Infrastructure and Technology Innovations for Medical Device Coordination

Historically, medical devices have been developed as monolithic stand-alone units. This state of affairs stands in direct contrast to the pervasive integration and cooperation among computing devices in our world today. Despite the fact that modern medical devices increasingly incorporate connectivity mechanisms that enable device data to be streamed to elec- tronic health records and displays that aggregate data from multiple devices, connectivity is not being leveraged to allow an integrated collection of devices to work together as a single system (i.e., a "system of medical device systems") to automate clinical work flows. It is quite clear that numerous clinical motivations exist to deploy systems of integrated and cooperating medical devices. We believe that medical systems are undergoing a paradigm shift to provide functionality such as device data streaming directly into patient electronic health records (EHRs), integration of information from multiple devices in a clinical context (e.g., hospital room) into a single tailorable composite display, automation of clinical workflows via computer systems that control networks of devices as they perform cooperative tasks, remote-controlled/robotic surgery, and even au- tomatic construction and execution of patient treatments. These envisioned systems are excellent examples of cyber-physical systems (CPS) because reasoning about their end-to-end functionality and safety involves accounting for cyber aspects such as embedded software, connectivity protocols, middleware infrastructure, databases, and information visualization and presen- tation software, and physical aspects including both computer and networking hardware as well as caregiver interactions and patient physiological systems. These systems hold tremendous promise for improving the quality of health care and health care delivery systems, as well as for reducing the costs of health care.

This project is developing a medical device coordination infrastructure to support a broad-based community effort in the investigation of medical device integration and coordination. We are seeding this infrastructure with key technological advances that cover areas that we believe are especially important for realizing the vision of safe and effective medical device coordination frameworks. The key activities in this project are as follows:

• develop an open-source medical device coordination framework (MDCF) with sufficient realism to be convincing to industry and regulatory authorities - the framework distribution will provide middleware for integrating distributed medical devices, simulated medical devices, instructions for including real devices, and programming and display ca- pabilities for multiple coordination scenarios,

• build a model-based component-oriented approach to programming medical device coordination frameworks that is designed for rapid development, verification, and certification of device coordination scenarios,

• developaformalautomata-basedmodelingandautomatedreasoningframeworkthatisrichenoughtosupportmodeling of cyber-physical processes in this space including clinician workflows and activities as well as device behaviors and interaction protocols,

• develop a formal compositional contract-based approach for reasoning about important functional and non-functional properties such as timeliness, reliability, end-to-end communication latency, etc.

• develop a run-time monitoring framework that allows continuous monitoring of crucial safety properties and "black box" flight recorder technology for forensic study of system failures,

• develop an approach to representing regulatory approval arguments for device coordination scenarios in terms of assur- ance cases, and provide examples of regulatory artifacts to illustrate the approach,

• along with the MDCF open-source infrastructure, provide pedagogical materials including lectures, video presenta- tions, simulated devices, class projects that will enable others to explore research avenues related to medical device coordination and certification.

  Our project is benefiting from well-established collaborative relationships with regulatory authorities (engineers in FDA's Center for Devices and Radiological Health), industry (development teams at Cerner who are building device integration frameworks), and medical experts who are leading efforts in device coordination technology (Dr. Julian Goldman - anes- thesiologist at Massachusetts General Hospital and Director of Interoperability at the Center for Integration of Medicine and Innovative Technology).