I organized and spoke at the following conference:

Legal dimensions of Big Data in the Health and Life Sciences-From intellectual property rights and global pandemics to privacy and ethics

“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.For further information please contact Professor Timo Minssen (timo.minssen@jur.ku.dk) or Maria Lotz (maria.lotz@jur.ku.dk ).Time: Friday 20 May 2016, 15:00-18:15 followed by refreshmentsPlace: The staff canteen 02-3-44, Studiegaarden, Studiestraede 6, 3rd floor, DK-1455 Copenhagen K

Welcome note: The legal dimensions of Big Data Professor Timo Minssen, University of Copenhagen and PI of the Global Genes –Local Concerns project. “Our goal is to create a European Open Science Cloud to make science more efficient and productive and let millions of researchers share and analyze research data in a trusted environment across technologies, disciplines and borders”. – Carlos Moedas, EU Commissioner for Research, Science & Innovation “!The European Cloud Initiative will unlock the value of big data by providing world-class supercomputing capability, high-speed connectivity and leading-edge data and software services for science, industry and the public sector.” – Günther H. Oettinger, Commissioner for the Digital Economy and Society Ladies and Gentleman, I am very happy to welcome you to this seminar on the “Legal dimensions of Big Data in the Health and Life Sciences – From Intellectual Property Rights and Global Pandemics to Privacy and Ethics”. The importance of this topic is not only emphasized by the above statements from EU Commissioners announcing the European Open Science Cloud initiative. Multiple factors indicate that “Big Data” will play a crucial role in the evolution of health care and the life sciences. The ongoing paradigm shift is fueled by rapid technical advances that have greatly enhanced the collection and analysis of information from multiple sources. In addition, U.S. and European authorities and public entities have in recent years developed public platforms and infrastructures that provide access to vast volumes of health-care knowledge, including clinical trials and selected patients data. Meanwhile, several private actors, such as pharmaceutical companies, health care providers, laboratories and insurance companies, have stored many years of R&D data into databases and digitalized their patient records. This trend is accompanied by recent initiatives and legislation that are increasing the transparency of various forms of data, such as clinical trials data. As a result researchers, companies, patients and health care providers can now gain access to an enormously increased volume of personal and biological data. This information can be regarded as “big data,” i.e. not only because of the greater volume, but also for its’ increased variety, velocity, and veracity. Researchers can mine this data to identify the most effective treatments for particular conditions, to find 2nd and further medical uses, to detect patterns related to drug side effects or hospital readmissions, and gain other important information that can help patients and reduce costs. Although the data collections may be colossal and the quality of the data is often very diverse – depending on different database structures and technical characteristics- rapid technological advances have improved the ability of scientists to effectively analyze and use such data. It is expected that these developments will push the trend towards precision medicine and help us to address pressing problems, such as divergences in healthcare quality and ever-increasing healthcare costs. These vast prospects of Big Data and the gradual shift to more “personalized”, “open” and “transparent” innovation models highlight the significance of an effective and well-calibrated regulation, governance, and use of biological and personal data. At the same time, the ultimate goal of widespread data- sharing, as well as the risky and costly translation of Big Data science into safe and efficient “real world” applications raises multiple legal challenges relating to i.a. public-private research collaborations, data integrity, privacy, and ethics. In addition we will have to tackle pressing issues at the interface of intellectual property law, competition law, R&D incentives and commercialization. As it will be discussed in the following sessions, we will have to ask ourselves and the decisions makers if the current legal frameworks need to be re-calibrated in specific areas to unlock the full potential of Big Data in the health and life sciences. Does our current toolbox have sufficiently flexible mechanisms in place or would we have to think in radically different ways and break new grounds? With the new ESS- ERIC and Max IV facilities and other large international research infrastructures being developed in this region, such as the BBMRI-ERIC in biobanking, this is highly relevant for both the EU and for shaping national innovation policies and legal frameworks. Moreover, these new facilities need to carefully consider complex legal issues when drafting their operational policies and guidelines. What makes this a very delicate task is that, there seems to be much confusion about the availability, nature and the legal effects of a great variety of often overlapping rights and remedies among multiple stakeholders in Big Data science. Against this background, we are of course delighted to have such a distinguished list of speakers among us. We will start out with a topic that concerns us all “Big Data, Intellectual Property and Global Pandemics!” Professor Yu, the stage is yours!