Confidentiality in the medical encounter is crucial to providing adequate patient care. Health data is therefore privileged and protected by legal mechanisms. Health systems use electronic records and large-scale databases. Increasingly consumers use also IT to collect, store and share data about daily life and health behaviors. Sharing data via network-based systems or storing it ‘in the cloud’ produces multiple ‘digital selves,’ health ‘data doubles’ and ‘virtual patients.’ With so many stakeholders involved much data is produced without clear governance structures, blurring the view of what is done with the data. These problems are exacerbated through the networked, distributed nature of health data collection and convergence of protected hospital systems, commercial collection and aggregation of data and consumer health technologies. This brings patient privacy into the realm of cybersecurity. This panel explores how cybersecurity impacts the governance of critical IT infrastructures and mitigation of threats, what sociotechnical challenges are related to protection of large-scale HIT systems, how surveillance and bioethics studies seek to understand threats to personal privacy in the context of networked technologies and finally what changes to laws and regulations would be required.
Protecting Patient Privacy in Cyber Environments by Jos Aarts, Samantha Adams, Bonnie Kaplan, Paul R. DeMuro, Anthony E. Solomonides :: SSRNDecember 1, 2016
Metaphor after Myriad: The Effect of Legal Rhetoric on Intellectual Property Protection for Biological Sequences by Charlotte A. Tschider :: SSRNNovember 13, 2016
The Association for Molecular Pathology v. Myriad Genetics (‘Myriad’), the U.S. Supreme Court’s first code-level determination of patent eligibility for biological sequences, ultimately barred isolated DNA patents in the United States while granting patent protection of cDNA. Myriad’s decision has, since 2013, continued to pose questions regarding legal protection for biological sequences as a whole: which types of biological sequences are patent-ineligible, and what legal strategy organizations should use to protect these sequences. As biotechnology companies continue to perform genetic testing and market pharmacogenomics products to the general public, the industry will likely demand appropriate legal instruments to safeguard significant investment in research and development. Although no clear direction has emerged for protecting biological sequences holistically, analyzing metaphors used in the Myriad decision may suggest a legal direction compatible with court reasoning. Based on metaphors used most prevalently in Myriad, courts seem to suggest thin compilation copyright and trade secret protection offer potential solutions for legally protecting biological sequences.
We describe the broad range of uncertainties faced by the developers of medical technologies. Empirically, we estimate the asset market incidence of two realizations of uncertainties we classify as within-market policy risks. The events we analyze concern the intellectual property of Myriad Genetics, Inc., an American molecular diagnostics firm. In July 2013, the Supreme Court invalidated several of Myriad’s intellectual property claims. Subsequently, the Center for Medicare and Medicaid Services reevaluated the reimbursements it pays for the services at issue in this patent litigation. We estimate that these events substantially moved Myriad’s market capitalization, by just under 25 percent in the case of the Supreme Court’s decision and nearly 20 percent in the case of CMS’s reimbursement rate re-determination. Myriad’s exposure to the realization of these intellectual property risks reflects its unusually high reliance on revenues linked to the services at issue. We discuss the implications of these risks for the total volume of medical innovation and for its organization across firms.
The Supreme Court is poised to take up the highly charged question of whether human genes can be patented. But another question could trump it: Has the field of genetics moved so far so fast that whatever the court decides, it has come too late to the issue?
The Return of Results in Genetic Testing: Who Owes What to Whom, When, and Why? by Stephanie Alessi :: SSRNMarch 21, 2013
With the advent of large-scale genetic research, discoveries about the human race that never before seemed possible are becoming a reality. To support these scientific discoveries, biobanks catalog library-sized collections of DNA samples and offer researchers access to an increasingly diverse supply of genetic material on which to do research. These stored samples provide the means for studies that, over time, will uncover benefits about which we can now only speculate.
Despite the enormous potential that the future of genetic research holds, the research process has potentially troublesome implications for the human subjects who contribute their genetic materials. Chief among these concerns is the question of what to do with the individual data that arise as a result of genetic research. Genetic material may reveal features of a person that she was not even aware existed, providing potentially useful insight into one’s health status that, if available, many individuals would want to know. On the other hand, some people, for moral reasons or otherwise, may prefer not to learn about their genetic predispositions due to the inherent uncertainty of such information. Thus, research design and governance must allow individuals to make their own decisions.
Furthermore, placing a responsibility on researchers to provide their subjects with all theoretically interesting or useful information can detract time and resources from a study’s primary purpose. As such, researchers frequently find themselves forced to balance the subjects’ personal interests against their research goals. Yet there exist no uniform standards on which either researchers or subjects may rely as they perform this balancing act; there is little guidance for either party as to what information should be communicated. They are thus left with the unanswered question: To what extent is there an ethical obligation, and to what extent should there be a legal duty to return genetic results to a research subject?
This paper balances three competing goals — promoting socially beneficial genetic research, protecting individual health and access to personal information, and protecting individual autonomy and privacy — and proposes the adoption of specific, limited duties regarding planning for, acquiring informed consent about, and reporting genetic results.
“When finally interpreted, the genetic message encoded within our DNA molecules will provide the ultimate answers to the chemical underpinnings of human existence” : A passion for DNA, Genes, Genomes, and Society, James D. Watson, 2 August 1989.
Genes are the medium through which living organisms transmit genetic information from one generation to next. It is our genetic code that make us the unique individuals that we are. The double-helical structure of DNA, initially admired for its intellectual simplicity, today represents to many a double-edged sword that can be used for evil as well as good. Since 1980 after the grant of first patent for living organisms by USPTO in Diamond v Chakrabarty the subject of patents has moved from human-made bacterial microorganisms to human cells to human genes today. Patents encourage invention and innovation but everyone must be careful not to rope off far-reaching areas of patent eligibility.
The patenting of human genetic material raises too opposing ethical questions. At first is it ethically permissible to patent segments of the human genome when these segments represent part of our individual & collective natural heritage & secondly is it ethical to deny patenting parts of human genome given the vast economic resources & human effort expended in identifying it.
The research paper will begin with the legal developments that led to patenting of a bacteria to the patenting of genes in human beings. Further it will discuss the ethical questions that surface with this controversy.The paper will then conclude with the future implication of gene patenting on humanity.
Pigs Fly – The Validity of Gene Patenting vis-a-vis the Myriad Patent Case and Other Cases by Manveer Sandhu, Abhinav Gaur :: SSRNMarch 14, 2013
In the past 20 years, inventions in the field of biotechnology have become a new focus of the patent system, particularly in relation to genetic materials and technologies. For over two hundred years living organisms had been excluded from patent laws; life forms were considered a “product of nature” and not an intellectual result of a human brain.
The non-patentable status of living organisms changed with the 1980 landmark United States Supreme Court case Diamond v. Chakrabarty, wherein, the court decided that a strain of bacteria that had been modified by the insertion of new genes was patentable.
Through this paper, we make an effort to deduce the word “Patent” in its most indispensable form. We analyse the meticulous history of the Patents with the contemporarily done research and development of Bio-technology in the field of Patents. We also analyse and scrutinize the system of DNA patenting followed in India. We also make an effort to put forward as to how the need for patent of Life forms arose with special reference to various cases such as the Myriad case in which the court found the claims of seven patents on the BRCA1 and BRCA2 genes invalid, and however the Federal appeals court overturned the ruling of the lower court.
The paper shall explore and give answers to some of the most vital questions such as: Is DNA patenting morally and ethically correct? Is it correct to give ownership of a whole pedigree of living organisms to a person or company? How can the flaws in the DNA patenting system be removed and how can it be made more reliable and made sure that it isn’t misused?