This is like a breath of fresh air for sure as patients and consumers should have control over what and who gets to see their data.  imageNow the company has gone to crowdsourcing it before an FDA approval is given.  I say go for it.  This also brings up the question too with FDA approval of mHealth devices, are they going to take into consideration privacy?  I think this could stand to be a million dollar question.  The FDA already has their own issues with compiling data for safe drugs and devices and now has competition from an insurer who is doing it for profit competing with the Sentinel program instead of contributing it appears. 

In doing this blog I read a lot and look at all kinds of software, devices and so on and if you read here often enough then you have seen my campaign for licensing and taxing data sellers who make billions with selling your data.  This is becoming even more controversial with the use of a “Faceprint” as well, more stuff to match and data to sell.  Also a while back I made a post about taking HIPAA out of the HHS silo, in other words make the rules and regulations more visible in other areas as we have entities that never fell under HIPAA before, right there now at square one as data is aggregated.  We talk about aggregating medical record data, so why not the laws and rules that apply to make access easier?

Time to Take HIPAA Out of the Healthcare Silo–Needs to Be Integrated In Overall Privacy Laws Healthcare Information Is All Over The Place And Privacy Efforts Will Fail Without Real Algorithmic Levels of Regulation

After all when it comes to any kind of privacy law, you need to establish who the players are and a license on data sellers would name them and add imageaccountability for sure.  I do get so tired of reading those legal privacy statements that kind of go around in circles that confuse consumers and if I get confused with some of them, I can imagine how the consumer with minimal tech knowledge feels today.  In the meantime we have DC just stumbling all over themselves listening to lobbyists and can’t come up with a proposed bill that can in effect do much of anything. 

Privacy Relative to Tracking Apps and Data Mining Legislation Will Fail If There is No Regulation Path Created–License and Excise Tax Data Miners & Sellers Otherwise It’s “Laws With No Balls”

So speaking of this product and the question of the FDA approving devices that do or do not sell data,  just one more great reason to license and tax data sellers to help fund this new and extra time consuming effort at both the NIH and FDA too. 


I’m also starting to wonder if the business models of some of these mHealth devices could stand alone, in other words could they make a profit as a business and produce a device without having to rely on the revenue from the data they sell?  I think this is something investors might want to kick around as privacy rules and conversations grow.  Again we keep seeing this kicked around and you need an IT infrastructure with everything today and this is no different. 

One More Good Reason to Tax the Data Sellers– Create Additional Funding for the NIH and FDA From Sources That Otherwise Are Too Greedy to Share & Contribute

Walter de Brouwer, Scanadu founder and CEO of the company said “we need an instrument or tool in that battle for the ownership of all the data that comes out of our body”…good stuff!   A good old fashioned concept of providing a device with value without selling the consumer down the river and the ability to use and share the information with your doctor.  You may have read where I have made the comments many times over to see if you can find a device that connects directly to a PHR as well, where you are in control and not having your data or data profile mass marketed to the profiteers of banks and big business.  BD

You’ll be able to analyze and track your health using the Scanadu Scout app.

Scanadu’s funding campaign website says that you will be the only person who has access to the data and that you can openly share the data with doctors and friends if you feel comfortable.

Scanadu has surpassed its goal on a fundraising website and plans to file for FDA approval to make Scanadu Scout an over-the-counter medical diagnostic tool.

You can still sign up to support the device and reserve a Scanadu Scout; the first shipments are expected to start in March of next year.


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