Beskrivelse“Big Data” plays a crucial role in the ongoing (r)evolution of health care and the life sciences. The paradigm shift is fueled by rapid technical advances that have greatly facilitated the collection and analysis of information from many different sources. Multiple definitions of “Big Data” often refer to the “four V’s”, i.e. greater Volume (vast amounts of data), Variety (significant heterogeneity in data-types), Velocity (speed at which data can be accessed and analyzed), and Veracity (accuracy and reliability of the data). In recent years, U.S. and European public authorities and entities have developed public platforms and infrastructures that provide access to vast stores of health-care knowledge, including clinical trials data and selected patient information. Meanwhile, several private actors, such as pharmaceutical companies, health care providers, laboratories and insurance companies, have accumulated years of R&D data into medical databases and digitized their patient records. The vast prospects of Big Data and the gradual shift to more “personalized”, “open” and “transparent” innovation models highlight the importance of an effective and well-calibrated regulation, governance, and use of biological and personal data. At the same time, the translation of Big Data science into safe and efficient applications raises many complex legal and ethical challenges relating to i.a. Intellectual Property Rights, research, privacy and ethics. This seminar features presentations by prominent U.S. and European experts and thorough discussions of some of the most important legal issues relevant for data-based life science research.
|20 jun. 2016