- 1 Product Brief - Regulated Reporting Domain (RR)
- 1.1 Product Name
- 1.2 Topics
- 1.3 Standard Category
- 1.4 Integration Paradigm
- 1.5 Type
- 1.6 Releases
- 1.7 Summary
- 1.8 Description
- 1.9 Business Case (Intended Use, Customers)
- 1.10 Benefits
- 1.11 Implementations/ Case Studies (Actual Users)
- 1.12 Resources
- 1.13 Relationship to/ Dependencies on, other standards
- 1.14 Links to current projects in development
Product Brief - Regulated Reporting Domain (RR)
HL7 V3: Regulated Reporting
- Individual Case Safety Report aka Safety Reporting Management
- Generic Incident Notification
Case Investigation Topic, aka Notifiable Condition Report, withdrawn
- Health Information Exchange Standards
Normative, ANSI standard (ICSR R1) DSTU (ICSR R2)
ANSI/HL7 V3 RRNCR, R1-2004 - HL7 Version 3 Standard: Public Health Reporting: Case Investigation Topic, Release 1; 11/3/2004aka Notifiable Condition Report, withdrawn
- ANSI/HL7 V3 RRCS, R1-2005, R2-2006 - HL7 Version 3 Standard: Public Health Reporting: Individual Case Safety Report (ICSR), Release 1; 4/25/2005, Release 2; October 2006
- HL7 V3 GIN, R1 - HL7 Version 3 Standard: Generic Incident Notification, Release 1; March 2007
- V3: Public Health: Tuberculosis Domain Analysis Model, Release 1
- HL7 Implementation Guide for CDA Release 2: Public Health Case Reporting, Release 1 (US Realm)
The domain includes messages and documents that are specifically designed to support reporting and investigation in the public health context. This scope includes:
- Communications within a health provider organization,
- Messages sent to public health regulatory agencies or other patient safety/quality improvement organizations from outside parties,
- Reporting among health care providers, manufacturers, and public health or patient safety/quality improvement organizations,
- Messages exchanged between public health organizations requesting investigation of exposures and other events of interest to public health.
The Public Health Reporting Domain Information Model captures the information to be exchanged about conditions or events that are to be subject to public health review or investigation. The model initially focused on the needs of the US Federal Government for HL7 messaging in the areas of disease surveillance and the reporting of adverse events, reactions or problems related to regulated products, as well as reporting by parties investigating incidents of public concern. However, the model is not limited to US based reporting, or to regulatory application - but has been generalized to be applicable across the HL7 community.
- The Public Health Reporting Domain contains specifications from a variety of healthcare focus areas (e.g., patient safety, consumer safety, environmental safety; regulatory vs. non-regulatory safety monitoring). Analysis is underway using an HL7 DAM (Domain Analysis Model) to determine whether a common Domain Information Model can support this variety of focus, or whether additional domain models (and thus additional domains) are needed. If new domains are established, the specifications in the present Public Health Reporting domain are likely to be distributed among those new domains.
- It should be noted that there is not currently a generally accepted Domain model for the PORR domain. Work is currently in progress involving PHER, Patient Safety, RCIRM, etc. to develop such a model.
Business Case (Intended Use, Customers)
Public Health Reporting includes those activities in which circumstances that are dangerous to the health of individuals and/or a population or group are reported to authorities whose responsibility it is to address those circumstances. The authorities that are reported to could be government bodies, e.g. departments of health, or they could be private bodies, e.g., the infection control body within a health care organization. This reporting differs from a clinician's recording of a patient's disease, condition, or problem, because the goal is to use the information in a context beyond the care of that particular patient.
The Regulated Reporting domain enables reporting of incidents affecting persons receiving health care services (patients) when that reporting is designed to influence care behavior and hence to improve the care that is provided.
- Legally or customarily mandated reporting of dangerous conditions, e.g., infectious disease, to public health bodies.
- Legally or customarily mandated reporting of potential and actual adverse events to regulatory and/or public health bodies. This reporting is normally associated with products whose sale is regulated by law.
- Requests - and the dialog pursuant to such requests - for investigations into incidents deemed to have a potential of affecting the public health.
Implementations/ Case Studies (Actual Users)
- U.S. FDA
- Center for Medical Devices Radiological Health
- Center for Veterinary Medicine
- Pilot testing through International Conference on Harmonization - see more at www.ich.org
- Patient Safety
- ISO TC 215 WG 6 Health Informatics and Pharmacy
- See more at http://hl7new.amg-hq.net/implement/training.cfm
Relationship to/ Dependencies on, other standards
- Common Product Model
- Structured Product Labeling
- CDISC content to HL7 messages