The following requirements have been shared by the FDA February 2018:
Note: in the excel, you would provide the activity data and then provide learner data for that activity. The current activity report model is not set up that way. We could make it more modular - define an activity, reference the activity in the activity report rather than giving a complete description each time.
Yellow shading indicates a potential addition to the activity report.
|Requirement||Current representation in MEMS||Activity Report Mapping||Other implementation notes|
|Learner masking identifier (ie an identifier that allows CE providers to map to a specific learner. Such an id should not allow anyone other than the CE provider to know the learner's identity. Equivalent to a study id.)||Not represented||Potentially UniqueID||This would require articulating a domain, ie the internet domain and type of identifier for id. If that is a barrier, we could create a new element.|
|State of primary practice||Not represented||Potentially StateOrProvince under Occupation InstitutionInfo||It may be better just to create a new element called State of PrimaryPractice rather than try to cram it in here.|
|Individual registration||--||New element needed|
|Profession||There is an occupation element which is a free text field||We could either create a more restricted version of the member spec and schema and restrict the values allowed for occupation or create a new element, MEMSProfessions or something like that.|
|Practice area||There is a specialty element in the member schema||Again, we could could either create a more restricted version of the member spec and schema and restrict values allowed for specialty or create a new element.|
|Performs surgical procedures||--||Create new element|
|Length of time in practice||--||Create new element|
|ReportingStartDate||ReportingStartDate||Create new element under ActivityReports|
|Reporting End Date||ReportingEndDate||Create new element under ActivityReports|
|Accrediting Body||lom:accreditingBody||We could continue to use this element under the metadata for a module, or use in a new location|
There is an activityID attribute, but it only allows for one. We could use ActivityInstanceID (which has a domain and allows multiple).
|Title||lom:title||We could continue to use this element under the metadata for a module, or use in a new location|
|Accredited Provider||hx:accreditedProvider||We could continue to use this element under the metadata for a module, or use in a new location|
|Activity Location||hx:activityLocation||We could continue to use this element under the metadata for a module, or use in a new location|
|Activity Date||hx:startDateTime||There is a StartDateTime under Module.We could use that, the hx:StartDateTime under module, or use in a new location.|
|Activity Type||hx:activityFormat||We could continue to use this element under the metadata for a module, or use in a new location|
|Commercial Supporter||CommercialSupportAmount suuportSource attibute||Create new element|
|Compliant to regulation (ie URL corresponding to specific REMS)||CompliantToRegulation||Create new element|
|Related to regulation (ie URL corresponding to specific REMS)||RelatedToRegulation||Create new element|
|Regulatory Classification (and subelements to indicate which blueprint components are addressed)||RegulatoryClassification||Createnew element|
Consider adding healthcare lom metadata under Activity as well as a reference to a REMS extension. If we put healthcare lom under the new schema for REMS, that may avoid ambiguity problems with validation.