Owen Carpenter


Integrated biotechnology is a quickly-approaching future legal issue that will blur the line between technology and person. The technology will likely run through some kind of software, and users of the technology will likely need to agree to some type of licensing agreement to use the software. End User License Agreements (“EULAs”) as they exist today have terms and clauses that will be problematic when applied to an implanted artificial heart, a replacement for the human eye that enhances vision, or other types of integrated technology. Current FDA regulation and EULAs are insufficient to deal with the problems that technology integration will create. This Note argues for a new form of licensing agreement that will apply to integrated biotechnology, called a Biotechnology Licensing Agreement (“BTLA”). The BTLA will contain certain clauses that strengthen the bargaining power of the future cyborg when dealing with the creators of the integrated technology. Further, for creation of a new subdepartment of the FDA, the Biotechnology Adjudication Bureau (“BAB”). The BAB will handle regulation of integrated biotechnology and will assist cyborgs in the near future world of half-human half-machines. These solutions will dampen the problems and legal issues that will arise as the integrated biotechnology space becomes more mainstream and more pervasive.