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3 Stud. Ethics L. & Tech. 1 (2009)

handle is hein.journals/selt3 and id is 1 raw text is: Maliapen: Clinical Genomic Data Use Introduction There is much concern about how individual privacy may be protected when medical information is shared and used across systems and international borders for genetic research. Without compromising the ideal of privacy and confidentiality, the knowledge gained from the use and analysis of personalized data needs to be reconciled with the value and benefit of the research to mankind. As a consequence of privacy legislation, the security and de-identification of patient medical information is playing an important role in every contemporary healthcare and research data system. Compliance with the Health Insurance Portability and Accountability Act 1996 (HIPAA) and Personal Information Protection and Electronic Documents Act (PIPEDA, 2005) and the implementation of other privacy and data standards to protect and maintain the quality of clinical and genomic data are critical. There is a lack of uniformity in addressing security and privacy standards across healthcare industry. Security and privacy issues, particularly the management of diagnostic clinical genomics consent data and the interfaces to clinical and hospital interfaces, can be difficult given that the data formats and data models impact its usability. The common thread throughout the clinical genomics data ecosystem is the need for knowledge derived from standardized patient co-variate, clinical, gene expression and proteomic data that can be shared across multiple corporate research agencies, physicians, healthcare providers and provided in a safeguarded, compliant manner based upon policies that define the rights and responsibilities for the data being accessed. HIPAA and PIPEDA limit the information that can be shared across and among institutions, placing researchers in a challenging position as they balance obtaining requisite data with patient rights. Information systems for managing de- identified patient data through universal global identifiers have been critical to addressing this issue (BM, (2003)). However, neither HIPAA nor PIPEDA explicitly designate a patient's genomic data as a personal identifier. As such, privacy protections for genomic information could arguably be satisfied through de-identification according to the Safe Harbour policy (Gupta, D. et. al. 2004) of the HIPAA Privacy Rule. Challenges in Patient De-Identification The challenges in patient de-identification can be broadly generalized into patient data anonymization to preserve patient confidentiality and the approach to define unique global identifiers for each patient. In order to comply with existing US and Canadian regulations, we need to address the intricacies worded in the legislation and then extend our database design and business rules framework 1

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