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HL7-Individual Case Safety Reporting (ICSR)

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Presentation on theme: "HL7-Individual Case Safety Reporting (ICSR)"— Presentation transcript:

1 HL7-Individual Case Safety Reporting (ICSR)
Terminology Challenges

2 Current model encompasses reporting of drug, device and vaccines related case safety reporting capabilities Model build upon ICH’s E2B Specifications Currently incorporating FDA and CDC’s adverse event reporting form contents: MedWatch (drug and devices adverse event reporting) and VAERS (vaccine adverse event reporting).

3 Future domains involved -
Blood Products Deviations Reporting Nosocomial Infection Reporting Requirements from National Patient Safety Agency, UK Food Supplements Veterinary Products, etc.

4 Where will the uses be? Messaging will be used in several different scenarios within hospital systems, hospital/provider to state/local government, hospital/provider to US Federal Agencies, hospital/provider to manufacturers, hospital/provider to stakeholder agencies (NPSA, UK), and other

5 Future work will also involve-
Taxonomy for Medical Errors, including near miss Taxonomy of healthcare processes to answer the questions about where in the healthcare process did events and contributory factors occur.

6 External terminologies HL7 internal terminology
Terminology needs External terminologies HL7 internal terminology

7 Terminology needs Terminologies used in other countries
External Terminologies SNOMED-CT LOINC RxNORM GMDN ISBT MedDRA ICD CPT HCPCS Country code Occupation/Job codes, etc. Terminologies used in other countries

8 HL7 internal terminology
Terminology needs HL7 internal terminology


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