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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?

Regulating mHealth Apps: Does it Limit Creativity?

Posted on May 23, 2012 I Written By

Katie Clark is originally from Colorado and currently lives in Utah with her husband and son. She writes primarily for Smart Phone Health Care, but contributes to several Health Care Scene blogs, including EMR Thoughts, EMR and EHR, and EMR and HIPAA. She enjoys learning about Health IT and mHealth, and finding ways to improve her own health along the way.

Last year, the FDA announced plans to regulate some smart phone apps that involve medicine or health. The specific apps that would be regulated “are used as an accessory to medical device already regulated by the FDA [or] transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices.” In addition, apps that suggest potential diagnoses or treatments for the person using it.

As I was perusing comment boards for various articles about this, the feelings were mixed. Some think that the FDA already has too much control. Others think it totally makes sense. A comment from someone on a Washington Post article sums up how I feel:

Yes, some software that turns a smartphone into medical use has to follow the same rules as developing a medical device — from the first moment you think about it. It’s not hard, but you had better know what you are doing because what the FDA gives you is basically the right to market the device and if you don’t follow the rules, you could end up with is a really neat program that you can’t even talk about to your customers.

I think it definitely makes sense to regulate these things. I mean, there are quack doctors out there that we don’t know about, who seem legitimate; how are we supposed to discern between a quack health app, and one that can actually be trusted? There needs to be some kind of regulation, but the question is — how much?

The issues I find with certain apps, is that if they get too advanced (such as an x-ray), people might start avoiding the doctor because they diagnose themselves. Basically, I think that without regulation, certain apps may seem awesome, but in reality, they have fatal flaws that could be just that — fatal. There shouldn’t be a chance that bad apps could possibly act as an authoritative source.

In the Washington Post article I previously referenced, Bakul Patel, a FDA adviser was interviewed. I thought he made a good point when he said:

We wanted to make sure that we are consistent in regulating medical devices so nothing has changed. If somebody makes a stethoscope on an iPhone, it doesn’t change the level of oversight we have of a stethoscope.

I mean, that totally makes sense. Just because something is digital doesn’t mean it should be able to bypass requirements. A stethoscope is a stethoscope. End of story.

Overall, I agree with the regulation. If medical and health apps are going to actually be taken seriously, we should be able to see right of the bat if it can actually be trusted as a medical device. I’m not a huge fan of the government controlling everything, so there should definitely be regulation on the apps that could actually determine the health status of a person. However, the rules shouldn’t be so strict that people can’t be creative in what they create. That’s my two cents on the issue, what are your thoughts?