HL7-Individual Case Safety Reporting (ICSR)

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. Terminology needs External terminologies HL7 internal terminology

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

8. Terminology needs HL7 internal terminology