HCMDSS Workshop, Philadelphia, June 2-3 2005

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WG1:Foundations for Integration of Medical Device Systems/Models

W. Rance Cleaveland II, PhD

CEO Prof. of CS Exec. Dir.

Univ. Maryland

HCMDSS Workshop, Philadelphia, June 2-3 2005

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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

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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

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Problem StatementSystems 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

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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

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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

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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

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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

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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

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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

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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

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Prioritized List of IT Research Needs

1. Model-based development and integration2. Electronic health records and enterprise-

level health-information sharing3. Virtual validation4. Monitoring and post-intervention analysis5. Ergonomic and ease-of-use issues in

human-device interfaces6. Plug and play device networks

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Roadmap for Next 5 & 10 Years

Vision: “plug and play medical systems” Basic science (1, 3, 4, 5) Application development (6) Standards (2)