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Lumeon Offers a Step Toward Usable Device Data in Health Care

Posted on August 8, 2018 I Written By

Andy Oram is an editor at O'Reilly Media, a highly respected book publisher and technology information provider. An employee of the company since 1992, Andy currently specializes in open source, software engineering, and health IT, but his editorial output has ranged from a legal guide covering intellectual property to a graphic novel about teenage hackers. His articles have appeared often on EMR & EHR and other blogs in the health IT space. Andy also writes often for O'Reilly's Radar site (http://oreilly.com/) and other publications on policy issues related to the Internet and on trends affecting technical innovation and its effects on society. Print publications where his work has appeared include The Economist, Communications of the ACM, Copyright World, the Journal of Information Technology & Politics, Vanguardia Dossier, and Internet Law and Business. Conferences where he has presented talks include O'Reilly's Open Source Convention, FISL (Brazil), FOSDEM, and DebConf.

The health care field floats on oceans of patient data, but like the real oceans on our planet, patient data is polluted. Trying to ground evidence-based medicine on billing data is an exercise in frustration. Clinical data is hard to get access to, and has its own limitations. For instance, it is collected only when a patient visits the clinic or hospital. The FDA recently put 100 million dollars in its budget to get patient data from electronic health records (which the commissioner called “real-world experience”).

One of the paths toward better data for research and treatment lies in the data from medical devices: it’s plentiful, detailed, and accurate. But device data has mountains to climb before researchers and clinicians can use it: getting this data in the first place, normalizing and standardizing it, and integrating it with the systems used for analysis and treatment. That’s what excites me about a recent new direction taken by Lumeon, a platform for workflow management and treatment coordination in health care.

I covered Lumeon’s platform a few months ago. The company already lays out an enticing display of tools for clinicians, along with EHR integration. What’s new is the addition of medical devices, an enhancement that required nine months of working with medical device manufacturers. Recently I had another chance to talk to Rick Halton, Vice President of Marketing and Product for Lumeon.

Along with the measurements provided by devices, Lumeon has tools for patient engagement and the measurement of outcomes. These outcomes go beyond simple quantitative scores such as limb rotation. Lumeon creates for each patient a patient-specific functional score (PSFS). For one patient, it may be whether he can play outside with his kids. For another, it’s whether she can they go back to work, and for another, how far she can walk.

Lumeon asks, how can a device be used in a patient journey? It uses the routine information to help provide consistent care throughout this journey pathway, and measures outcomes throughout to generate feedback that promotes better long-term outcomes.

Device data is currently stored in a Lumeon platform that may be on the clinician’s site or in the cloud. Using an API, Lumeon’s output can be embedded within an EHR (they currently do this with Epic) so that the output can be displayed as part of the EHR display, and the clinician doesn’t even have to know that the results are being generated outside the EHR. In the future, the data may be integrated directly into the EHR. However, Lumeon’s direct customers are the providers, not the EHR vendors.

Data from devices was popular among providers at first for discharge planning and other narrow applications. Lumeon’s device integration is now getting more attention from providers who are experiencing a squeeze on reimbursements, a growing alertness among payers for outcomes, and a slow move in the industry toward fee-for-value. One leading device manufacturer is already using Lumeon for better treatment of cardiovascular care, bariatric surgery, and diabetes. Other applications include chronic disease, perioperative care (readiness for the OR and enhanced recovery), the digital patient experience on the web or in an app, and the patient centered medical home.

If Lumeon can turn device data into better treatment, other clinical institutions and health care platforms should be able to do so as well. It’s time for health care to enter the 21st century and use the Internet of Things (or Internet of Healthy Things, as termed by Dr. Joseph Kvedar) for the benefit of patients.

Will Medical Device Makers Get Interoperability Done?

Posted on September 20, 2017 I Written By

Anne Zieger is a healthcare journalist who has written about the industry for 30 years. Her work has appeared in all of the leading healthcare industry publications, and she's served as editor in chief of several healthcare B2B sites.

Most of the time, when I think about interoperability, I visualize communication between various database-driven applications, such as EMRs, laboratory information systems and claims records. The truth is, however, that this is a rather narrow definition of interoperability. It’s time we take medical device data into account, the FDA reminds us.

In early September, the FDA released its final guidance on how healthcare organizations can share data between medical devices and other information systems. In the guidance, the agency asserts that the time has come to foster data sharing between medical devices, as well as data exchange between devices and information systems like the ones I’ve listed above.

Specifically, the agency is offering guidelines to medical device manufacturers, recommending that they:

  • Design devices with interoperability in mind
  • Conduct appropriate verification, validation and risk management to ensure interoperability
  • Make sure users clearly understand the device’s relevant functional, performance and interface characteristics

Though these recommendations are interesting, I don’t have much context on their importance. Luckily, Bakul Patel has come to the rescue. Patel, who is associate director for digital health the FDA‘s Center for Devices and Radiological Health, offered more background on medical device interoperability in a recent blog entry.

As the article points out, the stakes here are high. “Errors and inadequate interoperability, such as differences in units of measure (e.g., pounds vs. kilograms) can occur in devices connected to a data exchange system,” Patel writes. Put another way, in non-agency-speak, incompatibilities between devices and information systems can hurt or even kill patients.

Unfortunately, device-makers seem to be doing their own thing when it comes to data sharing. While some consensus standards exist to support interoperability, specifying things like data formats and interoperability architecture design, manufacturers aren’t obligated to choose any particular standard, Patel notes.

Honestly, the idea of varied medical devices using multiple data formats sounds alarming to me. But Patel seems comfortable with the idea. He contends that if device manufacturers explain carefully how the standards work and what the interface requires, all will be well.

All told, If I’m understanding all this correctly, the FDA is fairly optimistic that the healthcare industry can network medical devices on the IoT with traditional information systems.

I’m glad that the agency believes we can work this out, but I’d argue that such optimism may be premature. Patel’s assurances raise a bunch of questions for me, including:

  • Do we really need another set of competing data exchange standards to resolve, this time for medical device interoperability?
  • If so, how do we lend the consensus medical device standards with consensus information system standards?
  • Do we need to insist that manufacturers provide more-consistent software upgrades for the devices before interoperability efforts make sense?

Hey, I’m sure medical device manufacturers want to make device-to-device and device-to-database data sharing as simple and efficient as possible. That’s what their customers want, after all.

Unfortunately, though, the industry doesn’t have a great track record even for maintaining their devices’ operating systems or patching industrial-grade security holes. Designing devices that handle interoperability skillfully may be possible, but will device-makers step up and get it done anytime soon?