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Advancing Wireless Medical Device Interoperability: 

Overview of Current Efforts

Introduction

Interoperability is one of the more daunting challenges facing the integration of 

advanced technologies in health care. Interoperability involves many complicated 

layers of functional and technical requirements, and has many practical, technical, 

and commercial implications that influence implementation and adoption. 

However, interoperability is a key enabler of improved health care delivery, and 

has become an imperative that numerous entities are now dedicated to making a 

reality. The objective of this paper is to overview efforts to advance interoperability 

within the context of wireless medical device technology.

What Is Interoperability?

Carefully considered, the definition of interoperability is contextual – and might 

appear to preclude a single definition. This paper takes as a working definition that 

wireless medical device interoperability can be said to exist when all relevant 

information is available whenever needed regardless of setting, and all desired 

interactions between disparate agents (devices, systems, individuals) are enabled 

by effective (timely, safe, secure) communication.
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Why Interoperability?

The interoperability value proposition includes improved clinical safety and health 

outcomes, and more efficient care delivery at lower cost. Much of the 

dysfunctionality in contemporary health care delivery is marked by balkanization of 

information into non- or poorly interacting silos. Electronic medical records (EMRs) 

were initially touted as the vehicle by which broad and seamless exchange of health

care information would be achieved. However, they have evidenced the same sort of 

dysfunctionality that inspired their creation, and have automated the process of 

confining information within proprietary networks, thus falling short of early 

expectations to create an interoperable network. This has resulted in needless, 

costly and time-consuming repetition of different elements within the clinical care 

paradigm; sub-optimal individual patient care; compromised clinical safety; and,

ineffective population health management. Furthermore, the absence of fully 

integrated and timely data has frustrated the ability to use advanced analytics on 

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aggregated data sets to test and validate existing models of care, or develop learning 

systems of care. 

There is growing need for predictable, reproducible and dependable ways to drive 

effective functional interaction between agents across the system. The growing 

acceptance (and soon ubiquitous use) of wireless medical devices provides a second 

chance to create an interoperability solution that has thus far eluded EMRs. 

Individual device manufacturers may create vertical integration within their 

product lines, but horizontal interoperability is required to break the stranglehold 

of silos and create a safer, functionally interactive and more efficient macro

environment. This imperative increases in urgency as our current health care 

delivery model shows signs of financial and logistical unsustainability, with an

undeniable need for us to 1) exploit the efficiencies of automatic, integrated and 

learning system architectures that have effectively revolutionized many other 

industries; and, 2) integrate remote diagnostics and titratable therapies into the 

management of chronic disease in non-traditional settings (home, office, etc.) – a 

model of “Infrastructure Independent” care1.

This new model of infrastructure-independent care is enabled by the ubiquitous 

availability of low-cost wireless communication and can be contrasted with the 

prevailing approach to care as follows:

Current Model Infrastructure 

Independent Model

Low frequency visits High touch

Acute-care focused Right treatment

Appointment driven When patients need it

Location centric Where patients are

High cost Low cost

The infrastructure-independent model of care is one in which health care delivery is 

extended on a foundation of wireless health technologies to become preventive, 

continuous, supportive and ubiquitous. This model enables providers to more 

efficiently and effectively care for patients, leading to improved health outcomes 

and lower costs. The vision of infrastructure independence includes the following 

scenarios:

- An individual uses a smartphone application for a medically validated 

weight-loss and fitness program specifically aimed at preventing diabetes.

- A heart-failure patient is discharged from the hospital and is monitored and 

supported by wireless technologies to prevent being readmitted.

 

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- An individual in a hospital is able to have the settings of an infusion pump 

adjusted automatically in response to a change in a biometric value (such as 

blood pressure) without having to wait for a human to directly intervene.

- A frail elder is monitored in her home to ensure she is eating properly, taking 

her medications, and that she is not at risk of a fall, all as a means of enabling 

her to remain at home and away from institutional long-term care.

The building blocks of infrastructure-independent care are:

Ubiquitous telecommunications

Communications infrastructure for all, regardless of location, is imperative. 

To support future data transmission needs, it must continue to rapidly 

increase bandwidth and coverage. Recognition of this is reflected in the 

growing pervasiveness of fourth-generation cellular and data services 

between settings, and maturing technologies such as Wi-Fi and Bluetooth 

within settings.

Sensors

Safe, reliable, wireless sensors can assess biometrics such as weight, blood 

pressure, blood glucose, blood oxygenation and blood coagulation. Sensors 

offer further value in their ability to provide other actionable diagnostics for 

common ailments whose management can be greatly improved by more 

frequent monitoring of disease activity and more accurate tailoring (course 

correcting) of potent therapeutics (e.g., malignancies, auto-immune diseases, 

neurodegenerative diseases). Even an individual’s environment and behavior 

can provide useful and actionable insights, particularly in the case of 

asthmatics and the frail elderly.

Advanced Analytics

Rapidly evolving analytics technologies can transform data from sensors and 

subjective assessment of patient risk factors into actionable knowledge and 

provide superior decision support not only for clinicians, but also for patients 

and their informal caregivers. These technologies can facilitate interactions 

between medical devices that ultimately could lead, for instance, to dynamic 

adjustment of medication dosing based on a measured change in a biometric 

value such as weight or blood pressure. They may also provide valuable 

input to clinical trials, and tertiary drug interaction and adverse reaction 

networks.

Data Sets

Large and growing data sets at both the individual and population levels that 

are mined to continually enhance the detection, assessment and management 

of a wide array of medical conditions.

Interoperability – ensuring relevant information is readily available to all agents 

regardless of setting – is necessary to realize the full benefits of infrastructure-
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independent care. A first tangible and addressable step in the path to overall 

interoperability is the relatively narrow case of wireless medical device 

interoperability, which has the greatest near-term potential to create the 

“Infrastructure Independent” environment. 

What Is Wireless Medical Device Interoperability?

Wireless medical device interoperability is a critical enabler of infrastructureindependent care. Independently operating medical devices are typically designed 

for specific and narrowly defined outcomes. They do not consider the larger context 

that often includes information from other medical devices that, if available and 

appropriately integrated, would enable improved outcomes. With increasing 

availability and adoption of independent (stand-alone) devices, not only has the 

opportunity for improved outcomes via effective interoperability grown, so too has 

concern regarding the potential perils of multiple independent systems 

inadvertently ‘conspiring’ to cause harm. Ubiquitous wireless communication 

affords a low-cost communication channel through which interoperability of 

otherwise independent medical devices could be achieved. It is clear, however, 

that the large and growing opportunity to improve effectiveness via 

interoperability and decrease the safety concerns associated with a growing 

plurality of independently acting and potentially confounding devices will not 

come about spontaneously – it requires positive, proactive effort.

To facilitate ease of understanding, wireless medical device interoperability can be 

considered by focusing on the functions involved. In basic terms, the functions that 

comprise an interoperable system include the following: collect, store, send, 

receive, validate, interpret, decide and act. Within each of these functions are 

multiple layers of sub-functions, which are often nuanced depending on the context 

in which they operate.
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In addition to considering the basic functions that are necessary to achieve 

interoperability, it is important to contemplate degrees of interoperability. A 

prominent framework for this is the Levels of Conceptual Interoperability Model 

(LCIM), in which each level progresses toward a fully interoperable state. This 

model describes the need for communication infrastructure and protocols; common 

data structures and formats; shared meaning of data and word definition; shared 

understanding of the context in which data are applied; systems to take advantage 

of changes in state, including effects on data interchange, that occur over time; and, 

alignment of assumptions and constraints related to data exchange. Other models 

address organizational and social issues, which are equally important contributors

to the success or failure of interoperability efforts.

With the foregoing acknowledgement of the detailed technical considerations 

required for technical interoperability, for purposes of this paper, we identify five 

functional levels of interoperability of wireless medical devices. 
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1. Device transmits details of its functions and available data.

2. Device receives details of other device functions and data.

3. Device integrates information from another to alter its behavior.

4. Device allows for control by another device.

5. Device assumes control of another device.

It is worth noting that the number and nature of actors involved in the direction of 

information exchange associated with each functional level of interoperability may 

vary. For example, there could be a consolidated display of transmitted data from 

multiple devices, or a single device could transmit to several other devices. 

Similarly, it is contemplated that the levels of interoperability may not be static, but 

instead vary with use case or in response to clinical/professional interaction. 

Devices are most useful when they act in concert to positively change care. For 

example, attainment of a specific clinical end point can be optimally reached by 

modulating the device providing therapy based on knowing that end point. An 

infusion pump that dispenses blood pressure control medication would be far more 

effective (in both timing and dose) if it knew the patient’s blood pressure, which it 

could directly obtain from a blood pressure cuff. In order for devices to operate 

differently by virtue of data learned from another agent, they would have to know 

the source providing that data. For this example, not all devices measure blood 

pressure the same way, so the infusion pump would need to be able to recognize the 

source device.

Who is Addressing Interoperability?

Several entities ranging from government to industry to traditional standards 

bodies are involved in the effort to advance medical device interoperability. The 

following chart offers a high-level snapshot of their activities:
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Organization Objectives Relative to 

Medical Devices Focus CreatesStandards

AAMI Association for the 

Advancement of Medical 

Instrumentation

Develop Interoperable Medical 

Devices Interface Standards 

(IMDIS)

 Clinical use cases

 Safety

 Quality

X

AdvaMed Advanced Medical 

Technology Association

Further standards efforts  Touches multiple 

aspects

AHIMA American Health 

Information 

Management Association

Promote standards for EHRs 

and HIEs

 Health ICT

X

ANSI American National 

Standards Institute

Promote voluntary consensus 

standards

 Touches every 

sector

X

ASTM International

(ASTM ICE)

Integrated Clinical 

Environment

Formerly American 

Society for Testing and 

Materials

Integrate devices and other 

equipment in clinical 

environment

 Patient safety in 

high-acuity clinical 

care

X

Continua Continua Health Alliance Certify that personal health 

devices are interoperable

 Personal Connected 

Healthcare

HITSP Healthcare Information 

Technology Standards 

Panel

Develop interoperability specs 

for EHRs, including transfer of 

remote monitoring data

 EHR data exchange

X

HL7 Health Level Seven 

International

Integrate health care device 

information at enterprise level

 Message exchange

 Terminology X

IEEE Institute of Electrical and 

Electronics Engineers

Develop communications 

standards for LANs and MANs; 

promote automatic exchange 

of data between devices

 Personal health care

 Acute care

 Wi-Fi networks

X

IHE

(IHE PCD)

Patient Care Device 

Domain

Integrating the 

Healthcare Enterprise

Support clinical needs thru 

integration profiles

 Point-of-care 

medical devices

 Specific clinical and 

operational domains

MD PnP

(Medical Device 

“Plug-and-Play” 

Interoperability 

Program)

Center for Integration of 

Medicine & Innovative 

Technology (CIMIT) and 

Massachusetts General 

Hospital

Provide interoperability 

building blocks and change

clinical and market 

expectations of what can be 

achieved

 Use cases

 Neutral lab 

environment

 Open research tools

 Regulatory pathway

MITA

(DICOM)

Digital Imaging &

Communications in 

Medicine

Medical Imaging & 

Technology Alliance

Oversee DICOM standard for 

medical images

 Medical image 

sharing

X

NIST National Institute of 

Standards and 

Technology

Facilitate development and 

adoption of standards for 

medical device 

communications

 Testing tools

 Personal health care X

UL Underwriters 

Laboratories

Develop safety standard for 

Interoperable Medical Devices 

Interface Standards (IMDIS)

 Safety specs for 

interoperability X
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AAMI (Association for the Advancement of Medical Instrumentation)

AAMI, a nonprofit organization with more than 6,800 multidisciplinary members 

from around the world, focuses on increasing the understanding and beneficial use 

of medical technology primarily through effective standards, educational programs 

and publications. In early 2010, AAMI formed an ad hoc group (“AAMI/HITI”) on 

health information technology and interoperability. This group concluded that AAMI 

should play a leading role in developing Interoperable Medical Devices Interface 

Standards (IMDIS), at the behest of the FDA. In this capacity, AAMI would focus on 

standards development for specific clinical functional (use cases) and nonfunctional (e.g., safety and quality) requirements, while avoiding duplication of 

existing device interoperability standards efforts. AAMI/HITI is close to publishing a 

white paper on medical device interoperability that includes a useful overview of 

medical device interoperability standards and related efforts.

AdvaMed (Advanced Medical Technology Association)

AdvaMed consists of companies that produce medical devices, diagnostic products 

and health information systems. Its members account for nearly 90 percent of the 

health care technology purchased annually in the United States and more than 50 

percent globally. AdvaMed members range from the largest to the smallest medical 

technology innovators and companies. AdvaMed represents its members’ interests 

in various standards and interoperability efforts.

AHIMA (American Health Information Management Association)

AHIMA is an association of health information management (HIM) professionals, 

originally founded in 1928 to improve the quality of medical records. Its more than 

63,000 members are dedicated to the effective management of personal health 

information required to deliver quality health care to the public. AHIMA is involved 

in standards and interoperability initiatives for electronic health records and health 

information exchanges. In July 2011, it became the new Secretariat and U.S. 

Technical Advisory Group Administrator for ISO’s Technical Committee on health 

informatics (ISO/TC 215). TC 215 works on the standardization of health 

information and communications technology (ICT) to allow for compatibility and 

interoperability between independent systems.

ANSI (American National Standards Institute)

ANSI is a not-for-profit organization whose mission is to enhance both the global 

competitiveness of U.S. business and the U.S. quality of life by promoting and 

facilitating voluntary consensus standards and conformity assessment systems, and 

safeguarding their integrity. It represents the interests of more than 125,000 

companies and 3.5 million professionals. ANSI oversees the creation, promulgation 

and use of thousands of norms and guidelines that directly impact businesses in 

nearly every sector: from acoustical devices to construction equipment, from dairy 

and livestock production to energy distribution, and many more. ANSI is also 

actively engaged in accrediting programs that assess conformance to standards.
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ASTM International

ASTM International, formerly known as the American Society for Testing and 

Materials, is a developer of international voluntary consensus standards. It has more 

than 30,000 members representing 135 countries. There are approximately 12,000 

ASTM standards in use around the world.

ASTM ICE (Integrated Clinical Environment)

Part one of the ASTM F2761–09 standard provides general requirements, a model 

and framework for integrating equipment to create an Integrated Clinical 

Environment (ICE). This standard specifies the characteristics necessary for the safe 

integration of medical devices and other equipment, via an electronic interface, from 

different manufacturers into a single medical system for the care of a single highacuity patient. Its purpose is to promote a medical system that has greater error 

resistance and improved patient safety, treatment efficacy and workflow efficiency 

than can be achieved with independently used medical devices. Proposed future 

parts of the standard include:

Part 2 – Requirements for network control and equipment interface

Part 3 – Requirements for device models

Part 4 – Requirements for supervision (the “ICE Supervisor” to host clinical 

decision support algorithms)

The technical work for ASTM ICE is led by the Medical Device “Plug-and-Play” (MD 

PnP) Interoperability Program based at CIMIT (Center for Integration of Medicine 

and Innovative Technology) and Massachusetts General Hospital. 

Current MD PnP projects include evaluating gaps in existing standards that would 

affect safe function of devices in four clinical scenarios. The selected scenarios 

represent common acute care devices and key device interoperability functionality: 

1) Patient-controlled analgesia (PCA) infusion pump safety interlock

2) Prepare intensive care unit (ICU) to receive post-op patient after cardiac 

surgery (e.g., coronary artery bypass graft (CABG))

3) Use of home tele-health devices in the hospital (i.e., maintain patient 

monitoring through the transition from home via ambulance to the 

hospital emergency department) 

4) Increasing levels of interoperability of medical devices in the hospital

Scenario four is the implementation of a “levels of interoperability” analysis 

produced by the FDA Prototype Regulatory Submission (PRS) Working Group., 

which was formed as a follow-on to the January 2010 FDA Workshop on Medical 

Device Interoperability: achieving safety and effectiveness, co-sponsored by the 

Continua Health Alliance and CIMIT. The purpose of the PRS is to identify scientific, 

engineering and organizational principles that will enable ICE systems to be built 

with adequate safeguards so that interoperability is safe and effective. This effort 

describes and illustrates – through mock regulatory submissions - a "component-
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wise" regulatory approach for ICE-compliant systems that avoids the need to rely on 

pair-wise clearance. The component-wise approach allows each ICE component to 

be cleared individually without having to enumerate a priori all the possible ways in 

which it might be combined and used within a system. The component-wise 

approach is enabled by standardized interfacing between components, a clear 

enumeration of the safety responsibilities and risks associated with each 

component, and evidence-based processes by which a component is shown to be 

safe and compliant with ICE interoperability standards.

Continua Health Alliance

Continua Health Alliance is a non-profit, open industry organization of health care 

and technology companies joining together in collaboration to improve the quality 

of personal health care. With more than 240 member companies around the world, 

Continua is dedicated to establishing a system of interoperable personal connected 

health solutions. Its focus on the personal telehealth arena encompasses disease 

management, health and wellness, and aging independently.

The Continua logo signals that a device is certified to be interoperable with any 

other Continua‐branded product. Continua acts as a certifying body for personal 

connected health devices, software, and services. There are currently more than 50 

Continua-certified products. These products tend to be small and portable, and 

generally rely upon personal area network (PAN) wireless protocols. Continua’s 

Design Guidelines contain references to the standards and specifications selected 

for ensuring interoperability of devices. The Guidelines are utilized to describe a 

complete end-to-end connection model that integrates several sets of standards into 

an interoperability paradigm. They also contain additional design guidelines for 

interoperability that further clarify standards and specifications by reducing options 

or adding missing features in the underlying standard or specification. These 

guidelines focus on interfaces to personal area network health devices, and between 

disease management services WAN devices (senders) and electronic health record 

devices (receivers). Existing standards such as IEEE 11073-20601 (plus device 

specialization standards), HL7, IHE Patient Care Devices, web security and wireless 

transport technology are used to fulfill use cases.

HITSP (Healthcare Information Technology Standards Panel)

HITSP was chartered by HHS to provide standards harmonization in the health 

information technology arena to meet the federal mandate for a universal electronic 

health record. It concluded its contract April 30, 2010. HITSP devised 

interoperability specifications (IS) based on use cases promulgated by the National 

e‐Health Collaborative (NeHC). The interoperability specifications are meant to be 

compulsory on any health care players that contribute to an electronic medical 

record.

Of particular interest to the medical device community is IS 77- Remote Monitoring. 

The Remote Monitoring Interoperability Specification addresses the information 

exchange requirements for the transfer of remote monitoring information from a 
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device physically attached to or used by a patient in a location that is remote to the 

clinician to an EHR system and/or a personal health record system. Moreover, 

HITSP’s “Device Connectivity Technical Note” (TN905) attempts to provide a 

roadmap for addressing more complex medical device connectivity situations. 

Specific requirements under consideration are only those arising from the 

Harmonization Requests assigned to HITSP that include device connectivity 

elements, especially the Common Device Connectivity (CDC) AHIC Extension/Gap 

(December, 2008), which includes generic types of devices such as ventilators and 

infusion pumps.

HL7 (Health Level Seven International)

HL7 is a not-for-profit, ANSI-accredited standards developing organization 

dedicated to providing a comprehensive framework and related standards for the 

exchange, integration, sharing, and retrieval of electronic health information. Its 

2,300+ global members include approximately 500 corporate members who 

represent more than 90% of the information systems vendors serving health care. 

Level Seven refers to the seventh level – the application level - of the ISO seven-layer 

communications model for Open Systems Interconnection (OSI). HL7 standards 

pertaining to electronic lab reporting to public health agencies, patient summary 

clinical document architecture and continuity of care documents, and messaging for 

public health surveillance and immunization submissions are included in HHS’ final 

rule for electronic health records.

HL7 established a Health Care Devices Working Group whose mission is to facilitate 

the integration of health care device information at the enterprise level. It proposes 

to establish standardized version 2.x and version 3 content; harmonize device data 

models between HL7 and other organizations (including ISO/IEEE 11073); 

coordinate device terminology usage within HL7 components; support revision of 

the Clinical and Laboratory Standards Institute (CLSI) Point of Care Test (POCT) and 

laboratory automation standards; and, work with other national and international 

organizations involved in health care device informatics and interoperability.

IEEE (Institute of Electrical and Electronics Engineers)

The IEEE Standards Association (IEEE-SA) is a globally recognized standards-setting 

body within IEEE. It develops consensus standards through engagement of a broad 

stakeholder community spanning more than 160 countries. The IEEE-SA has a 

portfolio of over 900 active standards and more than 500 standards under 

development. Two standards families of particular relevance to medical devices are

IEEE 802 and IEEE 11073.

IEEE 802.11

IEEE 802 standards deal with local area networks (LAN) and metropolitan area 

networks (MAN) that carry variable-size packets. The IEEE 802.11 standards

provide the basis for Wi-Fi-branded wireless network products. Wi-Fi has become 

increasingly relied upon for wireless health care devices. Despite the attractiveness 
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of low-cost, broad-based connectivity, Wi-Fi may not be well suited to safely support 

the proliferation of wireless medical devices.

IEEE 11073

IEEE 11073 standards pertain to medical, health and wellness device 

communications, and reflect joint efforts of the International Organization for 

Standardization (ISO) and the European Committee for Standardization (CEN).

Recent activity has targeted personal use of health and fitness devices (e.g., glucose 

monitors and weight scales), while continuing to focus on acute care devices (e.g., 

pulse oximeters, ventilators and infusion pumps). The 11073 standards promote 

automatic exchange and evaluation of vital signs between different medical devices, 

as well as remote control of those devices.

IHE (Integrating the Healthcare Enterprise)

IHE is a non-profit organization that was created in 1998 by health care 

professionals and industry to improve the way computer systems and other clinical 

technologies like medical devices share and use information. It is composed of more 

than 400 vendor, provider and government agency member organizations globally. 

It promotes the safe, secure and well-coordinated use of established technical 

standards (e.g., DICOM and HL7) to address specific clinical needs in support of 

optimal patient care. IHE is organized by clinical and operational domains (e.g., 

cardiology, eye care, radiology, and patient care coordination) and creates 

integration profiles. 

IHE is patient-, clinician- and process-centric. Therefore, by design, the IHE toolset 

integrates clinical and operational events using the context of clinical data (e.g., 

time, department and clinical and administrative process sequencing information) 

to trigger best practice alignment. IHE-compliant systems use best practice 

standards to generate health care quality notifications, data and reports. Because 

the internal architecture is designed for secure cross-enterprise, information 

exchange, there are product, institution, region, national, and trans-national 

implementations of IHE on several continents.

In 2005, IHE formed the Patient Care Device Domain (IHE PCD) to address issues 

related to integration of point-of-care medical devices both with each other and 

with enterprise systems. IHE PCD is based on use cases (e.g., reporting of 

implantable device data to EHRs) in which at least one actor is a patient-centric 

point-of-care medical device. An integration profile that describes actors, 

transaction(s), interface(s), and existing standard(s) is developed for each use case. 

This effort is co-sponsored by ACCE (American College of Clinical Engineering) and 

HIMSS (Healthcare Information and Management Systems Society). Each profile is 

designed to automate data transfer to EHRs and other medical devices to enhance 

clinical decision support and patient safety.

IHE PCD is addressing semantic interoperability thru its Rosetta Terminology 

Mapping (RTM) project. This profile maps proprietary medical device terminologies 
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to standardized ISO/IEEE 11073 concepts (including co-constraints that specify 

valid units of measurement and value enumerations). RTM supports harmonization 

activities within IHE, HL7, ISO TC215, IEEE 11073 and the International Health 

Terminology Standards Development Organisation (IHTSDO) to advance semantic 

interoperability.

IHE-compliant products are tested at five to seven annual “IHE Connectathon” 

events around the globe. IHE uses open-source testing software to coordinate the 

event, and integrates open source technical quality testing software written by NIST 

and similar national standards bodies from other countries to assure reliable test 

results. IHE is vender-neutral, and membership is free of charge to any vendor, 

health care organization, or government agency. All IHE profiles are balloted 

publically in the same manner as formal standards bodies. All IHE publications, 

software and Connectathon test results are publically available for examination or 

download worldwide at no charge.

MD PnP (Medical Device “Plug-and-Play” Interoperability Program)

The MD PnP program, established in 2004, has become a recognized leader in the 

development of the concepts and capabilities for integrated clinical environments of 

the future. MD PnP has been working to accelerate the adoption of medical device 

interoperability by providing interoperability building blocks (use cases, standards, 

a neutral lab environment, and open research tools) and by changing clinical and 

market expectations of what can be achieved.

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. CIMIT 

is a non-profit consortium of Boston's leading teaching hospitals and universities 

that fosters interdisciplinary collaboration among world-class experts in 

translational research, medicine, science and engineering, in concert with industry, 

foundations and government, to rapidly improve patient care. 

The MD PnP program has many collaborators, including the FDA, DoD, NIST, NSF, 

Veterans Health Administration, Anakena Solutions, DocBox Inc., Draeger, Draper 

Labs, Geisinger, Johns Hopkins Medicine, Kaiser Permanente, Kansas State 

University, LiveData, Massachusetts General Hospital, Mitre, Moberg Research Inc., 

Partners HealthCare System, Philips, the University of Illinois at Urbana-Champaign, 

and the University of Pennsylvania. It is funded in part by DoD/TATRC, NSF, NIST, 

CIMIT, and most recently a five-year Quantum Grant from NIH’s National Institute of 

Biomedical Imaging and Bioengineering toward overcoming technical, development, 

safety, clinical, regulatory, and certification adoption barriers to medical device 

interoperability through the creation of verified and validated interface software, 

development environments, and clinical environments. The project has been 

adopted as an affiliate of the SHARP (Strategic Health IT Advanced Research 
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Projects) program administered by HHS’ Office of the National Coordinator for 

Health Information Technology (ONC). 

The MD PnP program deliverables provided the foundation for the ASTM ICE 

standard, and the “MD FIRE” open source procurement language used by providers 

to specify interoperable medical devices and HIT through RFIs, RFPs, SOWs, and 

SLAs. The 1.0 version of this contract language was approved by Kaiser Permanente, 

Partners Healthcare, and Johns Hopkins. Version 2.0 is currently in development 

and will be released in February 2012. 

MITA (Medical Imaging & Technology Alliance)

MITA, a division of the National Electrical Manufacturers Association (NEMA), is the 

leading organization for medical imaging equipment manufacturers, innovators, and 

product developers. It represents companies whose sales comprise more than 90 

percent of the global market for medical imaging technology. These technologies 

include medical X-ray equipment, computed tomography (CT) scanners, ultrasound, 

nuclear imaging, radiopharmaceuticals, radiation therapy equipment, magnetic 

resonance imaging (MRI), and imaging information systems. MITA is responsible for 

overall management and administration of the DICOM Standard, and its committees 

and work groups.

DICOM (Digital Imaging and Communications in Medicine)

DICOM is a global standard that is used in virtually all hospitals worldwide. It is 

designed to ensure the interoperability of systems used to produce, store, display, 

process, send, retrieve, query or print medical images and derived structured 

documents, as well as to manage related workflow. DICOM establishes a set of 

communication protocols; specifies syntax and semantics of commands and 

associated information exchanged using these protocols; specifies media storage 

(file formats and medical directory structure); specifies format for devices to claim 

conformance to components of DICOM, and a protocol to negotiate which 

components of the standard are supported and will be used for any given 

communication.

NIST (National Institute of Standards and Technology)

Founded in 1901, NIST is a non-regulatory federal agency within the U.S. 

Department of Commerce. NIST's mission is to promote U.S. innovation and 

industrial competitiveness by advancing measurement science, standards, and 

technology in ways that enhance economic security and improve our quality of life.

Medical Device Communications Testing Project 

NIST researchers are collaborating with medical device experts to facilitate the 

development and adoption of standards for medical device communications 

throughout the health care enterprise as well as integrating it into electronic health 

records. They are developing point-of-care medical device communication 

standards that address plug-and-play medical device interoperability.
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NIST researchers have developed test tools and corresponding electronic 

representation of an international standard's information model that provides 

several important capabilities leading toward device interoperability. Test tools 

include the following:

ICSGenerator – Implementation Conformance Statement (ICS) generator that 

facilitates creation of vendor conformance statements that would be 

applicable to testing a particular ISO/IEEE 11073 (X73) device.

ValidatePDU – Provides basic syntax and structure check, and low-level 

semantic checks for one or more captured messages.

NIST’s Information Technology Laboratory (ITL) is collaborating with ISO/IEEE 

11073 (X73) Medical Device Communications, IHE PCD domain working groups, and 

the Personal Health Devices working group. They are developing conceptual 

information-based frameworks and test tools that ensure device implementations 

are conformant to medical device standards. This effort ultimately contributes to 

high priority needs to reduce medical errors, promote patient safety and provide 

accurate information into electronic health record systems.

UL (Underwriters Laboratories)

UL is a global independent safety science company with more than 116 years of 

history. It employs more than 6,900 professionals in over 100 countries, and has 

five distinct business units -- Product Safety, Environment, Life and Health, 

University, and Verification Services.

UL filed a project initiation notification with ANSI (American National Standards 

Institute) to develop a standard for safety for interoperable medical devices 

interface standards (IMDIS). According to the May 13, 2011 ANSI Standard Action, 

BSR UL 2751-201x defines the safety and related specifications of medical device 

interface(s) required when it is declared an interoperable medical device. The 

standard will address the available medical device interface characteristics needed 

to operate under safe interoperable conditions. The standard will focus on the safety 

and risks mitigation associated to the interoperability of the medical device 

interface within an integrated clinical environment and interoperable scenario.
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© 2012 West Health. All Rights Reserved.

How Can FDA Advance Wireless Medical Device Interoperability?

The importance of wireless medical device interoperability to improving health care 

delivery is generally accepted. Furthermore, the efforts of many groups, particularly 

those highlighted above, suggest that interoperability is technically achievable.

Importantly, experience has shown that overarching system value and 

technical feasibility alone are insufficient to incentivize an interoperability 

solution. Rather, market-based innovation will, as it did in the case of EMRs, 

perversely incentivize a series of ‘walled-garden’ proprietary solutions, each limited 

to a segment of the overall health care ecosystem. 

In order to accelerate the imperative of wireless medical device interoperability, we 

believe there is a key role for the FDA to play. The agency can enhance 

interoperability by advocating for it, assuring a rational and uniform set of 

requirements, enabling testing against those requirements by certified bodies, and 

granting specific labeling related to interoperability. The market has yet to produce 

interoperable devices, despite their acknowledged benefits – enabling the safety and 

efficacy of health care – and end users’ requests. The FDA can fill this void by using 

its leadership position to assert that interoperability is vital and appoint certifying 

bodies to test interoperable solutions. The agency already has several mechanisms 

at its disposal to encourage interoperability, including establishing requirements for 

labeling claims for wireless medical device interoperability, modifying device 

review processes, helping standards development efforts, updating policies, 

leveraging and coordinating interoperability efforts with the Office of the National 

Coordinator for HIT, etc. Three primary actions include:

1. The agency, in concert with the above listed organizations and other critical 

stakeholders (hospital system CIOs and CTOs, medical device manufacturers,

etc.), needs to establish a regulatory pathway for specific levels of functional 

interoperability claims.

2. The agency needs then to recognize external certifying bodies that test and 

validate candidate devices against the requirements for those claims.

3. The agency should encourage demonstration of the benefits of deploying

interoperable-certified wireless medical devices through affirmative actions

with model hospitals and other setting-oriented constructs. 

Creation of a mechanism to assert, certify, and demonstrate interoperability claims 

would enable regulators to more quickly evaluate devices; device manufacturers to 

more effectively innovate; end users to better assess the tools they wish to employ; 

and, patients to be assured that their care is being optimized.
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© 2012 West Health. All Rights Reserved.

Next Steps

A common understanding of the challenges associated with wireless medical device 

interoperability and close coordination of remediation efforts are necessary to 

develop solutions that will be broadly adopted and implemented. Solution efforts 

must begin with the end in mind – solving unmet clinical needs as espoused by 

the health care delivery system. Action across several fronts will be necessary to 

advance interoperability efforts. We offer the following suggestions:

 Engage Implementers. Those entities and individuals (e.g., CIOs and CTOs) 

that bear responsibility for delivering care and integrating interoperable 

solutions lend a critical voice. They are a resource for the FDA, 

manufacturers and industry to understand clinical needs and functional 

requirements, and can best assess the feasibility of solutions. Broad 

representation of the voice of health care delivery is inadequate in efforts to 

derive concrete, implementable solutions, and should be included in a 

greater, structured capacity.

 Leverage Procurement Power. A key hurdle to breaking vertically 

integrated silos is the lack of a business model for manufacturers to do so. If 

customers (ie, health care delivery) were to demand interoperability and 

specify functional requirements in RFPs, there would be greater “pull” from 

the demand side. 

 Include Interoperability in Meaningful Use. Adoption of interoperable 

solutions (and thereby development) could be advanced by incorporating 

interoperability requirements into meaningful use criteria. These 

requirements should be grounded in open standards-based medical device 

interoperability solutions that are informed by clinical needs.

Summary

Advancing wireless medical device interoperability is critical to improving health 

care delivery and health outcomes, improving the costs and speed of innovation, 

lowering the cost of care, and enabling a sustainable and affordable health care 

system. Despite these recognized benefits and the requests of end users, the market 

understandably has failed to deliver broad interoperability. To alleviate this market 

failure, the government has a responsibility to act. 

The FDA is uniquely positioned to enhance interoperability by requiring it. A 

pathway to interoperability should be construed in consultation with the health care 

delivery system and other parties that have long been engaged in this complex 

effort. Key facets will include understanding the clinical needs to be met and 

establishing a testing and certification mechanism that is open to all manufacturers.
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© 2012 West Health. All Rights Reserved.

The health care delivery system, established manufacturers, innovation community, 

standards development bodies and regulatory agencies must come together to forge 

interoperability solutions. These solutions should ensure that devices work together

(by learning patient information from each other) to change care for the better. We 

must arm our health care system with the tools to prevent the onset of illness while 

supporting a population that is aging with a greater burden of chronic disease.

Issue date: 20 January 2012

For more information, please contact:

Kerry McDermott, MPH

Senior Policy Director

West Health Policy Center

kmcdermott@westhealth.org

202.617.6009