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

2. HCMDSS Workshop, Philadelphia, June 2-3 2005 2 Participants  M. Brian BlakeGeorgetown University blakeb@cs.georgetown.edu blakeb@cs.georgetown.edu  Andrew CasertanoDepartment of Veterans Affairs andrew.casertano@med.va.gov andrew.casertano@med.va.gov  Rance CleavelandReactive Systems Inc. and University of Maryland cleaveland@reactive-systems.com cleaveland@reactive-systems.com  Sherman EaglesMedtronic, Inc.sherman.eagles@medtronic.comsherman.eagles@medtronic.com  Scott Henninger University of Nebraska at Lincoln scotth@cse.unl.edu  David W. HislopU.S. Army Research Office david.w.hislop@us.army.mil david.w.hislop@us.army.mil  Zachary IvesUniversity of Pennylvaniazives@cis.upenn.eduzives@cis.upenn.edu  Tomasz PetelenzSarcos Research Corp.t.petelenz@sarcos.com  Jane W. S. LiuAcademia Sinica, Taiwan janeliu@iis.sinica.edu.tw janeliu@iis.sinica.edu.tw  Tom MartinVirginia Techtlmartin@vt.edutlmartin@vt.edu  Gregory SharpMassachusetts General Hospital gcsharp@partners.org gcsharp@partners.org

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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”

9. 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

10. 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?)

11. 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

12. HCMDSS Workshop, Philadelphia, June 2-3 2005 12 Prioritized List of IT Research Needs 1.Model-based development and integration 2.Electronic health records and enterprise- level health-information sharing 3.Virtual validation 4.Monitoring and post-intervention analysis 5.Ergonomic and ease-of-use issues in human-device interfaces 6.Plug and play device networks

13. 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)