A MEDICAL DEVICE INFORMATION SYSTEM

AND ITS ARCHITECTURE

Daniela Luzi and Fabrizio Pecoraro

Institute for Research on Population and Social Policies (IRPPS), National Research Council, Rome, Italy

Keywords: Clinical investigation, Medical device, National competent authority’s information system, System

architecture, Document management.

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.

1 INTRODUCTION

Progress in clinical research depends largely on the

results of clinical investigations (CIV). CIVs are

complex processes encompassing different steps,

from specification and planning to execution and

final result analysis. There are an increasing number

of applications that support CIV data management,

project management and data quality control,

contributing to reduce time and costs and most

importantly to improve research quality (Oliveira

and Salgado, 2006).

However, not much attention has been put on

information systems that support applicants in the

regulatory submission of CIV proposals as well as

National Competent Authorities (NCA) in the

process of evaluating proposals and monitor CIV

execution. The adoption od these systems contribute

to reduce time for CIV start, enhance transparency

of evaluation criteria and improve the monitoring of

ongoing and concluded CIVs at national level.

The paper describes a Medical Device

Information System (MEDIS) developed by the

National Research Council within a project

supported by the Italian Ministry of Health. MEDIS

plays the role of both a registry of clinical

investigation data and a content repository of

documents submitted by manufacturers to the NCA

to obtain the approval for the clinical investigation

start. In particular, MEDIS supports manufacturers

in the documentation submission process as well as

NCA evaluators in assessing the regulatory

documentation received. It also manages the

communication among the different stakeholders

and collects the data produced during the whole

lifecycle of clinical investigations. A high level

description of the CIV business process is described

in details in previous works (Luzi et al., 2009,

Pecoraro et al., 2010, Luzi et al., 2010). The design

of the MEDIS system was based on the analysis of

the domain of CIV on MDs in close collaboration

with the office in charge for the evaluation of CIV

proposals, according to national laws, European

Directives (EU, 2007) and ISO technical norms

(ISO, 2008). Moreover, MEDIS design has been

based on the application of Health Level 7 (HL7) v.3

standards to develop a flexible and interoperable

system. This paper presents the results of the

MEDIS development describing in particular its

architecture and giving an example of its interface.

2 MEDIS ARCHITECTURE

From an architectural point of view, MEDIS is a

client-server three-tiered system. The high level

description of the MEDIS system architecture is

depicted in figure 1 using the UML Component

Diagram notation. All the components of the

MEDIS system reside at the application logic layer,

using the Tapestry framework based on Java

technologies such as JSP and Servlet. The MEDIS

presentation layer is composed by two web clients

providing specific interfaces for both applicants and

547

Luzi D. and Pecoraro F..

A MEDICAL DEVICE INFORMATION SYSTEM AND ITS ARCHITECTURE .

DOI: 10.5220/0003153005470550

In Proceedings of the International Conference on Health Informatics (HEALTHINF-2011), pages 547-550

ISBN: 978-989-8425-34-8

 2011 SCITEPRESS (Science and Technology Publications, Lda.)

NCA evaluators. The web pages are transmitted to

the web client using the protocol HTTP. Moreover,

the HTTPS protocol is used to guarantee both

reserved transfers and secure channels over the web.

The application logic layer consists of a set of

modules in charge of the following functionalities:

1) The authentication of internal users is managed

by MEDIS, while external users access the system

through a single sign on portal which controls their

access to multiple and independent systems. The

authorization of both external and internal users

depends on their profiles. Each external user can

access his/her portion of MEDIS system containing

the list of submitted notifications together with those

that are in the process of submission. Once a

notification is submitted no change is allowed. The

authorization of internal users depends on the role

played in the evaluation of the CIV proposal

(supervisor, medical/technical evaluator,

administrative secretary). For instance each

evaluator can access and modify only the evaluation

report he/she is in charge of, while the supervisor

can access the evaluation report only when the

evaluator allows him/her to do it and use it to make a

final evaluation report.

2) The enterprise data manager supports

information related to external users, the role they

are allowed to play in the notification submission

(manufacturer, authorized representative) and the

data related to organizations responsible for the

notification or delegated to do it. The administrative

secretary accesses this component and gives the

users the right to initialize a new notification.

3) The DAM (Domain Analysis Model) component

manages MEDIS conceptual model based on HL7

RIM. This component supports: a) the rules that

validate the association between DAM objects; b)

the rules that manages the workflow of the CIV

lifecycle. The design of MEDIS DAM and related

data model are described in details in previous

works (Luzi et al., 2009). This component specifies

the underlying workflow determining the allowed

steps depending on the state of the CIV lifecycle

enabling specific functionalities according to the

CIV actual state as well as to the user profile.

4) The proposal data manager supports the

acquisition of the notification, guiding applicants in

the collection and submission of regulatory data and

documents as well as verifying the completeness and

consistency of data and documents submitted.

5) The CIV data manager supports the evaluation

team to write an evaluation report focused on crucial

aspects such as MD characteristics, risk analysis and

procedures planned for patient safety. This

component makes it also possible to share the report

among the evaluation team as well as to edit the

official communication of CIV approval or deny.

Moreover, it supports the communication between

applicants and NCA during the CIV performance,

allowing applicants to notify important steps reached

by an ongoing CIV and register clinical protocol

amendments and/or serious adverse events. This

component also manages the acquisition of the

report of CIV final result.

6) The Dossier Manager supports the storage and

retrieval of documents uploaded as well as those

created during the CIV lifecycle (i.e. NCA internal

documents and communications). Through the XML

component filled electronic forms are transformed in

XML documents and then in PDF (Report builder)

in order to produce a digital signed document.

7) The vocabulary/classification manager connects

MEDIS to external systems to retrieve data such as

vocabularies, classifications, and nomenclatures (i.e.

MESH, MD repertoires, etc.).

Functionalities used in the above-described

components that manage the CIV lifecycle are:

a) The communication exchange that supports the

information flow between applicants and the NCA

evaluation team (e.g. request for data and/or

document integration; reports of amendments and/or

serious adverse events), and also takes track of the

communication exchange.

b) The control of the completeness and consistency

of the data and documents uploaded in a single form

or in a correlated set of forms.

c) The dynamic generation of the electronic forms

depending on the user, the MD under investigation,

and the state reached in the workflow, so that certain

types of communication is allowed only in a specific

phase of the CIV lifecycle.

d) The legal authentication of the documents and

data submitted through a digital signature.

Finally, the persistence layer is divided into:

1) A relational database containing information on

applicants and their belonging organization, as well

as the organization that delegates them to submit

CIV proposals.

2) A relational database that contains data

describing MD and CIV instances, data tracking the

CIV lifecycle workflow and metadata related to

documents stored in the content repository.

3) A content repository in charge of archiving

documents uploaded as attachments of the

HEALTHINF 2011 - International Conference on Health Informatics

548

Figure 1: Architecture of the MEDIS system.

Figure 2: MEDIS interface for accessing the dossier documents.

notification or generated by the system starting from

the data filled in the electronic forms.

3 DOSSIER MANAGEMENT

One of MEDIS features is represented by the content

management component. Data and documents

exchanged between NCA and applicants are closely

related to the different phases of the CIV lifecycle.

Given the amount of data and documents exchanged,

their legal value that includes also the management

of different document versions, a Dossier manager

component was developed (see § 2).

An example of the MEDIS interface showing a

representation of the Dossier is depicted in Figure 2

showing the entry point to retrieve detailed

information of each CIV. Each Dossier has it own

A MEDICAL DEVICE INFORMATION SYSTEM AND ITS ARCHITECTURE

549

unique identification code that identifies the set of

the different types of related documents (technical

and administrative) collected during CIV process.

On the left side MEDIS provides two menus, the

upper one is dynamically created according to the

state of the notification. In this case it allows an

applicant to access the dossier as well as to reply to a

received request of further information (Riscontro).

The lower menu allows the applicant a) to access the

notification area (Area notifiche) where the user can

view its CIV proposals and/or make a new one, b) to

access the Organization area (Area Azienda) to view

and update information on the manufacturer and/or

authorized representative. On the right side, the

upper table shows the list of documents exchanged

during the CIV lifecycle, note that each document

type is linked to the attached documents (Documenti

allegati). In this case the notification identified by

the code i.5.i.m.2/6/2009 (meaning the 6

notification of pre-market CIV received in the year

2009) gathers all regulatory documents submitted

for the CIV approval. The lower table shows the list

of requests (Richiesta) and eventually the related

response (Riscontro) given by the applicant. In both

tables applicants can access the full text of the

document selected clicking on each item of the list.

4 CONCLUSIONS

MEDIS is a NCA’s information system developed to

support both CIV applicants to correctly submit trial

proposals and NCA to evaluate them as well as

monitor CIVs carried out at national level.

Moreover, MEDIS was designed on the basis of

HL7 v.3 methodology and standards in order to

make the system interoperable with other National

registries and in particular with the European

Databank on Medical Device (EUDAMED) that is

also developing an European system comprising

information on CIVs. At the moment the MEDIS

system has to be validated by real users in order to

test system performance and functionalities.

The role played by the content management

component has been described in this paper

considering it one of the main feature of NCA’s

information systems. The Dossier management has

the function of storing and retrieving documents and

data exchanged in the different phases of the CIV

lifecycle.

Moreover, clinical protocols describing CIV on

MDs as well as investigator’s brochures have been

analysed both in their structure and content

following the recommendation of Good Clinical

Practice (ISO, 2008) that guide applicants to

correctly write these technical documents. On the

basis of these features, our future intension is to

adopt HL7 CDA standard to further specify the

structure and semantic of CIV documents, taking

also into account BRIDG conceptual model

(Fridsma et al., 2007). This is in line with the

MEDIS design and development based on HL7 RIM

and it would further improve document exchange as

well as information retrieval of meaningful parts of

these documents.

ACKNOWLEDGEMENTS

This study was supported by the Italian Ministry of

Health through the MEDIS project (MdS-CNR

collaboration contract n° 1037/2007).

REFERENCES

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.

Fridsma, B. D., Evans, J. Hastak, S., mead, C. N. (2007).

The BRIDG project: a technical report. JAMIA 15, pp.

130-137.

Health Level Seven, Inc. HL7 Reference Information

Model. Ann Arbor, MI: Health Level Seven, Inc.

Available at: www.hl7.org.

International Organisation for Standardization (2008).

Clinical investigation of medical devices for human

subjects – Good clinical practice. draft international

Standard ISO/DIS 15155, ISO TC 194 (revision of

ISO 14155-1:2003 and ISO 14155-2:2003), ISO 2008.

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.

Luzi, D., Pecoraro, F., Mercurio, G., Ricci F. L. (2009). A

medical device domain analysis model based on HL7

Reference Information Model. In: Medical Informatics

in a United and Healthy Europe. Proceeding of MIE

2009, IOS Press, 162-166.

Oliveira, G. A., Salgado, N. C. (2006). Design aspects of a

distributed clinical trials information system. Clinical

Trials, 3, 385-396.

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.

HEALTHINF 2011 - International Conference on Health Informatics

550