The impact of openmedicine findings for standardization

Transcription

1 The impact of openmedicine findings for standardization Giorgio Cangioli - HL7 Int. Foundation OpenMedicine Workshop 20th December, 2016 Swedish ehealth Agency, Stockholm

2 The choice ISO Identification of Medicinal Products (IDMP) Standards openmedicine Stockholm(SE) 1/23/2017 2

3 What is needed? IDMP attributes and identifiers have to be timely available to end users systems Conv ersation BPMN 2.0 Conv ersation View Legend Standards available or under definition Guidance and/or Updates needed Missing Standards Clinical Information Systems Pharmacovigilance EMA Data Exchange (National) MPD Discovery Product Discovery MPD Provider National Agency Manufacturer National Agencies may act as MPD provider (local) MPD Discovery (IDMP) Product Discovery Product Registration openmedicine Stockholm(SE) 1/23/2017 3

4 What is needed? IDMP attributes and identifiers have to be timely available to end users systems Conv ersation BPMN 2.0 Conv ersation View Legend Standards available or under definition Guidance and/or Updates needed Missing Standards Clinical Information Systems Pharmacovigilance EMA Data Exchange There are HL7 Project Proposals (PSSs) with (National) MPD Product Discovery Discovery several WGs involved to work on communication National Agency MPD Provider Manufacturer about products between Agency / MPD provider (local) MPD National Agencies may Discovery act and as MPD providerclinical Systems. (IDMP) Product Discovery Product Registration openmedicine Stockholm(SE) 1/23/2017 4

5 What about the other standards? What is the impact on other HL7 products e.g. HL7 V2, FHIR, other HL7 V3 messaging or services, CDA templates;.. What does it mean to use IDMP out of the regulatory use cases o Just use few IDMP identifiers? o To comply with the IDMP model (or a subset of it) [model to model mapping] o Use IDMP terminologies? What should be the migration path? o What of the IDMP can be used and when o What products under development (e.g. ) should do? openmedicine Stockholm(SE) 1/23/2017 5

6 openmedicine & (I)PS openmedicine openmedicine Stockholm(SE) 1/23/2017 6

7 CEN/HL7 Common scope for the CEN and HL7 project: Minimal and non-exhaustive Patient Summary, specialty-agnostic, condition-independent, but readily usable by all clinicians for the unscheduled (cross-border) care of a patient. Principles for the standards specification for the : o implementable o applicable for (free) global use o sustainable openmedicine Stockholm(SE) 1/23/2017

8 IDMP openmedicine & (I)PS Products PhPID PS Substances MPID, PCID G-SRS openmedicine Allergies & Intolerances Medication Summary Dose form, RoA,.. EDQM Product Product class.. Substances openmedicine Stockholm(SE) 1/23/2017 8

9 IDMP openmedicine & (I)PS Products PhPID MPID, PCID openmedicine Substances G-SRS Dose form, RoA,.. EDQM.. openmedicine Stockholm(SE) 1/23/2017 9

10 IDMP openmedicine & (I)PS o o o implementable applicable for (free) global use sustainable Products PhPID, Substances G-SRS Substance name openmedicine Dose form, RoA,.. EDQM Under Discussion hypothesis UNII ATC XEVMPD (?) G-SRS XEV MPD SNOMED CT G-SRS Beyond Local Global (now) Global (future) Future Version openmedicine Stockholm(SE) 1/23/

11 IDMP openmedicine & (I)PS o o o implementable applicable for (free) global use sustainable Products PhPID, Substances G-SRS Product name openmedicine Dose form, RoA,.. EDQM Under Discussion hypothesis RxN orm Local Codes ART 57 Scientific Product? PhPID, MPID,...???? PhPID,.. Beyond Local Global (now) Global (future) Future Version openmedicine Stockholm(SE) 1/23/

12 openmedicine findings: (Templated) CDA R2 Medicines data are represented in CDA using the class manufacturedmaterial Not enough for IDMP! Extensions are needed A code and a name that can be used for any level of product: packaged product, medicinal product, classes or clusters or products,..; HL7 : not rely on IDMP identifiers and attributes, but be open for supporting at least the IDMP identifiers openmedicine expert London (UK) 1/23/

13 openmedicine & (I)PS describe medicines.. Extension based on the HL7 R_Medication CMET openmedicine.. to IDMP.. Proposal to update the extension with HL7 Common Product Model CMET (that used in the SPL for the IDMP implementation Guide).. IDMP ready.. [under discussion] Refer to HL7 CPM CMET to be provide future support to IDMP openmedicine Stockholm(SE) 1/23/

14 Take-away questions.. How the results of openmedicine can be used with a view to the transitional phase? What are the implications of potential different choices for substances (e.g. XEVMPD versus SNOMED CT) while waiting for a global identifier (G- SRS)? How the ehdsi and the work can be kept aligned among them and with the (current and future) openmedicine work? o Substances o CDA Implementation (e.g. R_Medication vs CPM) openmedicine Stockholm(SE) 1/23/

15 openmedicine Stockholm(SE) 1/23/