A Medical Device Domain Analysis Model based on HL7 RIM Daniela - - PowerPoint PPT Presentation

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A Medical Device Domain Analysis Model based on HL7 RIM Daniela - - PowerPoint PPT Presentation

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A Medical Device Domain Analysis Model based on HL7 RIM Daniela Luzi*, Fabrizio Pecoraro*, Gregorio Mercurio , Fabrizio L. Ricci *National Research Council - Institute of Research on Population and Social Studies (IRPPS), Rome, Italy

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Daniela Luzi*, Fabrizio Pecoraro*, Gregorio Mercurio§, Fabrizio L. Ricci§

*National Research Council - Institute of Research on Population and Social Studies (IRPPS), Rome, Italy

§National Research Council - Institute for Biomedical Technologies (ITB), Rome, Italy

A Medical Device Domain Analysis Model based on HL7 RIM

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MIE 2009 – Sarajevo, Bosnia and Herzegovina

Index

Objective

Background information on Medical Devices (MDs)‏ and main differences with pharmaceutical product

MEDIS project

Introduction to HL7 standards

MEDIS Domain Analysis Model

Conclusion and future works

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MIE 2009 – Sarajevo, Bosnia and Herzegovina

Development of an interoperable system managing information on Clinical Trials for MD supporting:

  • Process of notification and evaluation
  • Distribution and exchange of information on current Clinical

Trials and their lifecycle Challenges:

  • 1. Define a dataset
  • 2. Identify a common language
  • 3. Adopt a suitable standard

Objective

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MIE 2009 – Sarajevo, Bosnia and Herzegovina

Medical Device: definition

 Desease  Compensation for

an injury of handicap

 Anatomy or

  • f a physiological

process

 Conception  Diagnosis  Prevention  Monitoring  Treatment  Alleviation  Investigation  Replacement  Modification  Control  Software  Accessories  Alone  in combination  Instrument  Apparatus  Appliance  Software  Materials  Other article

Of To be used specifically for With Used MD can be an/a (EU Directive 2007/47/CE)

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MIE 2009 – Sarajevo, Bosnia and Herzegovina Immagine da: www.assobiomedica.it

Some implantable Medical Devices

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MIE 2009 – Sarajevo, Bosnia and Herzegovina

Some diagnostic Medical Devices

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Drug MD Mechanism of action chemical physical Production process discovered invented Development clinical trial, error process, laboratory test design, prototyping, production phases Scientific evidence multi-phased trials (I-III phase) clinical investigation, scientific literature, single confirmatory study Trial objectives safety and efficacy safety, efficacy, and MD performance Interaction with patients whole body reversible body parts difficult to remove

Main differences between MDs and drugs

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MIE 2009 – Sarajevo, Bosnia and Herzegovina

Medical Devices regulation

European Directive

  • EU 2007/47/CE

Italian National laws

  • D.Lgs. 46/97 (MD)
  • D.Lgs. 507/92 (AIMD)

Clinical investigation (from EU 2007/47/CE): any designed and planned systematic study in human subjects undertaken to verify the safety and/or performance of a specific device.

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MIE 2009 – Sarajevo, Bosnia and Herzegovina

Medical Device regulation

European Directive

  • EU 2007/47/CE

Italian National laws

  • D.Lgs. 46/97 (MD)
  • D.Lgs. 507/92 (AIMD)

Needing of common language for exchanging data Clinical investigation (from EU 2007/47/CE): any designed and planned systematic study in human subjects undertaken to verify the safety and/or performance of a specific device.

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MIE 2009 – Sarajevo, Bosnia and Herzegovina

State of the art

Medical Device: at initial stage in MD domain Pharmaceutical: common practice (i.e. CDISC, HL7)

Drug MD Data standardization Common practice Initial stage Registry in Europe EUDRACT EUDAMED: Initial stage Few local registries

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MIE 2009 – Sarajevo, Bosnia and Herzegovina

State of the art

European level: EUDAMED project is planning an information system to exchange data related to MD Clinical Investigation Country level: development of local systems

Drug MD Data standardization Common practice Initial stage Registry in Europe EUDRACT EUDAMED: Initial stage Few local registries

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MIE 2009 – Sarajevo, Bosnia and Herzegovina

European level: EUDAMED project is planning an information system to exchange data related to MD Clinical Investigation Country level: development of local systems

State of the art

Drug MD Data standardization Common practice Initial stage Registry in Europe EUDRACT EUDAMED: Initial stage Few local registries ITALY MEDIS project

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The core of MEDIS is composed by:

  • registry of clinical investigation data and content

repository of documents exchanged between Clinical Investigation proposer and National Competent Authority during the whole clinical investigation lifecycle

MEDIS project

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MIE 2009 – Sarajevo, Bosnia and Herzegovina

Notification phase Acquisition of data and documents required by the national and European Directives to

  • btain the approval for the activation of a

Clinical Investigation (CI) Evaluation phase Investigation phase Communication exchanges

  • between CI proposer and NCA evaluators

that manage the requests of further information for assessment as well as the updating of CI data and documents

  • among NCA evaluators that manages the

assignments of roles as well as the agenda

MEDIS project

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Objective

To develop a flexible and interoperable system for sharing information among MD clinical investigation stakeholders Standardization

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Standardization

Objective

HL7

To develop a flexible and interoperable system for sharing information among MD clinical investigation stakeholders

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MIE 2009 – Sarajevo, Bosnia and Herzegovina

HL7 provides healthcare standards based on:

  • A conceptual model (Reference Information Model,

RIM)

  • An exchange model for clinical documents (CDA,

Clinical Document Architecture)

  • A model for messaging exchange (Domain

Message Information Model, DMIM)

What is HL7

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MIE 2009 – Sarajevo, Bosnia and Herzegovina

HL7 provide healthcare standards based on:

  • A conceptual model (Reference Information Model,

RIM)

  • An exchange model for clinical documents (CDA,

Clinical Document Architecture)

  • A model for messaging exchange (Domain

Message Information Model, DMIM)

What is HL7

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MIE 2009 – Sarajevo, Bosnia and Herzegovina

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Plays Scopes

people, places and things, nouns relators prepositions verbs

0..1 0..* 0..1 0..* 0..1 0..* 0..1 0..*

i.e. temporal order associations i.e. relation between

  • rganizations

HL7 RIM – Definition

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MIE 2009 – Sarajevo, Bosnia and Herzegovina

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Plays Scopes

people, places and things, nouns relators prepositions verbs

0..1 0..* 0..1 0..* 0..1 0..* 0..1 0..*

i.e. temporal order associations i.e. relation between

  • rganizations

HL7 RIM – An example

“The manufacturing enterprise Device & Co. submits a notification through its legal representative Mr. Jack Smith”

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MIE 2009 – Sarajevo, Bosnia and Herzegovina

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Plays Scopes

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HL7 RIM – An example

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MIE 2009 – Sarajevo, Bosnia and Herzegovina

HL7 RIM – An example

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Plays Scopes

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MIE 2009 – Sarajevo, Bosnia and Herzegovina

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Plays Scopes

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HL7 RIM – An example

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Plays Scopes

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HL7 RIM – An example

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MEDIS DAM

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MEDIS DAM – Stakeholder

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MEDIS DAM – Person

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MEDIS DAM – Document

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MEDIS DAM – Medical Device

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The application of the HL7 RIM in the MD context:

  • Has proved to be useful for the representation of

Clinical Investigation lifecycle

  • Its adoption represents a first step forward for the

development of a common standard language This is particularly important in a domain where standardization is at its initial stage

Conclusion

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MIE 2009 – Sarajevo, Bosnia and Herzegovina

At the moment the system has been developed and is actually under a testing phase. The HL7 Domain Message Information Model is under construction and will be proposed to the HL7 group for balloting.

State of the art and future works

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MIE 2009 – Sarajevo, Bosnia and Herzegovina

Thank you for your attention

Fabrizio Pecoraro

fabrizio.pecoraro@irpps.cnr.it