Business and Research Responses to the Changing Legal Environment for Data ManagementPDF
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We are in the midst of major legal changes affecting data collection, storage, transfer and use. For example, in the U.S., a major revision to the Common Rule for human subjects research will take effect in early 2018, the Federal Trade Commission has unexpectedly moved into the regulation of health data, and the federal government has interpreted HIPAA to expand patients' access to raw genomic data. In the European Union, a new General Data Protection Regulation will take effect in 2018, with major implications for both collecting health and research data and transferring it to the U.S. John Conley's presentation at the 2018 Bio-IT World Conference & Expo reviewed these developments and then discussed how Bio-IT companies and institutions should respond. The most fundamental questions were: who needs to worry, and what should they do?