EUROPEAN COMMISSION
DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY
General Affairs
Information systems
eHealth DSI – Change Proposal (CP) form
Tracking information:
Change Proposal ID:
Change Proposal
CP-eHealth DSI-013
Status1:
Under Assessment
Date of last update:
27/01/2017
Person assigned:
Version of Change Proposal:
0.8
Change Proposal Summary information:
MVC update for eHDSI Wave 1 Go Live
Submitter’s Name(s) and e-mail address(es):
Oskar Thunman ([email protected])
Submission Date:
30/09/2016
Component(s) or Configuration item(s) to be
changed2:
Actor(s) affected:
None.
Specifications/documentation impacted:
Change estimated
TSAM Sync is the mostly affected component.
The other components who use the ValueSets rely on the
contents of the LTR:
TSAM
TSAM EXPORTER,
TM
Portal
impact3
MVC, and eP, eD and PS Implementation Guides
(minor, major):
Major
Reason/Business justification for the Change Proposal:
 Provide a formal specification for CDA L1 used for transmitting the original content as PDF
Change Proposal Document history:
Version
Date
Person
Short description of changes
1
Status options: New, In Registration, Under Assessment, Preparation for Consultation, In Consultation, In
Consolidation, For Approval, For Publishing, Closed
2
Component examples: Client connector, WS server, OpenNCP Portal, epSOSWeb, OpenATNA, TRC-STS,
Security Manager, TSL-Sync, TSL-Editor, TSL-Util, Protocol Terminators, TSAM Sync, Stork Plugin, CDA
display tool, xslttransformer, tsamexporter, cdautils, epsos-util, configuration manager, epsos-common-components,
e-SENS eID richclient, e-SENS eID design-main…
3
Change estimated impact is the estimated order of magnitude of the change: a change will be qualified as major if
it introduces for instance a component that already exists or a new component, impacting the architecture; it will be
qualified as minor if it improves the existing behavior without impacting the architecture.
1
EUROPEAN COMMISSION
DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY
General Affairs
Information systems
0.1
2017-01-18
Oskar Thunman
First version
0.2
2017-01-18
Marcello Melgara
Clarifications on affected components and
current MVC status.
0.3
2017-01-18
Licinio Kustra-Mano
Clarifications on impact and affected
components.
0.4
2017-01-18
Oskar Thunman
Clarifications on technical value sets.
Added one more proposal to keep track of
suggested changes where the
recommendations are to do nothing at this
time.
Added list of questions at the end of the
document.
0.5
2017-01-18
Christof Gessner
Better use of terms such as codes, terms.
Provided a rationale against Proposal 5.
Added proposal 6.
0.5
2017-01-18
Oskar Thunman
Reformulated the proposed action for
Proposal 5, excluded two value sets from
proposal 5.
0.6
2017-01-26
Oskar Thunman
0.7
27/01/2017
Christophe DUMONT
Consolidated version ready for submission
0.8
ASSESSMENT (as foreseen in the 2nd step of the eHDSI CP procedure)
eHDSI Solution Provider
Author
Assessment

Adopt the change proposed, i.e. formalising in the MVC 2.2? to be used for encoding
Recommended
actions

Update the affected CDA templates with technical Value Sets

Update MVC in Central Services

Consult the eHMSEG Semantic Task Force.
2
EUROPEAN COMMISSION
DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY
General Affairs
Information systems
PROPOSAL 1
INTRODUCE THE CONCEPT OF A VALUE SET STATUS IN THE MVC.
RATIONALE 1
To enable the MVC to hold information about retired value sets, as well as draft versions of
Value Sets.
It is therefore suggested that Value Sets in the MVC (as well as in Art Décor) are assigned a
status indicating if they are active, retired or drafts. Note that the status refers to one specific
version of a value set. This means that for a given value set (e. g. designated by its OID value)
there can be multiple "draft" versions, "active" versions, and "deprecated" versions of that value
set at the same time. In this context “Draft” and “Deprecated” is equal to having no Active
version of a Value Set.
At present, only ACTIVE ValueSets can be retrieved from the Terminology Server by the
TSAM Sync.
The EXPORT function of the Terminology Server could export everything: Draft, Active and
deprecated, but this export was not directly used in the NCP
All the NCP and Portal Components work on the current LTR.
The input to External MS related components, must be carefully managed by the MS
In HealthTerm, these attributes were handled: “Draft”, “Active” and “Deprecated”. The Coding
for this could make use of the pre-existing Value Set Conformance Resource Status in FHIR:
https://www.hl7.org/FHIR/valueset-conformance-resource-status.html
3
EUROPEAN COMMISSION
DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY
General Affairs
Information systems
PROPOSAL 2
RETIRE THE TECHNICAL VALUESETS IN THE MVC AND INSTEAD MAKE THEM
PART OF THE IMPLEMENTATION GUIDES FOR THE CDA SPECIFICATIONS
RATIONALE 2
Some value sets in the MVC 2.0 are used in the CDA implementation guides (IG’s) as a
designator to specify what type of information is sent in another attribute. The origin for these
value set specifications is therefore the IG through the choice of data type used. As an integral
part of the information modelling within the CDA document structure, it is not something that
can be decided in the management of the MVC.
Secondly, the way the CDA Pivot documents encode this information makes it not possible to
translate this information (they are not used in a datatype that can hold information about
translations) and they are therefore not subject to translation/transcoding by the translation
manager (TM).
Thirdly, this information is technical and not clinical information.
This leads to the risk of Countries attempting to translate these value sets although the
information is not clinical per se.
It is therefore suggested that these value sets should be made part of the technical specifications
(IG’s) and removed from the MVC to make the purpose of the MVC more clear (it holds clinical
information that lends itself to translation and/or transcoding), to make the distinction between
codes of technical versus clinical nature more clear. Thereby, the technical implementation of the
services becomes easier as it considers the technical value sets as integral part of the IG (i.e.
there is no need to consult the MVC for these value sets):
•
epSOSActCode, 1.3.6.1.4.1.12559.11.10.1.3.1.42.29
•
epSOSActSite, 1.3.6.1.4.1.12559.11.10.1.3.1.42.44
•
epSOSEntityNamePartQualifier, 1.3.6.1.4.1.12559.11.10.1.3.1.42.33
•
epSOSIHEActCode, 1.3.6.1.4.1.12559.11.10.1.3.1.42.35
•
epSOSIHERoleCode, 1.3.6.1.4.1.12559.11.10.1.3.1.42.36
•
epSOSURL, 1.3.6.1.4.1.12559.11.10.1.3.1.42.42
This affects the TSAMSync as it makes use of the proposal 1. It may affect also tsamexporter,
depending on tsamexporter implementation.
4
EUROPEAN COMMISSION
DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY
General Affairs
Information systems
PROPOSAL 3
CHANGE THE STATUS OF THE VALUE SETS NOT USED IN THE CDA IG’S TO
“DRAFT”.
RATIONALE 3
These value sets are not used in the IG’s and therefore will not be used to encode information
until the necessary attributes are introduced in the IG’s. They are there because of a request
during the epSOS project to hold information about the type of equipment used and setting in
which measurements were captured.
It is therefore suggested to make the status of these value sets “Draft” and indicate to MS that the
translation of these Value Sets is optional as it is not information to be used in the Pivot CDA:s
during wave 1. The value sets are

epSOSMedicalEquipment

epSOSObservationInterpretation.
Note: epSOSObservationInterpretation is considered technical in the epSOS MVC and may be
subject to further changes, i.e. moved to the IG’s. However, as it’s not part of the IG’s today it
should remain in the MVC for the time being, following the principle of minimal changes.
This affects the tsamexporter as it makes use of the proposal 1. May affecting TSAM Sync
depending on tsamexporter implementation.
5
EUROPEAN COMMISSION
DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY
General Affairs
Information systems
PROPOSAL 4
UPDATE THE VALUESETS THAT ARE BASED ON CODE SYSTEMS THAT ARE
SUBJECT TO REOCCURING RELEASES OF NEW VERSIONS
RATIONALE 4
The MVC 2.0 that was prepared for EXPAND was based on the latest version of the underlying
code systems. This was done one year ago, and since then there have been releases of new
versions of these value sets.
The proposed way to handle new versions is to make a yearly release of the MVC where this
type of changes is incorporated.
The code systems that have this type of release cycle that makes them subject to this proposed
change are

ATC;

EDQM;

ICD-10;

Snomed CT.
It is therefore suggested to update the value sets that are based on these code systems, removing
deprecated codes, updating descriptions that have changed and introducing new codes that meet
the inclusion criteria of the Value Set selection:
•
epSOSActiveIngredient, 1.3.6.1.4.1.12559.11.10.1.3.1.42.24
•
epSOSDoseForm, 1.3.6.1.4.1.12559.11.10.1.3.1.42.2
•
epSOSPackage, 1.3.6.1.4.1.12559.11.10.1.3.1.42.3
•
epSOSRouteofAdministration, 1.3.6.1.4.1.12559.11.10.1.3.1.42.12
•
epSOSIllnessesandDisorders, 1.3.6.1.4.1.12559.11.10.1.3.1.42.5
(None of the Snomed CT based ValueSets are affected by the 2016 release by IHTSDO/Snomed
International and therefore does not need updating).
This has no effect on any components or configuration.
6
EUROPEAN COMMISSION
DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY
General Affairs
Information systems
PROPOSAL 5
REDEFINE THE SELECTION OF CONCEPTS FOR A FEW VALUESETS IN THE MVC
RATIONALE 5
The rationale here is stated per Value Set
epSOSCountry, 1.3.6.1.4.1.12559.11.10.1.3.1.42.4:. The binding rules in the IG’s has already
been changed4 to ISO 3166-1, 1.0.3166.1, the Value Set should be in the MVC to be translated,
but should contain all countries, not just a subset.
epSOSLanguage, 1.3.6.1.4.1.12559.11.10.1.3.1.42.6: Specify that the concepts are taken from
IETF RFC 5646. The concepts are not from ISO 639-1, but are the combination of the language
code from ISO 639-1 together with the country code from ISO 3166-1, eg sv-SE. These
“combined concepts” are what makes up the Code System IETF RFC 5646.
This might affect the TM, TSAM, TSAMSync, CDA display tool and epSOSWeb as new value
sets/code systems will be used.
4
This needs to be verified.
7
EUROPEAN COMMISSION
DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY
General Affairs
Information systems
PROPOSAL 6
SUGGESTED CHANGES WHERE THE RECOMMENDATIONS IS TO DO NOTHING AT
THIS TIME.
•
epSOSSubstitutionCode, 1.3.6.1.4.1.12559.11.10.1.3.1.42.7: Consider the results
of the openmedicine project for possible future updates
•
epSOSUnits, 1.3.6.1.4.1.12559.11.10.1.3.1.42.16: Adopt the wider set of units see
e.g. Table of Example UCUM Codes for Electronic Messaging - Version 1.3.
Concider having several valueSets for different purposes.
•
epSOSProcedures, 1.3.6.1.4.1.12559.11.10.1.3.1.42.10: : re-evaluate the need of
updating this value set. Ask member states to add concepts to the ValueSet
•
epSOSReactionAllergy, 1.3.6.1.4.1.12559.11.10.1.3.1.42.11: : this value set
should be reconsidered for possible updates. Ask member states to add concepts
to the ValueSet
•
epSOSSocialHistory, 1.3.6.1.4.1.12559.11.10.1.3.1.42.14: Consider making the
listed concepts obsolete, Specify an ad hoc (new) value set for describing Diet.
Ask member states to add concepts to the ValueSet
•
epSOSVaccine, 1.3.6.1.4.1.12559.11.10.1.3.1.42.28. Ask member states to add
concepts to the ValueSet
•
epSOSAdministrativeGender, 1.3.6.1.4.1.12559.11.10.1.3.1.42.34: Retire in the
MVC and change the binding rules in the IG’s to make use of HL7 Value Set
AdministrativeGender, 2.16.840.1.113883.5.1
•
epSOSConfidentiality, 1.3.6.1.4.1.12559.11.10.1.3.1.42.31: Change the binding
rules in the IG’s to the HL7 value set Confidentiality, 2.16.840.1.113883.5.25
RATIONALE 6
These changes would require further analysis. At the time they lack a proposed solution, with
dependencies to MS activities and in the case of epSOSSubstitutionCode external projects. The
risk of delaying the release of the next MVC version is deemed to outweigh the benefit of
finalizing the proposed solution to these issues for this release cycle.
If the need for adding codes to these value sets (or any other value sets) should arise during
preparation for wave 1, this is intended to be handled as a minor release of the MVC with
corrections.
8
EUROPEAN COMMISSION
DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY
General Affairs
Information systems
PROPOSAL 7
FOR epSOSUnits, value set 1.3.6.1.4.1.12559.11.10.1.3.1.42.16, UPDATE THE COLUMN
"ENGLISH DISPLAY NAME" USING DISPLAY VALUES ACCORDING TO THE ISO
80000 SERIES
RATIONALE 7
Codes for units of measure using UCUM are optimized for machine-processing. While the codes
usually are very close or even identical to the unit representation as symbols prescribed by the
ISO 80000 series for purposes of print or display, this is not always the case. For example, the
display symbol for the UCUM code ug should be "μg", the display name should be "microgram",
according to ISO 80000.
epSOS introduced "English display names" for units, e.g. "Microgram" for UCUM code "ug".
Those display names do neither follow the "Printing rules" for unit symbols as defined in ISO
80000 series, nor do they follow the rules for forming (English) names for the units. It is
proposed to replace the current display values by unit symbols according to the ISO 80000 series
or by the English names formed according to the ISO 80000 series. Which option is chosen
(symbol and/or name representation)? It is left to the discretion of the translator and may vary
from country to country, according to local legislation, convention and habits.
9
EUROPEAN COMMISSION
DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY
General Affairs
Information systems
Questions:

What about epSOSErrorCodes? Are they subject to translation? If so, should they be part
of the MVC?

Are all the display labels and similar ValueSets for the portal accounted for? Do they
need any updates before wave 1?
These questions are passed on to the technical community and will not be further analysed in the
Semantic Community.
TECHNICAL IMPACT ASSESSMENT – DSI SOLUTION PROVIDER (SANTE A4)
Marta TERRÓN CUADRADO
06 February 2017
 Adopt the proposed changes to update the MVC (Master Value Sets Catalogue) in
view of the CEF-eHDSI operations - Wave 1.
10