D-O-C-U-M-E-N-T in the Document Engineering Approach
Copyright 2006 Robert J. Glushko
D-O-C-U-M-E-N-T case study template
Structured Product Labeling in Pharmaceutical Industry
Clinical Data Standards in Health Care
IRS E-file
PESC Transcript
What is the business case for this project?
What document types are most important?
What processes are most important?
Were the "as-is" and "to-be" processes clearly understood?
What were the key decisions and events in this case study?
Were any mistakes made in this project?
"Labels" are complex document types to model. Why?
Drugs have been regulated a long time, and the standards for labels have also evolved. How?
What is a "backbone" standard? (vs. a "content" standard)
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
HL7 is 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
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 semantic building blocks
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
Taconic IPA/MedAllies -- Web portal that combines patient records, prescriptions, clinical results
California Clinical Data Project -- CHCF
PeaceHealth Integrated HIS/EMR
Washington DC Disease Surveillance System
National Cancer Institute Center for Bioinformatics
What kinds of financing strategies seem to work? Which ones don't?
Why would some hospitals not want to participate in healthcare information networks?
What document engineering concepts explain why some healthcare applications are harder to automate than others?
How does the way in which a standard is developed influence whether it is successfully adopted?
Data Exchange
specifications for format, data elements, and structure
Document Standards
types of information included in a document and where it can be found
Terminology
specific codes for clinical concepts
Conceptual Standards
allow data to be transported across systems without losing meaning
Application Standards
the way business rules are implemented and software systems interact
Architecture Standards
define the processes involved in data storage or distribution
Who benefits from automated filing of tax returns?
How many forms and supporting documents are contained in a typical corporate tax return? In a large return?
Are there XML schemas for every type of form and supporting document?
Will it be possible for the IRS to replace human auditors with XML-powered ones anytime soon?
What sorts of XML naming and design rules are being followed by the IRS?
Who benefits from the automated exchange of transcripts?
What's wrong with the EDI standard for transcripts?
Does the XML standard fix all the problems with the EDI one?
What sorts of XML naming and design rules are being followed by the PESC?
How are the business cases similar? How are they different?
Are legacy technologies and information dealt with in the same way?
How does a firm's size affect its adoption of new technology and processes?
What is the role of standards?
Chapter 8 of Document Engineering
Assignment 3 - Business Patterns, graded due 3 March
Assignment 4 - Course Project, ungraded description due 13 March
Assignment 5 - UML, ungraded due 13 March