The U.S. Food and Drug Administration (FDA) is increasing its capability to harness the power of big data – or more specifically of the “real world evidence” (RWE) – to assess the safety of medical products that are approved for the U.S. market. To that end, FDA is expanding its Sentinel System so that by the end of 2023 it would represent “a transformative, multi-purpose national data and scientific resource center for evidence generation that a wide array of stakeholders use to inform all aspects of healthcare decision making,” according to the recently released Sentinel System Five-Year Strategy.
An international human rights organization is urging the Chinese government to stop building big data policing technologies that aggregate and analyze citizens’ personal information. Though governments collecting information about its citizens is not new, China has begun pursuing newer and ambitious technologies, such as big data analytics, facial recognition, and cloud computing, to better and more quickly aggregate, mine, and leverage personal information.
The use of “big data” throughout all levels of the economy has led authorities in both Europe and the United States to begin examining how such data may be used as a commodity and, therefore, how it might regulated.
However, authorities on either side of the Atlantic seem to be offering different approaches on the matter; those in Europe are suggesting that big data should be subject to EU abuse of dominance law, whereas U.S. authorities are resisting the notion of big data as an “essential facility” and are suggesting it be considered as an asset within existing merger review processes.