A MEDICAL DEVICE INFORMATION SYSTEM AND ITS ARCHITECTURE

Daniela Luzi, Fabrizio Pecoraro

Abstract

The paper describes a Medical Device Information System (MEDIS) that supports applicants in the submission of a new clinical investigation (CIV) proposal as well as National Competent Authority in the evaluation and monitoring CIVs carried out at national level. An overview of system design is provided in the description of its conceptual model and architecture as well as providing an example of the interface of the system developed.

References

  1. European Parliament, Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007, Official Journal of the European Union, L 247/21, 21.9.2007.
  2. Fridsma, B. D., Evans, J. Hastak, S., mead, C. N. (2007). The BRIDG project: a technical report. JAMIA 15, pp. 130-137.
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  5. Luzi, D., Contenti, M., Pecoraro, F. (2010). The HL7 RIM in the design and Implementation of an Information System for Clinical Investigations on Medical Devices. In: First IMIA/IFIP Joint Symposium, Brisbane, 2010. Advances in Information and Communication Technology 335, Berlin, Springer, pp. 5-14.
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  8. Pecoraro, F., Contenti, M., Luzi, D. (2010). Clinical Investigation on Medical Device: A data model based on HL7 reference information model. Proceedings of IADIS 2010, Freiburg, 26-31 July 2010.
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Paper Citation


in Harvard Style

Luzi D. and Pecoraro F. (2011). A MEDICAL DEVICE INFORMATION SYSTEM AND ITS ARCHITECTURE . In Proceedings of the International Conference on Health Informatics - Volume 1: HEALTHINF, (BIOSTEC 2011) ISBN 978-989-8425-34-8, pages 547-550. DOI: 10.5220/0003153005470550


in Bibtex Style

@conference{healthinf11,
author={Daniela Luzi and Fabrizio Pecoraro},
title={A MEDICAL DEVICE INFORMATION SYSTEM AND ITS ARCHITECTURE },
booktitle={Proceedings of the International Conference on Health Informatics - Volume 1: HEALTHINF, (BIOSTEC 2011)},
year={2011},
pages={547-550},
publisher={SciTePress},
organization={INSTICC},
doi={10.5220/0003153005470550},
isbn={978-989-8425-34-8},
}


in EndNote Style

TY - CONF
JO - Proceedings of the International Conference on Health Informatics - Volume 1: HEALTHINF, (BIOSTEC 2011)
TI - A MEDICAL DEVICE INFORMATION SYSTEM AND ITS ARCHITECTURE
SN - 978-989-8425-34-8
AU - Luzi D.
AU - Pecoraro F.
PY - 2011
SP - 547
EP - 550
DO - 10.5220/0003153005470550