Medical Device Interoperability Research Articles

The Case for Medical Device Interoperability

The Case for Medical Device Interoperability

Usability Engineering Recommendations for Next-Gen Integrated Interoperable Medical Devices.

This article reports on the development of usability engineering recommendations for next-generation integrated interoperable medical devices. A model-based hazard analysis method is used to reason about possible design anomalies in interoperability functions that could lead to use errors. Design recommendations are identified that can mitigate design problems. An example application of the method is presented based on an integrated medical system prototype for postoperative care. The AAMI/UL technical committee used the results of the described analysis to inform the creation of the Interoperability Usability Concepts, Annex J, which is included in the first edition of the new ANSI/AAMI/UL 2800-1:2019 standard on medical device interoperability. The presented work is valuable to experts developing future revisions of the interoperability standard, as it documents key aspects of the analysis method used to create part of the standard. The contribution is also valuable to manufacturers, as it demonstrates how to perform a model-based analysis of use-related aspects of a medical system at the early stages of development, when a concrete implementation of the system is not yet available.

Usability Engineering Recommendations for Next-Gen Integrated Interoperable Medical Devices

This article reports on the development of usability engineering recommendations for next-generation integrated interoperable medical devices. A model-based hazard analysis method is used to reason about possible design anomalies in interoperability functions that could lead to use errors. Design recommendations are identified that can mitigate design problems. An example application of the method is presented based on an integrated medical system prototype for postoperative care. The AAMI/UL technical committee used the results of the described analysis to inform the creation of the Interoperability Usability Concepts, Annex J, which is included in the first edition of the new ANSI/AAMI/UL 2800-1:2019 standard on medical device interoperability. The presented work is valuable to experts developing future revisions of the interoperability standard, as it documents key aspects of the analysis method used to create part of the standard. The contribution is also valuable to manufacturers, as it demonstrates how to perform a model-based analysis of use-related aspects of a medical system at the early stages of development, when a concrete implementation of the system is not yet available.

Service-Oriented Medical Device Connectivity: Particular Interoperability Standards for High Frequency Surgical Equipment and External Control Devices

Abstract Manufacturer-independent medical device interoperability has been strongly demanded by the clinicians and healthcare delivery organizations (HDOs), however has not been achieved in practice for decades. The ISO/IEEE 11073 Service-oriented Device Connectivity (SDC) family of standards constitutes a paradigm shift. This work supplements SDC with Device Specializations (DevSpecs) or Modular Specifications (ModSpecs): particular interoperability standards for high frequency (HF) surgical equipment and external control devices, such as foot or finger switches. They provide models to describe these devices in a service-oriented medical device system and modes of interaction with other network participants. Additionally, we contribute to the ISO/IEEE 11073-10101 nomenclature standard to provide semantic descriptions of the exchanged information. This is a key enabler for safe and effective medical device interoperability to support the caregivers and improve patient safety as well as clinical outcome.

Service-Oriented Medical Device Connectivity: Particular Standards for Endoscopic Surgery.

To translate recent advances in medical device interoperability research into clinical practice, standards are being developed that specify precise requirements towards the network representation of particular medical devices connecting through ISO/IEEE 11073 SDC. The present contribution supplements this protocol standard with specific models for endoscopic camera systems, light sources, insufflators, and pumps. Through industry consensus, these new standards provide modular means to describe the devices' capabilities and modes of interaction in a service-oriented medical device communication architecture. This enables seamless data exchange and the potential for new assistive systems to support the caregiver.

GATOR: connecting integrated operating room solutions based on the IEEE 11073 SDC and ORiN standards.

Medical device interoperability in operating rooms (OR) provides advantages for both, patients and physicians. Several approaches were made to provide standards for successful device integration. However, with high heterogeneity of standards in the market, device vendors may reject these approaches. The aim of this work is therefore to provide a proof of concept for the connection of two promising integration solutions OR.NET and SCOT to increase vendor interest. The connection of devices between both domains is targeted by implementing an application to map device capabilities between the IEEE 11073 SDC and ORiN standards. Potential properties of the respective architectures are defined. The connection was evaluated by latency measurements in a demonstrator setup utilizing an OR light as an exemplary device. The latency measurements resulted in a similar transmission speed of the GATOR (53.0ms) and direct SDC-to-SDC (38.0ms) communication. Direct proprietary ORiN-to-ORiN communication was faster in any case (8.0ms). A connection between both standards was successfully achieved via the GATOR application. The results show comparable magnitudes of the communication between the standards compared to the direct standard-internal communication.

Service-Oriented Device Connectivity: Device Specialisations for Interoperability.

There are IEEE 11073 standards for foundational, structural, and semantic point-of-care medical device interoperability, but the first devices with this interface have yet to enter the market. One of the missing pieces for implementation and approval are Device Specialisations that specify how to use information and service models to represent a specific type of device on the network. Required and optional metrics need to be standardised as well as nomenclature terms, units of measure, and extension points. Finally, device-to-device interaction at runtime has to be defined for automatic verification during testing and approval. Applications include C-arm fluoroscopes used in different clinical settings.

Mitigating network-layer security attacks on authentication-enhanced openICE

Integrated Clinical Environment (ICE) is a standardized framework for achieving medical device interoperability. It utilizes high-level supervisory and medical apps and low-level communication middle-ware to coordinate medical devices to accomplish a shared clinical mission. With the potential to significantly improve healthcare productivity and reduce medical errors, the interoperability of medical devices also subjects ICE systems to unprecedented security threats. In this paper, we present a set of security attacks, namely interception, tampering, and replay attack, to the network level of ICE systems, which we identify through a threat modeling analysis on OpenICE, the best-known instantiation of ICE system. For these security attacks, we devise corresponding defense mechanisms on top of OpenICE. Our experiments demonstrate that these defense mechanisms can effectively protect OpenICE from the identified attacks with acceptable computational overhead.

OR.NET: a service-oriented architecture for safe and dynamic medical device interoperability.

Modern surgical departments are characterized by a high degree of automation supporting complex procedures. It recently became apparent that integrated operating rooms can improve the quality of care, simplify clinical workflows, and mitigate equipment-related incidents and human errors. Particularly using computer assistance based on data from integrated surgical devices is a promising opportunity. However, the lack of manufacturer-independent interoperability often prevents the deployment of collaborative assistive systems. The German flagship project OR.NET has therefore developed, implemented, validated, and standardized concepts for open medical device interoperability. This paper describes the universal OR.NET interoperability concept enabling a safe and dynamic manufacturer-independent interconnection of point-of-care (PoC) medical devices in the operating room and the whole clinic. It is based on a protocol specifically addressing the requirements of device-to-device communication, yet also provides solutions for connecting the clinical information technology (IT) infrastructure. We present the concept of a service-oriented medical device architecture (SOMDA) as well as an introduction to the technical specification implementing the SOMDA paradigm, currently being standardized within the IEEE 11073 service-oriented device connectivity (SDC) series. In addition, the Session concept is introduced as a key enabler for safe device interconnection in highly dynamic ensembles of networked medical devices; and finally, some security aspects of a SOMDA are discussed.

Knowledge management in cyberphysical systems: determining the quality requirements for health systems with the Kano model

This paper focuses on knowledge management in cyberphysical systems (CPS), dealing with the importance and influence of smart technologies for the creation of the smart health systems as a part of the smart home. This approach considers the reorganisation and adaptation of medicine and health systems, building the research framework upon knowledge management 4.0 for health systems. Customer satisfaction or dissatisfaction was researched using the qualitative methodology of the Kano model. The questionnaire deals with five factors that play a crucial role in the decision to purchase such a system: 1) software reliability; 2) medical device interoperability; 3) security and privacy; 4) system feedback; 5) architecture. The results show that attractive requirements, such as architecture and medical device interoperability, have high values for customer satisfaction and low scores for customer dissatisfaction.

Knowledge management in cyberphysical systems: determining the quality requirements for health systems with the Kano model

This paper focuses on knowledge management in cyberphysical systems (CPS), dealing with the importance and influence of smart technologies for the creation of the smart health systems as a part of the smart home. This approach considers the reorganisation and adaptation of medicine and health systems, building the research framework upon knowledge management 4.0 for health systems. Customer satisfaction or dissatisfaction was researched using the qualitative methodology of the Kano model. The questionnaire deals with five factors that play a crucial role in the decision to purchase such a system: 1) software reliability; 2) medical device interoperability; 3) security and privacy; 4) system feedback; 5) architecture. The results show that attractive requirements, such as architecture and medical device interoperability, have high values for customer satisfaction and low scores for customer dissatisfaction.

OpenICE medical device interoperability platform overview and requirement analysis.

We give an overview of OpenICE, an open source implementation of the ASTM standard F2761 for the Integrated Clinical Environment (ICE) that leverages medical device interoperability, together with an analysis of the clinical and non-functional requirements and community process that inspired its design.

The Need to Apply Medical Device Informatics in Developing Standards for Safe Interoperable Medical Systems.

Medical device and health information technology systems are increasingly interdependent with users demanding increased interoperability. Related safety standards must be developed taking into account these systems' perspective. In this article, we describe the current development of medical device standards and the need for these standards to address medical device informatics. Medical device information should be gathered from a broad range of clinical scenarios to lay the foundation for safe medical device interoperability. Five clinical examples show how medical device informatics principles, if applied in the development of medical device standards, could help facilitate the development of safe interoperable medical device systems. These examples illustrate the clinical implications of the failure to capture important signals and device attributes. We provide recommendations relating to the coordination between historically separate standards development groups, some of which focus on safety and effectiveness and others focus on health informatics. We identify the need for a shared understanding among stakeholders and describe organizational structures to promote cooperation such that device-to-device interactions and related safety information are considered during standards development.

Coordination or Collision? The Intersection of Diabetes Care, Cybersecurity, and Cloud-Based Computing.

Diagnosis and treatment of diabetes changed little from the Middle Ages through the early 19th century, when the first chemical test for the condition was developed. In the 20th century, advances in diabetes management gained momentum with home-use diagnostic devices and mass-produced insulin. In the 21st century, technological developments around diabetes are advancing so rapidly that a small, discrete system of medical devices that serve as an artificial pancreas are now possible. In this article, we assert that medical device interoperability and cyber security are necessary preconditions for safe, effective, and reliable widespread use of the artificial pancreas system.

Assessing a Hospital's Medical IT Network Risk Management Practice with 80001-1

Medical device interoperability has been identified as a key way of decreasing healthcare costs while improving patient care. 1 This has led to a shift toward placing more medical devices onto information technology (IT) networks. However, placing medical devices onto an IT network may lead to additional risks to safety, effectiveness and security of the devices, the network, and the data. ANSI/AAMI/IEC 80001-1 addresses the roles, responsibilities, and activities that need to be carried out when managing these risks. In this article, we describe an exercise undertaken to assess the medical IT network risk management practice implemented within a hospital to control risk associated with a clinical information system (CIS). The level of compliance with the 80001-1 standard was determined using an assessment framework developed by the Regulated Software Research Centre. The purpose of this exercise was to test and inform the development of an assessment method that is part of the assessment framework for this standard. The exercise also sought to identify how the management of such an existing CIS project meets the requirements of 80001-1.

On the Seamless, Harmonized Use of ISO/IEEE11073 and OpenEHR

Standardized exchange of clinical information is a key factor in the provision of high quality health care systems. In this context, the openEHR specification facilitates the management of health data in electronic health records (EHRs), while the ISO/IEEE11073 (also referred to as X73PHD) family of standards provides a reference framework for medical device interoperability. Hospitals and health care providers using openEHR require flawless integration of data coming from external sources, such as X73PHD. Hence, a harmonization process is crucial for achieving a seamless, coherent use of those specifications in real scenarios. Such harmonization is the aim of this paper. Thus, the classes and attributes of a representative number of X73PHD specializations for medical devices--weight, temperature, blood pressure, pulse and heart rate, oximetry, and electrocardiograph--along with the X73PHD core document--ISO/IEEE11073-20601--have been analyzed and mapped to openEHR archetypes. The proposed methodology reuses the existing archetypes when possible and suggests new ones--or appropriate modifications--otherwise. As a result, this paper analyzes the inconsistencies found and the implications thereof in the coordinated use of these two standards. The procedure has also shown how existing standards are able to influence the archetype development process, enhancing the existing archetype corpus.

5.6.1 System Engineering Enabling Transformational Change: Engineering a New Healthcare Ecosystem

AbstractThe healthcare industry is approaching a tipping point, which could lead to a radical transformation from closed system medical devices to a fully interconnected and integrated healthcare ecosystem. In fact, the change catalyst, an engineered future‐state system architecture, is currently under development through the MD PnP program's NIH‐funded Quantum Medical Device Interoperability (QMDI) project. The healthcare industry will require the support and input of systems engineers in the coming years more than ever before. Shared cross industry learning will be crucial for success. This paper provides a perspective on the need for transformative change and outlines the industry's progression towards evolution, including the planned outcomes of the Quantum project.

Medical Device Interoperability and Data Integration to Clinical Information Systems : Medical Device Data Alignment

<i>Medical Device Interoperability and Data Integration to Clinical Information Systems</i> : Medical Device Data Alignment

Helping the Cause of Medical Device Interoperability: A standards-based testing approach based on identifying and obtaining testable assertions

We present a black-box messaging test approach employed to achieve a level of rigor which improves, if not assures (given no optionality and fully constrained), correct data exchange. In particular, verifying that physiological information derived and communicated via messaging from a source medical device (e.g., an infusion pump) or healthcare information system, to another medical device (e.g., a patient monitor) or healthcare information system which consumes or make use of the data is syntactically and semantically correct. Our approach for developing a test system to validate messages is based on constraining identified and recognized specifications. The test system validation performed uses codified assertions derived from the specifications and constraints placed upon those specifications. To first show conformance which subsequently enables interoperability, these assertions, which are atomic requirements traceable by clause to the base specifications, are employed by our medical device test tools to rigorously enforce standards to facilitate safe and effective plug-and-play information exchange.

Trends and challenges of the emerging technologies toward interoperability and standardization in e-health communications

Information exchange has experienced a paradigm shift due to the appearance of wireless transport technologies. A wide variety of technologies have been proposed recently with different characteristics for diverse application environments. Such emerging technologies can be applied — depending on their specific features — to different e-health use cases. Additionally, some of those technologies have already adopted a path to medical device interoperability, while others are on their way to enable that potential. Hence the need to perform an overview of such technologies, which can be useful when designing interoperable, wireless-enabled e-health solutions. This article therefore reviews the emerging technologies that can be incorporated into the complex e-health information communication ecosystem and details the transport technologies that have adopted a specialized medical profile for ISO/IEEE 11073 interoperability such as USB, Bluetooth, and ZigBee. Discussion is focused on the expected path of novel emerging technologies toward ISO/IEEE 11073-compliant medical device interoperability. As a result, this article provides an up-to-date guideline for designers of standard-compliant wireless-enabled e-health architectures, helping in the selection of the appropriate technology for their designs.