87 found
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  1.  23
    Is Deidentification Sufficient to Protect Health Privacy in Research?Mark A. Rothstein - 2010 - American Journal of Bioethics 10 (9):3-11.
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  2.  11
    Unregulated Health Research Using Mobile Devices: Ethical Considerations and Policy Recommendations.Mark A. Rothstein, John T. Wilbanks, Laura M. Beskow, Kathleen M. Brelsford, Kyle B. Brothers, Megan Doerr, Barbara J. Evans, Catherine M. Hammack-Aviran, Michelle L. McGowan & Stacey A. Tovino - 2020 - Journal of Law, Medicine and Ethics 48 (S1):196-226.
    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 (...)
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  3.  30
    Returning a Research Participant's Genomic Results to Relatives: Analysis and Recommendations.Susan M. Wolf, Rebecca Branum, Barbara A. Koenig, Gloria M. Petersen, Susan A. Berry, Laura M. Beskow, Mary B. Daly, Conrad V. Fernandez, Robert C. Green, Bonnie S. LeRoy, Noralane M. Lindor, P. Pearl O'Rourke, Carmen Radecki Breitkopf, Mark A. Rothstein, Brian Van Ness & Benjamin S. Wilfond - 2015 - Journal of Law, Medicine and Ethics 43 (3):440-463.
    Genomic research results and incidental findings with health implications for a research participant are of potential interest not only to the participant, but also to the participant's family. Yet investigators lack guidance on return of results to relatives, including after the participant's death. In this paper, a national working group offers consensus analysis and recommendations, including an ethical framework to guide investigators in managing this challenging issue, before and after the participant's death.
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  4.  45
    Does Consent Bias Research?Mark A. Rothstein & Abigail B. Shoben - 2013 - American Journal of Bioethics 13 (4):27 - 37.
    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 (...)
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  5.  14
    Citizen Science on Your Smartphone: An ELSI Research Agenda: Currents in Contemporary Bioethics.Mark A. Rothstein, John T. Wilbanks & Kyle B. Brothers - 2015 - Journal of Law, Medicine and Ethics 43 (4):897-903.
    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 (...)
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  6.  32
    Ethical Issues in Big Data Health Research: Currents in Contemporary Bioethics.Mark A. Rothstein - 2015 - Journal of Law, Medicine and Ethics 43 (2):425-429.
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  7.  9
    Comparative Approaches to Biobanks and Privacy.Mark A. Rothstein, Bartha Maria Knoppers & Heather L. Harrell - 2016 - Journal of Law, Medicine and Ethics 44 (1):161-172.
    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 (...)
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  8.  40
    Rethinking the Meaning of Public Health.Mark A. Rothstein - 2002 - Journal of Law, Medicine and Ethics 30 (2):144-149.
    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 (...)
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  9.  7
    California Takes the Lead on Data Privacy Law.Mark A. Rothstein & Stacey A. Tovino - 2019 - Hastings Center Report 49 (5):4-5.
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  10.  8
    Rethinking the Meaning of Public Health.Mark A. Rothstein - 2002 - Journal of Law, Medicine and Ethics 30 (2):144-149.
    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 (...)
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  11.  17
    Currents in Contemporary Ethics GINA, the ADA, and Genetic Discrimination in Employment.Mark A. Rothstein - 2008 - Journal of Law, Medicine and Ethics 36 (4):837-840.
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  12.  60
    Currents in Contemporary Bioethics.Mark A. Rothstein - 2012 - Journal of Law, Medicine and Ethics 40 (2):394-400.
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  13.  13
    Compelled Authorizations for Disclosure of Health Records: Magnitude and Implications.Mark A. Rothstein & Meghan K. Talbott - 2007 - American Journal of Bioethics 7 (3):38 – 45.
    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 (...)
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  14.  14
    Time to End the Use of Genetic Test Results in Life Insurance Underwriting.Mark A. Rothstein - 2018 - Journal of Law, Medicine and Ethics 46 (3):794-801.
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  15.  26
    Genetic Exceptionalism & Legislative Pragmatism.Mark A. Rothstein - 2005 - Hastings Center Report 35 (4):27-33.
    : 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.
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  16.  31
    Epigenetic Exceptionalism.Mark A. Rothstein - 2013 - Journal of Law, Medicine and Ethics 41 (3):733-736.
    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 (...)
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  17.  32
    Epigenetic Exceptionalism.Mark A. Rothstein - 2013 - Journal of Law, Medicine and Ethics 41 (3):733-736.
    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.
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  18.  17
    Tiered Disclosure Options Promote the Autonomy and Well-Being of Research Subjects.Mark A. Rothstein - 2006 - American Journal of Bioethics 6 (6):20 – 21.
  19.  24
    Modernizing Research Regulations Is Not Enough: It's Time to Think Outside the Regulatory Box.Suzanne M. Rivera, Kyle B. Brothers, R. Jean Cadigan, Heather L. Harrell, Mark A. Rothstein, Richard R. Sharp & Aaron J. Goldenberg - 2017 - American Journal of Bioethics 17 (7):1-3.
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  20.  33
    Currents in Contemporary Ethics: Improve Privacy in Research by Eliminating Informed Consent? IOM Report Misses the Mark.Mark A. Rothstein - 2009 - Journal of Law, Medicine and Ethics 37 (3):507-512.
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  21.  8
    The Hippocratic Bargain and Health Information Technology.Mark A. Rothstein - 2010 - Journal of Law, Medicine and Ethics 38 (1):7-13.
    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 (...)
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  22.  17
    Expanding the Ethical Analysis of Biobanks.Mark A. Rothstein - 2005 - Journal of Law, Medicine and Ethics 33 (1):89-101.
    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.
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  23.  13
    Genetic Privacy and Confidentiality: Why They Are So Hard to Protect.Mark A. Rothstein - 1998 - Journal of Law, Medicine and Ethics 26 (3):198-204.
    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 (...)
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  24.  10
    Expanding the Ethical Analysis of Biobanks.Mark A. Rothstein - 2005 - Journal of Law, Medicine and Ethics 33 (1):89-101.
    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.
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  25.  24
    The Hippocratic Bargain and Health Information Technology.Mark A. Rothstein - 2010 - Journal of Law, Medicine and Ethics 38 (1):7-13.
    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 (...)
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  26.  6
    The End of the HIPAA Privacy Rule?Mark A. Rothstein - 2016 - Journal of Law, Medicine and Ethics 44 (2):352-358.
    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 (...)
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  27.  9
    Genetic Privacy and Confidentiality: Why They Are So Hard to Protect.Mark A. Rothstein - 1998 - Journal of Law, Medicine and Ethics 26 (3):198-204.
    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 (...)
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  28.  8
    The Role of IRBs in Research Involving Commerical Biobanks.Mark A. Rothstein - 2002 - Journal of Law, Medicine and Ethics 30 (1):105-108.
    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 (...)
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  29.  7
    Currents in Contemporary Ethics.Mark A. Rothstein - 2005 - Journal of Law, Medicine and Ethics 33 (1):154-159.
    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. (...)
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  30.  7
    Biobanking Research and Privacy Laws in the United States.Heather L. Harrell & Mark A. Rothstein - 2016 - Journal of Law, Medicine and Ethics 44 (1):106-127.
    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 (...)
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  31.  3
    Introduction: Unregulated Health Research Using Mobile Devices.Mark A. Rothstein & John T. Wilbanks - 2020 - Journal of Law, Medicine and Ethics 48 (S1):7-8.
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  32.  6
    Currents in Contemporary Ethics.Mark A. Rothstein - 2010 - Journal of Law, Medicine and Ethics 38 (2):412-419.
    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 (...)
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  33.  9
    Structural Challenges of Precision Medicine.Mark A. Rothstein - 2017 - Journal of Law, Medicine and Ethics 45 (2):274-279.
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  34.  16
    The Expanding Use of DNA in Law Enforcement: What Role for Privacy?Mark A. Rothstein & Meghan K. Talbott - 2006 - Journal of Law, Medicine and Ethics 34 (2):153-164.
    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 (...)
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  35.  3
    How Genetics Might Affect Real Property Rights.Mark A. Rothstein & Laura Rothstein - 2016 - Journal of Law, Medicine and Ethics 44 (1):216-221.
    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 (...)
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  36.  9
    Genetic Exceptionalism and Legislative Pragmatism.Mark A. Rothstein - 2007 - Journal of Law, Medicine and Ethics 35 (S2):59-65.
    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 (...)
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  37.  2
    Privacy Risks of Interoperable Electronic Health Records: Segmentation of Sensitive Information Will Help.Mark A. Rothstein & Stacey A. Tovino - 2019 - Journal of Law, Medicine and Ethics 47 (4):771-777.
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  38.  2
    Regulation of International Direct-to-Participant Genomic Research: Symposium Introduction.Mark A. Rothstein & Bartha Maria Knoppers - 2019 - Journal of Law, Medicine and Ethics 47 (4):579-580.
  39.  16
    Currents in Contemporary Ethics is GINA Worth the Wait?Mark A. Rothstein - 2008 - Journal of Law, Medicine and Ethics 36 (1):174-178.
    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 (...)
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  40.  24
    Pragmatic Tools for Sharing Genomic Research Results with the Relatives of Living and Deceased Research Participants.Susan M. Wolf, Emily Scholtes, Barbara A. Koenig, Gloria M. Petersen, Susan A. Berry, Laura M. Beskow, Mary B. Daly, Conrad V. Fernandez, Robert C. Green, Bonnie S. LeRoy, Noralane M. Lindor, P. Pearl O'Rourke, Carmen Radecki Breitkopf, Mark A. Rothstein, Brian Van Ness & Benjamin S. Wilfond - 2018 - Journal of Law, Medicine and Ethics 46 (1):87-109.
    Returning genomic research results to family members raises complex questions. Genomic research on life-limiting conditions such as cancer, and research involving storage and reanalysis of data and specimens long into the future, makes these questions pressing. This author group, funded by an NIH grant, published consensus recommendations presenting a framework. This follow-up paper offers concrete guidance and tools for implementation. The group collected and analyzed relevant documents and guidance, including tools from the Clinical Sequencing Exploratory Research Consortium. The authors then (...)
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  41.  2
    Currents in Contemporary Ethics: Research Privacy Under HIPAA and the Common Rule.Mark A. Rothstein - 2005 - Journal of Law, Medicine and Ethics 33 (1):154-159.
    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. (...)
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  42.  14
    International Health Research After Schrems V. Data Protection Commissioner.Mark A. Rothstein - 2016 - Hastings Center Report 46 (2):5-6.
    On October 6, 2015, in Schrems v. Data Protection Commissioner, the European Court of Justice, the European Union's highest court, held that the fifteen-year-old Safe Harbor Framework Agreement with the United States was invalid. Under the agreement, about forty-five hundred American companies each year self-certified to the U.S. Department of Commerce that they were in compliance with the essential privacy protections of the European Union, and therefore it was permissible for entities in the European Union to send personal data to (...)
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  43.  4
    Compelled Disclosures of Health Records: Updated Estimates.Mark A. Rothstein & Meghan K. Talbott - 2017 - Journal of Law, Medicine and Ethics 45 (1):149-155.
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  44.  19
    HIPAA Privacy Rule 2.0.Mark A. Rothstein - 2013 - Journal of Law, Medicine and Ethics 41 (2):525-528.
    On January 25, 2013, the Federal Register published the Department of Health and Human Services omnibus amendments to the Health Insurance Portability and Accountability Act Privacy, Security, Enforcement, and Breach Notification Rules. These modifications also include the final versions of the HIPAA regulation amendments mandated by the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act. Although the amended rules were effective on March 26, 2013, covered entities and their business associates have a compliance (...)
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  45.  11
    HIPAA Privacy Rule 2.0.Mark A. Rothstein - 2013 - Journal of Law, Medicine and Ethics 41 (2):525-528.
    On January 25, 2013, the Federal Register published the Department of Health and Human Services omnibus amendments to the Health Insurance Portability and Accountability Act Privacy, Security, Enforcement, and Breach Notification Rules. These modifications also include the final versions of the HIPAA regulation amendments mandated by the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act. Although the amended rules were effective on March 26, 2013, covered entities and their business associates have a compliance (...)
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  46.  10
    GINA at Ten and the Future of Genetic Nondiscrimination Law.Mark A. Rothstein - 2018 - Hastings Center Report 48 (3):5-7.
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  47. The Limits of Public Health: A Response.Mark A. Rothstein - 2009 - Public Health Ethics 2 (1):84-88.
    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 (...)
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  48.  23
    The Expanding Use of DNA in Law Enforcement: What Role for Privacy?Mark A. Rothstein & Meghan K. Talbott - 2006 - Journal of Law, Medicine and Ethics 34 (2):153-164.
    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.
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  49.  15
    Genetic Exceptionalism and Legislative Pragmatism.Mark A. Rothstein - 2007 - Journal of Law, Medicine and Ethics 35 (s2):59-65.
    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.
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  50.  20
    Genetic Discrimination in Employment Is Indefensible.Mark A. Rothstein - 2013 - Hastings Center Report 43 (6):3-4.
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