Just two months ago, there was a major shift in how our federal government views each of us in terms of our health. Understandably, the significance of this seemingly trivial governmental action went unnoticed by many (likely most) Americans. But this regulatory action was monumental for those who believe that, just as we each “own” our individual financial, legal, and social decisions and behaviors (and the favorable and unfavorable consequences of those decisions and behaviors), each of us should also “own our health;” that is, accept responsibility and accountability for our health and healthcare decisions and behaviors.

So, what was this explosive governmental decision that conferred some meaningful health ownership upon each and every one of us?

For the first time, the United States Food & Drug Administration (FDA) approved you to privately receive the results of ten of your personal medical tests (1) without the involvement of any health care professional and (2) with you alone deciding whether your personal medical test results are shared with anyone else.

Not quite as dramatic sounding as you expected, huh?

But make no mistake: this represents a seismic shift in our government’s approach to you and your individual healthcare. While you may well have received the results of your mammogram, chest X-ray, or other medical test in the mail, by the time they reach your mailbox, your medical results have become part of your medical record.  And it is overly optimistic to believe that other than your physician, no one will see your private medical record without your permission or even knowledge…

But now you can privately order these ten genetic tests from the private company, 23andMe, without the involvement of a physician or other medical professional.  And your test results (and, importantly as well, even the fact that you were tested) are not part of your medical record or shared with anyone without your formal consent (the company promises to “not share your individual-level information with any third party without your consent…including employers or health insurance companies…or to law enforcement [unless required by court order]”).

Now, this opens a whole other can of worms in terms of employment, insurance, etc., but still, whether intentional or not, the FDA’s action has deviated significantly in terms of who truly owns your health:  you.

Even more importantly, you are now being viewed as competent to understand and interpret complex medical testing results (including unpleasant, frightening results) in the absence of a trained health professionalOn your own. No doctor, no nurse, no certified genetic counselor sitting across the desk from you in an unfamiliar outpatient clinic office. Just you (and, should you choose, your spouse, your partner, a friend) sitting on the sofa in the privacy of your own living room, carefully reading, re-reading, and discussing your ten “Genetic Health Reports” provided solely to you.

No, I have no financial relationship with this company. I'm just very pleased at their success in demonstrating to our federal regulators that you, I, all of us can and truly should be the sole owners of our health (and, more specifically, our health information and decisions).

Because until now, complex, potentially significant medical information (especially unfavorable test results) has routinely been delivered to each of us in person or via phone by professionals, whether or not that is our preference. These doctors, nurses, and other clinicians serve as medical translators, if you will, explaining to you in real time the nuances, subtleties, knowns, and unknowns associated with your personal medical information. And this has usually been to the benefit of the patients. But it is also part of our traditional healthcare system which all too infrequently provides individuals with privacy or allows individuals adequate authority and responsibility when it comes to that which is truly most personal, our health. 

Thus I am not in any way criticizing the knowledgeable clinicians who patiently explain or discuss the results of a medical test with patients. No, such dedicated health professionals are a blessing. But just like financial advisors, shouldn't the individual who actually owns that health (or those finances) be allowed to decide if, when, and from whom they wish to receive guidance? Especially when that information may impact insurability, employment, legal processes, or other important activity?

So with this FDA approval, the federal government has accepted that not only are you the sole owner of your individual genome (the complex DNA code that is specific to you and only you), but that you have both the right and the ability to privately understand and evaluate the implications of your individual genetic test results and associated disease risks, and to decide who else if anyone should share your personal genetic information.

This represents a big change in how our government and healthcare system view each of us as health owners, given that understanding genetic test results is potentially both complex and significant in the implications for the individual and his or her family. Add to the complex genetic information that whether or not you develop a disease is often also impacted by environmental factors (such as your diet, weight, smoking history, etc.) and you can appreciate why leaving the understanding and interpretation of disease risk solely to non-clinical individuals might make some professionals (including those at the FDA) nervous. Why before the FDA’s recent decision, you could not learn about your personal genetic risk for ten significant diseases without speaking with a doctor or genetic counselor. And without your genetic information being recorded as an official part of your medical record (and potentially available to others without your consent or even your knowledge).

The U.S. FDA is now demonstrating the belief that you as an individual American citizen have not only the intelligence, but also the right to privately request, submit, obtain, view and understand at least ten of your own disease risk. To appreciate the nuances and subtleties that may have major implications for you, your loved ones, your future, and your life. All without the involvement of medical professionals, and without any employer, insurer, or the government itself having access to your test results without your consent.

This is indeed a major milestone in the journey towards true individual health ownership.

We are all too quick to criticize our government’s over-reach in regulating our lives.  So it's especially nice to say, thank you, FDA, for acknowledging that each of us is truly the sole owner of our most precious possession: our health.

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