MS & CC Engagement Workshop Luxembourg, April 21st, 2015

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2 08/05/2015 Member State & Competence Centres Engagement Workshop How can we make cross-border ehealth services a reality? MS challenges in implementing EC PS and ep Guidelines Iciar Abad MoH Spain Marcello Melgara LISPA Giorgio Cangioli HL7 Internatuional 2

3 EC Guidelines on PS & ep estandards

4 Patient Summary Guidelines Guidelines for Minimum / Non-exhaustive Patient Summary Dataset for Electronic Exchange Derived from epsos specification and experience Focused on Unplanned Care Set up as Guidelines within ehgi Approved and adopted by ehn Guidelines, not as Implementation Guide Indication for evolution of PS included in the Guidelines

5 Patient Summary Implementation issues Which are the major issues your MS encountered in implementing Patient Summary Service? Availability of National / Regional PS? Availability of Coded Data? Problems in transcoding from the Code Systems used in your MS and the epsos Master Value Set Catalogue? Others?

6 Gaps between epsos specs and EC PS Guidelines epsos/eu Directive EU epsos PS Guidelines Section Optionality Optionality Allergy R R Medical Alert Information (other alerts not included in allergies) R R Vaccinations O O List of resolved, closed or inactive problems O O Surgical Procedures prior to the past six months R O List of current problems / diagnoses R R Medical Devices and implants R R Major Surgical Procedures in the past six months R R Treatment Recommendations R O Autonomy / Invalidity R O List of current medicines R R Social History Observations O O Pregnancy history (Expected date of delivery) O O Physical findings (Vital Signs Observations) O O Diagnostic tests (Blood group) O O

7 Patient Summary Guidelines - Gaps Surgical Procedures prior to the past six months Minimal change from Optional to Required Do you think it is relevant? Is it included in your PS? Any foreseen issue?

8 Patient Summary Guidelines - Gaps Treatment Recommendations No specific ValueSet defined Do you think it is relevant? Is it included in your PS? Which Code Systems do you use? It could be an extension of Social History Any foreseen issue?

9 Patient Summary Guidelines - Gaps Autonomy / Invalidity In epsos it was an Optional data set, described in TEXT form Do you think it is relevant? Is it included in your PS? Which Code System / ValueSet do you consider as appropriate? Any foreseen issue?

10 Patient Summary Evolutions Master ValueSet Catalogue Evolution In use MVC1.8 Approved MVC 1.9 with the adoption of full ICD10 (previously 3 char) Under consideration: Adopt SNOMED-CT 2014: Minimum impact Adopt ICD Improve some ValueSet: Procedures Implanted Devices Allergies Allow Multiple Code Systems in a ValueSet? E.g. some MS s also use ICPC for some

11 Patient Summary Evolutions How relevant is to include planned care EC Dir. 2011/24 includes Planned Care Are PS in your Country already suitable for Planned Care? Which are the DataSets to be added / improved? Physical findings - Vital Signs Observations now: only blood pressure Diagnostic tests Now: only blood group To be considered also transferring of Images Others?

12 eprescription Guidelines Guidelines on eprescription Dataset for Electronic Exchange under the Cross-border Directive Derived from epsos specification and experience Set up as Guidelines within ehgi Approved and adopted by ehn Mainly a Guideline to set up a Roadmap for ep Indication for evolution of ep for the definition and adoption of new processes and standards: EMA Article 57 database ISO IDMP

13 eprescription Implementation issues Which are the major issues your MS encountered in implementing eprescription / edispensation Service? Availability of National / Regional ep? Availability of Structured / Coded Data? Problems in transcoding from the Code Systems used in your MS and the epsos Master Value Set Catalogue? Others?

14 eprescription Implementation issues Synergies between EXPAND and H2020 PHC-34 ii openmedicine: EXPAND assesses gaps ep Guidelines and epsos specifications and Considers Change Proposals from piloting MS to allow a wider / safer ep/ed services openmedicine assesses adoptability of EMA Art. 57 Database for pharmacovigilance and Returns implementation hypotheses to EXPAND that checks feasibility and MS readiness If MS agrees to perform changes feasible in the EXPAND scope: implements them, otherwise hands over to CEF indications for implementation openmedicine defines the medium / long term specifications for ep / ed, presumably based on the adoption of ISO IDMP

15 eprescription Change Proposals approved by MS Support for UCUM annotations: Explicitly allow the usage of UCUM annotations when the unit value is 1, without any constrain - in this version -about the conveyed content. Suggest to use the English terms Support for unknown or textual active ingredients [Multi-active ingredients products] Allow the usage of Nullflavors for the ingredient/code. Allow the distinction between the ATC code when used for the Pharmaceutical Substance (represented as drug classification) and the ATC code when used for active ingredient identification (also in line with EMA Art.57 database. Specified how to convey textual ingredients information Support for unknown or textual strengths [Multi-active ingredients products] Allow the usage of Nullflavors for the ingredient/quantity Specified how to convey structured textual strengths data

16 Gaps between EC ep Guidelines and epsos The epsos has a narrow scope (in term of supported medications) The gender is a required (not mandatory) element in epsos as part of the demographics traits (it is the Administrative gender not the Clinical Gender); in the guideline the «Gender is the biological distinction between male and female. The gender of the patient may be important for gender specific effects/contra-indication The concept of Prescription ID used in the guideline needs to be better clarified since two different IDs are used in epsos the ID of the global prescription and the ID of the prescription of each medicinal product. The Work address of the prescriber is mandatory in the guidelines optional in epsos The way the implementation of the (Digital or electronic) signature concept is supposed to be realized needs to be clarified; the signature is not included as such in the exchanged CDA. There are a set of concepts for which it is absolutely needed a further refinement of the guideline model for being able to assert the compliance of the current epsos specification. For most of them there are multiple CDA elements that fit with those concepts but no one is in one to one relationship with the source concept

17 Gaps between EC ep Guidelines and epsos epsos ep Guidelines R1.2 Gender R Optional R1.5 Patient Address R Optional R1.6 Patient s Telecommunication R Optional R Healthcare Facility (This is the Healthcare Facility that is responsible for the HCP (prescriber) ) R Healthcare Facility s name R Not Incuded R Not Incuded R Healthcare Facility s identifier R Not Incuded R Healthcare Facility s Address R Not Incuded R Healthcare Facilities s Telecom R Not Incuded R Legal Authenticator M To be analyzed : if is cohincident with the prescriber. Relationship with digital /electronic signature R Document Language Code M Not Incuded R2.4 Prescription Item ID M To be understood if this is related to the Identification of the prescribed product R4.5 Medicinal product package R Describe the type of outer package. Evaluated as not really needed but maintaned for backward compatibility.

18 EC Guidelines, epsos, EXPAND, H2020 PHC-34, A lot was done A lot remains to be done Centrally and in the MS How do you rate your MS readiness? 25% 50% 75% 100% 125% (i.e.: Guidelines and Implementation Guides can be extended NOW!)

19 Welcome and Introduction Jump in!