In the biomedical context, “Big Data” refers to databases that may include people’s genetic information, biological samples, lifestyle information and medical records. There are many medical databases in Israel, including those kept by the health funds and hospitals, as well as national databases such as MIDGAM and the database of Guthrie (dried blood spot) cards. Big data is a valuable resource for various purposes. Primary use of big data may aid in the treatment of a particular patient – for example, by yielding information regarding a cluster of patients. There is also great potential for secondary use of big data, mainly to promote public health and biomedical research that might aid the development of therapies and medicines. Secondary uses of databases may also include their employment for marketing purposes, for internal examination of operating procedures, and for improving or assessing treatment quality.
Selected ethical issues:
• Appropriate informed consent mechanisms – “open” consent / “broad” consent / “opt out” and so on.
• Protecting the privacy and medical confidentiality of big data participants, in relation to the level of anonymization and the level of the information’s sensitivity.
• Reporting back to database participants with incidental findings.
• Rights to data use (for example, of databases that constitute public resources).
o Fair and equal access to data – sharing it with researchers.
• Public trust and social solidarity as a basis for participation in the database.
• Fair and fitting use (for appropriate purposes) of big data, for the public benefit.