results4care@cs.com

Detailed Clinical Models: the relationship with Medical Devices

ISO CEN Meeting Edinburgh april 2009

Anneke Goossen MSc RNResults 4 Care

Content

Context EHR: purpose and contentHistory of DCMDetailed Clinical ModelExamples of DCMMedical device versus medical equipmentClassification of medical devicesISO StandardsDiscussion itemsConclusion after discussionWork planning?

Electronic Health RecordThe purpose of a EHR is to support the current or coming care/ treatment proces of a patient.Content includes patient demographics, medical history, medicine and allergy lists (including immunization status), assessments, laboratory test results, radiology images, billing records and advanced directives, care plan, etc…...Reduce medical errorsReuse data for aggregation

History DCM

EU: GEHR (The Good European Health Record) 1991-1995GEHR (Good Electronic Health Record) 2000 CEN 13606 (old) 1999GPICs (General Purpose Information Components)OpenEHR 2002CEN and ISO 13606 (actual) 2007-2009Archetypen 2001

History DCM

HL7 v2, developed in 1987 in VS, implementation in other countries in early ‘90Object Oriëntation, ‘80USAM (United Service Action Model) 1998?HL7 v3, CDA-Clinical Statement-Care ProvisionHL7 templates

History DCM

Memorandum of understanding: CEN and HL7 1999Harmonization work CEN, HL7 and ISO, starting in 2005

Fase 1: mutual recognitionFase 2: harmonize (data types)Fase 3: develop new standards togetherArchetypes and templates: DCM

Workshop Detailed Clinical Information ModelsDCM started in Intermountain Health (Utah)Continuation on initiative of Stan Huff and Craig Parker in Boca Raton 2006Brisbane 25 augustus, 2007Participants: CEN / ISO / HL7 / openEHR / health professionalsAgreement on: the term Detailed Clinical Models will be used in the context of harmonization http://detailedclinicalmodels.org

Detailed Clinical Model

Purpose: deliver content for the EHR and messagingStandard model for presenting the a small part of the clinical contentReusable for different technical standards and developmentsA tool for supporting communication between health care professionals and informaticists

Detailed Clinical Model

A good representation of the clinical contentin the EHR is important!From the perspective of the health care professional the technical part, CEN 13606, OpenEHR en HL7, is less important;It should not matter which technology is used for specified clinical content or data elementsBlood pressure in an archetype is the same as blood pressure in HL7 v3

DCM organise:

Clinical contentQuality issues:

Terminology/ semanticsMetadataetc

ModelingRepositoryhttp://detailedclinicalmodels.org

Essence : re-usability!

Cost control for the development of EHR’sand messagingHealth care professionals don’t have much time for standards developmentThe need for an optimal use of clinicians availability

Quality criteria

1. Meta information: if not present-> waste

Name and contact information When and for what developed -> see examples

2. Terminology and classification3. Translation must not affect the DCM4. Quality of clinical content5. Involvement of clinicians

Example Bloodpressure

Specification & unique codes -> DCM

Data TypeDeviceUsed; manual,

automatic, unknown

Future: SLOT Medical Devices?

Example Blood glucose meter

Specification & unique codes -> DCM

Part of e-Diabetes dataset

Data TypeDeviceUsed is missing

Future: SLOT Medical Devices?

Medical Device in Snomed CT

63653004: biomedical device (physical object); along list of devices, but not complete30234008: medical laboratory analyzer 426700006: medical device status; but no findings 405652003: equipment serial number

Medical device modeled in openEHR archetype

Definition Medical DeviceAny instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings (Directive 2007/47/ec of the European Parliament) .

Versus Medical EquipmentMedical equipment is designed to aid in the diagnosis, monitoring or treatment of medical conditions.Diagnostic equipment: medical imaging machines

Therapeutic equipment: infusion pumps

Life support equipment: dialysis machine

Medical monitors: ECG, EEG, bloodpressure

Medical laboratory equipment: Diagnostic Medical Equipment: Blood glucose meter

Classification

Classification of medical devices in EU

High risk devices

Medium risk devices

Low risk devices

ISO Standards

Several standards for:Development;Communication;Labels, labelling and information to be supplied;Quality management system;Application of risk management;Classification of safety risks from health software;Clinical investigation of medical devices;Coding structure for adverse event type and cause

etcetera

Discussion items

Medical device or medical equipment or both?What must be in the EHR in order to keep a relationship with a medical device?Goal is tracing of used device?Relationship with Quality Management?Relationship with Risk Management? Content DCM Medical Devices?Generic or specific?

Conclusions

Workplan?

Thanks for your attention drs A.T.M. Goossen-BaremansResults 4 Care B.V.De Stinse 153823 VM AmersfoortThe NetherlandsPhone: 06 48070146Fax: 033 2570169Mail: AnnekeGoossen@cs.comwww.results4care.nl