| Submitted By: Scott Gordon / Food and Drug Administration | |
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| Data Element Information | |
| Use Case Description(s) | |
| Use Case Description | Healthcare use case: While seemingly self-evident, the lack of a required identification of the recipient of a prescribed medication allows potential implementation that lack this obvious critical need. For interoperability purposes alone, a clear link between a drug and its recipient is essential. An FDA/clinical research context: Retrospective analyses of healthcare data are becoming a more common tool in clinical research for safety or efficacy for new indications of existing medications. In such analyses there may be one or more “exposure” drugs (ie, the drug of interest) and one or many “concomitant” medications. If there is no clear link between an prescription record and the intended recipient, there is no way to clearly determine who took any drug. |
| Estimated number of stakeholders capturing, accessing using or exchanging | All Electronic Healthcare Record systems, healthcare systems, clinical research users of healthcare data, regulatory reviewers of healthcare data |
| Link to use case project page | https://confluence.hl7.org/display/FHIR/2021-09+Vulcan+-+Real+World+Data+%28RWD%29+Submission+to+FDA |
| Healthcare Aims |
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| Maturity of Use and Technical Specifications for Data Element | |
| Applicable Standard(s) | In FHIR R4, https://www.hl7.org/fhir/medicationrequest-definitions.html#MedicationRequest.subject |
| Additional Specifications | FHIR US Core https://www.hl7.org/fhir/us/core/StructureDefinition-us-core-medicationrequest.html Each MedicationRequest must have: a patient |
| Current Use | This data element has been used at scale between multiple different production environments to support the majority of anticipated stakeholders |
| Supporting Artifacts |
HL7.FHIR.US.CORE\US Core MedicationRequest Profile - FHIR v4.0.1 https://www.hl7.org/fhir/us/core/StructureDefinition-us-core-medicationrequest.html Specifications - Epic on FHIR https://fhir.epic.com/Specifications?api=996 MedicationRequest | R4 API (cerner.com) https://fhir.cerner.com/millennium/r4/clinical/medications/medication-request/ |
| Number of organizations/individuals with which this data element has been electronically exchanged | 5 or more. This data element has been tested at scale between multiple different production environments to support the majority of anticipated stakeholders. |
| Supporting Artifacts |
HL7.FHIR.US.CORE\US Core MedicationRequest Profile - FHIR v4.0.1 https://www.hl7.org/fhir/us/core/StructureDefinition-us-core-medicationrequest.html Specifications - Epic on FHIR https://fhir.epic.com/Specifications?api=996 MedicationRequest | R4 API (cerner.com) https://fhir.cerner.com/millennium/r4/clinical/medications/medication-request/ |
| Potential Challenges | |
| Restrictions on Standardization (e.g. proprietary code) | none known |
| Restrictions on Use (e.g. licensing, user fees) | none known |
| Privacy and Security Concerns | none known |
| Estimate of Overall Burden | Possible unique privacy and/or security concerns must be addressed here. These concerns may invoke existing privacy and security regulations or restrictions such as HIPAA or 42 CFR Part 2. If a new data class/element is not specifically covered by these, this would need to be stated clearly, not assumed to be not applicable. |
| Other Implementation Challenges | none |
| ONC Evaluation Details Each submitted Data Element has been evaluated based on the following 4 criteria. The overall Level classification is a composite of the maturity based on these individual criteria. This information can be used to identify areas that require additional work to raise the overall classification level and consideration for inclusion in future versions of USCDI |
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| Maturity – Standards/Technical Specifications | Level 1/2 - Must be represented by a vocabulary standard or an element of a published technical specification |
| Maturity - Current Use | Level 2 - Used at scale in more than 2 different production environments |
| Maturity - Current Exchange | Level 2 - Demonstrates exchange between 4 or more organizations with different EHR/HIT systems |
| Breadth of Applicability - # Stakeholders Impacted | Level 2 - Used by a majority of patients, providers or events requiring its use |
Submitted by Larissa3430 on 2022-04-26
This field is for general…
This field is for general comments on this specific data element. To submit new USCDI data classes and/or data elements, please use the USCDI ONDEC system: https://healthit.gov/ONDEC