FDA suggested a few new data elements and new classes based on existing work. These additions are not reflected in this new ballot. It's suggested that the following elements should be discussed and added.

• Patient
o religion
o income
• ResearchSubject (Class)
o study (Data Element Name)
 status
• AdverseEvent
o Date: When the event occured
o event: Type of the event itself in relation to the subject
o severity: mild | moderate | severe
o suspectEntity: The suspected agent causing the adverse event
o causality: Information on the possible cause of the event
• Specimen
o Identifier: To identify the specimen obtained from a patient
o accessionIdentifier: Identifier assigned by the lab
o type: Kind of material that forms the specimen
o subject: Where the specimen came from\. This may be from patient(s), from a location (e\.g\., the source of an environmental sample), or a sampling of a substance or a device
o collection [x]: the date and time the specimen was collected
o Specimen transport mechanism: A new data element missing in USCDI and HL7 FHIR R4

(Comment 50 - imported by: Jean Duteau)