Abstract and Introduction
As research focused on personalized medicine has developed over the past decade, bioethics scholars have contemplated the ethical, legal and social implications of this type of research. In the next decade, there will be a need to broaden the focus of this work as personalized medicine moves into clinical settings. We consider two broad issues that will grow in importance and urgency. First, we analyze the consequences of the significant increase in health information that will be brought about by personalized medicine. Second, we raise concerns about the potential of personalized medicine to exacerbate existing disparities in healthcare.
In the last 10 years, as the technology and evidence base of personalized medicine were developing, bioethics scholars began contemplating the ethical, legal and social implications of the initial applications of this approach to medicine, forming the field of investigation known as 'ELSI' scholarship. Some of the foundational issues considered were safety and efficacy, informed consent, access and reimbursement. In recent years, technologies such as next-generation sequencers and gene expression assays have become less expensive and more suitable for clinical application, and as a result, personalized medicine has become established in a growing number of clinical areas. With these clinical applications, however, the implications of personalized medicine have expanded in scope and complexity. This trend is likely to continue in the coming years, with wider adoption throughout the healthcare system creating a need to broaden the focus of work in this area. This article considers two broad issues that will grow in importance: the consequences of the significantly increased amount of health information associated with personalized medicine (privacy, discrimination, physician–patient relationships and liability); and concerns about the potential of personalized medicine to exacerbate disparities in healthcare (the input–output problem, cost and access to healthcare and access to information technologies).
Personalized Medicine. 2015;12(1):43-51. © 2015 Future Medicine Ltd.