Sponsored By
Chris Newmarker

November 15, 2016

5 Min Read
Medtech Has a Major Interoperability Challenge

The dream is a seamless ecosystem of connected medical devices--all leading to more effective and affordable management of people's health. Here are the challenges standing in the way.

Tower-of-Babel.jpgChris Newmarker

Interoperability is a major challenge when it comes to creating medical devices that easily connect with everything from other devices and sensors to health providers' electronic medical record systems.

Think of the biblical story of the Tower of Babel and how the people of the Earth were thrown into confusion with different languages. That same type of confusion confronts anyone trying to develop a connected or mobile health device.

Qmed posed two major questions to three top connected medical device experts: What is interoperability, and what are the major challenges standing in the way of achieving it?

Here's what they said:

Bill Saltzstein

Bill Saltzstein
Founder

Code Blue Communications

Qmed: What is interoperability, and what does it mean to you in your role?

Salzstein: Interoperability is the capability of systems and/or devices to function cooperatively.  I consider it at various levels for medical devices:

  • Do no harm to each other: Can be used in the same environment and on the same patient;

  • Collect data and allow for consolidation, storage, and reporting in a system (perhaps third party like an EHR);

  • Use compatible hardware components such as sensors, cables, disposables;

  • Allow exchange of data between components within the system (with or without the system).

Qmed: What is the biggest challenge standing in the way of achieving interoperability?

Salzstein: Customer requirement for interoperability that is strong enough to drive manufacturers to do what is needed to accomplish the above. This could come through regulation, but that doesn't seem to be working. Lack of standards has been cited, but this is a red herring. There are plenty of standards, either choose/agree to one or provide an open standard for industry usage.

Steve Abrahamson
Steve Abrahamson

Senior Director, Product Cyber Security

GE Healthcare

Qmed: What is interoperability, and what does it mean to you in your role?

Abrahamson: "Interoperability" in the healthcare ecosystem is all about providing safe and effective healthcare via a system of systems with common workflows across multiple systems. This concept is now being further expanded to healthcare devices and data flows within the healthcare Internet of Things. In my role as director of product cyber security for a medical device manufacturer and service provider, I need to view these interactions and data flows as presenting security risks. How do we ensure that we are protecting the confidentiality, integrity, and availability of the interconnected assets within an environment where solutions with a high dependence on interoperability are increasing at a rapid pace? In assessing and remediating risks, interoperability, or more precisely medical data flows, must be an integral component of the risk assessment and ultimately fully integrated in the development of solutions.

Qmed: What is the biggest challenge standing in the way of achieving interoperability?

Abrahamson: This questions tends to lead toward a response addressing the technical difficulties of having devices with different functions, from different manufacturers, with different software technology, perform their functions safely and effectively. This is very challenging in and of itself, but I look further at the challenges of doing these things securely. I would say the biggest challenge for me, given my security role, is achieving the next step in healthcare through integrating interconnected medical devices with cutting-edge data analytics services, while protecting these devices and services against ever-growing malicious threats.

John Zaleski
John Zaleski

EVP & Chief Informatics Officer

Bernoulli Health

Qmed: What is interoperability, and what does it mean to you in your role?

Zaleski:  Interoperability is a function, a noun, and a verb. In the context of healthcare and data, there are four dimensions, including the consistency and agreement of data in format, queries, and synchronization (data interoperability); consistency in transmission and receipt of data (communication interoperability); consistency on the meaning of communicated data between systems (semantic interoperability); and consistency on how technology supports and informs workflow, including decision support, clinical guidelines, rules, and user interfaces (workflow interoperability). All of these aspects are integral to my role.

Qmed: What is the biggest challenge standing in the way of achieving interoperability?

Zaleski: There is more than one challenge, and there are co-dependencies among the challenges. Some of the challenges include business motivation by companies to achieve interoperability; consistency across and alignment in the four dimensions listed ... above; impact of migrating to more interoperable technical solutions on clinical workflow and the ability to uptake key aspects of interoperability by clinical and supporting technical and information technology staff so as to ensure continuous and uninterrupted operations within the healthcare enterprise; lack of universal guidelines on the four dimensions above (note: there have been major efforts to achieve this by IHE, NIST, HL7 and others... the pile is being moved forward slowly). Many more exist, but I am running long here.

Chris Newmarker is senior editor of Qmed. Follow him on Twitter at @newmarker.

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[Image by Pieter Brueghel the Elder (1526/1530-1569) - Levels adjusted from File:Pieter_Bruegel_the_Elder_-_The_Tower_of_Babel_(Vienna)_-_Google_Art_Project.jpg, originally from Google Art Project., Public Domain]

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