10th International Symposium on Medical Information and Communication Technology, 2016

Abstract:
Modeling the electromagnetic response of the human body to various stimuli is directly dependent on the availability and correct usage of anatomically accurate and numerically efficient computational phantoms. These digital representations of actual human patients are painstakingly reconstructed from available medical image data to enable virtual examination of the impact of electromagnetic stimuli in a way that is not easily possible with traditional experimental methods. This tutorial will provide an overview of available computational phantoms, discuss their construction and composition, offer metrics to assess model quality and suitability, describe methods for custom tailoring phantoms to specific applications and examine their use in several relevant settings.

Speakers:
Gregory M. Noetscher, Electrical and Computer Engineering, Worcester Polytechnic Institute, U.S. Army Natick Soldier Research Development and Engineering Center
Sara Louie, ANSYS, Inc.
Sergey N. Makarov, Electrical and Computer Engineering, Worcester Polytechnic Institute

Panel 1: Securing Medical Cyber-Physical Systems: Challenges and Future Directions
March 21, 12:30-14:00, Odeum A/B, Lunch Box

Abstract:
Recent years have seen an explosion in the diversity of medical cyber-physical systems (MCPS) that are becoming available for managing a variety of healthcare issues. From interoperable medical device systems in ICUs to tele-surgery robots to wearable and ingestible technologies, MCPS are making it possible for healthcare to be pervasive, autonomous, and effective.
Much work has been going on in designing MCPS to be safe, especially in the cases where the underlying system components fail. However, the safety-critical nature of MCPS (e.g., closed-loop actuation capabilities) makes them obvious targets for exploitation by adversaries. The failures from such exploitation usually have features that are inherently different from models of failures that MCPS designers typically assume.
Therefore, preserving MCPS operation under adversary induced failures is essential for ensuring patient safety. In this panel, we will discuss several important questions in this regard including what are the appropriate threat model for the MCPS? Are existing network and system attack prevention, detection, and response solutions sufficient for MCPS? What roles can data-driven models play in dealing with the internet complexity of MCPS and developing effective security solutions for them? Can we leverage work done in the fault-tolerance and robust control domain to alleviate some of these problems? How can we make MCPS resilient, and continue their often critical operations, during attacks?
The panel seeks to debate and seek various viewpoints on these questions. The discussion of this panel will be relevant to anyone interested in designing secure MCPS."

Organizer:
Krishna Kumar Venkatasubramanian, Assistant Professor, CS Department, WPI
"Securing Medical Cyber-Physical Systems: Challenges and Future Directions"

Panelists:
David Arney, Partners Inc.
"Medical Device Interoperability and Cybersecurity"
Eugene Vasserman, Assistant Professor, Computing and Information Sciences, Kansas State University
Melissa Chase, Information Technology and Cybersecurity Integrator, Information Technology Technical Center, MITRE

Panel 2: Medical Device Safety Co-Session with MIT Partnership for a Systems Approach to Safety (PSAS) annual conference
March 21, 16:30-18:00, MIT Stata 52-123, 32 Vassar St., Cambridge, MA

Abstract:
This joint panel with IEEE ISMICT2016 focuses on application of systems and control-theory based hazard analysis to medical device design, most notably for those devices that are connected, and provides a model for the design, evaluation, regulation and use by service providers and patient care communities.
STAMP is a new accident causality model based on systems theory and systems thinking described in Nancy Leveson's book "Engineering a Safer World." STAMP integrates into engineering analysis the causal factors in our increasingly complex systems such as software, human-decision making and human factors, new technology, social and organizational design, and safety culture.
STPA is a powerful new hazard analysis technique based on STAMP while CAST is the equivalent for accident/incident analysis. This free workshop will provide attendees with the opportunity to learn how to use these new tools, to meet with users and to hear about applications, evaluations, and the latest developments in this powerful new approach to system safety engineering and to cyber security in the context of medical devices that are increasingly connected.

Organizer and Keynote:
Nancy Leveson, Director, MIT: Systems Thinking and Medical Device Safety
"Systems and Control Theory-Based Hazard Analysis - Medical Device"

Applications:
Todd Pawlicki, PhD, FAAPM, Professor and Vice-Chair, Department of Radiation Medicine and Applied Sciences, University of California, San Diego, USA
"Application of Systems and Control Theory-Based Hazard Analysis to Radiotherapy"
John Thomas (substitute of Kristie Chung), research engineer, Safety and Security Research Laboratory, MIT
"STPA Analysis of Intravenous Patient-Controlled Analgesia"

Workshop 1/Panel 3: Medical Device Regulatory Science Panel
March 22, 09:00-12:30, Odeum A/B

Abstract:
This panel presents new research and development results in the area Medical Device Regulatory Science (MDRS) with a focus on the safe and reliable application of advanced technologies in information communications technology, biology and medical engineering.
In Medical ICT research topics may range from RF Frequencies and protocols to scientific approaches to the analysis of medical device safety data. Recent years have seen an explosion in the diversity of software defined radio systems (SDR) that are becoming available for managing a variety of healthcare issues. In Japan, new Multi-mode and Multi-Service Software Radio Communication Systems are being developed by companies such as NTT, Toshiba, CRL, Sony/Textronix, Toyo Communication and Anritsu and as are being tested at Yokahama National University. These systems range from 1.5 and 1.6/1.9/5.8 GHz bands to 2.45GHz band RF frequencies. Further, physical layer wireless security has been a research topic in light of the safety-critical nature of MCPS (e.g., closed-loop actuation capabilities) which must be protected.
In order to develop leading-edge combined ICT medical and healthcare systems such as wireless-enabled (BAN) medical devices and to support their certification, a variety of methods to quantitatively assess the efficacy and risk based on the scientific data are necessary.
Big Data analysis: In clinical trials, traditional (frequentist) statistical methods traditionally used information from previous studies only at the design stage. Then, at the data analysis stage, the information from these studies was considered as a complement to, but not part of, the formal analysis. Today regulators are applying Bayesian ideas to consider prior information and the trial results as part of a continual data stream, in which inferences are being updated each time new data become available.
Bio-Medical Science research may range from novel nanoparticles and their derivatives effect on cell differentiation, new methodologies for biomarkers detection, to novel systems for synthesizing biomarkers for reducing stress to the human body.
In this panel, we will discuss regulatory best practices for preserving RF Frequencies for healthcare applications, internal and external to the human body. Are existing network and system standards and best practices sufficient for MCPS? What roles can data-driven models play in dealing with the complexity of MCPS and developing effective solutions for them? The panel seeks to debate and seek various viewpoints on these questions.

Panel Moderator:
Ryuji Kohno, Yokohama National University, Japan
Masayuki Fujise, PhD., Yokohama National University, Japan
Opening Talk

Keynotes:
Gregory Campbell, formerly FDA, USA
"Medical Device Regulatory Science: A View from 20 Years at FDA's Device Center"
Michael Marcus, Marcus Spectrum, USA

Panelists:
Lorenzo Mucchi, PhD., Dept. of Information Engineering, University of Florence, Italy
"Introduction to Standardization of Smart Body Area Networks in EU"
Jari Iinatti, Centre for Wireless Communications, University of Oulu, Finland/IAS Visiting Professor, Yokohama National University, Japan
"Wireless Medical Communications (WiMeC) for 'Challenges and Future Directions in Medical Device Regulatory Science (MDRS)'"
Henry Chang, IBM T.J. Watson Research Center, USA

Panel 4: Building an Internet of Medical Things - Connecting Data Sources with FHIR API's - Protocol / interoperability requirements for cell and gene therapy
March 22, 12:30-14:00, Odeum A/B

Abstract:
Autologous chimeric antigen T-cell (CAR-T) therapies are generating remarkable remissions in hard-to-beat blood cancers, and have the potential to treat a wide variety of other cancers, as well. The starting material for these therapies are stem cells, which are harvested in the hospital from the patient to be treated. The patient has typically previously undergone multiple failed treatment regimens. Additionally, a variety of protocols can be used to prepare the patient for the stem cell harvest. These factors, which are part of the patient record, could significantly impact the quality of the apheresis product used for CAR-T manufacturing. The current CAR-T manufacturing process is characterized by a high degree of variability, and access to information regarding factors affecting the quality of the patient's apheresis could be used to optimize the manufacturing protocols for these personalized cell therapy products.
This panel includes perspectives from Clinical Research, Process Control and Healthcare IT perspectives on new and emerging protocol requirements for what information clinicians/researchers need to access in patient records and how this information can be used to optimize delivery of autologous cell and gene therapy products to critically ill patients. Further discussion of what data from this product/process, in association with a Unique Identifier, should be saved with a patient record.

Organizer:
Stephen Miles, MIT Center for Biomedical Innovation
Opening Talk

Keynote:
Josh Mandel, Lead Architect, SMART Health IT, Boston Children's Hospital and Harvard Medical School
"SMART API using HL7 FHIR emerging standards to define patient data resources"
Janet Campbell, Vice President of Patient Experience, Epic
"OpenEpic"

Panelists: "Use Cases from Gene and Cell Therapy"
Myriam Armant, TransLab, Boston Childrens Hospital and Dana Farber Cancer Institute
Jacqueline Wolfrum, Research Scientist, MIT Center for Biomedical Innovation
Jeremy Kolenbrander, P.E., Terumo BCT

Workshop 2: Workshop on Recent Advances in Video Capsule Endoscopy
March 22, 14:00-15:30, Odeum A/B

Abstract:
Video capsule endoscopy (VCE) is an emerging imaging technique that enables medical professionals to monitor inside the body. Specifically, it facilitates monitoring of portions of the gastrointestinal (GI) tract, such as the small intestine, that is unreachable by conventional endoscopy techniques.
Current VCE systems are passive tools that are mainly used for diagnostic purposes only. The patient swallows a pill-sized capsule, containing a camera, which travels through the gastrointestinal tract by normal muscle movement. The camera captures images and the capsule transmits them wirelessly to an external receiver. Current VCE systems are FDA-approved for clinical use and have been used in clinical trials, however, there are some issues that need to be resolved in order to take full advantage of these systems. The first issue is the localization of endoscopy capsule inside the GI tract. This is a significant problem because if the images received from an endoscopy capsule convey the presence of an abnormal condition (such as a lesion or a tumor), the existing systems cannot localize the location of the abnormality within the GI tract. This makes subsequent surgical interventions considerably more difficult and time consuming. Localization of a passive endoscopy capsule within the GI tract is, therefore, a problem that needs to be addressed. In addition, the current VCE systems mostly use narrowband transmission techniques in the MICS band (402-405 MHz) and have very limited energy storage. Thus, they can only transmit images with a limited resolution. In order to facilitate image transmission at a higher resolution, power-efficient narrowband and possibly wideband transmission techniques (such as ultra-wide band) need to be investigated.
Recently, there has also been a lot of interest and R&D work devoted to developing active VCE systems (also known as robotic endoscopes) that can be maneuvered within the GI tract. The problem of capsule/robot localization is even more important in this case. In fact, since the location of the capsule is required to be known for providing appropriate feedback to the actuation system, the capsule needs to be localized much faster and with higher precision in this case. In addition, in some cases (such as magnetic actuation and localization), it is possible that the actuation and localization systems will interfere with each other, causing severe performance degradation.
This workshop within ISMICT-2016 solicits original papers on VCE systems including the following topics: Localization approaches for passive VCE, power-efficient transmission techniques for VCE, and wireless power transmission techniques for VCE.