Up at 5AM: The 5AM Solutions Blog

MoB: Your Health Data Belongs to You

Posted on Thu, Oct 23, 2014 @ 03:00 PM

Lab results must be returned to patients who request them

These Map of Biomedicine blog posts have been focused on how diagnostic tests get to market, from an interesting biological discovery to a test that your doctor can order to help guide your treatment or diagnose disease. We saw that there were different ways this could happen, with or without the involvement of the Food and Drug Administration.

Now let’s talk about what happens when a test is on the market. It seems fairly straightforward, at least from the outset - your doctor meets with you, and orders a test. You might have to go to a lab company’s office, or a hospital, or some other site to get a scan, have blood drawn, or give some other kind of sample. Samples are sent to labs where they are processed reports get generated. The results can be processed by analytical software which will be reviewed by one or more people, like lab technicians and lab directors. The process is similar for scans like X-rays and MRIs.

The report is then sent to the physician who ordered it. If the test was ordered by a specialist, it might be sent to your primary care or other provider. In some cases, although certainly not all, you'd also get a copy of the results. In my experience, this usually means getting a paper copy of the report in the mail. Then, your physician, or someone in their office, will call you, or set up an appointment to review the results.

Hopefully, in these days of electronic medical records, your doctor might also keep an electronic copy of the data in your records. Otherwise, that paper will be put in your file.

However, there’s been an important development recently that everyone should know about. In the most recent changes to the Health Insurance Portability and Accessibility Act (HIPAA), there are rules that mean you can ask for a copy of your test results. If those results are kept electronically, they have to send them to you in electronic form.

I think this is really important for everyone to understand. That health data is yours, and you should be able to get it if you want to. In fact, you can get your entire medical record if you want, and the same criteria about electronic delivery holds true. There is a government standard, called Blue Button, to facilitate the return of patient data to patients, which is being implemented within the Veterans Administration. Pharmaceutical companies have adapted the Blue Button standard, and 5AM worked with Pfizer on their project to return results to clinical trials participants..

Now why is this important? Maybe most people feel like they wouldn’t understand all this information anyway, so why bother. First off, just like your financial records, this data is yours – why shouldn’t you have it? Next, if you ever want to get a second opinion, having all your health records and test results will make it much easier to seek help for tough health problems. I’d hate to think that anybody wasn’t getting access to medical help because their health information wasn’t available.

And, here's why keeping health data under wraps is harmful...

I’ve talked before about Myriad Genetics (here, here, here, and here) and their genetic test to tell women if they have an increased risk of developing breast and ovarian cancer. Their test actually looks at entire gene sequence of the BRCA1 and BRCA2 genes, and there are many genetic variants in those genes that can increase risk of cancer. There’s an open area of research into whether all these variants are created equal – it’s possible that the risk of getting cancer is different depending on which variant you have. Since Myriad had a monopoly on the BRCA tests until the Supreme Court ruling last year, they have run thousands of these tests, and have all the results. But nobody else can see the entire data set, so nobody can do this incredibly important research.

But remember, I mentioned that you can get a copy of your test results if you ask for it, in electronic form. There is an effort to leverage this to accumulate a useful set of BRCA variant data so this research can be done. It’s called Free the Data – and you can donate your Myriad test results to them and help this important research.

But maybe we should be thinking bigger. There are many efforts now to do research to improve healthcare by looking at electronic medical records, and how health outcomes can be correlated with the care and treatments that people get. Your entire medical record, when combined with thousands, or millions, of other medical records, could be the source of better treatments and care for future generations. This kind of research is being done now within institutions like health systems and insurance companies, but I hope there’s a way to free that data, too.

We’ll talk more about this in upcoming posts, but I’ve added a box the Map (see it below and full size here) called "Manage Personal Health Record," which is a kind of electronic health record that captures all your information, not just the data from one hospital or doctor. As with "Manage Genome," it’s not really clear who will provide this service. There are personal health record companies, but for now they are not widely used. I’m sure that will change in the future.

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Tags: map of biomedicine, electronic health record, electronic medical records, health data


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