Detailed Clinical Models for Medical Devices

Project Summary

The intent of this project is to create and maintain one generic Detailed Clinical Model that defines the main concepts of using medical device-related data safely and traceably for patient care. This DCM is intended to be reused in other domains where devices play a role in assessment and treatment. In addition, several specific DCM will be developed for exemplar medical devices to iteratively test the generic model. Furthermore, the project will organize clinical content from and about medical devices in such a manner that it becomes reusable in different domain models, standards and technologies, thus supporting consistency of representation and semantic interoperability.

This summary presents one vision of the project. Further discussion is available in the Charter section, below.

Project GForge

• DCMMD Project GForge
  • Subject Matter Experts Meeting Minutes
  • Business Use Cases

Ballot Reference

• Detailed Clinical Models for Medical Devices: Domain Analysis Model

Project Team

• Anneke Goossen-Baremans
• John Rhoads
• Greg Staudenmaier
• Ioana Singureanu
• Todd Cooper
• Christof Gessner
• Jan Wittenber
• Melvin Reynolds
• Catherine Hoang
• Holly Miller
• Donna DuLong
• Luigi Sison
• Jay Lyle

Meeting Agendas/Minutes

Template for Meeting Minutes (Detailed Clinical Models for Medical Devices)

• 2010.10.25 DCM-MD Meeting (conference call)
• DCM Meeting Minutes 20 July 2010
• DCM Meeting Minutes 16 July 2010
• 2010.05.12 DCM-MD Coordination Meeting @ ISO TC215 WG7 in Rio de Janeiro
• 2010.05.07 DCM-MD Project Kickoff Meeting (conference call)
• 2010.06.21 DCM-MD Meeting (conference call)
• 2010.07.05 DCM-MD Meeting (conference call)

Project Scope

The intent of this project is to create and maintain one generic Detailed Clinical Model that defines the main concepts of using medical device-related data safely and traceably for patient care. This DCM is intended to be reused in other domains where devices play a role in assessment and treatment.

In addition, several specific DCM will be developed for exemplar medical devices in order to iteratively test the generic model. Furthermore, the project will organize clinical content from and about medical devices in such a manner that it becomes reusable in different domain models, standards and technologies, thus supporting consistency of representation and semantic interoperability.

The overall purpose of a Detailed Clinical Model (DCM) is to enhance the semantic interoperability between different standards, systems and developments. This includes internal HL7 harmonization efforts. Patient Care WG is currently creating a top 10 of DCM which is part of HL7 project 320 on DCM.

The DCM criteria and methodology is addressed by ISO NIWP 13972, approved July 2009, the methodology for HL7 Domain Analysis is documented in the HL7 Development Framework (HDF).

DCMs are created for a variety clinical domains. The core part of a DCM is the full data item specification and determination of relationships between data elements. In many types of DCM (in particular the Blood Pressure, Body Weight, O2 Saturation and others) medical device measurement are an integral component of the clinical data used by nurses and physicians.

The stakeholder requirements (use cases, mind maps) will be used by the facilitators to create models that use a formal notation (UML2) and may be published and balloted as Domain Analysis Models.

An assessment of the DAM and DCM modeling methodologies intended to inform decisions regarding our approach can be found here.

Charter

The Charter document, formerly in Word, is now posted here, in 3 pages, for your input.

Because questions in the charter have not been resolved, it has become necessary to treat this ballot as a process pilot, the goal of which is not to complete a model but to identify the best way to complete a model. We have begun capturing Detailed Clinical Models for Medical Devices Lessons Learned

Definition of Medical Devices

The baseline for medical device DCM is the following definition based on the Information Document Concerning the Definition of the Term “Medical Device”. GHTF/SG1/N29R16:2005 published by the Global Harmonization Task Force, (2005): Medical device means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article: 1) intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:

• diagnosis, prevention, monitoring, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
• investigation, replacement, modification, or support of the anatomy or of a physiological process,
• supporting or sustaining life,
• control of conception,
• disinfection of medical devices,
• providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body;

and

2) which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.”

Use Cases

• Use Case Candidates
• Use cases Proposed for September 2010 DCM for Medical Devices Ballot
• Use cases Proposed for January 2011 DCM for Medical Devices Ballot

Action items

Action	Description	Timeline	Status
1.Create draft Domain Analysis Model to support a Medical Devices DCM		August 2010
1a.Mindmap for the domain of medical devices			In progress
1b.Identify use cases for medical devices uses	The use cases will be further defined but they will include: Tracking and tracing functionality, identifiers, incident reporting; Regulatory purposes, GMDN, UMDNS; Clinical communication about medical device data -> LOINC and SNOMED 'observables' equivalence; Device communications -> 11073 standards		MR: Seems to me that only the things I've emphasised in bold are high level use cases - the remainder are methods. JL: see list on the Use case candidates page. We can start to classify cases, methods, scenarios, rules, etc.
1c.Create workflow diagrams for each use case
1d.Identify the information exchanged for each use case
2.Derive the generic/reusable medical device DCM following the Patient Care guidelines for DCM, add the DCM to the HL7 repository		August 2010
3.Produce example DCMs for particular medical devices (e.g. blood glucose meter)		August 2010
4.Align the Domain Analysis Model with SAEAF Conceptual Model		August 2010
5.Create a glossary		August 2010
Informative Domain Analysis Model Ballot (I1)		January 2011
6.Create clinical value sets in both SNOMED-CT and in LOINC, according to Terminfo guidelines	This includes appropriate use of principles regarding how the information model and terminology model interact properly with respect to medical devices.	March 2011
7.Apply quality criteria	This is for DCM clinical content, terminology, classification and unique coding, language translations, generic information modeling independent of a particular standard, transformations via tooling from generic models to standards specific modeling dedicated to DCM for medical devices	March 2011
8.Document mapping of the Medical Device DCM Domain Analysis Model to an HL7 D-MIM / R-MIM / template and/or archetype for medical devices		March 2011
9.Develop transformation of the generic DCM for medical devices	Into HL7 v3 RIM / R-MIM / Clinical statement modeling and message development	March 2011
10.Develop transformation of the generic DCM for medical devices into CEN/ISO / OpenEHR archetypes		March 2011
11.Develop a guideline to combine the generic and specific DCM for medical devices into larger clinical templates		March 2011
Informative Domain Analysis Model Ballot (I 2)		May 2011