Part III – Disease Registries
What is a Registry?
Registries are collections of patient data usually focused around a particular disease. Cancer have been mandated by law in most states and some cites for many years. If you have cancer and a pathologist reads the slide of a specimen that turns out to be cancer, your name and varying amounts of data about you and your cancer are reported to one or more cancer registries. https://www.cdc.gov/cancer/npcr/ This can include the genome of the tumor which, of course, will include some of your genome. You have probably heard a lot about these registries lately because of former Vice President Biden’s “Cancer Moon Shot” which seeks to collect extensive genomic data about cancer and the people who have developed cancer.
What is Meaningful Use?
The Health Information Technology for Economic and Clinical Health (HITECH) Act, enacted as part of the American Recovery and Reinvestment Act of 2009, put incentives in place to encourage the use of electronic health records (EHRs). Shortly after that, there came regulations to encourage the use of those EHRs “Meaningfully” which is where a program called “Meaningful Use” began. This program is administered by the Office of the National Coordinator for Health IT (ONC) which is part of Health and Human Services (HHS). There are, so far, three stages to Meaningful Use. The first was relatively simple for most EHRs to achieve, the second much more difficult and the third is just now in progress.
Meaningful Use and Exchange of Data
A large element of Meaningful Use revolves around gathering and exchanging data. In fact, exchanging data is probably the most important element and yet, as of right now, the goal of easing the exchange of data has not been met despite the expenditure of $36 Billion in incentive payments for installing Meaningful Use Certified EHRs and using them “meaningfully”.
Most patients would like it to be much easier to have their data exchanged and be able to get it themselves. What they often don’t realize is that there is a lot of data being released about them without their permission and that this exchange of data without permission is exploding. We discussed one very important way in part I, the Quality Measure Reporting.
The push to Create New Registries and Submit Data
One method of providing data without the patient’s permission being promoted by Meaningful Use and even outside of Meaningful Use is submitting data to patient registries. Not all registries will take data without permission, but the creation of registries and submission of data to them without patient permission seems to be on a fast track right now with HHS and the health committees in Congress such as the Senate HELP Committee.
A typical patient registry being promoted is a diabetes patient registry. These registries are felt to be important for research and the “greater good” so you will almost never hear of anyone from Congress or HHS voicing any concern for patient privacy. Many are hoping that a plethora of patient registries will be created and that data will be submitted to all of them.
Would you agree with sharing your medical data with registries?
I believe 85 percent or more of patients would be willing to fully share their health records, but I don’t believe that those who want their privacy protected should be forced into giving up what should be their right to decide. I also believe that patients should have the option of withdrawing permission if they wish.
There are significant concerns for some who might otherwise be willing to share their data that have nothing to do with their own privacy, but have to do with the implications of how sharing the data might affect their relatives. It might also affect their relationships with others with whom they work or have significant contact if it were known what ailments they were suffering from.
To me it is simple, patients should be ASKED and health care providers should not be asked to share personal patient data without their permission. In this era of Big Data, this also includes most de-identified patient data.
Now is the time to protect your privacy!
Let your Representative, Senators and Tom Price know you want to have a say sharing your healthcare information about you!
Nancy Anthracite, MD