WG1: Foundations for Integration of Medical Device Systems/Models

1. WG1:Foundations for Integration of Medical Device Systems/Models W. Rance Cleaveland II, PhD HCMDSS Workshop, Philadelphia, June 2-3 2005

2. Participants • M. Brian Blake Georgetown University blakeb@cs.georgetown.edu • Andrew Casertano Department of Veterans Affairs andrew.casertano@med.va.gov • Rance Cleaveland Reactive Systems Inc. and University of Maryland cleaveland@reactive-systems.com • Sherman Eagles Medtronic, Inc. sherman.eagles@medtronic.com • Scott Henninger University of Nebraska at Lincoln scotth@cse.unl.edu      • David W. Hislop U.S. Army Research Office david.w.hislop@us.army.mil • Zachary Ives University of Pennylvania zives@cis.upenn.edu • Tomasz Petelenz Sarcos Research Corp. t.petelenz@sarcos.com • Jane W. S. Liu Academia Sinica, Taiwan janeliu@iis.sinica.edu.tw • Tom Martin Virginia Tech tlmartin@vt.edu • Gregory Sharp Massachusetts General Hospital gcsharp@partners.org HCMDSS Workshop, Philadelphia, June 2-3 2005

3. Outline of summary presentation/report for each working group • Problem statement • Summary of state of the art • R&D challenges • Prioritized list of IT research needs • Roadmap for the next 5 and 10 years HCMDSS Workshop, Philadelphia, June 2-3 2005

4. Problem Statement Systems of medical devices are complex, costly and poorly understood. Design artifacts are often simplistic and ad hoc, and intelligible only to the engineer who developed them; thus they are often misconstrued and misused in system development, evolution and maintenance. There is a pressing and immediate need for well understood models, theories and tools for reasoning about component interfaces and evolution, composition / integration of systems from components, and systems of systems that support predictive analysis of end-to-end system properties of importance to medical applications, such as: • efficacy • safety • security • privacy • traceability • confidence HCMDSS Workshop, Philadelphia, June 2-3 2005

5. Summary of State of the Art • Standards for medical-device communication • DICOM (Digital Imaging and Communications in Medicine) • HL7 (Health Level 7: communcation standard for medical information systems) • IEEE 1073 (medical-device communication standard) • Standards and regulations for medical-system development • ISO 13485 (Quality management system for medical-system engineering) • IEC 60601-1 and -2 (Safety standards for medical electrical equipment) • ISO 14971 (Risk management) • QSR, MDD • Mobile devices and integration • Power consumption improvements over past decade drive invention of new implanted and mobile devices • Improved radio, infrared communication for embedded devices, no data standards • Validation technology • System-based, standards-driven to manage risk • “Phantom-based testing” • Applications of modeling • UML use cases: medical-information systems requirements, computer-assisted surgery • State-machine modeling: infusion-pump design HCMDSS Workshop, Philadelphia, June 2-3 2005

6. R&D Challenges (1/6) Plug and play device networks • Standards and regulatory concerns for systems of systems (current guidelines impede standards) • Legacy-device integration • Portable devices: power consumption, communication, safe and secure ad hoc networking HCMDSS Workshop, Philadelphia, June 2-3 2005

7. R&D Challenges (2/6) Model-based development and integration • Component-based end-to-end reasoning about functionality, security, privacy, safety (safety interlocks, alarms, etc.) • Catalog, reference models, benchmark usage scenarios of medical-device types • “Reference protocol stack” for medical applications (from pixels to information, data standards) • Open experimental platforms (cf. DARPA MoBIES for auto, aero) • Models of variability of human-device interface • Standardized modeling paradigms for medical applications • Design patterns, service-oriented computing for medical applications • Models as basis for training, end-user programming • Data integrity & integration HCMDSS Workshop, Philadelphia, June 2-3 2005

8. R&D Challenges (3/6) Electronic health records and enterprise-level health-information sharing • Selective field security • Audit trails of “who has seen what” HCMDSS Workshop, Philadelphia, June 2-3 2005

9. R&D Challenges (4/6) Virtual validation • Accurate patient models (control-theoretic), models of caregivers • In vivo test planning based on virtual testing • Component-based testing HCMDSS Workshop, Philadelphia, June 2-3 2005

10. R&D Challenges (5/6) Monitoring and post-intervention analysis • Error-handling / fault-tolerance / fault-diagnosis & isolation in systems of systems • Post-procedure replay and analysis (black-box-like technology) • Responsibility separation (if something goes wrong, who’s to blame?) HCMDSS Workshop, Philadelphia, June 2-3 2005

11. R&D Challenges (6/6) Ergonomic and ease-of-use issues in human-device interfaces • Interface to caregiver, patient • Medical devices in non-medical settings (untrained users, interfaces with consumer electronics) • Mode confusion, data fusion for decision support HCMDSS Workshop, Philadelphia, June 2-3 2005

12. Prioritized List of IT Research Needs • Model-based development and integration • Electronic health records and enterprise-level health-information sharing • Virtual validation • Monitoring and post-intervention analysis • Ergonomic and ease-of-use issues in human-device interfaces • Plug and play device networks HCMDSS Workshop, Philadelphia, June 2-3 2005

13. Roadmap for Next 5 & 10 Years Vision: “plug and play medical systems” • Basic science (1, 3, 4, 5) • Application development (6) • Standards (2) HCMDSS Workshop, Philadelphia, June 2-3 2005