New developments in genetics could affect a variety of real property rights. Mortgage lenders, mortgage insurers, real estate sellers, senior living centers, retirement communities, or other parties in residential real estate transactions begin requiring predictive genetic information as part of the application process. One likely use would be by retirement communities to learn an individual's genetic risk for Alzheimer's disease. The federal Fair Housing Act prohibits discrimination based on disability, but it is not clear that it would apply to genetic (...) risk assessments. Only California law explicitly applies to this situation and there have been no reported cases. (shrink)

In the post-genome world of biomedical research, an increasingly common research strategy is to focus on large repositories of biological specimens. There are now several well-known efforts to compile vast collections of biological materials, reanalyze extant samples, collect new ones, and link the samples to medical records. The significant issues of law, ethics, and policy raised by these research activities usually are heightened when commercial enterprises play a leading role in accumulating and distributing the samples. Emerging companies are not only (...) compiling repositories for their own use, but some companies are positioning themselves to act as intermediaries, developing vast biobanks for sale to a wide range of other researchers. (shrink)

DNA identification is being used in ever-widening ways, including databases of greater scope, familial and lowstringency searches, and DNA dragnets. After examining the law enforcement and privacy interests, the article concludes that forensic DNA uses must be consistent with privacy and civil liberties.

The seemingly interminable debates about health care reform in the last few years have focused mainly on health care access, quality, and cost. Debates on the medical malpractice component of the issue have focused almost entirely on cost. The familiar arguments in favor of limiting liability include the financial and health costs of defensive medicine; decreased physician supply in certain specialties and geographic areas; excessive awards; and high transaction costs, including attorney and expert witness fees. The equally familiar arguments in (...) favor of maintaining tort liability include the need to promote civil justice, deter substandard care, identify incompetent practitioners, and encourage systemic quality improvement.Numerous studies have explored the possible effects of damage caps and other measures on malpractice premiums, health care costs, and other financial endpoints. One relatively under-examined aspect of the issue is how federal legislation expanding access to health care might alter the number of medical malpractice claims. With the enactment of the Patient Protection and Affordable Care Act of 2010, it is especially appropriate to consider what effect, if any, the new law will have on the rate of medical malpractice claims. (shrink)

Mobile devices with health apps, direct-to-consumer genetic testing, crowd-sourced information, and other data sources have enabled research by new classes of researchers. Independent researchers, citizen scientists, patient-directed researchers, self-experimenters, and others are not covered by federal research regulations because they are not recipients of federal financial assistance or conducting research in anticipation of a submission to the FDA for approval of a new drug or medical device. This article addresses the difficult policy challenge of promoting the welfare and interests of (...) research participants, as well as the public, in the absence of regulatory requirements and without discouraging independent, innovative scientific inquiry. The article recommends a series of measures, including education, consultation, transparency, self-governance, and regulation to strike the appropriate balance. (shrink)

Public health is a dynamic field. Outbreaks of new diseases, as well as changing patterns of population growth, economic development, and lifestyle trends all may threaten public health and thus demand a public health response. As the practice of public health evolves, there is an ongoing need to reassess its scientific, ethical, legal, and social underpinnings. Such a reappraisal must consider the disagreement among public health officials, public health scholars, elected officials, and the public about the proper role of public (...) health and the distinctions, for example, between public health and clinical care, and public health and health promotion.In this article I will attempt to characterize the main points of contention as well as offer my own views regarding the proper scope of public health. Greater clarity and consensus on the meaning of public health are likely to lead to more efficient and effective public health interventions as well as increased public and political support for public health activities. (shrink)

Public health is a dynamic field. Outbreaks of new diseases, as well as changing patterns of population growth, economic development, and lifestyle trends all may threaten public health and thus demand a public health response. As the practice of public health evolves, there is an ongoing need to reassess its scientific, ethical, legal, and social underpinnings. Such a reappraisal must consider the disagreement among public health officials, public health scholars, elected officials, and the public about the proper role of public (...) health and the distinctions, for example, between public health and clinical care, and public health and health promotion.In this article I will attempt to characterize the main points of contention as well as offer my own views regarding the proper scope of public health. Greater clarity and consensus on the meaning of public health are likely to lead to more efficient and effective public health interventions as well as increased public and political support for public health activities. (shrink)

Researchers increasingly rely on large data sets of health information, often linked with biological specimens. In recent years, the argument has been made that obtaining informed consent for conducting records-based research is unduly burdensome and results in ?consent bias.? As a type of selection bias, consent bias is said to exist when the group giving researchers access to their data differs from the group denying access. Therefore, to promote socially beneficial research, it is argued that consent should be unnecessary. After (...) analyzing the biostatistics evidence and bioethics arguments, the article concludes that (1) claims about the amount of consent bias are overstated; (2) commonly used statistical methods usually can account for consent bias; and (3) any residual effects of consent bias are below an acceptable level of imprecision and constitute a reasonable social cost for conducting ethically responsible research. (shrink)

Beginning in the 20th century, scientific research came to be dominated by a growing class of credentialed, professional scientists who overwhelmingly displaced the learned amateurs of an earlier time. By the end of the century, however, the exclusive realm of professional scientists conducting research was joined, to a degree, by “citizen scientists.” The term originally encompassed non-professionals assisting professional scientists by contributing observations and measurements to ongoing research enterprises. These collaborations were especially common in the environmental sciences, where citizen scientists (...) participated in counting wildlife and measuring environmental conditions. Later, patient groups began to play a more active role in supporting clinical trials and collecting health records from affected individuals. (shrink)

Each year individuals are required to execute millions of authorizations for the release of their health records as a condition of employment, applying for various types of insurance, and submitting claims for benefits. Generally, there are no restrictions on the scope of information released pursuant to these compelled authorizations, and the development of a nationwide system of interoperable electronic health records will increase the amount of health information released. After quantifying the extent of these disclosures, this article discusses why it (...) is important to limit disclosures of health information for nonmedical purposes as well as how it may be possible to do so. (shrink)

Laws in the 20 jurisdictions studied for this project display many similar approaches to protecting privacy in biobank research. Although few have enacted biobank-specific legislation, many countries address biobanking within other laws. All provide for some oversight mechanisms for biobank research, even though the nature of that oversight varies between jurisdictions. Most have some sort of controlled access system in place for research with biobank specimens. While broad consent models facilitate biobanking, countries without national or federated biobanks have been slow (...) to adopt broad consent. International guidelines have facilitated sharing and generally take a proportional risk approach, but many countries have provisions guiding international sharing and a few even limit international sharing. Although privacy laws may not prohibit international collaborations, the multi-prong approach to privacy unique to each jurisdiction can complicate international sharing. These symposium issues can serve as a resource for explaining the sometimes intricate privacy laws in each studied jurisdiction, outlining the key issues with regards to privacy and biobanking, and serving to describe a framework for the process of harmonization of privacy laws. (shrink)

In the early 1970s, Congress considered enacting comprehensive privacy legislation, but it was unable to do so. In 1974, it passed the Privacy Act, applicable only to information in the possession of the federal government. In the intervening years, other information privacy laws enacted by Congress, such as the Health Insurance Portability and Accountability Act, have been weak and sector specific. With the explosion of information technology and the growing concerns about an absence of effective federal privacy laws, the legal (...) focus has shifted to the states. Signaling a new direction in state data privacy and consumer protection law, the California Consumer Privacy Act establishes important rights and protections for California residents with regard to the collection, use, disclosure, and sale of their personal information. The CCPA is certain to spur similar legislation and to affect national and international businesses that collect data from California's residents. Understanding the new law is important for all data‐driven industries, including health care. (shrink)

: Can passing antidiscrimination laws ever be a bad idea? Yes, if broad policy reform is abandoned in favor of genetic-specific legislation. But in spite of its serious flaws, both in concept and in practice, genetic-specific legislation is sometimes worth passing anyway—sometimes a bad idea is reasonable.

Genetic privacy and confidentiality have both intrinsic and consequential value. Although general agreement exists about the need to protect privacy and confidentiality in the abstract, most of the concern has focused on preventing the harmful uses of this sensitive information. I hope to demonstrate in this article that the reason why genetic privacy and confidentiality are so difficult to protect is that any effort to protect them inevitably implicates broader and extremely contentious issues, such as the right of access to (...) health care. Moreover, the tentative legislative and policy steps undertaken and proposed thus far have been, for the most part, misguided, simplistic, and ineffective. (shrink)

Biobanks are repositories of human biological materials collected for biomedical research. There are over 300 million stored specimens in the United States, and the number grows by 20 million per year. In the post-genome world of high throughput gene sequencing and computational biology, biobanks hold the promise of facilitating large-scale research studies. New organizational and operational models of research repositories also raise complex issues of big science, big business, and big ethical concerns.

Since the fourth century, B.C.E., the Oath of Hippocrates has been the starting point in analyzing the obligations of physicians to protect the privacy and confidentiality interests of their patients. The pertinent provision of the Oath reads as follows: “What I may see or hear in the course of the treatment or even outside of the treatment in regard to the life of men, which on no account must be spread abroad, I will keep to myself, holding such things shameful (...) to be spoken about.”This part of the Oath is subject to more than one interpretation, but its commonly accepted meaning provides the ethical foundation for the physician’s duty of confidentiality. The Oath expressly declares that a physician’s obligation of confidentiality applies beyond matters of medical care. At a time when there were no hospitals or physician offices, patients received medical care in their homes or in public places. Physicians treating patients in their homes could be expected to see and hear a wide range of activities that might be considered embarrassing, immoral, or even illegal. (shrink)

Biobanks are repositories of human biological materials collected for biomedical research. There are over 300 million stored specimens in the United States, and the number grows by 20 million per year. In the post-genome world of high throughput gene sequencing and computational biology, biobanks hold the promise of facilitating large-scale research studies. New organizational and operational models of research repositories also raise complex issues of big science, big business, and big ethical concerns.

From the earliest days of the Human Genome Project, the holy grail of genomics was the ability to perform whole-genome sequencing quickly, accurately, and relatively inexpensively so that the benefits of genomics would be widely available in clinical settings. Although the mythical $1,000 genome sequence seemed elusive for many years, next-generation sequencing technologies and other recent advances clearly indicate that inexpensive whole-genome sequencing is at hand.Whole-genome sequencing has demonstrable value in elucidating the genetic etiology of rare disorders, in identifying atypical (...) variants in common diseases, in determining pharmacogenomically appropriate drugs and dosages, in performing tumor genome sequencing, and in aiding other clinical applications for the diagnosis and treatment of individuals who are symptomatic or whose family health history places them at substantial risk. Undoubtedly, the clinical applications of wholegenome sequencing will increase in the future. (shrink)

The 2009 pandemic of influenza A was relatively mild, but a subsequent outbreak of pandemic influenza could be much worse. According to projections from the Department of Health and Human Services, the potential health consequences of a severe influenza pandemic in the United States could be literally overwhelming: up to 1.9 million deaths; 90 million people sick; 45 million people needing outpatient care; 9.9 million people hospitalized, of whom 1.485 million would need treatment in an intensive care unit ; and (...) 742,500 patients needing mechanical ventilators. Even a less cataclysmic, moderate pandemic would result in 209,000 deaths; 90 million people sick; 45 million people needing outpatient care; 865,000 people hospitalized, of whom 128,750 would need treatment in an ICU; and 64,875 patients needing mechanical ventilators. (shrink)

The shift to longitudinal, comprehensive electronic health records means that any health care provider or third-party user of the EHR will be able to access much health information of questionable clinical utility and possibly of great sensitivity. Genetic test results, reproductive health, mental health, substance abuse, and domestic violence are examples of sensitive information that many patients would not want routinely available. The likely policy response is to give patients the ability to segment information in their EHRs and to sequester (...) certain types of sensitive information, thereby limiting routine access to the totality of a patient's health record. This article explores the likely effect on the physician-patient relationship of patient-directed sequestration of sensitive health information, including the ethical and legal consequences. (shrink)

Genetic privacy and confidentiality have both intrinsic and consequential value. Although general agreement exists about the need to protect privacy and confidentiality in the abstract, most of the concern has focused on preventing the harmful uses of this sensitive information. I hope to demonstrate in this article that the reason why genetic privacy and confidentiality are so difficult to protect is that any effort to protect them inevitably implicates broader and extremely contentious issues, such as the right of access to (...) health care. Moreover, the tentative legislative and policy steps undertaken and proposed thus far have been, for the most part, misguided, simplistic, and ineffective. (shrink)

This article considers the distinctive features of epigenetics and discusses whether, as a matter of ethics and law, epigenetics should be considered separate from genetics.

Emerging fields of science often create new challenges for ethics and law. In assessing the broader societal implications of scientific discoveries, a reasonable analytical starting point is determining how the discoveries compare with existing science. If the new field is substantially similar to an established one, then the ethical and legal analyses are likely to be comparable. On the other hand, if the new scientific developments are extraordinary in kind or degree, then a new analytical framework and new approaches to (...) ethics and law may be necessary. (shrink)

Privacy is protected in biobank-based research in the US primarily by the Health Insurance Portability and Accountability Act Privacy Rule and the Federal Policy for Protection of Human Subjects. Neither rule, however, was created to function in the unique context of biobank research, and therefore neither applies to all biobank-based research. Not only is it challenging to determine when the HIPAA Privacy Rule or the Common Rule apply, but these laws apply different standards to protect privacy. In addition, many other (...) federal and state laws may be applicable to a particular biobank, researcher, or project. US law also does not directly address international sharing of data or specimens outside of the EU–US Safe Harbor Agreement, which only applies to receipt of data by certain US entities from EU countries, and is in the process of revision. Although new rules would help clarify privacy protections in biobanking, any implemented changes should be studied to determine the sufficiency of the protections as well as its ability to facilitate or hinder international collaborations. (shrink)

For nearly twenty-five years, federal regulation of privacy issues in research involving human subjects was the primary province of the federal rule for Protection of Human Subjects. As of April 14, 2003, the compliance date for the Privacy Rule of the Health Insurance Portability and Accountability Act, however, the Common Rule and the Privacy Rule jointly regulate research privacy. Although, in theory, the Privacy Rule is intended to complement the Common Rule, there are several areas in which the rules diverge. (...) In some instances the inconsistencies result in gaps in privacy protection; in other instances the inconsistencies result in added burdens on researchers without additional privacy protections. In all instances, the lack of harmonization of these rules has created confusion, frustration, and misunderstanding by researchers, research subjects, and institutional review boards. In this article, I review the major provisions of the Privacy Rule for research, explain the areas in which the Privacy Rule and Common Rule differ, and conclude that the two rules should be revised to promote consistency and maximize privacy protections while minimizing the burdens on research. (shrink)

In the post-genome world of biomedical research, an increasingly common research strategy is to focus on large repositories of biological specimens. There are now several well-known efforts to compile vast collections of biological materials, reanalyze extant samples, collect new ones, and link the samples to medical records. The significant issues of law, ethics, and policy raised by these research activities usually are heightened when commercial enterprises play a leading role in accumulating and distributing the samples. Emerging companies are not only (...) compiling repositories for their own use, but some companies are positioning themselves to act as intermediaries, developing vast biobanks for sale to a wide range of other researchers. (shrink)

Genetic-specific nondiscrimination laws have been enacted in most states, but the laws are ineffective and increase the stigma of genetic conditions. Whether these laws are better than no new legislation depends on their consequences and a recognition of their limitations.

For nearly twenty-five years, federal regulation of privacy issues in research involving human subjects was the primary province of the federal rule for Protection of Human Subjects. As of April 14, 2003, the compliance date for the Privacy Rule of the Health Insurance Portability and Accountability Act, however, the Common Rule and the Privacy Rule jointly regulate research privacy. Although, in theory, the Privacy Rule is intended to complement the Common Rule, there are several areas in which the rules diverge. (...) In some instances the inconsistencies result in gaps in privacy protection; in other instances the inconsistencies result in added burdens on researchers without additional privacy protections. In all instances, the lack of harmonization of these rules has created confusion, frustration, and misunderstanding by researchers, research subjects, and institutional review boards. In this article, I review the major provisions of the Privacy Rule for research, explain the areas in which the Privacy Rule and Common Rule differ, and conclude that the two rules should be revised to promote consistency and maximize privacy protections while minimizing the burdens on research. (shrink)

The HIPAA Privacy Rule is notoriously weak because of its incomplete coverage, numerous exclusions and exemptions, and limited rights for individuals. The three areas in which it provides the most protection are fundraising, marketing, and research. Provisions of the 21st Century Cures Act, pending in Congress, and the Notice of Proposed Rulemaking to amend the federal research regulations, awaiting final regulatory action, would weaken the privacy protections for research. If these measures are adopted, the HIPAA Privacy Rule would have so (...) little value that it might not be worth the aggravation and burden. (shrink)

The Journal of Law, Medicine &Ethics, Volume 43, Issue 4, Page 673-674, Winter 2015.

DNA identification methods are such an established part of our law enforcement and criminal justice systems it is hard to believe that the technologies were developed as recently as the mid-1980s, and that the databases of law enforcement profiles were established in the 1990s. Although the first databases were limited to the DNA profiles of convicted rapists and murderers, the success of these databases in solving violent crimes provided the impetus for Congress and state legislatures to expand the scope of (...) the databases with little critical examination of each expansion's value to law enforcement or cost to privacy and civil liberties.We are now entering a new stage of DNA forensics, in which successive database expansions over the last decade have raised the possibility of creating a population-wide repository. In addition, new applications of DNA profiling, including familial and low stringency searches, have been added to DNA dragnets, the use of medical samples for forensic analysis, and other measures to create a series of crucial, yet largely unexplored, second-generation legal and policy issues. (shrink)

One of the most important and contentious policy issues surrounding genetics is whether genetic information should be treated separately from other medical information. The view that genetics raises distinct issues is what Thomas Murray labeled “genetic exceptionalism,” borrowing from the earlier term “HIV exceptional-ism.” The issue of whether the use of genetic information should be addressed separately from other health information is not merely an academic concern, however. Since the Human Genome Project began in 1990, nearly every state has enacted (...) legislation prohibiting genetic discrimination in health insurance; two-thirds of the states have enacted laws prohibiting genetic discrimination in employment, and other state laws have been enacted dealing with genetic discrimination in life insurance, genetic privacy, and genetic testing. Bills in Congress also would prohibit genetic discrimination in health insurance and employment. (shrink)

Boehl Chair of Law and Medicine and Director of the Institute for Bioethics, Health Policy and Law, University of Louisville School of Medicine, 501 East Broadway # 310, Louisville, Kentucky 40202, USA. Tel.: 502 852 4980; Fax: 502 852 4963; Email: mark.rothstein{at}louisville.edu ' + u + '@' + d + ' '//--> Abstract In his article in this issue, Daniel Goldberg advocates a broad definition of public health and expressly rejects the narrow definition of public health I proposed (...) in a 2002 article. Goldberg asserts that public health should include all of the root causes of ill health in populations. Such a definition, however, would include within public health war, famine, crime, illiteracy and numerous other conditions on which public health professionals and agencies lack the resources, expertise and public support to act. The appropriate definition explicitly recognizes that public health is a legal term of art referring to specifically authorized activities by public officials to protect, promote and improve population health. CiteULike Connotea Del.icio.us What's this? (shrink)

Hastings Center Report, Volume 52, Issue 1, Page 8-9, January/February 2022.

It has been pending in Congress for twelve years, despite the support of the last two presidential Administrations and the National Institutes of Health. It has been the subject of extensive affirmative lobbying by academic medical centers, pharmaceutical and biotech companies, genetic disease advocacy groups, and civil rights organizations. It has overcome vehement objections by employers and insurers. Its final passage, however, has been thwarted by a few Congressional leaders, who have prevented enactment despite overwhelming bipartisan support in both houses (...) of Congress.Based on this legislative history, one could not help but assume that the Genetic Information Nondiscrimination Act is a revolutionary piece of legislation that, if finally enacted, would provide extensive, effective, and comprehensive protection against genetic discrimination in health insurance and employment Unfortunately, such an assessment would be incorrect. Indeed, GINA may be a case of too much ado about too little. (shrink)

There is widespread concern among public health and emergency response officials that there could be a shortage of health care providers in a public health emergency. At least the following three factors could cause an inadequate supply of physicians, nurses, and other health care providers: the severity of the emergency might greatly increase the demand for health services and outstrip the available supply; health care providers might become unavailable because of their own high rates of illness, as was the case (...) in the SARS epidemic; and many health care providers might not report for duty for personal, family, or professional reasons.One way of addressing the shortage is to encourage health care providers from unaffected areas or parts of the country to volunteer their services. A variety of measures have been enacted to facilitate the use of such volunteers. (shrink)