How Medical Device Interoperability Connects Healthcare

According to the Healthcare Information and Management Systems Society (HIMSS), interoperability is “the ability of different information systems, devices, and applications to access, exchange, integrate, and cooperatively use data in a coordinated manner, within and across organizational, regional, and national boundaries, to provide timely and seamless portability of information and optimize the health of individuals and populations globally.”¹

Interoperability in the medical device industry today is characterized by impressive advances as well as persistent challenges. The COVID-19 pandemic clarified the need for interoperability not only among IT systems, but also with medical devices. Massive amounts of health data continue to be generated by a growing number of more complex and capable devices—however, the data is frequently fragmented or, in some cases, completely inaccessible. The lack of a fully integrated, interoperable, and secure healthcare infrastructure (including medical devices) makes it difficult to break down silos so vital medical data can flow efficiently in real time for better-informed decision-making.

“The challenges are often complex, multi-dimensional, and anything but easy to solve—especially for new entrants,” said Amit Trivedi, senior director of informatics and HIT standards for HIMSS, a Chicago, Ill.-based member-based society that helps medical device manufacturers (MDMs) and healthcare systems adopt digital solutions, including for interoperability. “Patient safety is paramount—so approaches that may work in other industries do not always translate easily in the healthcare environment. Data privacy and security of systems cannot be overlooked. Regulatory requirements can differ at the international, national, or local level.”

For interoperability, it is extremely difficult to get all stakeholders moving forward in the same front. Although considerable progress has been made, significant barriers and complexities still hinder seamless data exchange and collaboration among devices and systems. MDMs are eager to expand from a sole-device or sole-purpose platform to a much more integrated approach. Not only are medical devices becoming smarter, they also can deliver information to a number of other different platforms. Although priorities vary among manufacturers and providers, most would agree that “responding to customer demands and integration with EMR [electronic medical records] systems is becoming increasingly important,” said Jay Hill, vice president of advanced technology for GE HealthCare, a Chicago, Ill.-based medical technology firm that provides diagnostic and digital solutions to healthcare organizations.

“Interoperability is a prime focus area for streamlining patient care,” added Mohammad Waqas, principal solutions architect for healthcare for Armis, a leading asset visibility and security company. “Applications are able to import and export data, but also trigger workflows. Health information systems [HIS]/EMR are getting even larger with different modules for care, web portals for streamlined clinical workflows, mobile applications for patients to access care results, and establishing regional care services.”

At the Forefront

The medical device industry is making continuous efforts to improve data exchange, integration, and collaboration in healthcare. For interoperability, companies typically vary in their progress and implementation, with some being more advanced and others lagging behind. However, it is important to note that no single company is universally ahead in all areas of interoperability, observed Hill. “Each company has its own strengths and weaknesses, and progress may vary depending on factors such as standards adoption, resources, collaborations, regulatory environment, and the complexity of legacy systems,” he said.

Building a coherent framework for interoperability is a top goal for MDMs. Currently, a variety of different approaches (and complexities) for establishing interoperability exist, at different levels. For example, interoperability between the products of a single vendor will be different than those between different vendors. In most cases, each device vendor and its medical devices are unique in their output and ability to connect to other systems. The data needs to be accessed and then aggregated so applications can analyze and share data and insights across the care team. The data also must be normalized and prepared for use by one or multiple systems to support documentation in the EMR.

Sometimes, because of complexity and scale, interoperability can seem like a scramble—for example, the Fast Healthcare Interoperability Resources (FHIR) standard. As per the Gartner Hype Cycle, the interest surrounding FHIR continues to grow, but it is important to note that although FHIR holds promise, it does not address all complexities related to interoperability. Consequently, “some disillusionment regarding its ability to fully solve interoperability challenges has emerged,” said Hill. “It is crucial to manage expectations about one standard solving all interoperability issues, and recognize that achieving comprehensive interoperability requires addressing a range of technical, organizational, and standardization complexities.”

Interoperability can appear daunting to MDMs with non-dedicated personnel and/or limited resources. This is where integration consultants can work with MDMs to build seamless integration across different enterprises. Additionally, prominent technology firms are increasingly venturing into healthcare as providers of cloud services and data aggregation solutions for clinical and research applications.

Many larger MDMs have a core focus group working with their systems, sometimes in collaboration with prominent HIS players and other groups. “However,” said Waqas, “there are many ‘middleware’ companies focused explicitly on interoperability, as well as larger organizations such as Microsoft that are helping enable interoperability between the different systems. This really helps because, regardless of size, interoperability benefits can be achieved whether you have an entire ecosystem of products, or you are extracting information from a median solution.”

Categories of Interoperability

Organizational interoperability is the ultimate level of interoperability—it involves the governance, policy, social, legal, and organizational considerations to facilitate secure, seamless, and timely communication. This includes the flow of data across workflows and processes, both internal and external to the organization.
Other categories of interoperability to consider are:

• Foundational: The inter-connectivity requirements and technical aspects for one system to connect to another
• Structural or syntactic: Ability for systems to exchange data using compatible formats and syntax
• Semantic: Common models and codification of data providing shared understanding and meaning to the user

Different levels of interoperability correspond to the increasing complexity of systems and devices. “As a system becomes more complex, achieving higher levels of interoperability becomes more challenging and intricate,” said Hill.

For example, newer and smarter devices often have more features that are ready for adoption and can unlock additional potential that older legacy devices cannot. Medical devices, especially the more expensive ones, may not get replaced as often—so interoperability is not only based on compatibility and design, but also on the adoption rate and readiness of the organizations. “In some cases,” noted Waqas, “additional efficiencies for an interoperable-first organization will continue to be achieved as newer generation devices are introduced. However, interoperability’s greatest success comes from a strategic push from the top. It cannot be up to one department to push it simply because their vendor ecosystem allows for it. Rather, senior leadership must make it a strategic approach for all systems, with the key goal of integrating systems to achieve greater efficiencies.”

Top Challenges for Interoperability

There are different dimensions of interoperability to consider, depending on the device and its use. For example, for workflow, how does data move from device to device, or to another system? “Will data be contained within an organization or system, or will it be cross-organization?” asked Trivedi. “Diagnostic devices need to pay more attention to how the data is collected and calibrated as part of an overall data payload.”

Some major obstacles to achieving interoperability in medical devices today include inadequate standards, cybersecurity and privacy, interfacing effectively with legacy systems, and integrating EMR systems. MDMs are always looking for technologies that give them as much flexibility in interoperability as possible for meeting customer needs, with the simplest platform.

“The challenge with interoperability is always about getting data to flow between platforms—say, from Platform/Technology 1 to Platform/Technology 2, without having to significantly change either platform,” said Kevin Morwood, software engineering manager for Thornhill Medical, a Toronto, Ont.-based designer and manufacturer of mobile medical technology for military, emergency, disaster, and extreme environments. “An additional challenge is that the number of interesting platforms is constantly changing. We can no longer simply target Windows as the standard—it is one standard, but there are many others now.”

In the U.S., a baseline standardization of terminologies, communication transport protocols, and cybersecurity requirements have been put forth by the Office of the National Coordinator’s certification program for EMR and health information technology product developers. However, medical devices have largely been left out of these regulatory requirements. “The vast array of use cases, information payloads, connectivity options, product designs, as well as the existing regulatory environment for medical device manufacturers all present additional challenges and barriers to interoperability standards development and adoption,” said Trivedi.
Healthcare organizations often rely on a variety of systems, including many legacy applications that require custom or specialized interfaces. Standards like FHIR aim to address these types of challenges by leveraging application programming interfaces (APIs), thereby accelerating the adoption of the FHIR standard in medical devices (and throughout the healthcare industry), which will likely lead to specific regulations, mandates, and incentives.

The variety of systems in use is a major factor in the creation of fragmented data, which slows down interoperability. Medical device data are currently fragmented by device type, ranging from consumer health applications to wearables, ambulance-mounted equipment, and both moveable and stationary devices in clinical settings. “This fragmentation underscores the need to facilitate seamless interfacing by providing common language, protocols, principles, and ground rules,” stated Brian James Miller, assistant professor of Medicine at Johns Hopkins University, in JAMA Health Forum.²

Connected devices also present security challenges by introducing potential vulnerabilities into a system. In healthcare, ensuring the security and privacy of patient data is essential for protecting against unauthorized access, data breaches, and potential harm to patients. Cybersecurity is an increasing concern for the FDA as medical devices become more complex; the agency’s recommendations for protecting devices and systems from cybersecurity vulnerabilities can be viewed at its Cybersecurity page.³ New guidelines as of March 2023 are posted at Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices Under Section 524B of the FD&C Act.⁴

Armis recently analyzed data from all connected medical and Internet of Things devices on the Armis Asset Intelligence and Security Platform and found that nurse call systems are the riskiest connected medical device: 39% of them have critical severity unpatched common vulnerabilities and exposures (CVEs), with nearly half (48%) having unpatched CVEs. Infusion pumps are the second-most risky medical device, with 27% having critical severity unpatched CVEs and 30% having unpatched CVEs.

“We also found that nearly one in five (19%) connected medical devices are running unsupported operating system versions,” said Waqas. “With healthcare delivery organizations often relying on legacy devices, outdated operating systems are a pervasive security challenge.”

Recent Successes

Improvements in interoperability are largely software-driven. Recent technology and software advances that enhance medical device interoperability include:

• Cloud computing provides scalable storage, processing power, and connectivity, enabling seamless integration and data exchange among different devices and systems.
• APIs offer standardized interfaces for data exchange, facilitating interoperability between healthcare systems and devices.
• Microservices architecture, where applications are built as independent services, enable flexibility, scalability, and independent development and deployment of services.
• Incorporating wearables, fitness trackers, and remote monitoring devices into healthcare systems enables the integration of valuable health data for improved patient care and population health management. This data can be used to create early warning score systems for patients—if vital signs for a patient decline, a rapid response team of nurses and other clinicians is deployed immediately to assess the patient.

These technology tools and systems help MDMs and healthcare facilities ensure their data flows in a standard way that can reach external systems safely and securely. “For a smoother process to reach system-wide interoperability, find a technology partner that can take data coming from hundreds of different devices and bring it through one pipeline that can read it, manage it, and send it to different places across the organization, so that care providers can easily access and use it to make informed clinical decisions,” said Elad Benjamin, general manager for clinical integration and insights for Philips, a Netherlands-based medical technology company. “Comprehensive medical device integration can support the way care is delivered by integrating devices across a health system and the care continuum.”

With the support of Philips’ Medical Device Integration Platform, one of the largest hospital systems in Texas built a clear plan to connect disparate medical devices and associated technologies across its sites. This included implementing comprehensive medical device integration standards so all existing and future devices meet the same criteria to ensure seamless communication across clinical settings. “After four years, the healthcare system achieved system-wide interoperability and has more than doubled the number of connected devices across its enterprise in less than four years,” said Benjamin. “When interoperability is achieved with the support of medical device integration software, the resulting ease of retrieving patient information across the system’s sites and departments, time given back to clinicians, and organizational cost savings will contribute to an increased standard of care and improved clinical outcomes.”

Another successful use case is the widespread adoption of IHE [Integrating the Healthcare Enterprise] Scheduled Workflow (SWF). This solution has been embraced by over 4,000 hospitals and 1 million providers that capture, access, and exchange diagnostic imaging orders and reports using SWF elements. “Nearly all GE HealthCare imaging systems support IHE SWF, highlighting its effectiveness and broad implementation in enhancing interoperability,” said Hill. “We also intend to develop the Edison Digital Health Platform to aggregate data from multiple sources and enable clinical applications that support integrated care pathway management.”

Thornhill Medical is actively using its “data pipelining” capabilities to build APIs and other interfaces. “These protocols are the language the device speaks,” said Morwood. “We’re building translators into APIs that allow the data conveyed by that language to be understood by any application without having to learn the language itself. This decoupling of the device from the potential uses gives us a great deal of flexibility. We can even change/extend the underlying language without breaking the APIs.”

The company is also engaged in several interoperability research projects across North America. In 2021 Thornhill Medical and Cognitive Medical Systems announced a collaboration with the U.S. Department of Defense Medical Technology Enterprise Consortium to advance medical device interoperability and remote control. This work is part of a sustained drive to improve military field care, particularly focusing on innovations that enable flexible, dynamic capacity to meet local critical care demand with remotely controlled and eventually autonomous medical devices.⁵

Moving Interoperability Forward

According to Facts and Factors, the global medical device interoperability market was valued at about $23.5 billion in 2021 and is estimated to grow to about $41 billion by 2028, a compound annual growth rate of approximately 9.7%. Key drivers of growth are the healthcare industry’s pressing need to reduce costs, utilize EMR more effectively, and adopt a variety of cloud technologies.⁶

Many of the efforts to move interoperability forward are collaborative in nature between industry, government agencies, and academia. For example, HIMSS, as an industry association and convener of leaders in health information technology, is very involved in interoperability for healthcare. HIMSS supports a number of activities and initiatives that helps advance interoperability in the medical device industry such as:

• HIMSS Interoperability Committee
• The Interoperability Showcase: Use case-based, real-world standards-based exchange demonstrations at the HIMSS Global Conference
• IHE USA (Integrating the Healthcare Enterprise; www.iheusa.org)
• IHE Device/Patient CARE Device Domain and Technical Framework
• IHE North American Connectathon

Cybersecurity for medical devices is a critical concern, especially as devices become increasingly complex. Secure data interoperability decreases the impact of breaches. By understanding the full scope of risk to continuity of operations for healthcare organizations, the Armis Platform can provide high-fidelity information, security data visualization, and response capabilities throughout the entire clinical workflow process to help improve the quality of care and reduce inefficiencies at the same time. “Newer smart connected devices have so many attributes they can collect to, report on, or integrate with,” said Waqas. “It is important to understand how to secure them and how they should behave, and to continuously monitor them to ensure the different components that create an integrated system remain secure.”

Innovation and digitization have helped healthcare systems improve patient experience and achieve better outcomes while reducing costs and improving staff experiences; however, there are still plenty of challenges and data complexities that can jeopardize efficiency and outcomes. Now, more than ever, health systems are looking for enterprise-wide strategies to achieve end-to-end data integration. Continued improvement in interoperability will require the dedicated and collaborative work of MDMs, healthcare leaders, health-technology firms, and regulatory agencies to standardize protocols and platforms.

For example, in partnership with healthcare providers, Philips leverages its clinical and IT expertise to develop innovative solutions that advance digital transformation and deliver greater quality of care. “We have always been deeply engaged in the development and advancement of industry standards, including those specifically associated with medical devices such as Integrating the Healthcare Enterprise and the IEEE 11073 service-oriented device connectivity protocol,” said Benjamin. “We have prioritized ensuring our solutions are vendor-neutral and are committed to open platforms, helping shape the open exchange of health data in our informatics applications. Our chief focus is on developing products and solutions with an enterprise-wide approach to interoperability that can ensure insight-rich data is put to meaningful and appropriate use and help transform the delivery of healthcare for everyone.” 

References

1. bit.ly/mpo230731
2. bit.ly/mpo230732
3. bit.ly/mpo211021
4. bit.ly/mpo230734
5. prn.to/43lEf17
6. bit.ly/mpo230736

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Mark Crawford is a full-time freelance business and marketing/communications writer based in Corrales, N.M. His clients range from startups to global manufacturing leaders. He has written for MPO and ODT magazines for more than 15 years and is the author of five books.