Medical Device Interoperability

The lack of interoperability between medical devices 

can lead to preventable medical errors and potentially 

serious inefficiencies that could otherwise be avoided.

Overview

From acute care clinical settings, to vital-sign monitoring, and devices that make 

telemedicine an accurate diagnostic and treatment discipline, medical devices are 

playing an ever-increasing role to transform healthcare delivery. These devices have the ability to capture critical medical 

data, available (perhaps) multiple times per second, on a per-patient basis. However, for the most part, they are unable to 

communicate with one another and offer almost no plug-and-play interoperability.

Industry Need Addressed

Lack of reference implementations for existing device interface standards and unanswered questions regarding the safety 

and performance of networked systems-of-systems are among the challenges to achieving medical device interoperability.

NIST Approach

In collaboration with experts from other federal agencies, industry, and academia, NIST researchers are currently working 

on efforts that promote standard-based medical device interoperability and communication.

• Medical Device Interoperability Project - NIST researchers in collaboration with the Massachusetts General 

Hospital and the Center for Integration of Medicine & Innovative Technology are working to achieve the vision of 

interoperability by conducting research in clinical requirements as outlined by the American Society for Testing 

and Materials (ASTM) F2761 standard. This standard specifies requirements and characteristics necessary for 

the safe integration of medical devices in operating rooms, emergency rooms and intensive care units. The 

research effort includes a gap analysis of the medical device communication standard ISO/IEEE 11073 versus 

use case scenarios outlined in the ASTM F2761 standard. NIST software engineers are also working with the 

ASTM F2761 Standards Committee to improve the functional architectures embodied in the standard, and with 

developers of reference implementations funded through National Institute of Health (NIH) grants. This work will 

result in testable prototypes and improved standards documents for use by industry to develop improved medical 

devices.

• Medical Device Communication Project - NIST researchers are collaborating with medical device vendors and 

domain experts to facilitate the development and adoption of standards for medical device communications 

throughout the healthcare enterprise, as well as integration into the electronic health record. NIST is actively 

developing medical device communication test methodologies and tools to provide a key tool set needed to 

enable consistent and correct communication between medical devices, device-gateways, and across the 

healthcare enterprise. This work serves to provide standards-based and rigorous validation of medical device 

communication through conformance leading to interoperability. Rigorous testing is essential to achieve multivendor and enterprise-wide interoperability and must be predicated on sufficiently specified medical device and 

enterprise-communication standards. NIST is developing and advancing software test tools to support device 

communication in point-of-care and personal health settings. These tools are derived and implemented to meet 

medical device-level communication requirements defined in the ISO/IEEE 11073 Medical Device 

Communication (x73) family of standards and enterprise/electronic health record level defined in the Health Level 

7 (HL7) messaging standard.

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Medical Device Interoperability

Impact

The result of these efforts will help the development of a standard-based interoperable framework that allows novel 

clinical solutions to be safely and efficiently incorporated. This will lead to:

• Fewer transcription errors and a richer set of information with which clinicians can manage their patients.

• Synchronization, safety interlocks and closed-loop device control for medical devices.

• New generation of medical sensors and actuators that can be integrated with the existing infrastructure 

as they become available.

• Easily deployable protocols and treatment solutions that are driven by what the healthcare providers need 

instead of what a technology manufacturer can supply.

Key Contacts

Kamran Sayrafian

Program Manager

Information Technology Laboratory

kamran.sayrafian@nist.gov

Medical Device Interoperability project:

Vince Stanford

Information Technology Laboratory

Information Access Division

vincent.stanford@nist.gov

Medical Device Communication project:

John Garguilo

Information Technology Laboratory

Software and Systems Division

john.garguilo@nist.gov

For additional information, please visit http://www.nist.gov/healthcare/emerging/deviceinteroperability.cfm

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