Privacy & Health Information Technology (LAW-719-003)
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Health care is a heavily regulated profession and industry, but some believe that federal and state regulation has not successfully provided adequate protection for health information. An important part of the regulatory process includes issues implicated by privacy and confidentiality, security, and data breach concerns, particularly when sensitive individually identifiable health information is created, stored, used, and disclosed, and subjected to data mining. Health care delivery and payment, and associated biomedical research and innovations have emerged as a growing part of health care with much more information being created, and radical changes in the way the ever growing amount of health information is used and in the minds of some, sometimes abused, despite applicable laws, is a growing concern. Included in areas of substantive concern are the Administrative Simplification Subtitle of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended, the Health Information Technology for Economic and Clinical Health (HITECH) Act enacted as part of the American Recovery and Reinvestment Act of 2009, the Genetic Information Nondiscrimination Act of 2008 (GINA), the Patient Safety and Quality Improvement Act of 2005 (PSQIA), and the Patient Protection and Affordable Care Act (referred to as PPACA or the Affordable Care Act or the health reform law), and certain state laws, as well as the European Data Protection Directive and relevant laws of foreign nations. The emerging area of life sciences law and related federal Food and Drug Administration regulatory and information use and disclosure concerns,including software as a medical device and mobile health, sometimes referred to as mHealth, involve many fascinating issues that are publicized heavily in the media and implicate complex legal issues relating to genetics and genomics, and privacy and security. Privacy and confidentiality, security, health information technology, electronic medical and health care records, using information in research including stem cell research and ownership of information, data mining and marketing, telemedicine and eHealth, and other relevant topics relating to health care generally and the life sciences specifically, will be considered.
Textbooks and Other Materials
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First Class Readings
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