Overview:
The Medical Device Strategic Health IT Advanced Research Project (MD SHARP) is led by the Medical Device Plug-and-Play (MD PnP) Interoperability Program based at the Center for Integration of Medicine & Innovative Technology (CIMIT) and Massachusetts General Hospital (part of the Partners HealthCare System). MD PnP is an interdisciplinary, multi-institutional medical device informatics research program that seeks to improve patient safety and clinical efficiency by enabling standards-based integration of medical devices, and is developing a framework and capabilities for integrated clinical environments of the future. We have been working to accelerate the adoption of medical device interoperability by providing interoperability building blocks (use cases, standards, a neutral lab sandbox, and open research tools) and by changing clinical and market expectations of what can be achieved.

MD SHARP is a Quantum Project funded by the National Institute of Biomedical Imaging & Bioengineering at the National Institutes of Health and adopted as an affiliate project of the SHARP program. The goal of the MD SHARP project is to develop a prototype health care intranet for medical device interoperability with improved health outcomes, which includes an open platform and tools to enable clinical application development. Our platform is being designed to be compliant with the ICE standard (Integrated Clinical Environment, ASTM F2761) and will build on four core Clinical Scenarios, selected to represent common acute care devices and key device interoperability functionality.

Main Themes:

• Safe integration of medical devices into patient-centric networked systems

• Synergy with current work on developing regulatory pathways for interoperable medical devices

• Development of testable clinical requirements for key aspects of medical device interoperability, including architecture and safety

• Development of safe hospital protocols for interoperable medical devices, including clinical decision support protocols with technical and process requirements

• Creation of validated, safe, reliable, secure, and re-usable software interfaces that are easily re-used by the medical device industry, health IT vendors, academia, and government

• Updates and improvements to existing medical device interface standards

• Technical solutions to improve accuracy of medical device data time-stamps

• Creation of a simulated clinical environment and related tools where workflows, protocols, interactions, and technology can be tested and validated

Program Goals:

• Create a complete eco-system for medical devices interoperability, and interoperability between a medical device and the EHR in high-acuity environments, to support innovation in patient safety and health care quality

• Create industry-adopted solutions that will prime industry focus on delivering interoperable medical devices for acute care

• Delivery of more accurate and comprehensive device data to the EHR

• Clinical Scenarios and related Use Cases for testing other projects’ tools

• Critical knowledge of regulatory context

• Shareable platform, tools, neutral lab environment

Principal Investigator
Julian M. Goldman, MD, Massachusetts General Hospital and CIMIT