Design Comments: Free text entry of the human readable title of the document. It is this title of a document that is rendered. The title describes (but does not guarantee) the content of the document.The title is either a simple string (ST) or an XML content (ED) with limited NarrativeBlock markup which allows for stylesCode, super- and sub-script, line breaks and few other functions, but explicitly excludes tables, lists, etc.

Design Comments: The release date of the product labeling document.

Design Comments: Specifies confidentiality of the entire document. May be overriden for specific parts of the document. Values may be drawn from the Confidentiality vocabulary domain. Values other than those in the HL7 vocabulary domain (such as local codes) can also be used if necessary.

Design Comments: A code specifying the human language of character data in the product labeling document (whether in contents or attribute values). The values of the attribute are language identifiers as defined by the IETF (Internet Engineering Task Force) RFC 3066: Tags for the Identification of Languages, ed. H. Alvestrand, 1995 (http://www.ietf.org/rfc/rfc3066.txt), which obsoletes RFC 1766. Language is a contextual component of SPL, where the value expressed in the header holds true for the entire document, unless overridden by a nested value.

Design Comments: An optional globally-unique identifier, that remains constant across all document revisions that derive from a common original document.

Design Comments: An optional version number is incremented for each subsequent version of a document. For example, an original document is the first version of a document, and gets a new globally unique "id" value; it can also contain a new value for "setId" and a value of "versionNumber" set to equal "1".

Design Comments: A Participation clone that links a Document (or Section) to the Person who originated the document (or section, respectively), and, through AssignedEntity, also links to the Organization that owns the document. If desired, the author(s) of specific sections can be identified using the same structures as it is done for Document.author, which will then override the author(s) specified for the Document. (Note: In the SPL RMIM, this class is represented as a "shadow" of the author class for document, indicating that this participation is used by both the section and the document classes.

Design Comments: In some realms there may be a requirement to capture a legal authenticator of the labeling content. A legally authenticated document exists when an individual with the proper legal authority has attested to the accuracy of the document content. A document can be legally authenticated by zero or more people. Requirements for capture of information about a potential legal authenticator have not been defined to date. However, in the case where a local document is transformed into a SPL document for exchange, authentication only occurs on the local document and the fact of authentication is reflected in the exchanged SPL document. An SPL document can reflect the unauthenticated or authenticated state. The unauthenticated state exists when no authentication information has been recorded (i.e., it is the absence of being authenticated).

Design Comments: Represents reviewers, typically within the regulatory agency, where the AssignedEntity.representedOrganization provides details about the organization (e.g., the regulatory agency) for which the verifier is working. (It is possible to indicate reviewers of a different organization, such as the manufacturer itself, the representedOrganization specification will tell what level of review the Verifier participation represents.)

Design Comments: Links the "document body" to the Document.

Design Comments: A reference to another Document. The set of attributes in this class has the purpose of identifying the related document by identifiers only. To learn the contents of the related document, one needs to retrieve that document by the identifier(s) provided here.

Design Comments: A comment left by the participant.

Design Comments: The time of participation by the author (usually the time of origination).

Design Comments: Document the existence of a signature if the value for signatureCode is "S" (for "signed"). Verification may involve signing of the document either manually or electronically by the responsible individual.

Design Comments: A token representing the participants electronic or digital signature.

Design Comments: A comment left by the participant.

Design Comments: The time of participation by the legal authenticator (the time at which the document was authenticated, i.e., signed).

Design Comments: Document the existence of a signature if the value for signatureCode is "S" (for "signed"). Authentication involves signing of the document either manually or electronically by the responsible individual.

Design Comments: Represents an electronic or digital signature of the participant.

Design Comments: A comment left by the participant.

Design Comments: Indicates the time of participation by the verifier (usually the time of review).

Design Comments: Document the existence of a signature if the value for signatureCode is "S" (for "signed"). Verification may involve signing of the document either manually or electronically by the responsible individual.

Design Comments: Represents an electronic or digital signature of the participant.

Design Comments: Represents a document body that is in some format other than SPL XML (e.g., a PDF document.)

Design Comments: Represents an XML document body that is comprised of one or more Sections.

Design Comments: Connects the top-level sections with the Document.

Design Comments: Provides a means of organizing the product labeling content into the commonly understood sections generally found in these documents. The Section class is a container used to wrap other containers. A section element can occur in the StructuredBody, or can be nested within another Section. A section can also be replaced by another section. A section can contain nested section elements or other structures such as observations. The SPL section contains the actual product labeling text and graphics to be rendered. There are three logical components of the SPL section:General section information.Information about participants in creation of the section.The actual product labeling text and graphics to be included in the label section (and which will be rendered), along with structured data elements (that may be used for machine processing).The mechanisms to uniquely identify a specific product labeling section, to indicate a standard type code and name for the section, and to include a local name for the section (e.g. realm or language specific name; possibly constrained by the type code) are all included.Note the section element contains an optional local identifier (represented as an XML ID attribute) that can serve as the target of an XML reference.

Design Comments: Interval of time, the lower boundary specifying the section origination time, i.e., when the section was created, the upper boundary (if any) how long the section remains in effect.

Design Comments: Can override the confidentialityCode attribute in Document.

Design Comments: Specifies the human language of character in the same way that Document.languageCode works. Language is a contextual component of SPL, where the value expressed in the header holds true for the entire document, unless overridden by a nested value

Design Comments: Association linking the to the Section a description of a product or substance which is the subject of that section.

Design Comments: #nosuffix

Design Comments: An explicit representation of the relationships between versions of sections. Whether and how this information is used depends on the document management system in use. A replacement section replaces an existing section.

Design Comments: A relationship that links the product use guideline directly to the section [NEW: even without the highlights.]

Design Comments: Connects a section with one of its sub-sections or a multimedia component.

Design Comments: The relationship which links the Highlight to the Section which is being excerpted by the Highlight.

Design Comments: Links a comment to a section. The section is the subject of the comment. The comment does not participate in the context of the document, i.e., is never assumed to be attributed to the document or section author and is not considered part of the document.

Design Comments: A choice between a product or substance as the subject of the description section.

Design Comments: A section that is related to the section it replaces through the replacementOf relationship (an ActRelationship clone).

Design Comments: Provides a means of organizing the product labeling content into the commonly understood sections generally found in these documents. The Section class is a container used to wrap other containers. A section element can occur in the StructuredBody, or can be nested within another Section. A section can also be replaced by another section. A section can contain nested section elements or other structures such as observations. The SPL section contains the actual product labeling text and graphics to be rendered. There are three logical components of the SPL section:General section information.Information about participants in creation of the section.The actual product labeling text and graphics to be included in the label section (and which will be rendered), along with structured data elements (that may be used for machine processing).The mechanisms to uniquely identify a specific product labeling section, to indicate a standard type code and name for the section, and to include a local name for the section (e.g. realm or language specific name; possibly constrained by the type code) are all included.Note the section element contains an optional local identifier (represented as an XML ID attribute) that can serve as the target of an XML reference.

Design Comments: Holds multi-medial content, that is logically a part of a product labeling document, but may be stored outside the document and incorporated by reference. Multimedia that is integral to a document, and part of the attestable content of the document, requires the use of observationMedia. (An example might be the molecular structure for a drug in a drug product labeling document.) Multimedia that is simply referenced by the document and not an integral part of the document can use linkHtml. The XML ID attribute on the observationMedia element is used by the renderMultiMedia element (of the Narrative Block) to identify the media to be rendered.

Design Comments: An optional instance identifier of the media. Note that for certain historical reasons, this may not be the identifier used to make reference to the media for the purpose of rendering it. Instead, a different attribute (ID, upper case) is used on the observationMedia element to later refer to it. It is probably a good idea to consider this id and the "ID" attribute two representations of the same id, therefore, to keep them the same.

Design Comments: Used to describe the image in words suitable to the visually impaired readers.

Design Comments: An abstract or excerpt of a single topic discussed in a single section or sub-section. This abstract is presented in the form of a short text fragment as well as with structured information. The highlights are targeted at prescribers and judiciously chosen to present the most important information the prescriber needs to know in order to prescribe a medicine safely and effectively.The Highlights can be assembled to form a short abstract of the comprehensive prescribing information as a "quick reference" for the prescriber.All structured information to specify the clinical use of the drug is connected through the highlights element. The practical purpose of this construct is to focus the coding of information on the most important points guiding the appropriate use of the medicine without attempting to code nuances which would not be part of a concise summary. It also facilitates review of the structured information for correctness. Specific information structures cover the general topics: Indication, Dosage and Administration, Adverse Events, Interactions, Contraindications and other Cautions or Warnings, as well as Monitoring guidelines.

Design Comments: The relationship which links the Highlight to the product use guideline as its subject matter.

Design Comments: Editorial comments much like the comments which can be attached to text with some word processors. Comment.text contains the free text of the comment. The comment can reference a precise location in the section text using the TextFragmentReference. The following is an example:

<section>

...

<text>Pramoxicol SM is <content ID="cmt123">the cure for hair loss</content>.</text>

...

<subjectOf>

<comment>

<text>This is a unfounded hype, you need to strike this</text>

<statusCode code="active"/>

<effectiveTime .../>

<subject>

<textFragmentReference>

<text>

<reference url="#cmt123"/>

</text>

</textFragmentReference>

</subject>

</comment>

</subjectOf>

...

</section>

A comment should be attributed to an author but this author is separate from the document author (explicitly not inherited). Even if no specific author is assigned to a Comment, such Comment is not automatically attributed to the document or section author. A Comment is not even considered part of the Section; it only references the Section and can be sent along with a Section but might be stripped from the Section without such stripping being considered an alteration of the Section. Such a Comment would never be considered part of the authenticated (signed) content of the Document.

Design Comments: Allows narrowing the subject of the comment down to a specific fragment inside the Section.text.

Design Comments: Links to an earlier comment, such that one commenter can respond to another comment. When linking comments, the response to a comment is nested as a sequel/comment inside the comment element to which it responds.

<section> ... <text><content ID="cmt987" revised="delete">Pramoxicol SM is <content ID="cmt123">the cure for hair loss</content><content>.</text> ... <subjectOf> <comment> <text>O.K. you're right, we did strike the whole sentence.</text> <statusCode code="active"/> <effectiveTime .../> <subject> <textFragmentReference> <text> <reference url="#cmt987"/> </text> </textFragmentReference> </subject> <sequel> <comment> <text>This is a unfounded hype, you need to strike this</text> <statusCode code="active"/> <effectiveTime .../> <subject> <textFragmentReference> <text> <reference url="#cmt123"/> </text> </textFragmentReference> </subject> </comment> </sequel> </comment> </subjectOf> ... </section>

Design Comments: References a specific fragment in the section text using the XML ID attributes on the content element in the section.

Design Comments: A reference to another Document. The set of attributes in this class has the purpose of identifying the related document by identifiers only. To learn the contents of the related document, one needs to retrieve that document by the identifier(s) provided here.

Design Comments: Can be used to support conventional revision numbering in addition to the explicit links to the ancestor versions using the RelatedDocument.id. One example scenario is: The new replacement Document gets a new globally unique id value, and uses the same value for setId as the RelatedDocument being replaced, and increments the value of versionNumber. The RelatedDocument is then considered superseded, but is still retained in the system for historical reference.

Design Comments: Can be used to support conventional revision numbering in addition to the explicit links to the ancestor versions using the RelatedDocument.id. One example scenario is: The new replacement Document gets a new globally unique id value, and uses the same value for setId as the RelatedDocument being replaced, and increments the value of versionNumber by 1. (If used, the versionNumber will be incremented by one when a document is replaced, but can also be incremented more often to meet local requirements.) The parent document is considered superseded, but is still retained in the system for historical reference.