: Tuesday, January 22, 2013: 10:00-13:00

Title: Action Plan

Location: INSERM – Stair D (Centre de Recherche des Cordeliers)

Participants: SALUS Project : Gokce Banu Laleci (SRDC), Dirk Colaert (AGFA), Gunnar Declerck

(INSERM), Sajjad Hussain (INSERM)



Topics: 9:30-11:00: Action plan between CDSIC IHE QRPH, SALUS, EHR4CR

11:00-12:00: Joint EHR4CR-eTRIKS meeting (+ Y.Guo)

As presented in the agenda, one of the first actions was to discuss EHR4CR and SALUS

pilots in detail. It has been realized that, EHR4CR mostly focuses on clinical trials, while

SALUS focuses on post marketing safety studies. One of the use cases of EHR4CR project

(4th use case) will be about adverse event reporting, however it is estimated that this pilot will

be realized within the last six months of the project. SALUS project’s ICSR reporting tool

will already be available by then, EHR4CR project will evaluate its application in EHR4CR

project too.

SALUS project reported that they do not want to invest on IHE RFD, CRD profiles much, as

they are not capable of handling semantic mismatches in a dynamic way. The new IHE Data

Exchange (DEX) profile is discussed in detail, and SALUS project presented that they would

like to go with IHE DEX approach. It has been provisionally agreed that, EHR4CR and

SALUS projects will both use DEX profile. Apart from that a joint projectathon does not

seem feasible at least for now. SALUS team will check whether they can use IHE RPE Profile

for defining very basic study protocols for describing post marketing safety studies.

SALUS team presented possible implementing options for IHE DEX profile, by listing the

possible standards that can be used for each transaction. Gokce and Landen will continue to

work on these, to complete Volume 2 of the profile proposal. The team altogether discussed

the initial Volume 1 description of IHE DEX profile.

SALUS Team introduced the ideas of metadata registries (MDR), and presented briefly the

ISO/IEC 11179 based MDR implementation they are carrying out. It has been discussed that

this open source implementation can be used by EHR4CR project too. EHR4CR team

presented that they are working on an editor for creating Data Element definitions. It has been

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discussed that this editor can be integrated to the MDR implementation carried out in SALUS

project.

Logistic issues regarding the joint AMIA Clinical Research Informatics Summit Panel has

been discussed, and it has been agreed that SALUS will be represented by Anil, as Gokce will

have to be in Brussels in the same days.

6.2.4 Convergence Initiative Meeting, Paris 22 January 2013

The EHR4CR Consortium hosted a “Convergence Initiative” linked to their Semantic

Interoperability workshop, organised by WP4 of the EHR4CR project. The workshop intended

to do a gap analysis and to rescope the semantic interoperability workplan for the EHR4CR

project, considering they are moving on from PFS (protocol feasibility services) to PRS (patient

recruitment services) and clinical trial execution.

Pharmacovigilance, the SALUS domain of application, will only be addressed by EHR4CR as

their Fourth domain of application, domain of reuse of EHR data.

Agenda of the meeting

Presentations

The presentations are made available on the following web address

http://www.w3.org/wiki/HCLS/ClinicalObservationsInteroperability/Convergence

Minutes

The purpose of the meeting is to have better insight of the semantic interoperability issues in

the five projects represented.

The focus of each of the projects is actually more on a stage before the semantic

interoperability, but rather at the level of the syntax, on the level on how formatted information

from different origin, from different sources can be merged in common datasets.

All the projects participating in the convergence meeting are shortly presented in section 5.

A more detailed report will be made available by Sajjad Hussain and Christel Daniel of

INSERM.

An overview of semantic issues and how they were addressed was presented as conclusion of

the convergence initiative and updated during the session.

http://www.w3.org/wiki/HCLS/ClinicalObservationsInteroperability/Convergence

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Researc

Projects

Information

Models

(MDRs)

Clinical

Terminologies

/Ontologies

Terminology

Services

(Management

& Mappings)

Query

Language &

Query

Builder

(GUI)

EHR Data

Quality and

Preparation

Data

Exchange

Format

Use-cases /

Scenarios

Description

Current

Issues

Others

EHR4CR HL7 v3 models

«StudyDesign»

*

CDA , CDISC

IHE Profiles

LOINC,

ATC,ICD,

SNOMED-CT,

PathLex

MedDRA

Mapping

Browsing

Searching

Expansion

Management

Eclectic/

OCL/

SPARQL

Template-

based

EHRETL

CDWs

Dealing with

clinical data

structures

templates, data

elements

EURECA CTS Canonical

Model

EHR Canonical

Model

Core Dataset

Relevant set

from BioPortal

Core dataset

(SNOMED-CT

LOINC,MedD

RA

ICD,CDISC)

Reasoning

Mapping

SPARQL

with Regular

Exp,

annotated

criteria,

Rule-based,

Script-based

Unstructured

data/ plain

text

Dealing with

Common Data

Models

(standard

information

models)

SALUS SALUS CIM

(CDA, OMOP

ODM, CDISC

ISO EN

13606), Data

Definition

Model of

ORBIS system

IHE Profiles

SNOMED-CT

MedDRA

ICD-9/10

LOINC / ATC

SALUS

Harmonized

Ontologies

CDE Ontology

MDR ISO

11179

Reasoning

Convergence

rules

SPARQL

Rule-based

calculations

(Temporal

Constraints)

HQMF

Queries for

eligibility

-IHE profile

based

interaction

with EHRs

(for

collecting

anonymized

medical

summaries

for research

studies)

SPARQL

endpoints on

EHRs

Interfacing

with DEX,

IHE profiles

other standard

information

models

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Salus Presence

SDRC Gokce Banu Laleci

Agfa Health Dirk Colaert

EuroRec Jos Devlies

INSERM Gunnar Declerck

Marie-Christine Jaulent

Christel Daniel

Sajjad Hussain

OpenPhacts VoID

QUDT

Various Data

BioPortal

sources

UMLS,

ChEBI, etc

Mappings

Reasoning

Provenance

Curation

Application-

specific

GUIs

SPARQL

Restful

Services/API

RDF(S)

OWL

Dealing with

memory issues

with triple

stores

API vs

SPARQL

Ontologies:

Requirements

vs

Recommendati

ons

Linked2Saftey HL7/openEHR

RxNorm,

DSM-4,

SNOMED,

LOINC,

Reasoning

Mapping?

SPARQL Unstructured

data

SPARQL

endpoints on

EHRs?

Data-cube

building

SIG

recruitment

Legal ethical

framework and

exploitation

strategy

eTRIKS Common Data

format

Omics Data &

Mappings

Common

Ontology

eTRIKS

ontology

management

service

Storage

SQL (DB))

ETL

i2b2

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6.2.5 The Brussels Convergence Conference on secondary use of EHR data,

March 20-21, 2013

A large audience “Conference on secondary use of EHR data” is planned in Brussels, March 20

and 21, 2013. The conference will organised in cooperation with DGSanco and DG Connect.

An exhaustive report of that meeting will be included in Deliverable D2.4.2.

7 CONCRETE PROJECT TO PROJECT COOPERATION

7.1 Possible Collaboration with EHR4CR Project

As a result of the bilateral convergence meeting held on January 18, 21 and 22 2013, some

concrete collaboration opportunities have been agreed between SALUS and EHR4CR projects.

These are presented in Section 6.2.3.

7.2 Possible Collaboration with CDISC2RDF Initiative

There is an explorative initiative, called CDISC2RDC

4, for making standards

from CDISC (Clinical Data Interchange Standards Consortium) available using generic

standards from W3C (World Wide Web Consortium), i.e. generic standards from the stack of

standards for the Semantic Web (RDF triple based). This initiative has been proposed by early

adopters in AstraZeneca and Roche5. After the presentation of the initial efforts to implement

SALUS Semantic metadata repository based on ISO 11179 Standard in ApacheCon 2012;

CDISC2RDF effort has showed interest in SALUS work in this field. SALUS project had the

opportunity to present the current progress and also the vision of implementing a semantic

metadata registry for enabling semantic interoperability between clinical research and care

domains to CDISC2RDF on November 29, 2012 through a teleconference. Kerstin Forsberg

from AstraZenaca, Frederik Malfait from ROCHE and Charlie Mead (NCI, NIH USA, co-chair

of W3C HCLS Clinical Observation Interoperability group) have attended to this

teleconference. After this teleconference, the available work of SALUS project,

(https://github.com/sinaci/semanticMDR) has been shared with CDISC2RDF community, and

further collaboration opportunities will be pursued.

7.3 Possible Collaboration with IHE Quality, Research and Public Health

Domain (QRPH)

SALUS Project has initiated contact with IHE Quality, Research and Public Health Domain

(QRPH), in order to work on new profile proposals that are of interest to SALUS project

4 http://cdisc2rdf.com/

5 Semantic models for CDISC based standard and metadata management,

http://kerfors.blogspot.se/2012/05/semantic-models-for-cdisc-based.html

http://www.cdisc.org/

http://www.w3.org/

http://www.w3.org/standards/semanticweb/

https://github.com/sinaci/semanticMDR

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interoperability approach. In particular, Dr. Gokce B. Laleci (SRDC) and Dr. Christel Daniel

(INSERM) will collaborate with Dr. Landen Bain (CDISC) in the preparation of IHE Data

Exchange (DEX) Profile. The aim of IHE DEX Profile is to exploit a metadata registry to

annotate both eCRF or ICSR forms and also medical summaries (that may be represented in

HL7 CCD) format with Common Data Elements maintained in a metadata registry, so that,

interoperability between clinical research and care domains can be achieved on the fly, by

retrieving extraction specification of a certain data element in one domain from a standard

document in another domain. This work is quite parallel with the improvements proposed in an

early SALUS publication: “Providing Semantic Interoperability between Clinical Care and

Clinical Research Domains”, Laleci, G., Yuksel, M. ; Dogac, A., IEEE Transactions on

Information Technology in Biomedicine; hence SALUS project will take active participation in

the preparation of this profile.

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8 ADVISORY BOARD

8.1.1 Members of the advisory board

The members of the Advisory Board are external experts nominated on basis of their

experience in re-use of EHR data for pharmacovigilance related research.

The Full Members of the Advisory Board are:

Mrs. Vanessa Binamé, Belgium, Belgian Federal Food and Drug Administration, Drug

Surveillance Agency

Mrs. Kerstin L. Forsberg, Sweden, Astra Zeneca

Prof. Dr. Dipak Kalra, United Kingdom, Centre of Health Informatics, University

College London

Dr. Mauro Venegoni, Italy, Regione Lombardia, responsible for pharmacovigilance

Dr. Xavier Kurz, United Kingdom, European Medicines Agency (EMA), coordinator

of the PROTECT project on monitoring post-authorisation outcome of medicines (IMI

project)

Vanessa Binamé, actually head of the Directorate Generam Post(marketing) of the Federal

Agency for Medicines and Health Products, graduated as Pharmacist at the University of Liège,

Belgium, 1998. She has a Management Masters Degree of the Institute St. Louis, Brussels and

obtained a post-graduate in Pharmacology and Pharmaceutical Medicine at Free University of

Brussels (ULB. She is administrator of CBIP/BCFI the editor of the Belgian National Drug

Database, member of the reimbursement commission of the National Health Insurance Institute,

Kerstin L Forsberg, AstraZeneca R&D Information, Principle Informatics Scientist within the

Analytics, Information and Knowledge Engineering Practice (AIKE). Kerstin has 25+ years of

experience in information and knowledge management strategies, standards and solutions,

across the pharmaceutical, news and automotive sectors. For the last 11 years, her focus has

been on improving the utility and value of clinical information. Externally she is engaged in the

IMI project on Electronic Heath care Records for Clinical Research (EHR4CR), W3C Health

Care and Life Science (HCLS) interest group for semantic web, Open Biomedical Ontologies

(OBO) community, and Clinical data standards organization (CDISC). Kerstin has a Ph.Lic

degree in Informatics and she is the author of research publications in computer supported

collaborative work (CSCW) and semantic web.

Dipak Kalra, is a Clinical Professor of Health Informatics at University College

London, President of the EuroRec Institute and a Director of the openEHR Foundation.

He plays a leading international role in research and development of electronic health record

architectures and systems, including the requirements and models needed to ensure the robust

long-term preservation of clinical meaning and protection of privacy. He has led the

development of CEN and ISO standards on I interoperability, personal health records, I

requirements, and has contributed to several I security and confidentiality standards. Dipak

is involved in European research on I system quality 47abeling, semantic interoperability and

clinical knowledge discovery. Dipak leads a EU Network of Excellence on semantic

interoperability, and a project to develop a European roadmap on patient empowerment

innovations. He and his UCL team are partners in I4CR, an Innovative Medicines Initiative on

the re-use of electronic health record information for clinical research, alongside ten global

pharmaceutical companies. EuroRec is the Managing Entity of I4CR.

Mauro Venegoni, MD, is consultant of the Pharmacovigilance regional Centre of Lombardy,

Milan, since 2010. He was graduated in Medicine (Milan, Italy, 1971), specialized in Internal

Medicine (Milan, 1976), Allergology and Clinical Immunology (Milan, 1980), and took a

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Diploma in Epidemiology and Biostatistics (McGill University, Montreal, CA, 1995). His

career developed mainly as Hospital doctor for more than 30 years (since 1974 to 2005) in

Internal Medicine Departments: since 1997 as Head of Medicine Department, Fatebenefratelli

Hospital, Milan. He was involved since 1989 in research and activity in Pharmacovigilance and

Pharmacoepidemiology: Scientific Director of Regional Centre of Pharmacovigilance of

Lombardy from 2000 to 2005, in late 2005 was called at the Italian Drug Agency /(AIFA) as

Head of Pharmacovigilance Unit. Since March 2008 to December 2009 was the Italian delegate

at the CHMP-Pharmacovigilance Working Party, European Medicine Agency (EMA), and in

2009 was the Italian delegate in the Technical Committee on the new legislation on

Pharmacovigilance in Brussels. He is author of more than 100 publications. He read and speaks

with proficiency English, French, Spanish.

Xavier Kurz, graduated in 1982 as a Medical Doctor at the University of Liege, Belgium. He

specialised in Tropical Medicine and worked for several years in public health projects in

Africa and Asia. He obtained a MSc (1991) and a PhD (1997) in Epidemiology and

Biostatistics at McGill University, Montreal, Canada. He joined the Department of

Pharmacology of the University of Liege, where he developed and conducted pharmaco-

epidemiological and pharmacoeconomic studies on vascular disorders and dementia. He joined

the Belgian Centre for Pharmacovigilance (Ministry of Health) as scientific expert in 1995 and

the Pharmacovigilance and Risk Management Sector of the European Medicines Agency

(EMA) in 2005. As Signal Detection Scientific Advisor and Project Leader, he chairs the

Signal Validation meeting and has coordinated the EMA activities for the safety monitoring of

Influenza A/H1N1 pandemic vaccines in 2009-2010. He is coordinator of the IMI PROTECT

(Pharmacoepidemiological Research in Outcomes of Therapeutics by a European ConsorTium)

project and Principal Scientific Advisor to the European Network of Centre for

Pharmacoepidemiology and Pharmacovigilance (ENCePP).

8.2 Mission of the advisory board

The advisory board is expected to review and to comment mainly the use cases, the privacy

options, the technological implementation and business development strategy defined by the

Salus consortium.

The advisory board is expected to provide that input in complete independence.

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8.3 First Meeting of the Advisory Board on January 16-17, 2013

8.3.1 Invitation

8.3.2 Introduction and Agenda of the AB meeting

The following documentation was send to the members of the Advisory Board. This enabled

them to prepare the meeting considering the actual status of the project.

FP7-287800 SALUS


December 11, 2012

Dear Advisory Board Members,

First of all, as the coordinator of the SALUS Project, I would like to thank you once again for being a

part of SALUS Advisory Board. As you know, our first Advisory Board Meeting will be organized on

January 16-17, 2013.

Enclosed I would like to present you a summary of the progress of the ICT 287800 SALUS Project

(Scalable, Standard based Interoperability Framework for Sustainable Proactive Post Market Safety

Studies) between Month 1-Month 10 (February 2012 – November 2012).

First, the Project Web site is: http://www.salusproject.eu/

Brief information about SALUS Workpackages can be found in:

http://www.srdc.com.tr/projects/salus/index.php/project-overview/workpackages

The current progress can be viewed from:

http://www.srdc.com.tr/projects/salus/index.php/work-progress

All of the SALUS Public Deliverables are also available from this page.

SALUS ID Card is available from:

http://www.salusproject.eu/docs/SALUS-fp7factsheet.pdf

An overview of SALUS Project’s objectives is summarized in our first White Paper. It is

available from:

http://www.salusproject.eu/docs/SALUSwhite_paper-Final.pdf

One of the first activities of SALUS Project was the investigation of the requirements of SALUS

Pilot applications. For this purpose, first of all, current situation and practices in ADE detection

and ADE reporting, clinical research studies including clinical trials and post market safety

studies at Technical University of Dresden (TUD) and Lombardy Region are analysed. In addition

to this, an analysis of the current I Systems, and the corresponding Data Warehouses used for

statistical research in TUD and Lombardy Region is conducted. Secondly, the current practices

for pharmacovigilance studies at Uppsala Monitoring Center are examined. In particular, the

process and systems used for collecting case safety reports, signal detection methods utilized

using case safety reports and signal detection methods utilized using EHRs are analysed. The

standards used in these processes are also examined. Thirdly, the post market safety study

processes at ROCHE are examined. These are reported as a part of D8.1.1. In addition to these,

six different pilot application scenarios have been defined and analysed to extract the

requirements for pilot applications at clinical sites. These pilot scenarios are also discussed in

http://www.salusproject.eu/

http://www.srdc.com.tr/projects/salus/index.php/project-overview/workpackages

http://www.srdc.com.tr/projects/salus/index.php/work-progress

http://www.salusproject.eu/docs/SALUS-fp7factsheet.pdf

http://www.salusproject.eu/docs/SALUSwhite_paper-Final.pdf

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“Deliverable 8.1.1 – Pilot Application Scenario and Requirement Specifications of the Pilot

Application”, which is available from:

http://www.salusproject.eu/docs/D8_1_1-Final.pdf

After the finalization of Pilot requirements, within the scope of Task 3.3, the “Requirement

Specification of SALUS Architecture” is reported in accordance to IEEE 1233-1998 & IEEE 830-

1998. Initial software components and the interactions between these were identified through use

case descriptions. The functional, interface, data, and non-functional requirements are

documented. The resulting requirements analysis provides a more consistent view of the

challenge to be addressed by the SALUS system and defines a common terminology. SALUS

“Deliverable 3.3.1 – Requirement Specification of SALUS Architecture” is available from:

http://www.salusproject.eu/docs/D3_3_1%20Requirement%20specif%20SALUS%20Architectur

e%20v1.2.pdf

The Consortium then worked on the conceptual design of the SALUS architecture according to

the document guidelines presented in IEEE-1016 Recommended Practice for Software Design

Descriptions (SDD). As an SDD document, this document aims to show how SALUS software

system will be structured to satisfy the requirements identified in the SALUS software

requirements specification, i.e. D3.3.1. It is a translation of requirements into a description of the

software structure, software components, interfaces, and data necessary for the implementation

phase. In essence, the SDD becomes a detailed blueprint for the implementation activity. SALUS

“Deliverable 3.4.1 – Conceptual Design of the SALUS Architecture” is available from:

http://www.salusproject.eu/docs/D3_4_1ConceptualDesignoftheSALUSArchitectureFinal.pdf

After the finalization of the conceptual design of SALUS Architecture, several different tasks in WP4

(Semantic Interoperability Framework for Post Market Safety Studies), WP5 (Functional

Interoperability Profiles and Toolkits for Exposing EHRs for secondary use in Post Market Safety

Studies) and WP6 (Integrating Clinical Research with Clinical Care) are initiated to build the SALUS

architecture iteratively. These have not been finalized and reported yet, however we will provide

information about our studies and progress to you during our meeting.

Up to now, SALUS has four publications:

Gokce B. Laleci, Mustafa Yuksel, Asuman Dogac, Providing Semantic Interoperability between

Clinical Care and Clinical Research Domains, Accepted for publication in IEEE Transactions on

Information Technology in BioMedicine

Gokce B. LALECI ERTURKMEN, Asuman DOGAC and Mustafa YUKSEL, SALUS: Scalable,

Standard based Interoperability Framework for Sustainable Proactive Post Market Safety Studies,

MIE 2012, Pisa- Italy, 26-29 August 2012.

Gokce B. Laleci Erturkmen, Asuman Dogac, Mustafa Yuksel, Sajjad Hussain, Gunnar Declerck,

Christel Daniel, Hong Sun, Kristof Depraetere, Dirk Colaert, Jos Devlies, Tobias Krahn, Bharat

Thakrar, Gerard Freriks, Tomas Bergvall, Ali Anil Sinaci, Building the Semantic Interoperability

Architecture Enabling Sustainable Proactive Post Market Safety Studies, Accepted as a poster in

SIMI 2012 Wokshop (Semantic Interoperability in Medical Informatics), in ESCW 2012:

Extended Semantic Web Conference, May 27, 2012 in Heraklion (Crete), Greece

Gunnar Declerck, Sajjad Hussain, Yves Parès, Christel Daniel, Mustafa Yuksel, Ali Anil Sinaci,

Gokce Banu Laleci Erturkmen, Marie-Christine Jaulent, Semantic-sensitive extraction of I data to

support adverse drug event reporting, SWAT4LS Workshop, Paris – France, 30 November 2012.

You can access these publications from :

http://www.srdc.com.tr/projects/salus/index.php/publications

http://www.salusproject.eu/docs/D8_1_1-Final.pdf

http://www.salusproject.eu/docs/D3_3_1%20Requirement%20specif%20SALUS%20Architecture%20v1.2.pdf

http://www.salusproject.eu/docs/D3_3_1%20Requirement%20specif%20SALUS%20Architecture%20v1.2.pdf

http://www.salusproject.eu/docs/D3_4_1ConceptualDesignoftheSALUSArchitectureFinal.pdf

http://www.srdc.com.tr/projects/salus/docs/ICSR_Reporting_Tool_SWAT4LS_V2.pdf

http://www.srdc.com.tr/projects/salus/docs/ICSR_Reporting_Tool_SWAT4LS_V2.pdf

http://www.swat4ls.org/workshops/paris2012/


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Our Advisory Board Meeting will start at 17:00 o’clock on January 16, 2012. First of all, we will

present you SALUS Project in general summarizing our activities and current progress. On January

17, 2012, we aim to discuss four different topics with you:

- SALUS Semantic and Technical Interoperability Approach

- ADE Detection and ICSR Reporting Processes

- SALUS Pilot application scenarios

- Possible exploitation approaches and business value

For these, we will have short presentations presenting SALUS approach, current results, and

discussion points and would like to hear your feedback on these.

I am at your disposal for any further information request.

Many thanks and best regards,

Dr. Gokce Banu Laleci Erturkmen

Coordinator of 287800 SALUS Project

8.3.3 Minutes

January 16th

Gokce did first a general overview presentation of the SALUS project by explaining briefly the main

objectives, active tasks, pilot application scenarios and the progress so far. She stated that the details

of some major activities will be presented on January 17th.

Her presentation is available from:

http://www.srdc.com.tr/projects/salus/docs/SALUSOverviewJanuary2013v2.pdf

An initial set of comments were made after that introductory presentation. They are reported in the

SALUS Paris Meetings Minutes – January 15-17, 2013. Hereby an extract of some of the questions

and the answers provided by the consortium:

1. Xavier Kurz: what kind of data are you including when you use data from the EHRs.

Gokce: we have two different EHR sources of data: TUD (University of Dresden) and

LISPA, the clinical data warehouse of the Lombardy Region. The first are hospital

EHR data, the second are mainly administrative patient summaries.

2. Xavier Kurz: You mention ADEs, but we are more interested in adverse reactions

Niklas: the tool will detect adverse drug events, the physician will check them and

decide whether or not to report a suspected adverse

3. Vanessa Binamé: Will you involve other EHR sources? If so, how will you select them?

Gokce: This is a scoped project and we will proceed with our end-users only during

the life time of the project.

http://www.srdc.com.tr/projects/salus/docs/SALUSOverviewJanuary2013v2.pdf

FP7-287800 SALUS


4. Vanessa Binamé: When you work with many different hospitals from different countries, you

can face with many different interoperability challenges. Some attributes are mandatory in

some hospitals, not in some others, etc.

Gokce: We are trying to validate our methodology here. We do not claim that with

our actual implementation, it will be possible to integrate immediately all possible

EHR systems.

Gokce: We are also basing our efforts on top of widely used standards/profiles. For

example, we are already able to consume epSOS compliant patient summaries.

Dirk: When there are new EHRs to be integrated, there is of course new work to do.

But, this is more of similar work that is done for the previous systems; not totally

designing and implementing something new. Hence, the approach is scalable.

5. Xavier Kurz: What will happen to the pilot applications beyond the project?

Gokce: After the end of the project, it is up to our end-users to continue to use the

pilot applications that we have developed. This will be addressed in the exploitation

plan.

6. Vanessa Binamé: Be careful with the data protection issues

Dipak Kalra: Do not pool the data

Gokce: We already have a specific task for de-identification and pseudonymization of

medical data, and we already completed the implementation of some reusable

methods. We will work with our end-users' data protection officers to apply these in

our pilot applications. In the mean time, we have applied to their ethical boards as

well.

7. Dipak Kalra: Having a middleware approach and basing on well-known standards is a very

scalable and acceptable approach that I appreciate. It is a very brave project.

8. Dipak: But, this is a STREP and you have very ambitious objectives. Each of your use cases

is almost a project of its own. So, this is my concern. You do not have enough time and effort

to complete everything that you aim. I would expect to see that you are scoping yourselves,

e.g. only for cardiovascular diseases domain.

Gokce: We scope ourselves with the pilot application use cases that we have. For

example, we will not reason on top of all / complete terminology systems. We will

demonstrate according to our requirements in pilot applications.

Dirk: We are also not starting from scratch. For example, you know we did similar

things for Debug-IT as well.

January 17th

Up to 6 presentations were given with details on specific aspects of the SALUS project:

- The ADE notification and detection tool by Tobias

- The ICRS reporting tool by Gunnar Declerck

- The UMC use cases by Niklas

- The ROCHE use case by Bharat

- The SALUS Semantic and Technical Interoperability Approach by Dirk Colaert

- The SALUS exploitation approach by Dirk Colaert

The presentations are available on the web site of Salus.

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Several interesting remarks were made by the Advisory Board Members.

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ADE Notification and Detection Tool

1. Xavier Kurz: EMA and UMC have produced an Excel DB including all the known ADEs

(with the appropriate MedDRA codes).

Developed within the PROTECT project.

DB available and can be used by SALUS to check whether the ingredient is included in the

PROTECT database, then you can check whether it is really an ADE.

- Kerstin Forsberg: I should be ideally if this data source could be provided ideally

as RDF.

- Gokce: the SALUS project can provide such an RDF data source for further use.

2. Xavier Kurz: ADE detection rules are very complex. This is a huge task. You will need an

expert medical group for that. May be possible for a limited domain: a specific diseases, a drg

domain.

3. Dipak Kalra: what is (regarding ADE detection) the denominator? You should be concerned

about “noise”.

ICRS Reporting Tool

1. Vanessa Binamé: Healthcare Professionals do not want to spend time. This has an impact on

the design of the tools.

2. Dipak Kalra: HPs are patient oriented, not drug safety oriented.

3. Dipak Kalra: forget the word “relevant” for the data reported.

- Niklas: The human element is key in this project. It would be best if we can know

the answer to “why do you think that this is an adverse reaction?”

- Dipak Kalra: Fine, and for that the machine should deal with the boring stuff.

(note: not only relevant stuff)

The ADE Notification and ICRS Reporting Tool presentation is available on the Salus web site:

http://www.srdc.com.tr/projects/salus/index.php/publications . See under “Other Materials”

Use Cases UMC and ROCHE

Only a few comments were given:

1. Niklas: “Signal detection is just like crime scene analysis; while EHRs are similar to close-

circuit surveillance camera systems.

2. Dipak Kalra: nice use case (ROCHE) to assess the value of SALUS

Semantic and Technical Interoperability Approach

1. Kerstin Forsberg: “You should not just formalize your big resources such as EHRs, but also

smaller resources such as the known ADE list that Xavier mentioned.”

2. Dipak Kalra: “I have a comment about the Domain Ontology (DO). You cannot have a single

ontology to represent everything. You can have multiple focused ontologies, which are

linked.”


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- Dirk, Gokce: We do not aim to define the unique healthcare domain ontology.

We will provide a set of linked semantic resources. The first is not maintainable.

We will also focus on our requirements in SALUS; we will not address all

healthcare / patient safety domains.

Possible exploitation approaches

1. Dipak Kalra: “I would be tempted to separate anything that supports clinical trials from

observational research”

2. Xavier Kurz: “The focus should be on increasing the quality”

8.3.4 Main recommendations made by the advisory board

1. The project might be too ambitious. The project should try to focus on the low hanging fruit

to be sure that this will be realised. (Prof. Dipak Kalra)

2. “Detection” of new ADEs may not be realistic to realise within the project (Dr. Xavier Kurz)

3. Make use of the ADE database produced by the PROTECT project. (Dr. Xavier Kurz)

4. Be aware that Healthcare Professionals are patient care oriented. (Prof. Dr. Dipak Kalra)

FP7-287800 SALUS


9 INTERNATIONAL BODIES IN DRUG SURVEILLANCE

9.1 ID and main activities of the International Bodies

9.1.1 European Medicines Agency – EMA

The European Medicines Agency is the European Union body responsible for coordinating

the existing scientific resources put at its disposal by Member States for the evaluation,

supervision and pharmacovigilance of medicinal products. The Agency provides the Member

States and the institutions of the EU the best-possible scientific advice on any question

relating to the evaluation of the quality, safety and efficacy of medicinal products for human

or veterinary use referred to it in accordance with the provisions of EU legislation relating to

medicinal products.

The Agency is responsible for EU marketing authorizations in the centralized procedure

where the pharmaceutical companies can apply for a single authorization that is valid

throughout the EU member states as well as the Europeans Economic Areas.

The Agency also monitors the safety of medicines through the pharmacovigilance network. It

will also take actions if adverse reactions are detected for a specific medicine.

Website: http://www.ema.europa.eu

The Agency is well informed on the SALUS, one of his directors (Xavier Kurz) being

member of the Advisory Board.

9.1.2 National Pharmacovigilance Authorities

The National Pharmacovigilance Authorities are responsible for regulation and surveillance

of the development, manufacturing and sale of drugs and other medicinal products. They aim

to ensure that patients and healthcare professionals use safe and effective medicinal products.

Together with the other National Authorities they strive to improve the control of medicines.

A major part of the work is devoted to the approval of medicines and safety analysis to

monitor the effect of products on the market.

Two National Pharmacovigilance Agencies are represented in the Advisory Board. Mrs.

Vanessa Binamé represents the Belgian Agency, Dr. Mauro Venegoni the Lombardy

Regional Agency.

9.1.3 European Federation of Pharmaceutical Industries and Associations –

EFPIA

The European Federation of Pharmaceutical Industries and Associations (EFPIA) represent

the pharmaceutical industry operating in Europe. Through its direct membership of 33

national associations and 37 leading pharmaceutical companies, EFPIA is the voice on the EU

scene of 1,900 companies committed to researching, developing and bringing to patients new

medicines that will improve health and the quality of life around the world.

EFPIA supports a vision of modern and sustainable healthcare systems in Europe, where

patients have equal and early access to the best and safest medicines, which supports

http://www.ema.europa.eu/

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innovation, empowers citizens to make informed decisions about their health and ensures the

highest security of the medicines supply chain.

Web site: http://www.efpia.eu/

EFPIA is represented in the consortium by ROCHE.

9.2 Other Cooperation and Dissemination Activities

Dissemination activities and diverse cooperation activities are reported in Deliverable D2.2.1

http://www.efpia.eu/

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10 SALUS COLLABORATION TEMPLATE

A template has been provided to the Consortium Members in order to facilitate collaboration

reporting.

Collaboration Report / Suggestion6 Purpose of the form

The form should be used to report/document as well as to suggest collaboration activities linked to the Salus project and/or

to nominate experts for the advisory board or for other specified activities within the project.

The form should also be used to report effective reuse of developments from other projects as well to document why some

options used in other projects will not be used within the Salus project. The reports will be used to populate Deliverable

D2.4.1/2 and 3. Each “technical” work package and/or task leader should produce (at least) yearly such a report.

Partner submitting report / suggestion

Partner:

Name & first name:

Date:

Issue addressed

Collaboration with another project Advisory Board

Collaboration with an organisation (other than a supporting or organising partner)

Other:

Identification of the collaboration partner:

Name of the contact person / expert:

Organisation / Project / Company7:

Address:

Contact e-Mail:

Web address:

Way of cooperation:

Reuse of documentation from the partner, e.g. a deliverable. Describe:

6 Select report or suggestion.

7 Specify department if any

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Direct contact with the identified person/expert. Describe:

Attending an event organised by the partner:

Other:

Domain of collaboration8:

Related to the following task within Salus:

Description of the input from the partner into Salus9:

8 Specify the domain of collaboration, e.g. security & privacy issues, semantic interoperability, ontology, EHR related

issues, etc…

9 Describe possible input, possible added value for Salus from the collaboration for suggested collaboration. Describe

effective input from reported collaborations. In case of no input, please motivate the option (to be included in the

collaboration report deliverable.