Healthcare is a complex sector and in order to enter this market, all products and services must prove their safety, benefits, and values before being adopted. Digital Health particularly provides the opportunity to access big data, which is described as “the new oil”   for the future economy since Big Data is seen as boosting creativity and innovation, and positively impacting the economy. Big data is considered a critical asset in the health system because of the impact resulting from the evidence generated from Big Data. This evidence supports policymakers in making informed decisions and regulatory authorities in assessing benefits and risks of medicines. However, generating, analysing, storing, and combining big data as well as other data has several challenges  .
 The world’s most valuable resource is no longer oil, but data, The ECONOMIST, 2017. https://www.economist.com/leaders/2017/05/06/the-worlds-most-valuable-resource-is-no-longer-oil-but-data
 Back in 2017, The Economist published a story titled, "The world's most valuable resource is no longer oil, but data." Since its publication, the topic has generated a great deal of discussion, and "Data is the new oil" has become a common refrain.
 Organisation for Economic Co-operation and Development: OECD Health Working Paper No. 129 Empowering the health workforce to make the most of the digital revolution, 2021. https://www.oecd-ilibrary.org/docserver/37ff0eaa-en.pdf?
 Union Agency for Fundamental Rights - Council of Europe-European Court of Human Rights - European Data Protection Supervisor E. Handbook on European data protection law. doi:10.2811/58814