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Talk:Template Functional Requirements

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HL7 V3 Templates maintain a set of functional requirements. What is the list of functional requirements required of Templates for use in HL7?

This document does not discuss implimentation of these requirements, which will be addressed in a different document.


Disclaimer


The purpose of this work - working through the joint CEN and openEHR Archetype Requirements in detail - is to provide the basis of understanding for the requirements of HL7 Templates only. This work is NOT intended to be the formal HL7 Templates requirements document.

Acknowledgements


The specification of HL7 templates defined here has been produced under work program of the HL7 Templates Special Interest Group. It has been greatly influenced by the work contained within the CEN 13606-2:2005 (Annex A) draft standard which defines formal requirements for 'archetype' representation. Representatives of the CEN and openEHR standards working group have supplied this in the interest of harmonisation of CEN and HL7 standards work in the templates area. Many thanks to Dr Dipak Kalra for his support of this process and continuing engagement with HL7, CEN, and openEHR harmonisation work.


HL7 Template Metadata

Identification Metadata - Mandatory


LM: => Does this mean all of these elements are mandatory (can’t have a template unless they’re all filled in) or merely ‘required’ (all template registries must be able to capture this data and there must be a place for it in the MIF)?  If the latter, are any of these elements mandatory?
DK: => I believe these should be mandatory – an instance must have these values (no nulls!)
BE/RH: Can CEN rework document semantics to include MUST, SHALL, MAY, etc. ?

TemplateId

A globally unique, non-semantic, identifier for the Template. This is the primary identifier for all Templates.

 LM: Why must it be an OID?  A template is just a static model like any other and should 
be named accordingly.  OIDs may be used in the ‘realm’ portion of the identifier to 
indicate the organization or group responsible for the template.  
E.g. “RX=2.25.2034.15.82=123456=01” would be version 1 of the pharmacy template 123456 
issued by organization with the OID 2.25.2034.15.82. I’ve added support for OIDs as an 
optional “secondary” identifier.  However, primary identifier will still be the HL7 form. 
Note that the OID id is isn’t mandatory, though we could add a Schematron rule that makes 
it mandatory for LIMs (templates) if you want.


WG: Sources of this OID can be multiple organisations. Especially those 
organisations that are responsible for the clinical content could / should
 issue OIDs.
DK: It need not be an OID, but it needs to be a globally unique reference 
that can be used by look-up services and registries in an international 
distributed computing environment, and can be stored within each instance as a 
permanent record of the knowledge artefact to which it conforms. I would suggest 
that we postpone a final decision on the data type until we know how registry 
services might be established.templateName


BE/RH:  Agreed.  Accept 1.1.1 as is, no need to specify datatype at this point.

templateName

A free text natural language name identifying the Template. It is anticipated that there will be far too many templates to be able to assign a unique mnemonic or meaningful name to all of them. This is the secondary identifier for all Templates. (Refer to templateCodedTerm.)

 LM :=>Corresponds to “business name”.  There can be different business names for the same template 
in different realms and the names can exist in multiple languages.  Note that this isn’t mandatory,
 though we could add a Schematron rule makes it mandatory for the static model level for LIMs 
(templates) if you want.
 WG:=>Name will be available in different languages, representing the language in which the template
 is used.
 DK:=> This name is the primary “business name” in the natural language of the author. If coded, 
it can be cross-mapped to other coding schemes and languages on retrieval. A separate mechanism 
is proposed for representing descriptions in multiple languages. I do not agree that templates will
 be too numerous to name: it is not a requirement that the name be globally unique.
 BE/RH:=> Accept 1.1.3 as is.

originatingAuthorEntityID

A globally unique non-semantic identifier for the original author of the Template.

NOTE: Determining the form of the ID and its issuer etc is necessary but out of scope for the Templates SIG.

 LM:=> Who issues these?  Are they OIDs or what?  I believe this corresponds to 
header.responsibleGroup.groupId.  Note that this isn’t mandatory, though we could add 
a Schematron rule makes it mandatory for the static model level for LIMs (templates) if 
you want.
 DK:=> There is a need for us to define demographic registration policies to enable individuals
 to be authorized to be template authors, by a approved “scoping” organization. This is part 
of an editorial/certification policy that we will need to develop in the near future 
(openEHR is starting this now).
 BE/RH: Accept 1.1.2 as is, with the intent on mapping this to header.responsibleGroup.groupId.

templateIntention

A free text natural language description of the intent and scope of the Template. The purpose is to provide the author’s initial intent for the Template.

Example: The intention may include the realm or sub-realm within which the Template was designed to be used for.

NOTE: A change to the semantic meaning or intent of a Template will constitute a new Template, not a new version of the Template.

 LM:=> Use the “UsageNotes” annotation which talks about how the static model is intended to be 
used and any constraints/restrictions on usage.  Note that this isn’t mandatory, though we could 
make it mandatory for the static model level for LIMs (templates) if you want.
 WG:=> Important issue. Also the purpose of Templates itself needs briefly addressed in a 
template description document: where can I use  templates for? And then: where can I use 
this particular template for in clinical documentation, messaging, data aggregation, DSS, 
queries etc. 
DK:=> Agreed – no change in the requirement statement is indicated.


BE/RH:=> Keep this as is.  Question, how does this map to 1.2.5?

templateVersion

The version identifier for the Template. The ability to determine the correct version of a Template is essential to its identification.

NOTE: Changes to the Template that do not change the semantis or intention of the Template will constitute a new version of the Template being created. Any change to the semantic meaning of the Template will constitute the creation of a new Template.

LM:=> This is part of the identifier for the model.  This isn’t technically ‘required’ but will 
always be present before publication.  (I.e. when you’re in draft, you don’t have a version id.)
WG:=>Crucial for referring to it, but also in developmental stage to track advancement. Thus 
a status (Draft / Open for review / Final / New Release) might also be important.
 DK:=> We need to clarify the modifications that may constitute a new version of an existing 
template, as opposed to a new template. The main guiding principle is that conformant instances 
would remain directly comparable.
BE/RH:=> Agreed that this needs further discussion.  We need to identify the needs for version and status further.  

==== templateReferenceModelID ==== The globally unique identifier of the reference model against which the Template was developed. The underlying reference model may be A DIM, LIM, or Profile or Template.

LM: Templates can be constraints against numerous models.  These are shown using derivation
 relationships to the models derived from (RIM, DIM, CIMs, other LIMs, etc.
DK: Yes, a given template might apply to more than one model, but will inevitably have been 
designed with one in mind, and it will be optimized for this. An alternative approach would 
be to list the models for which the template has been “certified” for use i.e. some verification 
has been undertaken to ensure that instances can be constructed that are faithful to the template.
 However, given how far we are from achieving such certification, I would suggest we leave this
 requirement as it is.


BE/RH: Agreed, keep this requirement. This corresponds to 1.1.5

==== templateRepositoryIdentifier ==== The identifier of the repository where the Template is located. This is a required metadata item since the core functional purpose of a Template is reuse, and things in general are much harder to reuse when they cannot be easily located.

Open Issue: What form should this identifier take? This will be addressed in the Template Implimentation guide, and will likely be ITS dependent.

LM: Have added a URL for the ‘primary’ repository.  Note that a given template can be stored in numerous repositories and it doesn’t make sense to include all in the metadata, especially as it will change over time.  However, I’ve added primary repository as the location most likely to contain updates, new versions, etc.  I’ve also used a URL rather than an id because an id doesn’t buy you much.
WG: Possibly also refer to multiple repositories i.e. to have the language issues tackled. (Dutch Apgar at NICTIZ? English at???). 
DK: I think that even language translations must be consolidated within a single reference copy of the template. The template itself needs to document the reference repository that can be queried to ensure that a particular version that you hold is still current. This does not prevent multiple copies existing, but provides a mechanism to enable currency to be verified. An alternative is a single central index that knows the repository holding the master version and version status of each template, but this is too complex an infrastructure for the near future.
BE/RH: Rephrase to be: "The identifier of the repository where this Template instance came from."  Move as a new CEN requirement under the publication section.

==== templateRegistrationAuthority ==== The identifier of the registration authority (organization, institution, committee, or individual ) for the Template.

Open Issues: What are registration rules? What is the relationship between the repository and registration? What is the purpose of regsistration?

LM:Because I’ve changed the repository id to a URL, I don’t think we need the name of the 
authority.  You can look it up by going to the URL.  If you’re searching for a template, 
then you’re generally searching within a single repository anyhow, so the assigning organization 
name isn’t going to help much.  No plans to support this in the MIF unless a stronger case is 
made for adding it.
WG:I miss the authorship. The one(s) writing the template and additional information, must 
be identified. This is usually not the one registering the template. I miss the source 
material used. Templates can come from assessment scales, requiring linkage to scientific 
sources, or based on guidelines referring to the particular guideline, or a project document 
etc.
DK:=I am not sure where the properties William mentions have gone: they are in the CEN/openEHR
 archetype requirements. I do agree that we need to add the identifier of the certification body 
who has certified this template, if it has been certified. More work is needed on a certification
 data set, which we are doing in Europe through 2006.


BE/RH: Agreed more work needs to be done to flush this out.  Lloyd's comment on changing repository ID to a URL is very acceptable.

Identification Metadata - Optional


==== templateCodedTerm ==== The coded concept that uniquely represents the templateName within a given code system. A concept code can be assigned to an entire Template, providing it with a language independent method of secondary indentification. This can be used in conjunction with the templateName to convey the intended purpose and use of the template. (Refer to templateName.) The same templateCodedTerm and templateName may be used in multiple Templates.

LM: Will be added as a template-specific item.  Is the intent to be definitional?  
I.e. This template represents the definition of what is meant by the LOINC term “blood pressure”?
WG: Agree for the moment, but would need to see the implementation if this is OK. Currently 
we deal with codes concepts on the template level, but also on the variable list which can
 be expressed in a template, see Barthel Index which has 10 concepts underlying. 
DK: We need to clarify how this differs from the Template Name. Do we really need both
 a free text and a coded term for the same thing? My intention originally was to offer 
either (since codes will not exist for some template concepts) but not both! Can I suggest
 that we consider combing these two attributes into a single “text or code” representation?


BE/RH:  Eliminate this.  Roll this into TemplateName (1.1.3)
BE/RH:  Accept 1.2.1 through 1.2.4, but revisit during versiong discussion.  Definately nedd to manage inter-relationships between templates.

Description Metadata – Mandatory


==== descriptionLanguage ==== The natural language in which the Template is represented.

This is description.text.language.  (All annotations including purpose, rationale, usage 
notes, etc. allow multiple translations.)  Language isn’t mandatory.  If not specified, it 
is inferred by the realm in which the template is created.

==== templateDescription ==== A free text natural language description of the intent and scope of the Template. The purpose is to provide the author’s initial intent for the Template.

This is the description annotation.  (Note that the definition here overlaps considerably with 
your ‘Intent’ earlier.  From the MIF, the difference between Description and UsageNotes is that
 description talks about what something ‘is’.  UsageNotes talk about what should or should not 
be done with it. Note that this isn’t mandatory, though we could add a Schematron rule makes it
 mandatory for the static model level for LIMs (templates) if you want.
WG: See our format: goal, underpinning, variable list, instructions for clinical use, 
interpretation, literature, examples from paper world, mapping from natural language to 
HL7, model itself. Etc. 
DK: William provides a useful list here. In discussing this description set structure within 
CEN we decided not to break down the description into those headings specificaslly, but to 
offer an informal note to recommend that those themes should be included in the detailed 
description (defined below) if relevant.

Description Metadata – Optional


==== implementationFormat ==== The preferred format that the Template should be implemented in from an ITS perspective. Implementation formats other than that recommended(if any) are not deemed suitable for this Template by the publishingAuthority. Other implementation formats are possible, but it is the responsibility of the translator to make the tralation to the new format, not that of the publishingAuthority.

Not sure what this is talking about.  For the purposes of the MIF, all templates are expressed 
as static models.  You can ‘implement’ them however you want – schemas, schematron, custom 
code, whatever.  Templates are abstract and should be independent of implementation.
This is key. Important issue to address is that yes a HL7 v3 format can easily be changed to 
OpenEHR archetype, but the other way round is very time consuming and not very handy at this 
stage. As long as we do not have transformation tools, one way to go we chose is to work in 
HL7 R-MIM formats until better tooling comes along. 
DK: I’m afraid, like Lloyd, I’m not sure what this means. Since the primary Reference Model 
is defined elsewhere, I assume this relates to the physical representation of this template. 
It will be important for repositories to be able to store more than one format if more than 
one proves to be useful to industry, but it should be a repository function to know the format 
of each instance it holds, rather than data within the artefact instance. 

==== evidenceSource ==== A description, reference or link to the published medical knowledge that was used in the definition of this Template.

LM:Have added a new annotation called “requirements” which can be used to describe where the need for a particular element (including a model) comes from.
DK: Requirements is probably not the best term: evidence source or sources would be better.

==== detailedDescription ==== A detailed explanation of the purpose of this Template, including features of intrest. This may include an indication of the intended user group for which this definition is intended.

DK: see my comment under templateDescription

==== cautionPoints ==== A formal statement regarding when this Template should not be used, or may be used erroneously. To define roles where the Template should not be used, or should be used with care. This field is used to expand in detail on the templateIntention.

This will also be handled in the “usage notes” annotation.  I.e. There will be no separation 
between templateIntention and cautionPoints.
DK: no strong feelings on this, as its free text anyway. It would help consistency with 
CEN & openEHR if they were separated.

Publication Metadata – Mandatory


==== publicationStatus ==== The current publication status for the template.

  • Development - LM: Draft
  • Test - LM: How is this different from “Development”? Is this equivalent to DSTU but without balloting?
  • Private - LM: Possibly “Localized Adaptation”?
  • Public
  • Preferred LM: - ? (preferred over what?)
  • Former - LM: If this means superseded, then the status would go to withdrawn and there’s be a link to the replacing template
  • Deprecated - Withdrawn
DK: Happy with Development becoming Draft; Test is intended for any instances that are never 
intended to be used in real life (but are not draft) e.g.used for teaching; Private could be 
Localised Adaptation; Public could be Normative, but might not have been through the same 
process as a balloted standard, since that is probably too heavyweight a process for a knowledge
 instance – I’d be happy to look for another term, such as Final; Former can be Withdrawn, 
and I agree that Deprecated probably means the same thing; Preferred was an idea I had, but 
I can see that it’s not so useful and should be removed.

==== publicationStatusChangeDate ==== The date that the current value for publicationStatus was applied of the Template.

LM: ApprovalInfo.approvalDate

==== publisher ==== The name of the author(s) institutional affiliations and contact infomation for the creators of the Template.

LM: Header.responsibleGroup and/or contributor
WG: Yes, see above

==== publishingAuthority ==== The autoritative body who has reviewed the Template for clinical accuracy and relevance, and autorized it for publication.

LM: Added reviewingAuthority to header.  (Default is HL7.)
WG: Yes, until now we have included the content determined externally by clinical groups and 
guideline developers. I.e. we have operationalised what these groups wanted. 
DK: We need to clarify how this differs from the templateRegistrationAuthority. We probably don’t 
need both: we need to identify who has certified the template.

==== revisionHistory ==== The free text description describing the changes in this version of the Template as compared to the previous version. Since Template versions are built off of previous versions, the net effect of this field is to function as a comprehensive historical reference of the Template.

LM: Every element has a historyItem which allows detailed tracking of changes including what changed,
 when it changed, why it changed and who did it.
WG: Also it is important to be able to track changes and reasons for the change. If it is left 
out, e.g. in a final version like we do, we loose this information, leading in some instances 
to duplication of efforts via reintroducing something in stage 3, which was there in first stage 
and removed in 2nd stage. 
DK: I suspect a full track changes across all attributes will be difficult, and I’d see this as 
an application issue (to generate a difference between any two versions of a template) rather 
than a property of each instance. We have adopted that approach in the EHR too.


technicalReview

Similar to the clinical review, also a technical review is necessary: this is a check on useability
 in a HL7 message (datatypes, OID for individual coded concepts, codes, cardinalities, value set
 bindings), alternatively in OpenEHR system use, or later in the CEN stuff. 

Also: storage of the item in EHR, functioning in CDA / DSS / Aggregation and so on can be 
tested and reported, thus giving details on the interoperability in different circumstances 
and reuse of many purposes.  This would require more input, especially in later stages of work.
DK: This is an important issue, and needs to be taken into account when defining certification
 policies. However, I do not think this requires any additional information to be incorporated 
within a template instance.


Publication Metadata – Optional


==== effectiveDate ==== The date after which the Template can be considered for use. Use of the Template prior to this date would be considered an invalid use of the Template.

DK: I agree, that it is unlikely that a template will be post-dated to start in the future, 
once it has been certified.

==== expirationDate ==== The date at which the clincal concept represented by this Template becomes stale, and should be reviewed for clinical relevance and accuracy. Use of the Template after this date would be considered venturesome.

LM: Corresponds to approvalStatus.withdrawalDate.  (It can be specified in the future)
DK: I had proposed a review date, rather than an expiry date. Human experience suggests that reviews are often done later than intended, and you don’t want a template to suddenly become unusable. It should be an informative date for the author and/or certification body.

Template Node Constraints

templateNodeExplicit

Explicitly defines a node in the template constraint definition. Template nodes are organised in a hierarchial structure. The top level constraint node is known as the 'root template node' or the 'template'.

templateNodeId

A globally unique, non-semantic, identifier for the template node. Within the context of HL7, a templateNodeID should take the form of an ISO Object Identifier (OID) or an HL7 Artifact ID.

LM: There is no single ‘id’ for a class or attribute.  However, you can reference them by specifying
 modelid, class name and association or attribute name
DK: What we need is for an instance to be able to refer unambiguously to the corresponding portion 
of a template to which it conforms (not just to the overall template) e.g. this EHR node corresponds
 to the cuff size node of a blood pressure template.

templateNodeReferenceModelID

The globally unique identifier (ISO OID or HL7 Artifact ID) of the reference model against which the Template was developed. The underlying reference model may be A DIM, LIM, or Profile or Template


There are multiple models that all templates are based on, as models exist in a derivation hierarchy.
  Furthermore, templates can be applied to models constructed from an independent derivation 
hierarchy, so long as the class structure of the template is compatible with the model to which it 
is applied at the point at which the template is invoked..  All models will be referenced by HL7
 artifact id.  (OIDs are only used for inclusion in registries in those circumstances where this 
is necessary.)  The chain of models from which a template is derived is found in the “derivedFrom”
 element.
DK: I am not sure why this is needed for every node, since the template declares its primary 
Reference Model in templateReferenceModelID.

templateNodeReference

References a template node that can be used in the template node hierarchy. This may be referring to a template root node or a template node within an explicit template definition.

Not clear what this is.  Is this the re-use of a class within the template?  In that case, it’s 
just a class name.
<pre>

<pre>DK: I am also unclear about this.


inclusionRationale

Annotation as to the rationale for inclusion of this template node reference at this point in the hierarchy.

This will map to the ‘rationale’ annotation.
DK: If we have evidence source, there should not be a need to explain each node individually – it
 would be overkill, and often difficult to point to the specific evidence on a node-by-node basis.

templateReferenceId

A node reference may refer to another template, this identifer (ISO OID or HL7 Artifact ID) specifies the relevant template. A node reference may refer to another template node contained within a template, this identifier (ISO OID or HL7 Artifact ID) specifies the relevant containing template.

LM: Templates will be referenced within templates the same way models are referenced within 
models – as CMETs
DK: I’m not sure what that is, but the template’s unique identifier is probably the key data 
value to include.

templateNodeReferenceId

A node reference may refer to a pre-existing template node by it's unique template node identifier (ISO OID or HL7 Artifact ID) The template node may be within the current template, or an external reference to a node within another template.


LM: References to CMETs must refer to the root class in the CMET.  You can’t start somewhere 
else.  References to other classes within a template are just by class name.
DK: this might be true for CMETs, but might not be true for all templates, so this 
feature is needed.

templateNodeConstrained

Another template node referenced by required attributes?? That is not defined by identifier but by rules governing allowed template nodes.


templateNodeChoice

A node choice allows the selection of one of a set of possible choices, this may be an explicit templateNode, reference templateNodeReference, constrained refererence templateNodeConstrained.


LM: This is a simple choice box (a specialization relationship in UML terms)
DK: fine, so a specific attribute might not be needed.

templateNodeConstraint

Constrains allowed nodes based on the attributes of a template node definiton. This inclusion constraint may be made against explicit or referenced template nodes.

inclusionRationale

Annotation as to the rationale for inclusion of this template node constraint at this point in the hierarchy.

LM: The rationale annotation for an attribute or association includes the rationale for both the
 presence of the element, as well as any constraints upon it (whether in a constraint annotation,
 or via domain name, cardinality, mandatory or other ‘explicit’ constraints.
DK: fine, so a specific attribute might not be needed.

constraintStatement

Statement of the constraints placed on template nodes that are allowed to be instantiated at this point corresponding to template node hierarchy.

LM: There can be multiple constraint annotations for a given node.  Each constraint statement 
must contain a “plain language” explanation of the constraint, potentially with translations to 
other languages.  It may also be accompanied by 0 or more formal expressions using different
 constraint languages.
DK: Good. Lloyd’s description actually implies a richer requirement, which I think is useful. 


cardinality

Constraints on the number of instances that can be instantiated corresponding to this template node.

logicalCondition

Constraint rule expression statement. This may include references to environmental parameters, relatively referenced instances or absolutely referenced instances.

expressionFormalism

The expression formalism used to express the logical condition. Such as OWL, OCL, GELLO etc.


codedTermBinding

Every template node must be associated with at least one clinical term.

Issue: not all nodes can be bound to clinical concepts

LM: First of all, HL7 templates are not specific to clinical.  You can have a template about an
 invoice structure as easily as a lab panel.  All nodes are associated with a definition – stored
 in the RIM.  Some of the definitions are supplemented by structural codes which determine the
 meaning of the instance.
DK: Lloyd is right – we do need to make the requirements a little less clinically-focussed, even
 though we intend to use them for clinical purposes in the first instance. The alternative is to
 scope this whole specification for “EHR Templates”. For discussion?

Each archetype node may be associated with additional clincal concepts, terms, or synonyms.

If you have a coded element, you can have multiple translations.  If you have a non-coded element, there’s no way to communicate synonyms, and it’s not clear what the purpose would be.  Need to understand this requirement better.  Is this making OWL equivalence statements.  I.e “This node is equivalent to a structure that looks like that?”
DK: I think not the latter, so a basic CD data type would do. We should tighten the requirement wording.

Coded term (mapping?) purpose must be labelled: - prinicpal concept - code system translation - language translation - synonym

LM: The allowed “concept-space” for coded terms are defined by the domain to which they are bound.  In some cases, it may be further constrained to a specific value-set drawn from one or more coding systems.  The overall purpose of the attribute is defined in the RIM.

Any referenced coded term must include code, code system (OID), and display name text.

Code and code system are indeed required (except where code system is fixed by the RIM).  
Display name is not required in general, though it could be made required by constraining 
the datatype used or using an appropriate datatype flavor.  Some committees and realms may 
explicitly prohibit the use of displayName.  (DisplayName is problematic because it is redundant,
 is specific to a particular language, and is frequently ignored by the receiver anyhow.  If 
you’re going to require something, it’s better to require “original text” which is what the user
 actually saw/typed/selected.)
DK: suggest rewording the requirement to original text.

attributeConstraints

A template node may specify constraints on attributes corresponding to a reference model.

This covers the case where RIM class attributes are constrained further as required by a particular template. This includes:

  • Restricting cardinality e.g. 0..* to 1..1
  • Restricting a data type to a specialisation e.g. GTS to TS (this is the equivalent to Data Type flavours)

Issue: this now asserts that datatypes are definately part of the reference model; NOT data values as examined in the next section.


attributeName

Name of the attribute corresponding to the underlying reference model.

attributeCode

Label/code of type of attribute describing its context. This may be role code, type code, etc.

cardinality

Cardinality constraints may be defined on instantiation of attributes.

instantiationConstraint

Other constraints or rules may be specified in a desired expression formalism.

collectionType

Multiple instances can be specified as unordered list, ordered list or a unique instance set.


HL7 Template Data Value Constraints

structuralAttributeConstraints


It must be possible to specify constraints and rules for the Structural Attributes within the Reference Information Model.

- in process

LM: Structural attributes are no different than any other from a constraint perspective.  Only limit is that coded structural attributes are always bound to a universal value-set so there’s no choice of code system.
DK: maybe delete this statement?

dataValueConstraints


It must be possible to specify data value constraint information, including:

  • Null and null flavor values as well as an optional reason to specify a null flavor value.
  • If the constraint or rule specifies inclusion or exclusion criteria.
  • The formalism (including version) in which this constraint specification is represented.
  • The intended fixed (prescribed) value for conforming instances.
  • The intended default value for conforming instances.
  • A list of permitted candidate values for conforming instances (i.e. to be a subset of those vales legally permissible in the underlying Reference Model.)

Quantity data types must be able to specify


==== inclusiveQuantity ==== A value range where the value(s) for conforming instances must be inclusive;

LM:Added allowedRanges element.

==== exclusiveQuantity ==== A value range where the value(s) for conforming instances must be exclusive;

LM:Added allowedRanges element.  An exclusive range is the combination of two inclusive ranges
 (negative infinity to low and high to positive infinity).

==== inclusiveCritical ==== A range within which values are considered to be clinically exceptional or critical.

LM:A range within which values are considered to be clinically exceptional or critical. This
 would be modeled as part of the instance, not part of the model.  I.e. If you want to create
 a definition for a test and indicate what the expected highs and lows are or the critical highs
 and lows, you would construct an instance in definition mood showing the maximums and minimums.
  A template is a model, not an instance.  “Knowledge” must be represented as instances in 
definition mood, not as templates.
DK: this (and below) needs further discussion, since we are really authoring a knowledge resource.

==== exclusiveCritical ==== A range ouside of which values are considered to be clinically exceptional or critical.

LM:ditto

Date data types must be able to specify


==== inclusiveDateValueRange ==== A value range where the value(s) for conforming instances must be inclusive;

LM:Added allowedRanges element.

==== exclusiveDateValueRange ==== A value range where the value(s) for conforming instances must be exclusive;

LM: Added allowedRanges element.  An exclusive range is the combination of two inclusive 
ranges (negative infinity to low and high to positive infinity).

==== dataValueUnits ==== The intended measurement units for conforming instances.

LM: Measurement units are expressed using the PQ datatype and are constrained to UCUM.  
You can constrain the allowed units by constraining the domain or value-set in a datatype 
flavor definition.

Textual Data Types


==== regularExpression ==== A Regular Expression pattern defining the range of possible values for a String.

 
LM: One of the constraint formalisms is Regex

codingScheme


The intended coding scheme to be used for conforming instances for the textual data.

LM: As in ASCII vs. others?  You could constrain the encoding property for ST or ED by using a datatype flavor or an ad-hoc constraint.  Note that the XML ITS places limits on the ability to mix encoding systems within one message.
DK: misunderstanding, as we mean terminology (clinical code) not characterset. Fully understand charactersets can’t be mixed, and we’d be unlikely to need to specify that.

Logic Operators


Constraint rules might be expressed using logical operators, and may include reference to environment parameters such as the current time or location or participants, or be related to the (preexisting) values other nodes in the instance hierarchy. Relative constraints may be nested, and include logical or set operators in order to represent compound rules.

LM: Environment parameters such as current time might be allowed.  All others would not be supported.  Constraints can only relate to data within the instance.  The concept of ‘now’ might be a reasonable exception.  Location or participants or previously received data is not because it’s completely outside the model defined by the template.
DK: as stated earlier, we need to review this requirement as a rule that conformance might not have
 to check.


  • Logical operators can be applied to a set of assertions to indicate which assertions in the set must be true or false. Example: (All | at least X | at most X | exactly X) of the assertions contained in this set must be (true | false).

Template Reference


The reference to a preexisting value must specify that instance precisely and unambiguously.

LM: Huh?  Not clear what this means.
DK: I need to reword this, but in any case it refers to external instance values.


==== templateID ==== The Template identifier (templateID) for the Template being referenced

The occurrence in the instance hierarchy

  • First
  • Most Recent
  • Any
  • N ordered by Y (the nth set of instances ordered on y)
  • highest value
  • lowest value
  • one or more instances within a definable time value
LM: This is a requirement for the ad-hoc constraint language.

Template Assertions

Static assertions


  • A template can constrain the cardinality of a clone’s association.
  • A template can constrain the cardinality of a clone’s attribute.
  • A template can constrain the allowable date/time values in a date/time field.
  • A template can constrain any attribute value to be a subset of those values legally permissible in the specification being constrained.
  • A template can constrain the range of allowable date/time values for attributes valued by date/time data types.
  • A template can constrain the range of allowable code values for attributes valued by terminology concepts.
  • A template can constrain the range of allowable numbers for attributes valued by numbers.
  • A template can express a regular expression constraint on attributes valued by strings.
  • A template can constrain any data type component, including recursively-nested components.
  • A template can constrain the range of allowable values of a clone’s attribute.
  • All additional constraints that can be expressed in a normative specification (including all the columns in an HMD) can be further constrained in a template.

Co-occurrence Assertions


  • The value of one field can be constrained based on the value of another field.
    Example: If fieldOne is “X”, then fieldTwo’s value must be “A”.

  • Chronological assertions can constrain the date/time value of one field based on the date/time of another field.
    Example: The start time for fieldOne is (earlier | later | equal to) the start time of fieldTwo.

  • Numeric comparison assertions can constrain the numeric value of one field based on the value of another field.
    Example: The value of fieldOne is (equal to | less than | greater than) the value of fieldTwo.

  • Numeric operation assertions can constrain the numeric value of one field based on a numeric operator applied to the value of another field or constant.
    Example: The value of fieldOne is (equal to | less than | greater than) the value of fieldTwo (plus 7 | divided by 27).

  • String comparison assertions can constrain the string value of one field based on the value of another field.
    Example: The string value of fieldOne is contained in the value of fieldTwo.

  • Any constraint a template and constituent archetypes can make can be made dependent on the value expressed in one or more other fields. For instance, in addition to constraining the cardinality of an association, a template and constituent archetypes can constrain the cardinality based on the value in a particular field.
    Example: If ((fieldOne is “X” or “Y”) OR (fieldTwo is “ABC”)) then ((a nested act relationship under Observation is required) AND (fieldThree in the nested act has a value of “A” or “B” or “C”) AND (fieldThree in the nested act cannot be NULL)).


Containment Assertions


  • Data descendant assertions can constrain allowable depth at which one component is nested within another component.
    Example: The vital-signs section must be (a direct child of | some descendant of | less than a depth of X from) the physical-exam section.

  • Items in a template and constituent archetypes can be “ordered” or “unordered”. In an ordered template and archetype, the order of the stated assertions is important. In an unordered template and archetype, the order is not important.
    Example: Assertion One: There is a nested act under observationOne that has an observation.cd for “hemoglobin”. Assertion Two: There is a nested act under observationOne that has an observation.cd for “hematocrit. If the template and constituent archetypes are “ordered”, the “hemoglobin” must come before the “hematocrit”. If the template and constituent archetypes is “unordered” the “hemoglobin” can come before or after the “hematocrit”.

•	Also the opposite is very important! Data ascendant assertions can constrain 
allowable hights at which one component is grouped or organised. 
•	Example:  The vital-signs section can be organised into a physical-exam section, 
or into a flow-sheet, or into a bedsite data-entry form (Care Provision Organiser allows 
a bottom-up grouping of atomic / molecular templates into larger wholes such as clinical 
statement collectors, e.g. allergy list, physical-exam, nursing assessment, 
discharge checklist).