The absence of open standards and related technologies for medical device integration is impeding national efforts to revolutionize the delivery of safe, efficient, high-acuity patient care. Many of the anticipated benefits that could be achieved through integrating devices and IT systems of different vendors remain theoretical: they cannot be deployed clinically because a infrastructure to create these integrated clinical systems does not exist, nor is there a framework or methodology to assess the safety and suitability of innovative solutions that would benefit from the healthcare intranet infrastructure. Just as the Internet enabled the development of the World Wide Web and revolutionized communication, collaboration, and commerce, a healthcare intranet is needed to provide a platform to develop broad innovations in the safety and efficiency of healthcare delivery. Creation of an open, standards based healthcare intranet is the equivalent of a """"""""medical moonshot"""""""" that, as with Web 2.0, will empower the global healthcare community to build smart """"""""integrated"""""""" clinical environments by contributing innovative interoperable technologies and clinical knowledge to improve healthcare. This project will develop a prototype healthcare intranet by providing the necessary software and clinical expertise. Building on existing inter-disciplinary collaborations, a multi-institutional team will develop a plug-and-play open platform for medical device connectivity, as well as software tools to ensure the safe and effective connectivity of medical equipment and decision support engines to support clinical care. A vendor- neutral laboratory will be developed to integrate the building blocks provided by collaborators and to implement a set of clinical use cases to assess the intranet capabilities. Our approach includes (1) selection and analysis of clinical scenarios, (2) assess existing network technologies that can be adapted, (3) develop new software for the proposed healthcare intranet, incorporating best practices from successful interoperability efforts in other environments, (4) implement these systems in the MD PnP Lab, and (5) perform workflow evaluations and formal validation with use cases in a pre-clinical (lab) setting. The lab will serve long-term as a national resource for medical device interoperability R&D, testing and validation.

Public Health Relevance

The absence of open standards and related technologies for medical device integration is impeding national efforts to revolutionize the delivery of safe, efficient, high-acuity patient care. This project will break through that barrier by providing sharable implementations, tools, and a prototype platform to enable innovation and error-resistance through device interoperability, to improve patient safety and healthcare efficiency.

Agency
National Institute of Health (NIH)
Institute
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01EB012470-02
Application #
8150362
Study Section
Special Emphasis Panel (ZEB1-OSR-E (A1))
Program Officer
Peng, Grace
Project Start
2010-09-30
Project End
2015-08-31
Budget Start
2011-09-01
Budget End
2012-08-31
Support Year
2
Fiscal Year
2011
Total Cost
$1,915,815
Indirect Cost
Name
Massachusetts General Hospital
Department
Type
DUNS #
073130411
City
Boston
State
MA
Country
United States
Zip Code
02199
Arney, David; Plourde, Jeffrey; Goldman, Julian M (2018) OpenICE medical device interoperability platform overview and requirement analysis. Biomed Tech (Berl) 63:39-47
Weininger, Sandy; Jaffe, Michael B; Goldman, Julian M (2017) The Need to Apply Medical Device Informatics in Developing Standards for Safe Interoperable Medical Systems. Anesth Analg 124:127-135
Batsis, John A; Pletcher, Sarah N; Stahl, James E (2017) Telemedicine and primary care obesity management in rural areas - innovative approach for older adults? BMC Geriatr 17:6
Weininger, Sandy; Jaffe, Michael B; Rausch, Tracy et al. (2017) Capturing Essential Information to Achieve Safe Interoperability. Anesth Analg 124:83-94
Weininger, Sandy; Jaffe, Michael B; Robkin, Michael et al. (2016) The Importance of State and Context in Safe Interoperable Medical Systems. IEEE J Transl Eng Health Med 4:2800110
Kang, Woochul; Sha, Lui; Berlin Jr, Richard B et al. (2015) The Design of Safe Networked Supervisory Medical Systems Using Organ-Centric Hierarchical Control Architecture. IEEE J Biomed Health Inform 19:1077-86
Vasserman, Eugene Y; Hatcliff, John (2014) Foundational Security Principles for Medical Application Platforms (Extended Abstract). Inform Secur Appl (2013) 8267:213-217
Venkatasubramanian, Krishna K; Vasserman, Eugene Y; Sokolsky, Oleg et al. (2014) Functional Alarms for Systems of Interoperable Medical Devices. Proc IEEE Int Symp High Assur Syst Eng 2014:247-248
Larson, Brian R; Hatcliff, John; Chalin, Patrice (2013) Open Source Patient-Controlled Analgesic Pump Requirements Documentation. Int Workshop Softw Eng Health Care :28-34
Pajic, Miroslav; Mangharam, Rahul; Sokolsky, Oleg et al. (2012) Model-Driven Safety Analysis of Closed-Loop Medical Systems. IEEE Trans Industr Inform :

Showing the most recent 10 out of 14 publications