In the United States, clinical testing is monitored by the federal and state governments, held to standards to ensure the safety and efficacy of these tests, as well as maintaining privacy for patients receiving a test. In order for the ABCTL to lawfully operate in the state of Arizona, it had to meet various legal criteria. These major legal considerations, in no particular order, are: Clinical Laboratory Improvement Amendments compliance; FDA Emergency Use Authorization (EUA); Health Insurance Portability and Accountability Act compliance; state licensure; patient, state, and federal result reporting; and liability. <br/>In this paper, the EUA pathway will be examined and contextualized in relation to the ABCTL. This will include an examination of the FDA regulations and policies that affect the laboratory during its operations, as well as a look at the different authorization pathways for diagnostic tests present during the COVID-19 pandemic.

Breast cancer affects about 12% of women in the US. Arguably, it is one of the most advertised cancers. Mammography became a popular tool of breast cancer screening in the 1970s, and patient-geared guidelines came from the American Cancer Society (ACS) and the US Preventative Task Force (USPSTF). This research focuses on ACS guidelines, as they were the earliest as well as the most changed guidelines. Mammography guidelines changed over time due to multiple factors. This research has tracked possible causes of those changes. Research began with an extensive literature search of clinical trials, the New York Times and the Washington Post archives, systematic reviews, ACS and USPSTF archives.