Under the supervision of Prof. David Stark, Ph.D. student Joan H Robinson, will engage in archival research and interviews to investigate the regulatory framework for home diagnostics, looking in particular at how home diagnostics have contributed to the development of American legal frameworks of personal privacy and disclosure. Utilizing archival materials at the National Archives and those attained through the Freedom of Information Act, she will study the primary sources used by the Food and Drug Administration in their deliberation regarding the Medical Device Amendments of 1976. The Co-PI, who is trained as a lawyer, will also examine over one thousand case laws relating patent disputes and misuse of these technologies.
Tools of self-diagnosis, from home HIV tests to monitors worn throughout the day, are becoming widespread. This research will increase our understanding of how home diagnostics are shaped by and shaping laws, attitudes and practices regarding privacy, disclosure, and surveillance.
