WG4 Discussion

1. WG4 Discussion • “as a mathematical discipline travels far from its empirical source, or still more, if it is a second and third generation only indirectly inspired by the ideas coming from ‘reality’, it is beset with very grave dangers. • … that the stream, so far from its source, will separate into a multitude of insignificant branches, and that the discipline will become a disorganized mass of details and complexities." • John Von Neumann, "The Mathematician" , 1957 WG4: Summary

2. Goal & Process • Goal: to generate a consensus of research roadmap for Embedded RT networked Infrastructure • Process: Identify and have a general agreement on top 3 • Lessons learned (Things not to do, overlooked) • Needs (focus on real problems) • Top 3 challenges in your area • Rank the ideas on the table (excluding your own) • Compare ours with current NSF view (Courtesy of Helen Gill) and provide feedbacks • Send me (lrs@cs.uiuc.edu) 1 page summary of your new views on the above issues by June 7. WG4: Summary

3. Needs & Lessons • EMF noises in WSN • Alarms standards (too many false alarms) • Software is not well productized, not characterized by size, defect rate, complexity. • Orders of mag. More Of data • Integrate with enterprise system in a feedback loop. Data needed to be kept 40 years (summary) How to abstract data based on clinical requirements? And other purposes… Hard requirements • Scalability of technologies to 1000 bed hospital in a hospital network • Understand the requirements in OR , use cases documented, open tool kits • Most device interface are proprietary • Latency in surgery robots. Currently 10 ms. 1 ms desirable WG4: Summary

4. Lessons & Needs • Classification scheme of medical devices. Different measurement ranges, features … IEEE 1073 • Monitoring components • Imaging • Decision support systems: RT sensor info. Database. • Clinically useful alarms & exception, e.g., heart rate > 110. Missing context information to make it useful • Lack infrastructure (Tool kit, FDA approval, standardized format and share clinical algorithms worldwide ) • … national testbed with FDA + standard support at the beginning • Difficult to generate user requirements for new devices. Simulation. WG4: Summary

5. Needs & Lessons • How to integrate multimedia stream and control stream (periodic + RT event) together in one framework. IEEE 1394 (firewire) / CAN / • Clinical use must drive work FDA HIPAA (insurance industry) and support at the beginning • Data integration from a multitude of devices • Support close loop control using distributed medical devices • Trust beyond authentication… pick up a cane , signals helpers if she wants to go outside. Trust has to do with usability. Risk of using a new devices from user perspective… If I know the failure mode & condition trigger it, I trust it. Source of the information, e.g., allergy: taken by expert or beginner? • Bridge radical new approach and practice in medical devices context • How to model grace degradation formally • Objective measures to gauge progress • Framework to access the cost of monitoring. If I failed to detect, what is the penalty? WG4: Summary

6. Lessons & Needs • Body oil causes measurement problems • A/D and D/D info loss • Expose instead of hiding distributed nature • STANDARD INTERFACES: allows hot swaps devices … meet clinical requirements • MANAGING STATIC and DYNAMIC CONTEXTUAL INFORMATION for using devices. Without it, not very useful. Context need to incorporate patient specific info. The error rates of the devices. Performance & delays. Models need to be developed • Not measuring things, fear of law suits WG4: Summary

7. NEEDS and LESSONS • Support of the customization of medical devices is difficult but important, e.g., computers, FPGA… Must be looked early on. rfab.cs.ucla.edu The granularity of customization is an important challenge. • Trackability of analysis • Dependability: Have to predict event rate (abnormality) of software. There are over 30 models. Robustness lab to see if we can discover events but we still discover events in the hospital instead of lab. … CONTEX and Configuration dependent • Design process needs to be dynamic to improve as discovery of new failure modes… • Implicit assumptions about environments that are not machine checkable… will become failures in new uses… • Devices will be used in new ways not anticipated by the designers … and there is not WG4: Summary

8. Needs and Lessons • EVOLUTION: Users expect old devices do not work like the new ones. User expect old devices can be used in the new environment. • EVOLUTION of Implantable devices: It is very difficult to upgrade/change an implanted device. Software can be upgraded by wireless means, so are charged. • Criticality: Class 1 to 3 (most critical) RISK driven • Testing is not scale up … • Medical devices industry does not have a rigid certification process like DO178B. • Testing cost is about 30% basically self certification … may be smaller ? • Finding ways to monitoring medical devices in the operating environment. WG4: Summary

9. Lessons and Needs • Devices co-existence in wireless network . Different wireless standards. They work on the same frequency band but cannot communicate with each other. It is an OPEN problem • QoS challenges in W Network Protocols do not support real time operations. • Support of security in simple wireless devices is difficult. Irregular radio ranges etc in W Networked devices. Can we create IP equivanet for WSN that factors in spacious, temporal, mobility and failure (patients sleep/fall on ANT) issues • How to organize context awares and trade off different QoS attributes such as security, real time, fault tolerance … WG4: Summary

10. WG4 Summary Embedded, Real-Time, Networked System Infrastructure for MDSS WG4: Summary

11. A Vision for the Future • Pervasive, ubiquitous, network of networked systems for secured, reliable, privacy-preserving, and cost-effective, personalized quality health care. • Always on, anywhere, any time • From reactive to predictive care • The network drives quality of life WG4: Summary

12. Design for Certification (I to M) • Develop a standard-based, certifiable networked medical devices infrastructure to lower the cost of development, approval, and deployment of new technologies/devices • Technical Challenges: certification cannot be an afterthought • Specify and design for verifiability and certification • Environment for the modular certification of interacting devices • Certifiable PnP • Process issues • Comply with mandatory safety certification, in collaboration with industry and regulatory agencies • Work with IEEE, ISO, … towards voluntary (market-driven) certification • interoperability/compatibility standards • QoS standards (Real Time, Fault Tolerance, Security) WG4: Summary

13. Safety and Criticality • From operating room to enterprise system, different devices and subnets have different levels of clinical criticality • Built in safety interlock for interacting devices operation (I) • Manage the flows of data streams with different criticality on the same network (I to M) • How to mediate and manage the interactions of devices with different criticality? Who can talk to whom? Authorization & authentication. (M) • How to support fail-safe operation of individual devices? (I to M) • How to ensure that erroneous data is contained and does not cascade? (M) • How to specify, design and verify operational networked systems applications in the presence of device-failures? (I) WG4: Summary

14. Security and Privacy (M to L) • Medical systems pose some new challenges in security and privacy because of the different costs and constraints. For example, may need to upgrade pacemaker arrhythmia detection software yet still be impervious to EMF-based attacks. Emergency personnel needing to access private data on demand, especially in wireless environment. • Software products used in the infrastructure must accommodate different classes of security • Better understanding of security & privacy requirement in medical systems • Develop new model of security and privacy tailored for medical needs • Develop modular and flexible architecture to incorporate and evolve security and privacy technologies • Cost-effective solutions appropriate for medical environment WG4: Summary

15. Interoperability (M to L) • How to specify, design and verify the properties and compliance of interoperable hardware and software interfaces? • How to develop unique patient (record) identifiers standard to support the integration of devices from different manufacturers? Currently, different vendors use different methods. • How to represent environmental assumptions implicitly embedded in the code, and make them machine checkable, user friendly? • Coordinates representation and metrics • Acceptable environmental conditions and device QoS • Evolvability as managed interoperability WG4: Summary

16. QoS • Build in support for multiple QoS levels (I to M) • At the system level QoS and safety are inseparable • Develop a coherent framework to address tradeoff between (M to L): • Real time performance constraints, • Hardware and software fault tolerance, and • Security and privacy requirements • Protocol developments and evaluation in each domain • Cross domain compatibility specification and verification • Model integration • Tradeoff analysis WG4: Summary

17. Wireless Network Infrastructure • Seamless integration of heterogeneous wireless networks into a “network of networks” (I to M) • Current generation of wireless networks operate in the same band • Interfere with each other • Unable to talk to each others • Poor QoS support (RT, FT, Security) • Environmental noise sensitive • Develop scalable and QoS managed wireless networks capable of (M to L) • Self testing • Self configuring • Self healing WG4: Summary

18. Medical Information Management • Build in support for integrated medical information management • Event sequence recording, correlation and analysis (I) • Context awareness for proper operation and management of medical devices and information (M to L) • Real time, context-aware alarm processing, filtering and delivery • Integration with enterprise systems to support record management and long time studies (L) • High volume data management • User friendly real time data collection, filtering, fusion & delivery (M) • Storage network and data mining support (I to M) • Surgery TiVO replay capability • Visualization of massive data sets (M to L) WG4: Summary