ACM SIGBED Review (ISSN: 1551-3688)
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SIGBED Review, Volume 6, Number 2, July 2009
Special Issue on the 2nd Joint Workshop on High Confidence Medical Devices, Software, and Systems (HCMDSS) and Medical Device Plug-and-Play (MD PnP) Interoperability


Note from the editor
Upcoming events
Introduction to the Special Issue
Special Issue on the 2nd Joint Workshop on High Confidence Medical Devices, Software, and Systems (HCMDSS) and Medical Device Plug-and-Play (MD PnP) Interoperability

Introduction to the Special Issue

This volume contains technical papers presented at the second Joint Workshop on High Confidence Medical Devices, Software, and Systems (HCMDSS) and Medical Device Plug-and-Play (MD PnP) Interoperability, held as part of the Cyber-Physical Systems Week on April 16, 2009 in San Francisco, CA.

The workshop series is based on the idea that bringing together the HCMDSS (High Confidence Medical Devices, Software, and Systems) and MD PnP (Medical Device "Plug-and-Play" Interoperability) communities of medical device specialists (researchers, developers, clinicians,regulators, and policy makers) from clinical environments, industry, research laboratories, academia, and government, would accelerate the development of science, technology, and practice to overcome crucial challenges facing the design, manufacture, certification, and use of medical devices. More reliable medical devices and interoperability standards will form the building blocks for patient-centric integrated medical device systems to improve the safety and efficiency of healthcare in diverse clinical settings.

The previous joint workshop was held on June 25-27, 2007, in Cambridge, MA. One-hundredforty-five attendees from academic and clinical organizations, government and industry, demonstrated their commitment to the vision and goals of the conference over three information rich days. Prior meetings on HCMDSS and MD PnP were held separately: the first HCMDSS workshop was held in June 2005 in Philadelphia, PA, and the MD PnP Interoperability program has held plenary meetings in May 2004, in November 2004 (at the FDA), and in June 2005. The synergies between the HCMDSS and MD PnP goals led to the joint workshop series to continue the momentum produced by the prior meetings, and to provide a forum to exchange new research and development results by the emerging community of researchers, developers, regulators, users, and manufacturers. (See Background section below for further information on both programs.)

Special Issue Guest Editors:
Julian M. Goldman, MD Massachusetts General Hospital
Insup Lee University of Pennsylvania


High Confidence Medical Devices, Software & Systems (HCMDSS). The development and production of medical device software and systems is a crucial issue, both for the US economy and for ensuring safe advances in healthcare delivery. As devices become increasingly smaller in physical terms but larger in software terms, the design, testing, and eventual Food and Drug Administration (FDA) device approval is becoming much more expensive for medical device manufacturers in terms of both time and cost. Furthermore, the number of devices that have recently been recalled due to software and hardware problems is increasing at an alarming rate. As medical devices are becoming increasingly networked, ensuring even the same level of health safety is a challenge.

Several federal and regulatory agencies have identified this growing problem and are interested in establishing a research agenda directed at improving the design, certification, and operation of current and future medical device software and systems. The 2005 High-Confidence Medical Device Software and Systems (HCMDSS) workshop was sponsored by various federal agencies, including the FDA, the National Institute of Standards and Technology, the National Security Agency, and the National Science Foundation, along with the National Coordination Office for Networking and Information Technology Research and Development.

The purpose of the first HCMDSS workshop was to provide a working forum for leaders and visionaries from industry, research laboratories, academia, and government concerned with medical devices. More than 90 experts from these sectors attended the workshop. They represented a mix of the relevant stakeholders including researchers, developers, certifiers, and users who can help identify emerging systems and assurance needs. The main goal of the workshop was to develop a road map for overcoming crucial issues and challenges facing the design, manufacture, certification, and use of medical device software and systems. An additional goal was to identify and form a sustainable research and development community for the advancement of HCMDSS. Of particular interest was the crystallization of technology needs and promising research directions that could revolutionize the way HCMDSS are designed, produced, and validated in the future but that are beyond the range of today's devices because of time-to-market pressures and short-term R&D practices. More information about the first HCMDSS workshop, including the presentations of the working groups, keynote speakers, and panelists, as well as the submitted position statements of participants in this workshop are available at

Findings from the HCMDSS workshops provided the basis for the report by the Networking and Information Technology Research and Development (NITRD) Program, titled "High-Confidence Medical Devices: Cyber-Physical Systems for 21st Century Health Care." The NITRD Program is an interagency activity within the U.S. Federal Government that coordinates research and development (R&D) in the areas of advanced networking, computing, and related information technologies. The report, released in February 2009, establishes national priorities in medical device R&D.

MD PnP Program. Medical devices are essential for the practice of modern medicine. However, unlike the inter-connected "plug-and-play" world of modern computers and consumer electronics, most medical devices are designed to operate independently, and do not employ open networking standards for data communication or for device control. The integration of individual medical devices into patient-centric networked systems can provide real-time comprehensive data for the electronic health record (EHR) and can create integrated clinical environments to support innovation in patient safety, workflow improvements, and reductions in medical errors and healthcare costs throughout the continuum of care: from the home, to pre-hospital transport, and to hospital areas as diverse as the OR, ICU, and general hospital ward.

The MD PnP program was established in 2004 to lead the evaluation and adoption of open standards and technology for medical device interoperability to support clinical innovation. The program is affiliated with Massachusetts General Hospital (MGH), CIMIT (Center for Integration of Medicine and Innovative Technology), and Partners HealthCare Information Systems, with additional support from TATRC (U.S. Army Telemedicine & Advanced Technology Research Center). Having evolved from the OR of the Future program at MGH, the MD PnP program remains clinically grounded. The program has a geographically dispersed, multidisciplinary, multi-institutional team of collaborators representing diverse stakeholder groups (clinicians, biomedical and clinical engineers, healthcare delivery systems, regulatory agencies, medical device vendors, standards development experts). Since the program's inception, more than 700 clinical and engineering experts and representatives of over 85 institutions that share a vision of medical device interoperability have participated in ongoing convening activities, including elicitation of clinical scenarios for improving healthcare through interoperability, implementation of selected clinical scenarios in a laboratory environment, and drafting an initial standard for the integrated clinical environment (ICE) required to support device interoperability (ASTM F-2761, being published in Spring 2009).

To support these goals, the CIMIT MD PnP Lab opened in May 2006 to provide a vendor-neutral "sandbox" to evaluate the ability of candidate interoperability solutions to solve clinical problems, model clinical use cases (in a simulation environment), develop and test related network safety and security systems, and support interoperability and standards conformance testing. In the Lab we are developing demonstrations of interoperability-based patient safety improvements, such as improving the safety and quality of portable x-rays, and patient-controlled analgesia systems that are used for pain management. Our team of collaborators includes participants from: Kaiser Permanente, Johns Hopkins, FDA, Univ. of Penn. Dept. of Computer and Information Science, Dräger Medical Systems, LiveData Inc., DocBox Inc., Moberg Research Inc., Univ. of Illinois at Urbana Champaign, Univ. of Waterloo, NIST, NSF, Geisinger Health System, as well as the Partners HealthCare System community (Massachusetts General Hospital Anesthesia, Biomedical Engineering at MGH and Brigham & Women's Hospital, PHS Information Systems, and PHS Materials Management).

Current activities include:

  • Developing clinical scenarios to inform interoperability solutions, and refining methodologies to analyze clinical scenarios to derive engineering requirements
  • Developing an ASTM International standard to define the "ecosystem" requirements of a patient-centric "Integrated Clinical Environment" (ICE), which includes system functions that could meet clinical, technical, regulatory, and legal requirements: data logging, data security, decision support, and connectivity to the hospital information system.
  • Collaborating with the FDA and others to elaborate a regulatory pathway for patient-centric networked medical devices
  • Sharing contract language to support the preferential acquisition of standards-conformant systems by healthcare organizations (as developed by Kaiser Permanente, Johns Hopkins, and Massachusetts General Hospital / Partners HealthCare)
  • Defining an open source platform to support ICE-compliant implementations of interoperability-driven clinical use cases.
Learn more at (including a link to streaming video coverage of the June 2007 Joint Workshop on MD PnP and HCMDSS).

Special Issue on the 2nd Joint Workshop on High Confidence Medical Devices, Software, and Systems (HCMDSS) and Medical Device Plug-and-Play (MD PnP) Interoperability

Note from the editor

After reorganization in the past several months, SIGBED Review is back. After years of exceptional service, two of the founding editors, Tarek Abdelzaher and Sandeep Neema, have moved on with their careers. Despite this change, the mission and goals of the newsletter remain the same.

SIGBED Review is dedicated to the rapid publication and open-access dissemination of new ideas in the embedded systems research and education. Contributions related to all aspects of embedded systems design, verification, validation, and implementation are welcome. Early and potentially controversial ideas that offer the prospect to revolutionize the field, however distant, are especially encouraged. In addition to individual submissions, SIGBED Review will continue the tradition of publishing special issues on embedded systems-related workshops, where such novel and controversial idea gestate and mature.

The newsletter is now hosted on a new server. All the archives, which date back to the first issue of the newsletter, are of course preserved.

Oleg Sokolsky
SIGBED Review Editor

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Welcome to the SIGBED Review. The peer-reviewed quarterly publication provides a dissemination forum for research on embedded computing. Topics of interest include, but are not limited to, embedded software, embedded system architecture, model-based design, distributed real-time middleware, real-time architectures, feedback control, low-power computing, sensor networks, security, and embedded applications. Submissions on these and other topics should be sent by e-mail to Oleg Sokolsky

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