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