Newsletter Vol. 3 March 2015 Medical Device Interoperability: A Foundation for Medical Cyber-Physical Systems Professors Insup Lee and Oleg Sokolsky (PRECISE Center, Department of Computer and Information Science, University of Pennsylvania) Motivation. Medical devices are undergoing significant transformations, embracing the potential of embedded software and network connectivity. Instead of standalone devices that can be designed, certified, and used independently of each other for patient treatment, networked medical devices will work as distributed systems that simultaneously monitor and control multiple aspects of the patient's physiology. The combination of embedded software controlling the devices, networking capabilities, and complicated physiological dynamics exhibited by patient bodies makes modern medical device systems a distinct class of cyberphysical systems (CPS). We refer to these as medical cyber-physical systems (MCPS) [1]. The goal of MCPS is to improve patient safety and treatment outcomes by leveraging diverse capabilities of individual devices to gain a more detailed and accurate picture of the evolving patient state. A distinguishing feature of MCPS, compared to other CPS domains such as avionics, is their reliance on a multitude of medical devices, separately developed for specific intended use. This plethora of choices gives a lot of flexibility for the clinical personnel to select the set of devices best suited for treatment of a particular patient. Increased connectivity of medical devices. In addition to relying more and more on software, medical devices are increasingly equipped with network interfaces. Interconnected medical devices are, effectively, a distributed medical device system of a larger scale and complexity that has to be properly designed and validated to ensure effectiveness and patient safety. Today, the networking capabilities of medical devices are primarily used for patient monitoring (through local connection of individual devices to integrated patient monitors or for remote monitoring in a tele-ICU setting) and for storing patient data in electronic health records. The networking capabilities of most medical devices today are limited in functionality and tend to rely on proprietary communication protocols offered by major vendors.

Insup Lee is Cecilia Fitler Moore Professor of Computer and Information Science and Director of PRECISE Center at the University of Pennsylvania. He holds a secondary appointment in the Department of Electrical and Systems Engineering. His research interests include cyber-physical systems, real-time and embedded systems, runtime assurance and verification, trust management, and high-confidence medical systems. He received a PhD in Computer Science from the University of Wisconsin, Madison. He is IEEE fellow. He received IEEE TC-RTS Outstanding Technical Achievement and Leadership Award in 2008. Oleg Sokolsky is a Research Associate Professor of Computer and Information Science at the University of Pennsylvania. His research interests include the application of formal methods to the development of cyber-physical systems, architecture modeling and analysis, specification-based monitoring, as well as software safety certification. He combines theoretical research with applications in the medical CPS domain. He received his Ph.D. in Computer Science from Stony Brook University.

There is, however, a growing realization among clinical professionals that this lack of open interoperability between different medical devices gets in the way of realizing the full potential of MCPS. Without interoperability, operation of an MCPS requires direct involvement of clinicians to coordinate and orchestrate individual devices, diverting their attention from actually treating the patient. Medical Device Plug-andPlay (MD PnP) Interoperability initiative is a relatively recent effort that aims to provide an open, standards-based framework for safe and flexible interconnectivity and interoperability of medical devices, in order to improve patient safety and health care efficiency. In addition to developing interoperability standards, MD PnP initiative collects and demonstrates clinical scenarios where interoperability leads to improvement over the existing practice. Physiological closed-loop systems. Traditionally, most clinical scenarios have a caregiver, and often more than one, controlling the process. For example, an anesthesiologist monitors sedation of a patient during an operation and decides when an action to adjust the flow of sedative needs to be taken. There is a concern in the medical community that such reliance on “human in the loop” may compromise patient safety. Caregivers, who are often overworked and operate under severe time pressure, may miss a critical warning sign. Nurses typically care for multiple patients at a

ASME Dynamic Systems and Control Division, Bio-Systems and Healthcare (BSHC) Technical Committee Publicity Chair & Newsletter Editor: Jin-Oh Hahn (University of Maryland, College Park)

Newsletter Vol. 3 March 2015 time and can be distracted at a wrong moment. Using an automatic controller to provide continuous monitoring of the patient state and handling of routine situations would be a big relief to the caregiver and can improve patient care and safety. Although the computer will probably never replace the caregiver completely, it can significantly reduce the workload, calling the caregiver's attention only when something out of the ordinary happens. Scenarios based on physiological closed-loop control have been used in the medical device industry for some time. However, their application has been mostly limited to implantable devices that cover relatively well understood body organs, such as the heart in the case of pacemakers and defibrillators. Implementing closed-loop scenarios in distributed medical device systems is a relatively new idea that has not yet made its way to the mainstream practice. Such an implementation, based on independently designed devices, requires a higher degree of semantic interoperability, where the controller can understand the input received from the medical devices involved in a scenario and properly interpret it, in order to adjust their operation or raise an alarm.

nostic evaluation of vital signs in real-time and make constant care possible. MCPS research highlights. PRECISE center has been developing the prototype interoperability platform and closed- loop control and decision support algorithms for several clinical scenarios [2] with collaboration with MD PnP program [3]. References [1] Challenges and Research Directions in Medical Cyber-Physical Systems, I. Lee, O’ Sokolsky, S. Chen, J. Hatcliff, E. Jee, B. Kim, A. King, M. Mullen-Fortino, S. Park, A. Roederer, and K. Venkatasubramanian, Special Issue on Cyber-Physical Systems, IEEE Proceedings, Jan 2012. [2] Medical Device Cyber Physical Systems, http://rtg.cis.upenn.edu/MDCPS/ [3] MD PnP: Getting Connected for Patient Safety, www.mdpnp.org Message from the TC Chair

Venkat Krovi (SUNY Buffalo) Welcome to the third edition of the newsletter of the Bio-Systems and H ealthcare (BSHC) Technical Committee (TC). A s i n c o m i n g C h a i r , I would like to express a debt of gratitude to Professor Rajesh Rajamani for his service t o t h e B S H C T C . Rajesh laid the groundwork for many new initiatives, including formalizing the organizational structure; launching the website and Newsletter; and will be continuing to help out as Past Chair of the TC.

Continuous monitoring and care. Due to a high cost associated with in-hospital care, there has been increasing interest in alternatives such as home care, assisted living, telemedicine, and sport-activity monitoring. Mobile monitoring and home monitoring of vital signs and physical activities allow health to be assessed remotely at all times. Also, there is a growing popularity of sophisticated technologies such as body sensor networks to measure training effectiveness and athletic performance based on physiological data such as heart rate, breathing rate, blood-sugar level, stress level, and skin temperature. However, most of the current systems operate in store-andforward mode, with no real-time diagnostic capability. Physiological closed-loop technology will allow diag-

From an activities perspective: A) The website (setup as a Google Site) at: https://sites.google.com/site/asmebshc/ now serves as the primary resource for: (i) contact information for all TC members, (ii) names of key officers of the TC, and ( i i i ) the TC guidelines. An email can be sent to all the members of the TC using the email alias [email protected]. B) The BSHC TC (together with the Mechatronics and Robotics TCs) is jointly sponsoring a symposium on the design, modeling, analysis and control of bio-mechatronics and physical hu-

ASME Dynamic Systems and Control Division, Bio-Systems and Healthcare (BSHC) Technical Committee Publicity Chair & Newsletter Editor: Jin-Oh Hahn (University of Maryland, College Park)

Newsletter Vol. 3 March 2015 man-robot interactions at the 2015 ASME Dynamic Systems and Control Conference (DSCC) held on October 28-30, 2015 in Columbus, Ohio, USA. The planned invited sessions include (i) Bio-mechatronics and Physical Human Robot Interaction; (ii) Assistive and Rehabilitation Robotics; and (iii) Biomedical and Neural Systems Modeling, Diagnostics and Healthcare. Organizers include H. Ashrafuion, J.O. Hahn, P. Ghorbanian, R. Bighamian, J. Ueda, A. Deshpande, N. Sharma and P. Artemiadis. C) A Special Issue on Bio-signal Sensing, Dynamics, and Control for Diagnostics and Rehabilitation in the ASME Journal of Dynamic Systems Measurement and Control is being planned by Hashem Ashrafiuon and colleagues. Please watch for more news on these items, both in your email and in this newsletter. D) The BSHC TC plans to continue to meet every year at the ASME DSCC conference and occasionally at the annual ACC conference. We plan to publish this newsletter bi-annually (April and October). E) Last but not least, I would like to thank all the active TC members for their enthusiasm and dedication. Special thanks also goes to Jin-Oh Hahn for his special efforts in launching and nurturing this newsletter. We look forward to your continued active participation in the BSHC TC activities and seeing you at the ACC2015 and the DSCC2015.

BSHC News Hashem Ashrafiuon (Villanova University) became a Senior Member of IEEE. Jaydev P. Desai (University of Maryland College Park) is the Editor-in-Chief of the newly launched Journal of Medical Robotics Research (JMRR). JMRR will be published by World Scientific Publishers (including Imperial College Press). JMRR invites fundamental scientific and technological contributions as well as clinical evaluation studies in several areas of medical robotics. JMRR is not an open access journal. However, the

publisher offers the authors open-access option, if the authors would like their papers to be freely available. JMRR submission site is now open and accepting regular papers, short papers, review papers, as well as video submissions. Accepted individual video submissions (those not accompanying a paper submission) by themselves will be published on the journal homepage. For more information, please contact the EiC at: [email protected]. Journal web-site is: http://www.worldscientific.com/worldscinet/jmrr. Desai is also the Editor-in-Chief of the multi-volume Encyclopedia of Medical Robotics. The Encyclopedia will be comprised of four volumes and will have a volume editor handling each volume. Currently, four volumes are planned in the areas of: Rehabilitation Robotics (volume editor: Dr. Sunil Agrawal, Columbia University), Minimally Invasive Surgical Robotics (volume editor: Dr. Rajni Patel, University of Western Ontario, Canada), Micro and Nano Robotics in Medicine (volume editor: Dr. Antoine Ferreira, INSA Centre Val de Loire, France), and Image-guided Surgical Interventions (volume editor: Dr. Jaydev P. Desai, University of Maryland, College Park, USA). Desai filed a provisional patent application: Jaydev P. Desai, Hardik J. Pandya, and Kihan Park, “Portable Multi-Parameter Cancer Diagnostic Device,” Provisional patent application filed on February 6, 2015. Application No. 62/112867. Venkat Krovi (SUNY Buffalo) organized a workshop entitled “Community Consensus Benchmarks for Clinical Translation of Medical Robots” at the IEEE/RSJ International Conference on Robotics and Systems (IROS) 2014. The workshop focused on 3 key facets: (i) Open research platforms, and system interoperability; (ii) Virtual and physical benchmark data corpuses; and (iii) Translational challenges for bench to clinical use. For further details please visit: https://sites.google.com/site/ieeerasmedicalrobotics/ Jun Ueda (Georgia Institute of Technology) explores the possibility of “soft-roll” landing in robots during the fall by studying mid-air orientation of cats, divers and astronauts (http://www.cc.gatech.edu/news/catsand-athletes-teach-robots-to-fall). Marcia O’Malley (Rice University) was promoted to a Professor of Mechanical Engineering, effective Jan 1, 2015.

ASME Dynamic Systems and Control Division, Bio-Systems and Healthcare (BSHC) Technical Committee Publicity Chair & Newsletter Editor: Jin-Oh Hahn (University of Maryland, College Park)

Newsletter Vol. 3 March 2015 Robert Webster (Vanderbilt University) received the 2015 IEEE Robotics and Automation Society Early Career Award. Xiaopeng Zhao (University of Tennessee, Knoxville) received a grant from NeuroNET to develop a neurofeedback system to enhance cognitive training. Cognitive rehabilitation aims to improve one’s cognitive ability to achieve better memory and more focused attention. The objective of this project is to identify neural patterns associated with cognitive ability during training and use the detected neural patterns as feedback to teach self-regulation during memory/attention training. The long-term goal is to apply neurofeedback based on noninvasive brain computer interface to enhance cognitive rehabilitation.

BSHC Publications 1) Ghorbanian, P., Ramakrishnan, S., Whitman, A.M., and Ashrafiuon, H., 2015, “A Phenomenological Model of EEG Based on the Dynamics of a Stochastic Duffing-van der Pol Oscillator Network,” Biomedical Signal Processing and Control, 15:1-10.

2) O. Celik and M.K. O’Malley (2014) Vary Slow Motion: Effect of Task Forces on Movement Variability and Implications for a Novel Skill Augmentation Mechanism, IEEE Robotics and Automation Magazine, 21(3): 115-122. DOI: 10.1109/MRA.2013.2275696. 3) A.U. Pehlivan, F. Sergi, A. Erwin, N. Yozbatiran, G. Francisco, and M.K. O’Malley (2014) Design and validation of the RiceWrist-S exoskeleton for robotic rehabilitation after incomplete spinal cord injury, Robotica Special Issue on Rehabilitation Robotics and HumanRobot Interaction, 32(8): 1415-1431. doi:10.1017/S0263574714001490. 4) V. Chawda and M.K. O’Malley (2015) Position Synchronization in Bilateral Teleoperation under TimeVarying Communication Delays, ASME/IEEE Transactions on Mechatronics, 120(1): 245-253. DOI: 10.1109/ TMECH.2014.2317946. 5) V. Chawda, O. Celik, and M.K. O’Malley (2015) A Method for Selecting Velocity Filter Cutoff Frequency for Maximizing Impedance Width Performance in Haptic Interfaces, ASME Journal of Dynamic Sys-

tems, Measurement, and Control, Vol. 137: 024503-1 – 024503-5. DOI:10.1115/1.4028526. 6) C. Duran, S. Estrada, M. O’Malley, A.B. Lumsden, and J.Bismuth (2015) Kinematics effectively delineate accomplished users of endovascular robotics with a physical training model. Journal of Vascular Surgery, 61(2): 535-541. 7) A.U. Pehlivan, F. Sergi, and M.K. O’Malley (available online ahead of print) A Subject-Adaptive Controller for Wrist Robotic Rehabilitation, ASME/IEEE Trans. on Mechatronics, DOI: 10.1109/TMECH.2014.2340697. 8) F. Sergi and M.K. O’Malley (available online ahead of print) On the stability and accuracy of stiffnesscontrolled non-backdriveable actuators through series elasticity, Mechatronics, doi:10.1016/j.mechatronics.2015.01.007.

9) M. Kim and J. Ueda, “Dynamics-based motion deblurring for a PZT-driven, compliant camera orientation mechanism,” The International Journal of Robotics Research, In Press.

10) M. C. Priess, J. Choi, C. Radcliffe, J. M. Popovich Jr., J. Cholewicki, N. P. Reeves, “Time-Domain Optimal Experimental Design in Human Seated Postu- ral Control Testing,” Journal of Dynamic Systems, Measurement and Control, Volume 137, Issue 5, May, 2015. 11) J. M. Popovich, Jr., N. P. Reeves, M. C. Priess, J. Cholewicki, J. Choi, C. J. Radcliffe, “Quantitative Measures of Sagittal Plane Head-Neck Control: a TestRetest Reliability Study,” Journal of Biomechanics, Volume 48, Issue 3, February 5, 2015, Pages 549-554. 12) M. C. Priess, R. Conway, J. Choi, J. M. Popovich, Jr., C. Radcliffe, "Solutions to the Inverse LQR Problem With Application to Biological Systems Analysis,” IEEE transactions on control systems technology vol. 23, No 2, March 2015.

13) M. M. Kabir, R. Tafreshi, D. B. Boivin, N. Haddad, “Enhanced Automated Sleep Spindle Detection Algorithm Based on Synchrosqueezing”, Medical & Biological Engineering & Computing, In Press.

ASME Dynamic Systems and Control Division, Bio-Systems and Healthcare (BSHC) Technical Committee Publicity Chair & Newsletter Editor: Jin-Oh Hahn (University of Maryland, College Park)

Newsletter Vol. 3 March 2015 14) R. Tafreshi, J. Abdul, J. Lim§, L. Tafreshi, “Automated analysis of ECG waveforms with atypical QRS complex morphologies”, Biomedical Signal Processing and Control, Vol. 10, pp. 41–49, 2014. 15) J. Abdul, B. Ahmed, R. Tafreshi, D. Boivin, L. Streletz, N. Haddad, “Improved spindle detection through intuitive pre-processing of electroencephalogram”, Journal of Neuroscience Methods, Vol. 233, 2014.

16) J. L. Gorlewicz, L. B. Kratchman, and R. J. Webster III, “Haptic Paddle Enhancements and a Formal Assessment of Student Learning in System Dynamics”, ASEE Advances in Engineering Education, vol. 4, no. 2, pp. 1-31, 2014. 17) S. Patil, J. Burgner, R. J. Webster III, and R. Alterovitz, “Needle Steering in 3D via Rapid Replanning”, IEEE Transactions on Robotics, vol. 30, no. 4, pp. 853-864, 2014.

18) J. C. McBride, X. Zhao, N. B. Munro, G. A. Jicha, F. A. Schmitt, R. J. Kryscio, C. D. Smith, and Y. Jiang, “Discrimination of Mild Cognitive Impairment and Alzheimer’s Disease via EEG Peak Inter-Regional Transfer Entropy Delays”, Journal of Healthcare Engienering, Vol. 6, No. 1, Pages 55-70, 2015. 19) J. C. McBride, X. Zhao, N. B. Munro, G. A. Jicha, F. A. Schmitt, R. J. Kryscio, C. D. Smith, and Y. Jiang, “Sugihara Causality Analysis of Scalp EEG for Detection of Early Alzheimer’s Disease”, NeuroImage: Clinical, Volume 7, Pages 258–265, 2015.

20) M. Abdollahzade, C.S. Kim, N. Fazeli, B.A. Finegan, M.S. McMurtry, J.O. Hahn, “Data-Driven Lossy Tube-Load Modeling of Arterial Tree: In-Human Study,” ASME Journal of Biomechanical Engineering, Vol. 136, No. 10, 101011, August 2014. 21) N. Fazeli, C.S. Kim, M. Rashedi, A. Chappell, S. Wang, R. MacArthur, M.S. McMurtry, B.A. Finegan, J.O. Hahn, “Subject-Specific Estimation of Central Aortic Blood Pressure via System Identification: Preliminary In-Human Experimental Study,” Medical and Biological Engineering and Computing, Vol. 52, No. 10, pp. 895-904, October 2014.

22) C.S. Kim, N. Fazeli, M.S. McMurtry, B.A. Finegan, J.O. Hahn, “Quantification of Wave Reflection Using Peripheral Blood Pressure Waveforms: A Feasibility Study,” IEEE Journal of Biomedical and Health Informatics, Vol. 19, No. 1, pp. 309-316, January 2015. 23) R. Bighamian, H.R. Mirdamadi, J.O. Hahn, “Damage Identification in Collocated Structural Systems Using Structural Markov Parameters,” ASME Journal of Dynamic Systems, Measurement and Control, Vol. 137, No. 4, 041001, April 2015.

24) J. Sovizi, S. Das, and V. Krovi, "Random Matrix Approach: Toward Probabilistic Formulation of the Manipulator Jacobian," ASME Journal of Dynamic Systems, Measurement, and Control, Vol. 137, No. 3 pp. 031012-031012, October 2014. doi:10.1115/1.4027871. 25) X. Zhou, S.-K. Jun, and V. Krovi, "A Cable Based Active Variable Stiffness Module With Decoupled Tension," ASME Journal of Mechanisms and Robotics, Vol. 7, No. 1, pp. 011005-011005, February 2015. doi:10.1115/1.4029308.

26) K. Singal, R. Rajamani, M. Ahmadi, A.S. Sezen and J.E. Bechtold, “Magnetic Sensor for Configurable Measurement of Tension or Elasticity with Validation in Animal Tissues,” IEEE Transactions on Biomedical Engineering, Vol. 62, No. 2, pp. 426-437, February 2015. 27) G. Nelson, R. Rajamani and A.G. Erdman, “Noise Control Challenges for Auscultation on Medical Evacuation Helicopters,” Applied Acoustics, Vol. 80, pp. 6878, June 2014.

28) Roy, Rajarshi, and Jaydev P. Desai. "Determination of Mechanical Properties of Spatially Heterogeneous Breast Tissue Specimens Using Contact Mode Atomic Force Microscopy (AFM)." Annals of Biomedical Engineering, 42(9), pp. 1806-1822, 2014. 29) Hardik J. Pandya, Wenjin Chen, Lauri A. Goodell, David J. Foran and Jaydev P. Desai, “Mechanical phenotyping of breast cancer using MEMS: a method to demarcate benign and cancerous breast tissues,” Lab on a Chip, vol. 14, 4523-4532, 2014; DOI: 10.1039/C4LC00594E.

ASME Dynamic Systems and Control Division, Bio-Systems and Healthcare (BSHC) Technical Committee Publicity Chair & Newsletter Editor: Jin-Oh Hahn (University of Maryland, College Park)

Newsletter Vol. 3 March 2015 30) Hardik J. Pandya, Rajarshi Roy, Wenjin Chen, Marina A. Chekmareva, David J. Foran and Jaydev P. Desai, “Accurate characterization of benign and cancerous breast tissues: Aspecific patient studies using piezoresistive microcantilevers,” Biosensors and Bioelectronics, vol. 63, pp. 414–424, 2015; DOI:10.1016/j.bios.2014.08.002.

Position Openings 1) The Vanderbilt Medical Engineering and Discover Laboratory seeks to hire new graduate students. The lab pursues research in surgical robotics as well as useful non-robotic medical devices. The primary characteristics we look for are a passion for positively affecting surgery and patient care through engineering, and an interest in robotics. Interested candidates should apply to the Vanderbilt University Mechanical Engineering program through the free online application system, and should also contact the laboratory director, Robert Webster, by email to express interest in working in the laboratory. 2) The Vanderbilt Medical Engineering and Discover Laboratory is hiring outstanding postdoctoral scholar applicants, and reviews applications on a rolling basis. The lab pursues research in surgical robotics, as well as useful non-robotic medical devices. Interested candidates should contact the laboratory director, Robert Webster, by email with a CV and description of your career goals and research interests, to express interest in working in the laboratory. 3) Texas A&M University at Qatar (TAMU-Q), Doha, Qatar is seeking a Postdoctoral Associate to fill a research position. Experts with interests in the areas of modeling, controls, and biomedical engineering are encouraged to apply. The applications include development of new techniques in exoskeleton based stroke rehabilitation. Excellent oral and written communication skills and the ability to prepare internal and external documents and presentations are required. TAMU-Q offers excellent benefits and a number of special items, including furnished accommodations at no cost, a local transportation allowance, and dependent education allowance. At the moment, there is no income tax in Qatar. Applicants can submit their curriculum vita to: [email protected]; Dr. Reza Tafreshi, Mechanical Engineering Program Texas A&M University at Qatar, Education City, P.O. Box 23874, Doha, Qatar, phone: 974-4423-0237.

Graduates 1) Efrain Teran (advisor: Jun Ueda; Georgia Institute of Technology) received MS degree in Mechanical Engineering in Fall 2014. The title of his thesis was “Development of a Control System to determine Influence of Rolling Resistance in Manual Wheelchair Dynamics and Mechanical Efficiency”. 2) Chenlu Han (advisor: Jun Ueda; Georgia Institute of Technology) received MS degree in Mechanical Engineering in Fall 2014. 3) Ray Lathrop (advisor: Robert Webster; Vanderbilt University) received PhD degree in Mechanical Engineering in December 2014. The title of his dissertation was “Dexterity and Guidance Without Automation: Surgical Robot-Like Capabilities at a Fraction of the Cost”. He is currently a postdoctoral scholar at the Vanderbilt University. 4) Xiaobo Zhou (advisor: Venkat N. Krovi, SUNY Buffalo) graduated in O c t . 2014 defending a dissertation entitled: “Towards Cooperative Manipulation Using Cable Robots. He was working on an NSF project IIS-1319084: “RI: Small: Dynamic Payload Transport and Manipulation by Teams of Cooperating Mobile Robotic-Cranes”. Xiaobo is currently pursuing his own startup company in Suzhou, China. 5) Seung-Kook Jun (advisor: Venkat N. Krovi, SUNY Buffalo) graduated in February 2014 defending a dissertation entitled: “A Home-Based Rehabilitation System For Deficient Knee Patients”. He was working on an NSF project CNS-1314484: “CPS: Medium: Quantitative Visual Sensing of Dynamic Behaviors for Home-based Progressive Rehabilitation”. He will be starting a position as a Research Scientist at Buffalo Manufacturing Works (http://buffalomanufacturingworks.com/).

ASME Dynamic Systems and Control Division, Bio-Systems and Healthcare (BSHC) Technical Committee Publicity Chair & Newsletter Editor: Jin-Oh Hahn (University of Maryland, College Park)