6. Case Studies: Healthcare & Medical Informatics
DE + IA (INFO 243) - 5 February 2007
Bob Glushko
Plan for Today's Class
- Structured Product Labeling in Pharmaceutical Industry
- Cracks in the Pharmaceutical Supply Chain
- Electronic Health Records (Zach Gillen)
- Recurring themes from the last two weeks of case studies and news stories
Structured Product Labeling in Pharmaceutical Industry (Thomas, XML 2004)
- Rationale and description of SPL
- Insights about document architectures and standards activities
- Impact of SPL on the "label life cycle"
- Internal format, or interchange format?
- Process conversion, or content conversion?
- NOTE: bookmark XML Conferences 2001-2005 and 2006
Structured Product Labeling
- "Labels" are complex document types to model. Why?
- Drugs have been regulated a long time, and the standards for labels have also evolved. How?
Label Content Mandated in 21 CFR 201.56
- Quality
- Chemical composition
- Strength and physical form
- Rules for storage and handling
- Efficacy
- Medical conditions for which it is indicated
- Therapeutic conditions of use
- Proper dosage for accepted indications
- Safety
- Potential side effects
- Contraindications of use
- Rules for monitoring patients
Sample Drug Package Insert
- Allegra insert on the "Daily Med" site
"Paper Kills" -- Newt Gingrich
Generic Tang Prescription
ePocrates
- http://www2.epocrates.com/products/rx/
Evolving Healthcare Standards and Document Architectures
- It has been recognized for a long time that standards in healthcare and pharma were important; first standards were for paper documents
- SPL's development was begun by the Pharmaceutical Research and Manufacturing Association but moved into HL7, an ANSI-accredited standards organization focusing on clinical and administrative information for healthcare
- The HL7 Version 2.x series contains 100s of separate messages and is the most common standard used for patient medical records, with legal status in the US and several other countries
- Until recently HL7 committees developed document type standards in a "bottom up" way, roughly one at a time, with whatever tags a specific document type needed
- But HL7 v 3.0 is based on a complete different document architecture that is based on a Reference Information Model (RIM) in which all document types use the same abstract semantic building blocks
SPL in the HL7 RIM
- The RIM uses very abstract structures to specify the information hierarchy in a document type: structured body -> component -> section
- All components derived from six base ones in an O-O type hierarchy, ACTS, ENTITIES, ROLES, PARTICIPATION, ACTRELATIONSHIP, ROLELINK
- Using the RIM establishes ontological relationships among all the elements used in any HL7 v 3.0 document type
- This goes way beyond even the approach in UBL and makes reuse robust for automated processes
- But this means that an SPL instance doesn't have the tag names you'd expect
SPL and the Labeling Process
- SPL could be used as an internal format in the authoring, revision, publishing processes or simply used as the submission format to the FDA
- Arguments in favor of internal SPL include...
- Arguments in favor of interchange SPL include...
Drug Label Life Cycle - Where's SPL?
FDA Sets Document Standards for Drug-Label Submissions
- Wall Street Journal, 2 November 2005 (wsj.com)
- US Food and Drug Administration is requiring all new and changed labels and package inserts to be submitted in XML "Structured Product Labeling" format instead of in PDF
- All will be available at http://dailymed.nlm.nih.gov/dailymed/about.cfm
Cracks in the Pharmaceutical Supply Chain
- The pharmaceutical industry supply chain is complex and opaque
- "Gray market" drugs hurt profits, but counterfeit drugs can kill you
- Barcode and RFID tracking can help, but aren't perfect solutions
- Italy has strong laws about traceability of prescription drugs, but "such an intrusion of privacy by the government would probably not be permitted in the United States"
Legitimate Drug Suppliers?
FDA Mandates Electronic Drug "Pedigree"
Electronic Health Records
- What are their core purposes and capabilities?
- What are the challenges in implementing them?
Introducing Our Guest Lecturer
Recurring Themes in the News Stories and Case Studies
- Standards for information components and document types
- Validation and automation
- Tracking and traceability
- Legacy technologies, people, and organizational models
- Co-evolution of technology and process
- Conflict or different perspectives by the participants / stakeholders
Readings for 7 February
- Chapter 3 of Document Engineering, pages 73-86
- "Business process modeling languages: Sorting through the alphabet soup. (Sections 1-3, pages 1-12)"
- Chapter 15 of Document Engineering, pages 505-509
