Precision medicine (PM, a term used interchangeably with the older term “personalized medicine”) is an area in which the boundaries between research, clinical uses, and the healthcare industry are blurred. This creates novel regulatory spaces and challenges. It would appear, however, that PM-related regulatory challenges are variations on familiar traditional tensions—individual liberty versus solidarity and public interest in PM-derived benefit; autonomy versus paternalism; and risk versus benefit.

This concise overview introduces the legal and ethical environments of big health data (and genetic samples) in Israel, particularly as they relate to research. It also briefly addresses PM in Israel, identifies key stakeholders within the Israeli system, and reviews ethical issues associated with the use of big health data as well as some PM specific issues. Looking into other non-research big health data uses (for example, for marketing or for a health organization’s internal control purposes) is beyond the scope of this review.

*The review was prepared and originally published prior to the publication of the Patient Rights draft Regulations (research use of health information), 2019.