Patient privacy and security concerns on big data for personalized medicine

Established and emerging organizational, methodological and technological paradigm changes health systems around the world are faced with, dramatically impact the administrative, legal and social framework as well as processes of, but also roles and responsibilities of actors involved in, health services delivery. Security, privacy and trust are major concerns in that context to be appropriately managed. After shortly illustrating the aforementioned paradigm changes, the resulting changes regarding roles and ways of acting of the different principals involved in health care, and especially the position and role of patients, for meeting the challenges for high quality health care and the efficiency and efficacy of related processes is described. For analyzing and designing future-proof health systems, new approaches are inevitable. The new health systems architecture is formally represented using a system theory based architectural model representing the different actors in the system within their specific context. The advanced and personalized health services approach offers big chances combined with big risks for the actors and first of all for patients. In this context, especially safety, security and privacy have to be mentioned. The structure and behavior of the system in question, and even more the rules the processes follow must be controlled by the main actor, formerly the health professional and now the patient. The resulting system has to be highly flexible and policy-controlled, where the patient’s policies are dominant. The paper summarizes the consequences for security and privacy, thereby especially highlighting security and privacy challenges of big data and analytics as well as bio-, nano- and mobile technologies for ubiquitous personalized health. In such environment, the status of the patient, his/her experiences, expectations and wishes, but also his/her personal and environmental context define the provision of health services. By that way, the patient turns from subject of care to the responsible manager of processes and conditions. The new role of the patient must be accompanied by appropriate basic policies, frameworks and tools to enable the patient playing that role