Biohacking is described as citizen or do-it-yourself biology.  This can mean individuals modifying their bodies using technology, taking dietary supplements, or simply increasing their amount of exercise.  However, some have taken it to the next level and are beginning to incorporate technology or cellular modification based approaches to health. This was the case for Josiah Zayner, a “biohacker” who livestreamed himself injecting DNA for the genetic engineering tool CRISPR directly into his arm.  Biohacking is an exciting field because it is not heavily regulated, but this also means more risks involved for individuals who decide to participate in it.

The Values of Biohacking

Biohacking offers people the chance to explore cybernetics, and play with the intersections between technology and physiology.  Many are also drawn to the field by the control it gives them over their personal data. Amid privacy disputes between big corporations and the public, biohacking offers an alternative way for the public to monitor and control their personal data.  This method of control is conducted by the individual–making it ideal for people concerned about their privacy.

Biohacking also allows for open source medicine, in which anybody can contribute to the field of medicine–not just scientists and researchers who have received adequate funding.  This allows for people to develop their own medicines without having to rely solely on the pharmaceutical industry.

Who is Doing it?

Biohacking experiments have ranged from the practical to the absurd.  Biohackers have begun modifying insulin pumps so that a certain level of insulin is delivered to the body, barcoding pet-owners by the feces left behind by their dogs, and injecting untested, experimental gene therapies into their bodies.  Which demographic has been performing these experiments?  Well-educated professionals appear to be the largest demographic, and most biohackers have received college degrees.  The majority of people performing these experiments also tend to be professional scientists, meaning that they are more qualified to experiment on their bodies in safe and controlled ways.  

The Bayh-Dole Act

It is important to consider the various implications of biohacking before beginning to experiment.  If you have an employment agreement, for instance, your scientific findings may end up being the property of your employer.  People such as professors who are funded by the government should also be wary. Under the Bayh-Dole Act, the government is permitted to use “march-in rights” to use patented products in a way that they deem appropriate. 

If you have any other questions about how to communicate with the FDA or how your past and/or current FDA communications affect you and your business goals, reach out to me on Twitter, LinkedIn, or send me a message here.

I also host a podcast called DarshanTalks, a show that discusses newsworthy FDA issues and how they apply to bringing a product to market – and keeping it there. From patient centricity in clinical trials to the government shutdown to CRISPR and bioethics to why big data is doomed to fail in healthcare, we’ve got quite the list of topics to review! Listen to the podcast on Google Play or on Soundcloud.

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The opinions stated in this blog are the sole and present opinions of the blogger and do not necessarily represent the opinions of the Kulkarni Law Firm, PC and/or its attorneys. Such opinion(s) may change over time. Such opinion(s) should not necessarily be attributed to the institution for which these individuals may work or otherwise represent in any capacity. These blogs do not constitute legal advice and should not be construed as such.