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As pointed out in my previous blog “Wearable Medical Devices: Always On for Better Health“, medical wearables may be the next big thing. Like probably any new trend, there may be some show stoppers out there. Mainly, who will accept a wearable medical device if it’s not trustworthy? It’s all about effectiveness, quality and safety.


1. Effectiveness:

What comes into mind first, is especially related to devices that monitor health indicators and life style. Will higher transparency really change behavior in a positive way? Do patients really want this kind of being watched – I mean do they truly want it. Everybody who has broken up a diet at least once in a life knows the difference between initial motivation and long-lasting will. Of course when medical wearables relieve from severe suffering, patients won’t go without them anymore. Secondly, do physicians have the capacity and tools to handle the additional information intelligently?


2. Safety:

Any kind of side-effect should be avoided. Side effects can be related to the body, e.g. google glass is suspected to have some health risk. Side effects may also relate to external actors trying to access your private data and misuse them. This is such a big concern that I will add a separate blog about privacy.


3. Quality:

This seems to be a no-brainer – when it’s about health, any measurements have to be precise, and all functions have to work perfectly. Otherwise the medical wearable would just contribute to confusion, false alarms, wrong actions or even worse consequences. And there are concerns that some medical apps don’t meet the high quality standards as they should. Depending on the feature of the wearable, quality also comprises sophisticated technical service for the customers and maintenance. As one of the main features is to be “always on” for improved health, manufacturers need to make sure to prevent a device gets broken, so they need excellent predictive analytics capabilities and the ability to deal with a huge amount of customer data rapidly in order to respond timely.

From companies that are not experienced with authority approvals for life sciences products, efforts do be done in order to get approved are sometimes under-estimated. However, it makes sense to double check if a wearable is classified as medical device. For example, the U.S. Food and Drug Administration (FDA) has just recently published their guidelines for Mobile Medical Applications, which points out a risk-based approach. If a mobile app poses minimal risk to patients, premarket review applications, registrations or listings are not necessary, e.g. apps providing regular educational information

So, when a manufacturer can tick all boxes mentioned above, technically the medical wearable is ready to take off. There is one more question remaining: What is about data privacy regarding wearables used to improve health? As this topic is hot, please find more about it in the next blog “Will Wearable Medical Devices Break Through? – Talking about Broad Acceptance and Privacy”.


What do you think about the issues discussed here? Continue the conversation in the comments below and on Twitter @SAP_Healthcare!

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