Sharing Data under Genetic Privacy Laws

Clinical medical practice and biomedical research utilize genetic information for specific purposes. Irrespective of the purpose of obtaining genetic material, methodologies for protecting the privacy of patients/donors in both clinical and research settings have not kept pace with rapid genetic advances. When the usage of genetic information is not predicated on the latest laws and policies, the result places all-important patient/donor privacy at risk. Some methodologies err on the side of overly stringent policies that may inhibit research and openended diagnostic activity, whereas an opposite approach advocates a high-degree of openness that can jeopardize patient privacy, identifying patient relatives and erode the doctor-patient privilege. As a solution, we present a unique approach that is based on the premise that acceptable clinical treatment regimens are captured in workflows used by caregivers and researchers and therefore their associated purpose can be extracted from these workflows. We combine these purposes with applicable consents (derived from applicable laws) to ascertain the releasability of genetic information. Given that federal, state and institutional laws govern the use, retention and sharing of genetic information, we create a three-level rule hierarchy to apply the laws to a request and auto-generate consents prior to releasing. We prototype our system using open source tools, while ensuring that the results can be added to existing Electronic Medical Records (EMR) systems. Keywords—genetic privacy, electronic medical records, ontology, health care, genomic medicine, SWRL