PARTNER Grant Agreement Number 215840

WP23 – Deliverable 4 - 11/2011

Requirements for shared clinical applications

Faustin Laurentiu Roman (WP22)

Supervisors: Prof. Manjit Dosanjh (CERN),

Prof. Jose Bernabeu (IFIC)

Daniel Abler (WP23)

Supervisors: Prof. Manjit Dosanjh (CERN),

Prof. Ken Peach (PTCRi, University of Oxford), Prof. Jim Davies (Computing Laboratory, University of Oxford)

Date 30.11.2011

Requirements for shared clinicalapplications

PARTNER Work Package 22 and 23, Deliverable 4:Collect comprehensive set of requirements for clinical applications to be

shared within the consortium and with referring hospitals

Faustin.Laurentiu.Roman@cern.ch, Daniel.Abler@cern.ch

November 2011

This is the 4th common deliverable of the PARTNER Work Package 22 and 23 withinthe Marie Curie Initial Training Fellowship of the European Community’s SeventhFramework Programme under contract number (PITN-GA-2008-215840-PARTNER).

The relevance of information sharing to hadron therapy along with the technical, legaland ethical challenges have been discussed in the first two deliverables. Following theseconcepts, during the third deliverable the PARTNER software demonstrator was im-plemented that allows medical doctors and patients to record adverse events followingcharged particle therapy treatment.

The present deliverable analyzes the requirements for clinical applications to beshared within the consortium and with referring hospitals. The requirements are col-lated from previous deliverables and compared with the present status of the platform.

Contents

1 Overview 5

2 Requirements 62.1 Summary of Requirements for shared Clinical Applications . . . . . . . 62.2 Recommendation for Life Science requirements to the European Grid

Initiative (EGI) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

3 Software implementation 10

4 Conclusion 14

Glossary 15

Bibliography 16

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Acknowledgment

Faustin Laurentiu Roman (WP 22)

Supervisors:Prof. Manjit Dosanjh manjit.dosanjh@cern.ch CERNProf. Jose Bernabeu bernabeu@ific.uv.es IFIC

Co-Supervisors:Dr. Jose Salt Cairols salt@ific.uv.es IFICDr. Gabriel Amoros amoros@ific.uv.es IFIC

Daniel Abler (WP 23)

SupervisorsProf. Manjit Dosanjh manjit.dosanjh@cern.ch CERNProf. Ken Peach k.peach1@physics.ox.ac.uk University of Oxford, PTCRiProf. Jim Davies jim.davies@cs.ox.ac.uk University of Oxford,

Department of ComputerScience

This work is a joint project of the PARTNER WP 22, 23, 24 Early Stage Re-searchers F. L. Roman, D. Abler, V. Kanellopoulos (CERN) within the framework ofthe CERN PARTNER Grid Project:

CERN (M. Cirilli, A. Di Girolamo, M. Dosanjh, J. Shiers, A. Valassi), in collabora-tion with IFIC (G. Amoros, J. Bernabeu, A. Fernandez, V. Mendez, J. Salt Cairols),University of Oxford ( K. Peach, J. Davies, S. Harris, C. Crichton), University of Surrey(K. Kirkby, N. Kirkby) and the Cambridge University Hospital NHS Foundation Trust(R. Jena).

Funded within the Marie Curie Initial Training Fellowship of the European Com-munity’s Seventh Framework Programme under contract number PITN-GA-2008-215840-PARTNER.

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1 Overview

The PARTNER [1] (Particle Training Network for European Radiotherapy) ICT WorkPackages developed a software demonstrator [12] that allows medical doctors and pa-tients to record the side effects during and after hadron therapy treatment. In addition,doctors can view a record of the patient’s side effects across institutions and researcherscan access statistical information. Medical data are left where created originally, andaccessed using federated queries via a Web 2.0 portal.

Details on the services developed by each WP can be found here:

• WP 22 [2] delivered services for data federation, presentation and security

• WP 23 [3] concentrates on data collection and semantic interoperability

• WP 24 [4] analyzed the medical information

This report gives an overview of the requirements for shared clinical applications withinthe consortium and with referring hospitals. The remainder of this report is structuredas follows:

Chapter 2 summarizes the requirements for shared clinical applications as found fromdiscussion with partners within the consortium and literature.

Chapter 3 gives a brief overview of the use case selected for the PARTNER platformand the software services designed to satisfy a subset of the requirements identified formedical applications in general and this use case in particular.

Chapter 4 summarizes the contribution of this deliverable.

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2 Requirements

The bases of the PARTNER Grid project were discussed in brainstorming sessionsamong project members (see acknowledgments) and domain experts Dr. Rajesh Jena(Cambridge Univ. H. NHS Foundation trust), Prof. Ramona Mayer (EBG MedAus-tron), Prof. Bleddyn Jones (Gray Institute, PTCRi), and consultations with radiother-apy departments in Valencia & Oxford hospitals.

The first part of this chapter (section 2.1) summarizes the outcome of these discussionsand results from literature reviews done for previous WP 22, 23 deliverables [5, 6, 7].

These requirements, together with initial implementation experiences, were submittedas recommendation for grid applications for life sciences to the European Grid Initiative(EGI) [11], section 2.2.

2.1 Summary of Requirements for shared Clinical Applications

Fulfilling the following high-level requirements concerning the usability of applicationsare essential for the acceptance and adaption of new applications among clinicalusers:

• Applications need to be intuitive and easy to use in order to minimizeschooling needs for healthcare professionals.Applications with a steep learning curve are unlikely to be accepted.

• Integrate into clinical workflow and fit to the “modus operandi” of itsusers.Provision of clinical care with limited resources requires an optimised work-flow for patient interaction. The role of software systems is to support thisworkflow.

• Provide added value for users compared to existing applications.This can be new important functionality or similar functionality providedin a way that allows time savings.

New clinical applications need to integrate into the existing IT environmentand conditions of hospital data handling, this poses certain technical requirements onnew applications.

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• Be fault tolerant in the perspective of clinical routine

• Be maintained and have reliable service.A preference for commercial solutions, or “business-ready” Open Source solu-tions that offer optional support services, can be observed.

• Compatible with existing hospital information systems (HIS), image archiv-ing systems (PACS) and departmental data management systems.

• Provide strong security framework able to enforce policies to fulfillthe legal and ethical requirements on medical data handling.

Additionally, applications shared among medical centres need to fulfill thefollowing requirements:

• Approaches to service and data interoperability beyond ad-hoc systemintegration.

• Provide security framework that can handle distribution of users, data andservices.

Sharing medical data for treatment and research purposes raises ethical andlegal issues. These were analyzed in the second common deliverable [7].

For the PARTNER platform different requirements with regard to the processing ofpersonal data for research and treatment purposes were found.

For treatment use:

• Leave medical data at the source and aggregate data only temporarily duringthe limited time of use.

• Empower the patient to decide on the type of information and people allowedto access it

For research use:

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• Access to medical data for research purposes may require review byan ethics committee or other forms of review and subsequent approval ofdata usage.Framework for data sharing needs to be able to enforce the data access rightsresulting from such reviews.

• The provider of data sharing services needs to hold agreements withdata providers and consumers about if/how the service provider makes useof the data and that it guarantees enforcing the data access rights betweendata providers and consumers.This implies

– providing secure communication between parties,

– logging the activities of a user to be able to verify if the actual usage ofdata is conform with the foreseen usage laid out in the data request,

– ensuring that unauthorized users cannot access personal data.

2.2 Recommendation for Life Science requirements to theEuropean Grid Initiative (EGI)

The common notion of “GRID-computing” is to provide mechanisms for sharing dis-tributed resources in order to solve processing expensive computing problems. Withinthe scope of the PARTNER usecase, sharing medical information for patient referral andresearch, the requirements on processing and storage capacity are only minor concerns.Nevertheless, GRID technology can provide added-value here through its certificatebased authentication and strong security enforcement mechanisms.

While the resource sharing aspect of GRID technology only plays a minor role withinthe PARTNER use case, there nevertheless is scope for the use of GRID in the bio-medical domain, see [5, 6]. With treatment techniques getting more sophisticated andthe desire to deliver individualized treatments taking into account medical and biologicalknowledge together with patient characteristics, the need for easily usable shared com-puting resources will increase and therefore mechanisms for sharing processing powerwill gain importance in the future, even for clinical routine applications.

The European Grid Infrastructure EGI [11] “enables access to computing resourcesfor European researchers from all fields of science”. According to our experience certainrequirements need to be fulfilled to introduce computing technology and applicationinto the medical domain, this also applies to GRID technology. Within the PARTNERGrid collaboration, a requirements matrix outlining the requirements for the applicationof GRID in the life sciences was developed and submitted to EGI.

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Figure 2.1: Requirements matrix for EGI.

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3 Software implementation

HISP (Hadron therapy Information Sharing Platform) [12] implied two distinctscenarios:

• a clinical scenario in which a patient goes from a local hospital to a hadron therapycenter for treatment (referral)

• a research scenario in which clinical data are used to draw scientific conclusions

The requirements presented in the previous section translated in software componentsbased on an open source, standard, free to use and enterprise ready philosophy. TheHISP implementation details are described in previous deliverables [8] and [9] and werepresented also to the PARTNER consortium [10]. The system (Fig. 3.1) is availableat http://vopartner05.cern.ch:8080/web/guest. Examples of features complying theaforementioned requirements:

• HISP uses two of the most popular database systems, one open source and theother commercial.

• The platform entry point is based on an enterprise web platform, conforming withmany standards.

• The user interface framework is easy to use both by users and developers, reducingcustomization time.

• Communication is secured by modern encryption protocols and based on publickey certificates, used for sensitive transactions in corporate information systems.

Considering the overall medical domain requirements HISP provides an alternative toturn-key solutions. The side of this is that investment is required in man power todeploy and support the platform (the individual components are maintained by bigcommunities). Also the certification process can be tedious, costly and risky. Theseshortcomings should be balanced with the other software features, e.g. standards basedand open source, that are one step closer than commercial solutions to the service anddata interoperability - one of the biggest issues not only in the medical domain.

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Figure 3.2: HISP patients in one database

Figure 3.1: PARTNER software architecture

Figures 3.2 and 3.3 show screen shots of patient administration within the portal andfigure 3.4 illustrates a form for adverse event reporting.

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Figure 3.3: HISP patient details

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Figure 3.4: Overview of web form for doctor recording of adverse events.

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4 Conclusion

This report presents requirements for shared clinical applications found in the contextof the PARTNER software platform.

Section 2 lists several high-level requirements that were found to be characteristicfor applications in the medical domain and for shared medical applications. Previousdeliverables provide more details on each of these requirements.

Compiling a truly comprehensive lists of “requirements for clinical applications to beshared within the consortium and with referring hospitals” would require close interac-tion with (hadron therapy) treatment centres and referring hospitals.

Since hadron therapy is slowly and gradually being introduced as a cancer manage-ment strategy in Europe, until now only limited information was, and still is, availableabout the hadron therapy specific requirements for patient referring processes. Withthe second European hadron therapy center, CNAO, having started patient treatmentrecently, the building of a referral network will also gain pace. The existence of sucha referring network is necessary to investigate further requirements specific to a pan-European hadron therapy patient referral scenario.

While the scope of the requirements collection might have been limited by externalfactors, the results found during the project time have been shared with the consortiumthrough the public PARTNER website with links to deliverables, e.g. [5, 6, 7, 8, 9, 12]as well as through presentations within the consortium and at conferences, e.g. [10, 12].

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Glossary

CERN European Organization for Nuclear Research

EGI European Grid Infrastructure

ESR Early Stage Researcher

HIS Hospital Information Systems

HISP Hadron therapy Information Sharing Platform

ICT Information and Communication Technology

PARTNER Particle Training Network for European Radiotherapy

WP Work Package

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Bibliography

[1] PARTNER Project, Particle Training Network for European Radiother-apy, FP7 Grant agreement no.: 215840-2, website, retrieved 13.11.2011

[2] PARTNER Work Package 22 website, retrieved 13.11.2011

[3] PARTNER Work Package 23 website, retrieved 13.11.2011

[4] PARTNER Work Package 24 website, retrieved 13.11.2011

[5] F. L. Roman, Health grids: overview and added-value, PARTNER WorkPackage 22 - Deliverable 1, Tech. rep., CERN (Nov. 2009). URL

[6] D. Abler, Data Integration for the PARTNER Hadron Therapy Infor-mation Sharing Platform, PARTNER Work Package 23 - Deliverable 1,Tech. rep., CERN (Feb. 2010) URL

[7] F. L. Roman and D. Abler, Services of the Hadron therapy InformationSharing Platform. Legal and Ethical implications, PARTNER Work-package 22 and 23 - Deliverable 2, Tech. rep., CERN (June 2010). URL

[8] F. L. Roman, Data-driven platform for hadron therapy, PARTNERWork Package 22 - Deliverable 3, Tech. rep., CERN (Apr. 2011). URL

[9] D. Abler, Data Capturing Services for Charged Particle Therapy, PART-NER Work Package 23 - Deliverable 3, Tech. rep., CERN (June 2011).URL

[10] F. L. Roman, D. Abler, V. Kanellopoulos, PARTNER HISP: Hadron-therapy Information Sharing Platform, PARTNER Annual meeting,Marburg (Nov. 2011). URL

[11] European Grid Infrastructure, URL: http://www.egi.eu/, retrieved13.11.2011

[12] F. L. Roman, D. Abler, V. Kanellopoulos, Data-driven portal for hadrontherapy, EGI User Forum 2011, 11-15 Apr. 2011, Vilnius. URL

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