is tested. It becomes questionable whether personal health information is truly one’s
own to reveal, hide, or give access to because it almost always involves health
information about blood relatives as well, meaning that their rights and interests are
at stake too.
This paper is not about confidentiality of health information. It is not about the
protection of personality rights of patients either or about legal and ethical conun-
drums in connection with predictive and preventive modern medical technologies.
It is about a combination of all of these issues, and more.
Scientists who analyze social, legal, economic, and ethical issues encounter
extreme demographic changes, which can exhort a dramatic pressure on social
security systems, especially the health care system.
Multiple questions arise in the context of personalized medicine.
2 Personalized Medicine and the Resulting Challenges
Personalized, stratified, individualized or even P4 medicine (personalized, predic-
tive, preventive, and participatory) are just some of the most commonly used terms
in literature, describing the same concept.^4
Personalized medicine is basically about a comprehensive doctor–patient rela-
tion based on individual genome-oriented diagnosis (thousands of cell-based pro-
cesses) and treatment, specific customized drug design, and, ultimately, targeted
drug delivery. Or, as Niederlag et al.^5 define it, personalized medicine means
optimized, patient-based medicine/health care, which includes individualized diag-
nostic (predict and prevent), especially obtaining information about individual
disease risk based on genetic biomarkers (individual prediction) and, in connection
therewith, creation of preventive instruments (disease prevention), individualized
drug treatment, individualized autologous cell therapy, patient model-based therapy
in the operating room, electronic patient records, individual care of patients in their
home environment with the use of technical systems and services. We agree with
these authors, but special attention should also be given to important issues of data
processing, or the so-called “Big Data.”
The objective of individualized, personalized, or stratified medicine is to
enhance and raise efficiency of medical treatment through modern diagnostic pro-
cedures and reduce undesired side effects and costs of treatment.^6 Targeted or
personalized medicine reduces drug consumption and at the same time has a
significant impact on overall health costs.
(^4) For various definitions of these terms, see, e.g., Radder et al. ( 2014 ), Bottinger ( 2007 ), Niederlag
et al. ( 2010 ), Qattan et al. ( 2012 ), Pavelic ́et al. ( 2015 ), and Taupitz ( 2011 ) and references
contained therein.
(^5) Niederlag et al. ( 2010 ), p. 776.
(^6) Kroemer ( 2012 ), p. 12.
Challenges of Personalized Medicine: Socio-Legal Disputes and Possible Solutions 33