Charlie Mead, MD, MSc Senior Associate Booz Allen Hamilton

1. Achieving Interoperability:Observations and Recommendationsfrom20 Years of Mistakes (and Some Learning) Charlie Mead, MD, MSc Senior Associate Booz Allen Hamilton “What’s right is what’s left when you’ve done everything else wrong.” – Robin Williams

2. The Starting Point (circa 1985) • 10 years experience building ambulatory ECG analysis application • Single stakeholder role (cardiologists) • Isolated, well-defined problem • Primitive tools • Minimal UI requirements • Minimal data sharing requirements • Stable data structures • Interoperability not a driving force

3. The Next Step (circa 1995) • Founded a company to bring ‘point-of-care’ computing to Home Healthcare • Multiple stakeholders (nurses, CFOs, payors, regulatory) • Complex, somewhat ill-defined (shifting) problem • Variety of tools (DBs, tablet computers, multiple target systems) • Considerable UI requirements • Type I vs Type II systems (“All the simple systems have been built” – Grady Booch) • Extensive data sharing requirements • Evolving data structures • Interoperability (clinical/administrative/financial) as a key requirement

4. Semanticinteroperability Syntacticinteroperability (interchange) Interchange vs Interoperability Syntax  Structure Semantics  Meaning • Main Entry: in·ter·op·er·a·bil·i·ty: ability of a system ... to use the parts or equipment of another systemSource: Merriam-Webster web site • interoperability: ability of two or more systems or components toexchange information and to predictably use the information that has been exchanged. Source: IEEE Standard Computer Dictionary: A Compilation of IEEE Standard Computer Glossaries, IEEE, 1990]

5. Concept 1 Concept 2 “We need to sign off on the protocol by Friday” • “Protocol XYZ has enrolled 73 patients” Thing 1 Thing 2 Study Document Concept 3 Thing 3 “Per the protocol, you must be at least 18 to be enrolled” Plan “Protocol” and the Semiotic Triangle Symbol “Protocol” Source: John Speakman

6. Semantic Interoperability – Different Perspectives • Exchanging meaning (not just structure) • Human-to-Human semantic interoperability • Hybrid/stepwise semantic interoperability • Computer-to-Computer semantic interoperability • The critical role of context • Where does it live? • Sharing semantics is not just about sharing static structures; definitions of dynamic behavior are also equally critical

7. The Communication Pyramid ` ProblemSpace SolutionSpace Implementation-Independent Abstraction Implementation-Specific Communication

8. Climbing the Communications Pyramid • Recognizing the features of complex systems • Multi-level vertical organizational structure (“the org chart”/silos of vertical isolation) • Horizontal processes for producing the system’s Products of Value • Healthcare is the epitome of a complex system • Cross-disciplinary project teams • Domain Experts / Requirements / Design / Development / Testing / Documentation and Training / Maintenance

9. Climbing the Communications Pyramid • Think architecturally • Uses and Users • Static structure • Dynamic behavior • Structural Walls / Partitions / Furniture • Dog houses vs Skyscrapers

10. Climbing the Communications Pyramid • Recognize the importance of Organizational Maturity in an integrated development/user community • Level 1: Heroism and Passion • Level 2: A Set of Directions • Level 3: A Map • Level 4: Gathering Process Variance • Level 5: Using Process Variance data to drive Process Improvement • Everyone wants to be Level 5 • Progression is stepwise • Level 1 does not mean incompetence!

11. Climbing the Communications Pyramid • Adopt a organization-wideprocess framework • The Waterfall Process works when… • The problem is isolated, well-defined, and stable • Requirements are stable • The Unified Process (framework) has evolved over 20+ years of feet-on-the-ground experience with failed projects, frustrated users, overworked developers, and angry customers • Iterative/Incremental (model human problem solving) • Risk-focused (“do the hard stuff first”) • Architecture-centric (“functional requirements vs quality requirements”) • Driven by visual models (“a picture is worth 1000 words”)

12. Standardized Models (UML) Non-standard Graphics ad hoc Drawings Structured Documents Free-text Documents Discussions The Communication Pyramid ` ProblemSpace SolutionSpace Implementation-Independent Abstraction Implementation-Specific Communication

13. Climbing the Communications Pyramid • Utilize standards whenever possible • Value sets • Messages • Documentation • Process frameworks • Standards facilitate interoperability • Standards leverage experience • Standards decrease maintenance/evolution costs

14. The Present (for now) (circa 2006) • This is a HARD PROBLEM! • Comprehensive Semantic Interoperability – i.e. human, computer, and/or hybrid/incremental in nature and meaningful to all stakeholders – in the context of complex systems is – and will always be – a huge challenge • Evolving technologies will make it incrementally easier….but it will always remain a complex, difficult, and challenging problem...the Semantic Web will not solve all of our problems • Consider the cost of not achieving semantic interoperability • Monetary • Social/Ethical

15. Top-Down Commitment(Not Micromanagement – Level 5 organization) • Willingness to commit management $$s • Willingness to provide management oversight • Willingness (and ability) to define standards-for-use • Process frameworks • Data exchange standards • Standards for Milestones/Deliverables • Management understanding of the short-term difficulties and the long-term rewards • Avoid the allure of simple solutions to complex problems • Avoid the pitfalls of schedule-based project management

16. Bottom-Up Passion and Dedication • Communication • Collaboration • Cooperation • Insatiable appetite for learning • Understanding must cross-domain boundaries • Indomitable spirit and vision: “Eyes on the prize.” • (Semantic) interoperability is still hard work • Some legacy data may not be computationally interoperable • Process frameworks and standards are your friend… • “This is more about sociology than technology” (George Komatsoulis)

17. 1001 0100 0100 1011 1110 0101 1001 0100 0100 1001 0100 0100 1001 0100 0100 1001 0100 0100 1011 1110 0101 1011 1110 0101 1011 1110 0101 1011 1110 0101 Stepwise Computational Interoperability Highly “Informational” Systems * * Less “Informational” Systems *HL7 Clinical Document Architecture: Single standard forcomputer processable and computer manageable data (Wes Rishel, Gartner Group)

18. Final Comments • CTWG initiatives • “Harmonize existing NCI IT systems” • Build a Clinical Trial database/data warehouse • Dr. Carmona’s call for “ending the silos” • “Healthcare is the only business where informationsharing is the norm rather than the exception. Those of us who build systems are not used to this framework. However, if we are to provide the healthcare system with the tools they need, we must embrace this paradigm completely, committing ourselves to defining, designing, and building fundamentally different types of system than those with which we have our predominate historical experience.”

19. Q & Q U E S T I O N S A N S W E R S A