Joint TC Meeting: EHR – RCRIM RCRIM Overview HL7 Working Group Meeting January, 2007 Presented by: Ed Tripp Program Director, eSubmissions Abbott (RCRIM TC Co-Chair)

© HL Agenda RCRIM Overview / History Project / Standards Portfolio Project Briefing: SPL (Structured Product Labeling) RPS (Regulated Product Submission) BRIDG Domain Analysis Model RCRIM / Clinical R&D perspective on EHR

© HL RCRIM Overview / History RCRIM – Regulated Clinical Research Information Management (Technical Committee) Formed as SIG in 2001, as TC in 2002 (joint effort between CDISC, FDA, and pharma industry) Mission This committee supports the HL7 mission to create and promote its standards by developing standards to improve or enhance information management during research and regulatory evaluation of the safety and efficacy of therapeutic products or procedures worldwide. RCRIM Sponsors the Patient Safety Special Interest Group (PSSIG)

© HL RCRIM Standards Domain: Public Health Individual Case Safety Report (ICSR) Generic Incident Notification (GIN) Domain: Regulated Products Structured Product Labeling (SPL) Regulated Product Submission (RPS) Domain: Regulated Studies AnnotatedECG (aECG) Clinical Trial Laboratory (CT Lab) Stability Study

© HL Project Portfolio Clinical Trial Registries Clinical Genomics Protocol Representation BRIDG (Domain Analysis Model) RCRIM Vocabulary

© HL RCRIM Project Briefing – SPL Business Driver: US HHS Directive - Develop standard for communicating the content of drug product labeling in both a human and machine-readable format to serve as the basis of a national repository Create national repository of all current approved labeling on National Library of Medicine DailyMed website DailyMed serves as the official source of approved labeling for prescribing physicians, patients and healthcare providers Based on HL7 Clinical Document Architecture (CDA) SPL Version 3 complies with new FDA Physician Labeling Rule, and includes encoded Highlights section, among other features. V1 mandatory after Oct 31, 2005 for all USPI labeling submissions V3 mandatory in US after June 30, 2006 for all new indications and efficacy supplements (with multi-year phase-in for remaining types of labeling applications)

© HL RCRIM Project Briefing – RPS Messaging standard (approved as HL7 DSTU) for submitting product information to regulatory authorities Message that can carry an ICH CTD submission and other submission types for drugs, device, veterinary products, food additives and other regulated products. RPS Storyboards include initial submissions, updates, amendments, withdrawals, referencing other submissions, etc. Testing of draft standard currently in progress Testing team members representing pharmaceuticals, med devices, vendors and associated divisions from FDA

© HL RCRIM Project Briefing – BRIDG BRIDG stands for "Biomedical Research Integrated Domain Group". Domain analysis model for the clinical research domain to harmonize clinical research standards among each other and to harmonize standards between clinical research and healthcare The BRIDG model defines standard entities, roles, attributes, and activities for the business processes in standard clinical trials. It could be used as a core data standard for managing the workflow in clinical trials and for generating clinical trial software applications that share the same semantics and thus can exchange data more readily. Mon, Donald T. "Defining the Differences between the CPR, EMR, and EHR. Journal of AHIMA 75, no.9 (October 2004): 74-75,77

© HL RCRIM / Clinical R&D Perspective on EHR Potential Touch Points: Clinical Trials Subject Recruitment / Enrollment Case Report Form data population Patient Record Creation Adverse Event Reporting Clinical Decision Support

Questions?

© HL BRIDG (cont.) Existing Standards Harmonization Existing CDISC msg BRIDG model UML submodel Existing object model UML submodel Existing HL7 message CC B\B\ B A Process A Harmonize existing HL7 DMIM for regulated clinical research Process B extract domain knowledge from existing messages and systems into formal UML models Process C Harmonize and merge UML models into BRIDG

© HL BRIDG (cont.) New Message and Application Development Process D Generate a release of BRIDG for formal requirements traceability with vetting within stakeholder organizations Process E HL7 message generation using HL7 mechanisms Process F Application development with annotation, semantic connector, UML loader DMIM BRIDG model BRIDG model release version X E D HL7 message generation F Annotated UML model App Development