My health data is MINE!

My data is MINE! Is your diabetes tech company putting their bottom line above your right to self?

Imagine if you will (Cue Twilight zone music) 

The financial institutions of the world deny users their transaction information. Account holders can now see a daily balance total, but in order to see individual transactions, they must to go the bank and read through a complicated digital log of microtransactions and add them together to determine how their money is moving.

Rather than knowing how much money they have going in and out, account holders now get a notification as to whether they have “enough money” or “insufficient funds” based on the banking establishment’s analysis of their income and spending habits over the last period of weeks. Saving money for a big expenditure is no longer an effective strategy and selecting what stock to invest in over time is impossible because you can not access information on company finances either! You now live in a world where the financial institution controls your financial stability all under the guise of simplifying your financial life.

Financial institutions will initially point to the widespread benefits of their decisions to blind people to their financial information. Many people in the world will be saved from bankruptcy by this simplified controlled cash flow. It will be lauded as a financial revolution! However others will find their financial world in ruins, and many more will simply be frustrated and will lose their financial freedom. As they begin to ask questions and dig deeper they find that, in fact, this blinding was entirely to the bank’s benefit. It allows them to make more money over other banks without revealing how they do it! They then trade among banks for rights to the most money-making strategy, without ever paying dividends to the customers.

Where would you stand for this kind of financial practice?

My financial information is MINE and mine alone! In fact, my financial institutions are required to have strict systems in place to protect that data security. While banks make money off of our money, they are also expected to maintain transparency in this area (within regulation) and pay dividends to their customers.

However, this is exactly the model that the Medtronic and Omnipod hybrid closed loop systems are built upon.

They base insulin delivery on their “Proprietary” (see also: makes them money so they won’t tell the user because their money means more than the customer’s rights) algorithms. This alone is blinding as they are purposely very opaque in what they will tell users about how the system calculates insulin dosage. But then they take it further by refusing to allow users to see how much insulin they are getting! The only way to get any indication is to sort through data points of basal delivery every 3-5 minutes over entire days! Even the Insulin on board displayed can not be reverse engineered to figure out where it came from. This leaves users at risk of getting more insulin than anticipated before high-risk hypo activities like driving or physical activities. It may also lead to users getting too little insulin in high-risk DKA times like illness.

Some clinicians have even refused to prescribe the systems as they are not comfortable working with a system that will not allow them to see how much insulin patients are getting, and in which the impact of their setting adjustments is vague at best.

What this all really comes down to is data ownership rights. We are in an information age, where the greatest fortunes are no longer built on the trade of goods and services, they are built on the trade of information. Specifically, our personal information. Where we shop, what we watch, how we spend our time, are all commodities traded for BIG profit. One thing to remember is that if you are not paying for a product, you ARE the product. That is to say that any app or service, particularly online, that you’re not paying for, and therefore paying to have your information secure, is a source for gathering your data for profit. This raises an ethical question then. If companies have the rights to user data, and have a legal responsibility to protect customer data, don’t patients have a right to see their data openly and easily?

At the state and federal levels, there are laws regarding data privacy that requires this info be protected. Diabetes companies have, thus far, done well with this. Their data uploading software and apps are encrypted and have not had a data breach thus far. However, protecting our data from theft and abuse is a long stretch from not allowing us to have transparent access to our own bodies! My insulin delivery is a part of the function of my body! I pay a company to provide a device that interacts with my body in an ongoing way and that makes it a part of my body as well. It is my right to have all of my medical information available with transparency. HIPAA (health insurance protection and accountability act) requires that all medical records and individual medical data be available to a patient upon request. It would be illegal for one’s medical record to then be released to them one word at a time over a series of several thousand emails over the span of a week is entirely unacceptable. This would be considered obstructing access to personal data which is illegal in the United States per federal law. Then why is it acceptable for our insulin delivery data to be parsed out to us in this exact manner?

It is also illegal to administer a medication to a patient without educating them on the dose, route, side effects, purpose and action of that medication. It is patient abuse to deliver a medication but refuse to tell the patient the dosage, or to deny them education on how that dosage is derived. So why is it legal for these companies to deliver to my body, an unspecified amount of insulin over time and deny me the right to know how that dose is going to be calculated?

To be clear, I am not accusing any company of breaking a law. What I am saying is that the laws have not been written to take insulin delivery devices into account.

We must demand that these laws be reviewed and a precedent set for our rights, as patients to access our own insulin data in an ongoing way. We must also demand legislation mandating transparency and our educational rights to all calculations and algorithms dictating insulin dosage. Manufacturers fear that this will cost them business, that their competitors will steal their algorithms. They further say that if they don’t make enough money, they will not be able to continue to innovate to improve diabetes care. However Tandem uses an openly published algorithm for their system and no one has stolen it and they have been growing in the diabetes marketplace. In fact, the entirely publicly available Loop systems have a far better set of outcomes than any FDA-approved algorithm and are leading the diabetes world in innovation while not having made its creators or developers income. (in reality it has made money for Omnipod and Medtronic as users are still purchasing their products to use with the Loop app).

As election season rolls around remember that data security and our rights to our own data is a huge legislative issue! We need to advocate in this space. We need to reach out to our legislators on the state and federal levels. We also need to support organizations that are already working in this advocacy space. And finally, we need to show our support for patient rights with how we spend our money as people with diabetes. Support companies and projects with transparency and show that the bottom line is determined by US.