Details
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Change Request
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Resolution: Persuasive
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Medium
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Electronic Medicinal Product Information (FHIR)
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1.0.0-ballot
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Biomedical Research & Regulation
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STU
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(NA)
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Craig Anderson / Norman Gregory : 7-0-0
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Clarification
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Non-substantive
Description
- Revise the title. The page title refers to "conformance requirements", but that is a lot of information that does not seem to be conformance requirements related,
Section 7.1 Lifecycle Management
Please clarify what is meant with
- Managing the resources as a document in a Bundle.
- Managing the document as a static Bundle versions that are manually updated vs managing a dynamic Bundle that is automatically updated anytime one of its leaf resources is updated.
Section 7.2 Case sensitivity
- In the context of this guide is not clear what is meant with "All data elements associated with controlled vocabularies are case sensitive. Refer to local guidance for case sensitivity rules."
Section 7.3 Display names
- revise or remove the sentence
NOTE:
- The display name shall be present for all code systems unless disallowed by the schema.
Not sure if this is true and enforced by the profiles.
Not sure what is meant here with schema, maybe is referring to the FHIR profiles ..
Section 7.4 Images
- revise or remove the sentence
"Images should also have descriptive, yet simple, file names."
not sure file names are anywhere used in the bundle
- revise or remove the sentence
"Alternative text (or alt text) is text that describes an image. It makes it possible for people using assistive technologies to access the information conveyed by an image. It also helps search engines better understand the purpose of the image."
not sure Alternative text are anywhere used
Section 7.5 Section headings
- Remove "Refer to the Annex for region specific details on section headings."
Section 7.6 Accessibility
- revise or remove the sentence
FHIR ePIs are encouraged to fulfill the success criteria for the WCAG 2.1, Level AA standard.
How the FHIR ePI is supposed to implement such a criteria? Is this not a feature that should be offered by the FHIR ePI reader?
Section 7.7 Semi-structured Text
- remove the sentence "For convenience, this section outlines HTML elements commonly used by ePIs"
- remove paragraphs 7.8-7.14. If 7.8-7.14 are kept they shall be sub-paragraphs of the 7.7
- Revise in general the section content removing/checking the editorial notes left (for example as [INSERT a list of standardized class attributes and meanings])
Section 7.15 Additional Monitoring Indicators
- The content of this section seems to be just an early draft, please review and complete; or remove the paragraph
Section 7.16 Hypertext links and cross-referencing
- Revise the format of the text in the gray boxes, some of them as And a link to the sample text: or To create hypertext links from text to content outside of the ePI document use the following format: should be normal texts
Attachments
Issue Links
- is voted on by
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BALLOT-46248 Negative - Giorgio Cangioli : 2023-Jan-FHIR IG EMEDICINAL PRODUCT INFO R1 STU
- Withdrawn