Over the Counter but Under the Radar: Direct-to-Consumer Genetics Tests and FDA Regulation of Medical Devices

- Vanderbilt Journal of Entertainment and Technology Law
Author/s: -Solberg, Lauren B
Journal: Vanderbilt Journal of Entertainment and Technology Law
Year: 2009
Volume: 11
Pages: 711
Start Page: 711

Notions of patient autonomy and informed consent are paramount in clinical research in the United States. 1 Such ethical constructs extend to general patient care, as physicians are now discouraged from abiding by the traditional professional paradigm of medical care, under which “professionals, as experts, make core decisions for patients,” and instead are encouraged to treat patients as informed consumers who should actively participate in medical decision-making. 2 As consumers become more sophisticated and informed about their medical care, their desire to know more about any underlying medical conditions they may have is inevitable, as this information is vital to their ability to make educated decisions about their care. 3

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