Question

in your opinion, what are the ethical, legal, or privacy centred problems surrounding the use of personalised medicine, facilitated by human genomics, for disease prediction?

Answer 1

As a 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.

Personalized medicine is information intensive. High-dimensionality data created using genomics and other ‘omics’ technologies are central to many of the predictive, diagnostic, and therapeutic applications, however, the substantial increase in individual health information this approach requires is also one of the main sources of ethical, legal and social concerns regarding personalized medicine. of personalized medicine. The capability to utilize genomic information in the clinic depends heavily on health information technologies. Electronic health records (EHRs) and EHR networks are being widely adopted in the developed world. Health information, traditionally in the sole possession of healthcare providers, increasingly is also in the possession of individuals (in the form of personal health records) and third parties (obtained pursuant to patient-signed authorizations).

Privacy

Privacy and related terms are often used imprecisely and therefore it is valuable, to begin with, some definitions.

he related concept of confidentiality is a condition under which information obtained or disclosed within a confidential relationship is not redisclosed without the permission of the individual . The paradigmatic example of confidentiality is a physician's duty not to disclose patient health information unless authorized by the patient or required by law. Security refers to the physical and electronic measures granting access to personal health information to persons or entities authorized to receive it and denying access to others.

In much of Europe, the term ‘data protection’ takes on a similar meaning to informational privacy in the USA . In any jurisdiction, there are three main reasons why the protection of informational health privacy is so important. First, individuals may suffer from embarrassment, stigma, discrimination and other harms to their dignity if sensitive information is inappropriately disclosed. Second, the quality of healthcare may be compromised if individuals who fear improper disclosure of their sensitive information forego timely treatment for stigmatizing conditions or engage in defensive practices, such as withholding certain information from their healthcare providers . Third, public health harms may occur if individuals with infectious diseases, mental illness, substance abuse or other sensitive conditions delay or decline treatment because they fear a loss of privacy

The development of EHRs and EHR networks in much of the industrialized world increases the privacy risk because EHRs are typically comprehensive (containing records of clinical encounters with essentially all of an individual's healthcare providers), longitudinal (containing health records over an extended period of time) and instantaneously distributed to multiple parties. One consequence is that even decades-old, sensitive information remains a part of an individual's record and can be viewed by anyone with access to the EHR. Technologies and policies to give patients greater control of the contents of their health records and to limit third-party access to them, including data segmentation, are being widely considered in several countries. These measures are quite controversial, however, because they can result in certain healthcare providers having incomplete access to patient information

Personalized medicine, with its potential to draw ever-finer distinctions among individuals, could play a part in ‘genetic discrimination’, because even small genomic differences can have significant economic implications. For example, genomic information could indicate not only that an individual is more likely to develop a certain illness in the future, but also that the individual would not be responsive to standard medications and therefore represented an increased morbidity and mortality risk.

As we enter the second decade following the Human Genome Project, we see a need to expand the scope of work on the ethical, legal and social challenges raised by personalized medicine to account for its growing clinical applications throughout the healthcare system. Fortunately, the fields of bioethics and clinical ethics have rich traditions of addressing issues such as health disparities, patient privacy and the physician–patient relationship. We believe it will be extraordinarily productive to expand the community of scholars working on the ethical, legal and social implications of genomic medicine to include new types of expertise. In particular, those who have worked on health policy and clinical ethics issues unrelated to genomics have much to contribute to ethical, legal and social implications scholarship. Collaborations with health economists, quality experts and implementation scientists could also be extraordinarily productive.

The issues this expanded community of ethical, legal and social implications scholars could be called upon to address are vast; the two issues we have identified are just a starting point. We anticipate, for example, that personal responsibility for health will be an increasingly important issue in healthcare in the coming years. As we observed earlier, the personalized medicine movement has demonstrated a strong interest in empowering patients to take responsibility for their health. We know, however, that the concept of individual responsibility for health is indelibly linked with debates in many countries over the best approaches to funding healthcare [52]. This interplay between personalized medicine, individual responsibility and ideologies surrounding the funding of healthcare is just one topic of importance that is likely to benefit from interdisciplinary examination in the near future. In order to best address these issues and others, the next decade in personalized medicine should be a time of collaborative, proactive work to anticipate additional challenges and find collaborative ways to improve patient care that are responsive to ethical, legal and social concerns.

​Source:

Ethical, legal and social implications of incorporating personalized medicine into healthcare

Kyle B Brothers*,1,2,3 and Mark A Rothstein3,4

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