Orange County Medical Device Design & Development Company DeviceLab Shares Top News and Blogs from the Week Ending 3/26/2017
DeviceLab is keenly interested in diverse aspects that relate to medical device design and development—in particular, mHealth and healthcare IoT. When we find information particularly exceptional or interesting, we often share it on our @devicelab Twitter feed (which we encourage you to follow). This is a weekly post that shares the best medical device design and development information that we found from the previous week.
This is a compelling question, especially as we are preparing to make an announcement about a recent HIPAA-compliant network certification we received. But back to the question: How do HIPAA regulations apply to wearable medical devices?
As the article attempts to answer, “There is a lot of ambiguity about exactly where HIPAA is triggered and where it’s not.” The ambiguity primarily relates to the relationship between the user and whom has access to the shared data.
If the whom is a “covered entity” such as “health plans, healthcare clearinghouses and certain providers that engage in certain payment and other financial transactions,” then it’s more likely that HIPAA regulations apply.
Otherwise, if the whom is not a “covered entity” that is “just interacting with the individual,” then HIPAA regulations probably don’t apply.
As this “ambiguity” has some significant impact in the need to ensure HIPAA compliance for a new wearable medical device during the crucial design and development phases, we will certainly be examining this topic in more detail in the near future.
UX, which of course is short for “user experience,” is one of many components of a truly superior medical device—wearable or not.
The article explains that “unobtrusive wearable tech used to be an oxymoron” because until recently, wearable medical device designers weren’t always able to provide “devices that function so naturally, wearers don’t even notice they have them on.”
We take some exception to that notion because the point of any new medical device innovation is to either introduce a device that doesn’t exist or to improve upon it if it does. Just because a medical device can now be worn doesn’t it mean UX—comfort, convenience, ease of use—should be sacrificed or reduced.
But, that is why we recognize the value of this article: It supports our philosophies for wearable medical device UX and it provides some excellent suggestions for achieving the “lofty goal” of designing wearables that aren’t intrusive.
College professors can be divided into two groups: Those that have “open book” exams and those that don’t. Professors that subscribe to “open book” exams often say the goal is to teach people how to continue learning and quickly access new information.
This article fits well within that context because just a few years ago, the “Internet of Things” and “IoT” were relatively obscure concepts. But as IoT continues to gain traction in a variety of industries—including medical devices—so does the “pertinent Internet of Things terminology you should be keeping your eye on.”
No, there won’t be a pop quiz next week, but do try to see how many you know—and how many you could or should learn.