91 results on '"Mark A. Rothstein"'
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2. Do privacy and security regulations need a status update? Perspectives from an intergenerational survey.
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Stacey Pereira, Jill Oliver Robinson, Hayley A Peoples, Amanda M Gutierrez, Mary A Majumder, Amy L McGuire, and Mark A Rothstein
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Medicine ,Science - Abstract
The importance of health privacy protections in the era of the "Facebook Generation" has been called into question. The ease with which younger people share personal information about themselves has led to the assumption that they are less concerned than older generations about the privacy of their information, including health information. We explored whether survey respondents' views toward health privacy suggest that efforts to strengthen privacy protections as health information is moved online are unnecessary.Using Amazon's Mechanical Turk (MTurk), which is well-known for recruitment for survey research, we distributed a 45-item survey to individuals in the U.S. to assess their perspectives toward privacy and security of online and health information, social media behaviors, use of health and fitness devices, and demographic information.1310 participants (mean age: 36 years, 50% female, 78% non-Hispanic white, 54% college graduates or higher) were categorized by generations: Millennials, Generation X, and Baby Boomers. In multivariate regression models, we found that generational cohort was an independent predictor of level of concern about privacy and security of both online and health information. Younger generations were significantly less likely to be concerned than older generations (all P < 0.05). Time spent online and social media use were not predictors of level of concern about privacy or security of online or health information (all P > 0.05).This study is limited by the non-representativeness of our sample.Though Millennials reported lower levels of concern about privacy and security, this was not related to internet or social media behaviors, and majorities within all generations reported concern about both the privacy and security of their health information. Thus, there is no intergenerational imperative to relax privacy and security standards, and it would be advisable to take privacy and security of health information more seriously.
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- 2017
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3. Correspondence on 'Exploring the motivations of research participants who chose not to learn medically actionable secondary findings about themselves' by Schupmann et al
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Lainie Friedman Ross, Mark A. Rothstein, and Ellen Wright Clayton
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Medical education ,Chose ,Psychology ,Genetics (clinical) - Published
- 2022
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4. The law of genetic privacy: applications, implications, and limitations
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James W. Hazel, Mark A. Rothstein, Barbara J. Evans, and Ellen Wright Clayton
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media_common.quotation_subject ,Genetic Information Nondiscrimination Act ,Control (management) ,Medicine (miscellaneous) ,privacy ,0603 philosophy, ethics and religion ,Biochemistry, Genetics and Molecular Biology (miscellaneous) ,Statute ,03 medical and health sciences ,0302 clinical medicine ,genomics ,medicine ,genetics ,030212 general & internal medicine ,Genetic privacy ,Genetic testing ,media_common ,HIPAA ,medicine.diagnostic_test ,Health Insurance Portability and Accountability Act ,DNA ,06 humanities and the arts ,GINA ,Variety (cybernetics) ,Law ,Original Article ,060301 applied ethics ,Business ,Diversity (politics) - Abstract
Recent advances in technology have significantly improved the accuracy of genetic testing and analysis, and substantially reduced its cost, resulting in a dramatic increase in the amount of genetic information generated, analysed, shared, and stored by diverse individuals and entities. Given the diversity of actors and their interests, coupled with the wide variety of ways genetic data are held, it has been difficult to develop broadly applicable legal principles for genetic privacy. This article examines the current landscape of genetic privacy to identify the roles that the law does or should play, with a focus on federal statutes and regulations, including the Health Insurance Portability and Accountability Act (HIPAA) and the Genetic Information Nondiscrimination Act (GINA). After considering the many contexts in which issues of genetic privacy arise, the article concludes that few, if any, applicable legal doctrines or enactments provide adequate protection or meaningful control to individuals over disclosures that may affect them. The article describes why it may be time to shift attention from attempting to control access to genetic information to considering the more challenging question of how these data can be used and under what conditions, explicitly addressing trade-offs between individual and social goods in numerous applications.
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- 2019
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5. Points-to-consider on the return of results in epigenetic research
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Jörn Walter, Mark A. Rothstein, Karen J. Maschke, Reiner Siebert, Tomi Pastinen, Yann Joly, Stephan Beck, Charles Dupras, Stephanie O.M. Dyke, Amy P. Webster, and Katie M. Saulnier
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0301 basic medicine ,Epigenomics ,Opinion ,lcsh:QH426-470 ,lcsh:Medicine ,Disease ,Return of results ,Social issues ,Epigenesis, Genetic ,03 medical and health sciences ,0302 clinical medicine ,Genetics ,Humans ,Bioethical Issues ,Genetic Testing ,Workgroup ,Molecular Biology ,Genetics (clinical) ,lcsh:R ,Bioethics ,Epigenome ,Incidental findings ,Personal Genome Project ,lcsh:Genetics ,030104 developmental biology ,ELSI ,030220 oncology & carcinogenesis ,Practice Guidelines as Topic ,Molecular Medicine ,Engineering ethics ,Epigenetics ,Psychology - Abstract
As epigenetic studies become more common and lead to new insights into health and disease, the return of individual epigenetic results to research participants, in particular in large-scale epigenomic studies, will be of growing importance. Members of the International Human Epigenome Consortium (IHEC) Bioethics Workgroup considered the potential ethical, legal, and social issues (ELSI) involved in returning epigenetic research results and incidental findings in order to produce a set of ‘Points-to-consider’ (P-t-C) for the epigenetics research community. These P-t-C draw on existing guidance on the return of genetic research results, while also integrating the IHEC Bioethics Workgroup’s ELSI research on and discussion of the issues associated with epigenetic data as well as the experience of a return of results pilot study by the Personal Genome Project UK (PGP-UK). Major challenges include how to determine the clinical validity and actionability of epigenetic results, and considerations related to environmental exposures and epigenetic marks, including circumstances warranting the sharing of results with family members and third parties. Interdisciplinary collaboration and good public communication regarding epigenetic risk will be important to advance the return of results framework for epigenetic science.
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- 2019
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6. Covid Vaccine Mandates and Religious Accommodation in Employment
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Mark A. Rothstein
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Employment ,employment discrimination ,COVID-19 Vaccines ,Health (social science) ,media_common.quotation_subject ,At Law ,reasonable accommodation ,Faith ,Politics ,State (polity) ,Political science ,Civil Rights ,Humans ,Employment discrimination ,media_common ,Covid‐19 ,SARS-CoV-2 ,business.industry ,Health Policy ,COVID-19 ,Undue hardship ,Object (philosophy) ,United States ,vaccine mandates ,Philosophy ,Issues, ethics and legal aspects ,religion ,Law ,Reasonable accommodation ,business ,Accommodation - Abstract
Many employers are requiring their employees to be vaccinated for Covid‐19 to comply with federal, state, or local laws, or to conform to employers' policies. Some employees object to vaccination on religious grounds. Title VII of the Civil Rights Act of 1964 prohibits discrimination in employment based on religion and requires employers to reasonably accommodate employees' religious beliefs or practices unless doing so would be an undue hardship to the employer's business. Although a religion need not be an established faith with many followers, philosophical or political objections do not count as religious beliefs. If an employee demonstrates a bona fide religious objection, the issue is whether it can be reasonably accommodated. This will depend on the employer's business, including whether close contact with coworkers or customers is required.
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- 2021
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7. Employer-Mandated Vaccination for COVID-19
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Dorit Rubinstein Reiss, Wendy E. Parmet, and Mark A. Rothstein
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Employment ,medicine.medical_specialty ,Emergency Use Authorization ,COVID-19 Vaccines ,Distrust ,Coronavirus disease 2019 (COVID-19) ,Vaccines: Building Long-Term Confidence ,media_common.quotation_subject ,Public health ,Vaccination ,Public Health, Environmental and Occupational Health ,COVID-19 ,Mandatory Programs ,Ambivalence ,Family medicine ,Political science ,Pandemic ,medicine ,Humans ,Misinformation ,Public Health ,media_common - Abstract
When the US Food and Drug Administration (FDA) decided to grant emergency use authorization (EUA) for the first two vaccines for COVID-19, the United States' response to the pandemic entered a new phase. Initially, the greatest challenge is having enough doses of vaccine and administering them to all who want it. Yet even while many wait expectantly for their turn to be vaccinated, a significant minority of Americans are hesitant. Lack of information or misinformation about the vaccine, a long-standing and well-entrenched antivaccination movement, distrust of public health officials, and political polarization have left many people ambivalent or opposed to vaccination. According to a poll by the Kaiser Family Foundation taken in late November and early December 2020, 27% of respondents surveyed stated that they would "probably" or "definitely" not be willing to be vaccinated.1 Reflecting the sharp partisan divide that has characterized views about the pandemic, Democrats (86%) were far more likely than Republicans (56%) to be vaccinated. (Am J Public Health. Published online ahead of print February 4, 2021: e1-e4. https://doi.org/10.2105/AJPH.2020.306166).
- Published
- 2021
8. Disclosing genetic information to family members without consent: Five Australian case studies
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Nicholas Pachter, Rebecca Macintosh, Margaret Otlowski, Sarah O'Sullivan, Marili Palover, Paul Lacaze, Mark A. Rothstein, Jane Tiller, Gemma A. Bilkey, and Stephanie Groube
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Legal duty ,medicine.medical_specialty ,Informed Consent ,business.industry ,media_common.quotation_subject ,Internet privacy ,Australia ,General Medicine ,Duty to warn ,Resource (project management) ,Genetics ,medicine ,Medical genetics ,Humans ,Confidentiality ,Family ,Genetic Predisposition to Disease ,Genetic risk ,business ,Psychology ,Duty to Warn ,Genetic Privacy ,Duty ,Genetics (clinical) ,media_common - Abstract
Genetic risk information is relevant to individual patients and also their blood relatives. Health practitioners (HPs) routinely advise patients of the importance of sharing genetic information with family members, especially for clinically actionable conditions where prevention is possible. However, some patients refuse to share genetic results with at-risk relatives, and HPs must choose whether to use or disclose genetic information without consent. This requires an understanding of their legal and ethical obligations, which research shows many HPs do not have. A recent UK case held that HPs have a duty to a patient's relatives where there is a proximate relationship, to conduct a balancing exercise of the benefit of disclosure of the genetic risk information to the relative against the interest of the patient in maintaining confidentiality. In Australia, there is currently no legal duty to disclose genetic information to a patient's at-risk relatives, but there are laws and guidelines governing unconsented use/disclosure of genetic information. These laws are inconsistent across different Australian states and health contexts, requiring greater harmonisation. Here we provide an up-to-date and clinically accessible resource summarising the laws applying to HPs across Australia, and outline five Australian case studies which have arisen in clinical genetics services, regarding the disclosure of genetic results to relatives without consent. The issues addressed here are relevant to any Australian HP with access to genetic information, as well as HPs and policy-makers in other jurisdictions considering these issues.
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- 2020
9. Unregulated Health Research Using Mobile Devices: Ethical Considerations and Policy Recommendations
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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, and Stacey A. Tovino
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Medical device ,Biomedical Research ,media_common.quotation_subject ,MEDLINE ,Guidelines as Topic ,Ethics, Research ,Citizen science ,Humans ,media_common ,business.industry ,Health Policy ,General Medicine ,Public relations ,Transparency (behavior) ,Mobile Applications ,Research Personnel ,Telemedicine ,United States ,Issues, ethics and legal aspects ,Balance (accounting) ,Policy ,Anticipation (artificial intelligence) ,Computers, Handheld ,Business ,Welfare ,Mobile device - Abstract
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.
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- 2020
10. The Occupational Safety and Health Act at 50: Introduction to the Special Section
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Mark A. Rothstein
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medicine.medical_specialty ,Public Health, Environmental and Occupational Health ,MEDLINE ,United States Occupational Safety and Health Administration ,Occupational safety and health ,United States ,Occupational Diseases ,Family medicine ,Political science ,medicine ,Special section ,Accidents, Occupational ,Humans ,AJPH Editorials ,Occupational Health ,Introductory Journal Article - Published
- 2020
11. Time to End the Use of Genetic Test Results in Life Insurance Underwriting
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Mark A. Rothstein
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0301 basic medicine ,Adverse selection ,Article ,03 medical and health sciences ,Information asymmetry ,Direct-To-Consumer Screening and Testing ,Life insurance ,medicine ,Humans ,Genetic Testing ,Genetic Privacy ,Genetic testing ,Actuarial science ,medicine.diagnostic_test ,Health Policy ,Medical record ,General Medicine ,United States ,Test (assessment) ,Issues, ethics and legal aspects ,Intervention (law) ,Insurance, Life ,030104 developmental biology ,Business ,Prejudice ,Underwriting - Abstract
The decreasing cost of genome and exome sequencing, including direct-to-consumer testing, produces information asymmetry between applicants and life insurance companies, which increases the risk of adverse selection. Rather than requiring applicants for life insurance to undergo genetic testing, life insurers ought to revise their policies and not use the results of genetic tests in the medical records of applicants for underwriting. Prohibitions on access to genetic test results already have been adopted without great upheaval in several other countries. There are two main reasons why this new approach should be used in the United States. First, genetic test results do not provide essential information that is not already available through traditional underwriting measures. Second, because many individuals at genetically increased risk of serious disorders currently decline testing out of fear of the economic consequences, policies prohibiting the use of genetic test results in life insurance will encourage genetic testing and facilitate timely surveillance and necessary medical intervention, thereby saving lives.
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- 2018
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12. Eliciting preferences on secondary findings: the Preferences Instrument for Genomic Secondary Results
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Kyle B. Brothers, Kelly M. East, Whitley V. Kelley, M. Frances Wright, Matthew J. Westbrook, Carla A. Rich, Kevin M. Bowling, Edward J. Lose, E. Martina Bebin, Shirley Simmons, John A. Myers, Greg Barsh, Richard M. Myers, Greg M. Cooper, Jill M. Pulley, Mark A. Rothstein, and Ellen Wright Clayton
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Adult ,Male ,Parents ,0301 basic medicine ,Health Knowledge, Attitudes, Practice ,Applied psychology ,030105 genetics & heredity ,Choice Behavior ,Article ,03 medical and health sciences ,Intellectual Disability ,Surveys and Questionnaires ,Research participant ,Intellectual disability ,Humans ,Medicine ,Genetic Testing ,Genetics (clinical) ,Aged ,Genetic testing ,Incidental Findings ,Genome ,medicine.diagnostic_test ,business.industry ,Patient Preference ,Genomics ,Sequence Analysis, DNA ,Focus Groups ,Middle Aged ,16. Peace & justice ,medicine.disease ,Focus group ,Information overload ,3. Good health ,Test (assessment) ,Comprehension ,Female ,business ,Raw data - Abstract
Purpose Eliciting and understanding patient and research participant preferences regarding return of secondary test results is a key aspect of genomic medicine. A valid instrument should be easily understood without extensive pre-test counseling, while still faithfully eliciting patients’ preferences. Methods We conducted focus groups with 110 adults to understand patient perspectives on secondary genomic findings and the role preferences should play. We then developed and refined a draft instrument, and used it to elicit preferences from parents participating in a genomic sequencing study in children with intellectual disabilities. Results Patients preferred filtering of secondary genomic results to avoid information overload and to avoid learning what the future holds, among other reasons. Patients preferred to make autonomous choices about which categories of results to receive and to have their choices applied automatically before results are returned to them and their clinicians. The Preferences Instrument for Genomic Secondary Results (PIGSR) is designed to be completed by patients or research participants without assistance and to guide bioinformatic analysis of genomic raw data. Most participants wanted to receive all secondary results, but a significant minority indicated other preferences. Conclusions Our novel instrument – PIGSR – should be useful in a wide range of clinical and research settings.
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- 2017
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13. Looking Beyond GINA: Policy Approaches to Address Genetic Discrimination
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Yann Joly, Stacey A. Tovino, Charles Dupras, Mark A. Rothstein, and Miriam Pinkesz
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Legislation, Medical ,Genetic Information Nondiscrimination Act ,Context (language use) ,Public Policy ,0603 philosophy, ethics and religion ,03 medical and health sciences ,Political science ,Genetics ,Regional science ,medicine ,Comparative law ,Humans ,Genetic Testing ,Genetic discrimination ,Genetic Privacy ,Molecular Biology ,Genetics (clinical) ,030304 developmental biology ,Genetic testing ,0303 health sciences ,Middle East ,medicine.diagnostic_test ,06 humanities and the arts ,Genomics ,Normative ,060301 applied ethics ,Prejudice - Abstract
Concerns about genetic discrimination (GD) often surface when discussing research and innovation in genetics. Over recent decades, countries around the world have attempted to address GD using various policy measures. In this article, we survey these approaches and provide a critical commentary on their advantages and disadvantages. Our examination begins with regions featuring extensive policy-making activities (North America and Europe), followed by regions with moderate policy-making activities (Australia, Asia, and South America) and regions with minimal policy-making activities (the Middle East and Africa). Our analysis then turns to emerging issues regarding genetic testing and GD, including the expansion of multiomics sciences and direct-to-consumer genetic tests outside the health context. We additionally survey the shortcomings of current normative approaches addressing GD. Finally, we conclude by highlighting the evolving nature of GD and the need for more innovative policy-making in this area.
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- 2020
14. Public Health and Privacy in the Pandemic
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Mark A. Rothstein
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medicine.medical_specialty ,Fever ,Coronavirus disease 2019 (COVID-19) ,Health information technology ,Internet privacy ,Pneumonia, Viral ,MEDLINE ,Proportionality (law) ,Public Health Ethics ,Political science ,Pandemic ,medicine ,Humans ,Mass Screening ,Justice (ethics) ,Pandemics ,Mass screening ,business.industry ,Public health ,Public Health, Environmental and Occupational Health ,COVID-19 ,Privacy ,Population Surveillance ,Law ,AJPH Covid-19 ,Public Health ,business ,Coronavirus Infections - Abstract
In deciding whether to use certain health information technology in a pandemic, policymakers should analyze and apply the following criteria, which have been derived from principles commonly cited in the public health ethics literature related to public health powers generally and applied to privacy: (1) necessity and effectiveness; (2) proportionality and minimal infringement; (3) purpose limitations; and (4) justice.
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- 2020
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15. Ensuring Compliance With Quarantine by Undocumented Immigrants and Other Vulnerable Groups: Public Health Versus Politics
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Christine N. Coughlin and Mark A. Rothstein
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medicine.medical_specialty ,media_common.quotation_subject ,Immigration ,Emigrants and Immigrants ,Vulnerable Populations ,Compliance (psychology) ,law.invention ,03 medical and health sciences ,Politics ,AJPH Immigration & Justice ,Social Justice ,law ,Environmental health ,Quarantine ,medicine ,Humans ,media_common ,030505 public health ,Public health ,Undocumented Immigrants ,Public Health, Environmental and Occupational Health ,United States ,Policy ,Public Health Practice ,Patient Compliance ,Business ,Public Health ,0305 other medical science - Abstract
A successful quarantine requires a high rate of compliance by individuals with potential exposure to a communicable disease. Many individuals would be reluctant to comply with a quarantine because they fear that contact with government officials will place them in legal, personal, or economic jeopardy. These include undocumented immigrants and individuals with a substance use disorder. For a quarantine to succeed, individuals must be granted temporary immunity from arrest, deportation, or similar adverse consequences, but doing so will be politically unpopular. We argue that public health considerations must take precedence over politics in protecting the health of the public.
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- 2019
16. Modernizing Research Regulations Is Not Enough: It's Time to Think Outside the Regulatory Box
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Suzanne M. Rivera, Kyle B. Brothers, R. Jean Cadigan, Heather L. Harrell, Mark A. Rothstein, Richard R. Sharp, and Aaron J. Goldenberg
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0301 basic medicine ,Biomedical Research ,Health Policy ,030105 genetics & heredity ,Article ,United States ,03 medical and health sciences ,Issues, ethics and legal aspects ,0302 clinical medicine ,Work (electrical) ,Stakeholder Participation ,Multidisciplinary approach ,030225 pediatrics ,Political science ,Government Regulation ,Humans ,Interdisciplinary Communication ,Engineering ethics ,Guideline Adherence - Abstract
We are a multidisciplinary collaborative made up of bioethicists, social scientists, clinicians, and lawyers whose work focuses on the ethical challenges posed by a networked approach to bioreposit...
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- 2017
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17. Pain Management and Public Health: Introduction to the Special Section
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Mark A. Rothstein, Daniel M. Fox, Christina M. Spellman, and Daniel B. Carr
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medicine.medical_specialty ,business.industry ,Family medicine ,Public health ,Public Health, Environmental and Occupational Health ,medicine ,MEDLINE ,Special section ,AJPH Editorials ,Pain management ,business - Published
- 2019
18. Introduction
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John T Wilbanks and Mark A. Rothstein
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Research design ,Issues, ethics and legal aspects ,Multimedia ,Computer science ,Health Policy ,MEDLINE ,General Medicine ,computer.software_genre ,Mobile device ,computer ,Introductory Journal Article - Published
- 2020
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19. Pragmatic Tools for Sharing Genomic Research Results with the Relatives of Living and Deceased Research Participants
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Laura M. Beskow, Carmen Radecki Breitkopf, P. Pearl O'Rourke, Susan A. Berry, Barbara A. Koenig, Conrad V. Fernandez, Benjamin S. Wilfond, Mark A. Rothstein, Emily Scholtes, Brian G Van Ness, Robert C. Green, Mary B. Daly, Bonnie S. LeRoy, Noralane M. Lindor, Gloria M. Petersen, and Susan M. Wolf
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0303 health sciences ,Medical education ,Genetic Research ,Informed Consent ,Information Dissemination ,Research Subjects ,Health Policy ,Genomic research ,030305 genetics & heredity ,Cancer ,General Medicine ,Genomics ,medicine.disease ,Article ,03 medical and health sciences ,Issues, ethics and legal aspects ,medicine ,Humans ,Family ,Forms and Records Control ,Psychology ,Duty to Warn ,Genetic Privacy ,Confidentiality ,030304 developmental biology - Abstract
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 (CSER) Consortium. The authors then negotiated a consensus toolkit of processes and documents. That toolkit offers sample consent and notification documents plus decision flow-charts to address return of results to family of living and deceased participants, in adult and pediatric research. Core concerns are eliciting participant preferences on sharing results with family and on choice of a representative to make decisions about sharing after participant death.
- Published
- 2018
20. From SARS to Ebola: Legal and Ethical Considerations for Modern Quarantine
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Mark A. Rothstein
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medicine.medical_specialty ,business.industry ,media_common.quotation_subject ,Public health ,Proportionality (law) ,Legislation ,Bioethics ,law.invention ,Supreme court ,State (polity) ,law ,Political science ,Quarantine ,medicine ,Effective treatment ,Health law ,business ,media_common - Abstract
Quarantine remains an important part of the strategy for containing infectious diseases, especially when there is no vaccine or demonstrably effective treatment. Experience with SARS and, more recently, Ebola indicate that quarantine is fraught with ethical challenges. In the United States, legislation authorizing quarantine has been enacted in every state, and these laws have been upheld by the Supreme Court. The problems have been in identifying when quarantine is necessary and in implementation. The following ethical principles should guide public health officials in deciding whether and how to impose a quarantine: (1) necessity, effectiveness, and scientific rationale; (2) proportionality and least infringement; (3) humane supportive services; and (4) public justification.
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- 2015
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21. Ethical, legal and social implications of incorporating personalized medicine into healthcare
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Kyle B Brothers and Mark A Rothstein
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Pharmacology ,medicine.medical_specialty ,business.industry ,Alternative medicine ,Clinical settings ,General Medicine ,Bioethics ,Article ,Health equity ,Education in personalized medicine ,Family medicine ,Health care ,medicine ,Molecular Medicine ,Engineering ethics ,Health information ,Personalized medicine ,business - Abstract
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.
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- 2015
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22. Reconsidering the duty to warn genetically at-risk relatives
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Mark A. Rothstein
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0301 basic medicine ,Referral ,Ethical issues ,Genetic counseling ,Genetic Counseling ,030105 genetics & heredity ,medicine.disease ,Duty to warn ,03 medical and health sciences ,Privacy ,medicine ,Humans ,Family ,Genetic Predisposition to Disease ,Medical emergency ,Genetic risk ,Psychology ,Genetics (clinical) ,Privacy rule ,Confidentiality - Abstract
The duty to warn genetically at-risk relatives of patients is one of the most misunderstood legal and ethical issues affecting clinical genetics. The legal doctrines are often associated with three state appellate court cases beginning in the mid-1990s. Since the HIPAA Privacy Rule went into effect in 2003, the duty to warn must be accomplished by warning the patient of the genetic nature of a diagnosed disorder or genetic risk and the necessity of warning at-risk relatives. Health-care providers are neither required nor permitted to warn at-risk relatives without the consent of their patients. Having warnings issued by the patient most closely aligns with traditional ethical principles and the interests of the parties. Physicians and other health-care providers can assist their patients by preparing jargon-free explanations of the genetic risk and offering consultation or referral services. In the future, the need for warnings is less likely to be triggered by diagnoses and more likely to be based on predictive information derived from genome sequencing and other technologies and data sources.
- Published
- 2017
23. Transgenerational epigenetics and environmental justice
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Heather L. Harrell, Mark A. Rothstein, and Gary E. Marchant
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0301 basic medicine ,Health, Toxicology and Mutagenesis ,010501 environmental sciences ,01 natural sciences ,Scientific evidence ,03 medical and health sciences ,Political science ,Genetics ,distributive justice ,Justice (ethics) ,Obligation ,environmental justice ,Distributive justice ,Molecular Biology ,Genetics (clinical) ,Egalitarianism ,0105 earth and related environmental sciences ,Environmental justice ,Government ,epigenetics ,Perspective (graphical) ,hazardous exposures ,Environmental ethics ,030104 developmental biology ,transgenerational epigenetics ,Perspectives - Abstract
Human transmission to offspring and future generations of acquired epigenetic modifications has not been definitively established, although there are several environmental exposures with suggestive evidence. This article uses three examples of hazardous substances with greater exposures in vulnerable populations: pesticides, lead, and diesel exhaust. It then considers whether, if there were scientific evidence of transgenerational epigenetic inheritance, there would be greater attention given to concerns about environmental justice in environmental laws, regulations, and policies at all levels of government. To provide a broader perspective on environmental justice the article discusses two of the most commonly cited approaches to environmental justice. John Rawls's theory of justice as fairness, a form of egalitarianism, is frequently invoked for the principle that differential treatment of individuals is justified only if actions are designed to benefit those with the greatest need. Another theory, the capabilities approach of Amartya Sen and Martha Nussbaum, focuses on whether essential capabilities of society, such as life and health, are made available to all individuals. In applying principles of environmental justice the article considers whether there is a heightened societal obligation to protect the most vulnerable individuals from hazardous exposures that could adversely affect their offspring through epigenetic mechanisms. It concludes that unless there were compelling evidence of transgenerational epigenetic harms, it is unlikely that there would be a significant impetus to adopt new policies to prevent epigenetic harms by invoking principles of environmental justice.
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- 2017
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24. Do privacy and security regulations need a status update? Perspectives from an intergenerational survey
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Amanda M. Gutierrez, Mark A. Rothstein, Stacey Pereira, Jill O. Robinson, Hayley A. Peoples, Mary A. Majumder, and Amy L. McGuire
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Male ,Information privacy ,Economics ,Health Status ,lcsh:Medicine ,Social Sciences ,050109 social psychology ,Surveys ,Political Aspects of Health ,Mathematical and Statistical Techniques ,Sociology ,Surveys and Questionnaires ,Medicine and Health Sciences ,Public and Occupational Health ,Computer Networks ,lcsh:Science ,Multidisciplinary ,05 social sciences ,Environmental resource management ,Social Communication ,Middle Aged ,Socioeconomic Aspects of Health ,Social Networks ,Privacy ,Research Design ,Physical Sciences ,The Internet ,Female ,Psychology ,Behavioral and Social Aspects of Health ,Personally identifiable information ,Network Analysis ,Statistics (Mathematics) ,Research Article ,Adult ,Computer and Information Sciences ,Adolescent ,Political Science ,Internet privacy ,MEDLINE ,Sample (statistics) ,Research and Analysis Methods ,050105 experimental psychology ,Young Adult ,Health Economics ,Humans ,0501 psychology and cognitive sciences ,Social media ,Statistical Methods ,Computer Security ,Aged ,Internet ,Analysis of Variance ,Survey Research ,business.industry ,lcsh:R ,Generation x ,Communications ,Health Care ,lcsh:Q ,Health information ,business ,Social Media ,Mathematics ,Health Insurance - Abstract
Background The importance of health privacy protections in the era of the “Facebook Generation” has been called into question. The ease with which younger people share personal information about themselves has led to the assumption that they are less concerned than older generations about the privacy of their information, including health information. We explored whether survey respondents’ views toward health privacy suggest that efforts to strengthen privacy protections as health information is moved online are unnecessary. Methods Using Amazon’s Mechanical Turk (MTurk), which is well-known for recruitment for survey research, we distributed a 45-item survey to individuals in the U.S. to assess their perspectives toward privacy and security of online and health information, social media behaviors, use of health and fitness devices, and demographic information. Results 1310 participants (mean age: 36 years, 50% female, 78% non-Hispanic white, 54% college graduates or higher) were categorized by generations: Millennials, Generation X, and Baby Boomers. In multivariate regression models, we found that generational cohort was an independent predictor of level of concern about privacy and security of both online and health information. Younger generations were significantly less likely to be concerned than older generations (all P < 0.05). Time spent online and social media use were not predictors of level of concern about privacy or security of online or health information (all P > 0.05). Limitations This study is limited by the non-representativeness of our sample. Conclusions Though Millennials reported lower levels of concern about privacy and security, this was not related to internet or social media behaviors, and majorities within all generations reported concern about both the privacy and security of their health information. Thus, there is no intergenerational imperative to relax privacy and security standards, and it would be advisable to take privacy and security of health information more seriously.
- Published
- 2017
25. The 1918 Influenza Pandemic: Lessons Learned and Not—Introduction to the Special Section
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Wendy E. Parmet and Mark A. Rothstein
- Subjects
03 medical and health sciences ,medicine.medical_specialty ,0302 clinical medicine ,Political science ,Family medicine ,0211 other engineering and technologies ,Public Health, Environmental and Occupational Health ,Special section ,medicine ,021107 urban & regional planning ,030212 general & internal medicine ,02 engineering and technology ,Influenza pandemic - Published
- 2018
- Full Text
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26. Recommendations for returning genomic incidental findings? We need to talk!
- Author
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Howard M. Saal, Lainie Friedman Ross, Robin L. Bennett, Ellen Wright Clayton, Susan M. Wolf, Bartha Maria Knoppers, Ingrid A. Holm, Gail E. Henderson, Gail P. Jarvik, Armand H. Matheny Antommaria, Ron Zimmern, Wylie Burke, Wendy R. Uhlmann, Mark A. Rothstein, Benjamin S. Wilfond, Nancy Press, Jeffrey R. Botkin, and Muin J. Khoury
- Subjects
Adult ,medicine.medical_specialty ,Genetics, Medical ,Psychological intervention ,MEDLINE ,Penetrance ,Genomics ,Disease ,Bioinformatics ,Article ,medicine ,Humans ,Exome ,Genetic Predisposition to Disease ,Genetic Testing ,Child ,Genetics (clinical) ,Genetic testing ,Incidental Findings ,medicine.diagnostic_test ,Genome, Human ,business.industry ,Patient Preference ,Sequence Analysis, DNA ,Patient Rights ,Family medicine ,Practice Guidelines as Topic ,Medical genetics ,business - Abstract
The American College of Medical Genetics and Genomics recently issued recommendations for reporting incidental findings from clinical whole-genome sequencing and whole-exome sequencing. The recommendations call for evaluating a specific set of genes as part of all whole-genome sequencing/whole-exome sequencing and reporting all pathogenic variants irrespective of patient age. The genes are associated with highly penetrant disorders for which treatment or prevention is available. The effort to generate a list of genes with actionable findings is commendable, but the recommendations raise several concerns. They constitute a call for opportunistic screening, through intentional effort to identify pathogenic variants in specified genes unrelated to the clinical concern that prompted testing. Yet for most of the genes, we lack evidence about the predictive value of testing, genotype penetrance, spectrum of phenotypes, and efficacy of interventions in unselected populations. Furthermore, the recommendations do not allow patients to decline the additional findings, a position inconsistent with established norms. Finally, the recommendation to return adult-onset disease findings when children are tested is inconsistent with current professional consensus, including other policy statements of the American College of Medical Genetics and Genomics. Instead of premature practice recommendations, we call for robust dialogue among stakeholders to define a pathway to normatively sound, evidence-based guidelines.
- Published
- 2013
- Full Text
- View/download PDF
27. Premature guidance about whole-genome sequencing
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Ellen Wright Clayton, Lainie Friedman Ross, and Mark A. Rothstein
- Subjects
Pharmacology ,Whole genome sequencing ,medicine.medical_specialty ,business.industry ,Psychological intervention ,Alternative medicine ,Genomics ,General Medicine ,Article ,Informed consent ,Family medicine ,medicine ,Molecular Medicine ,Medical genetics ,Guideline development ,Return of results ,business - Abstract
Recently, several success stories about clinical use of whole-genome sequencing (WGS) and/or whole-exome sequencing (WES) have been reported. In some cases, sequencing led to improved decision-making and prognosis, and in at least a few cases, led to successful therapeutic interventions. Importantly, in each case, sequencing was performed on an individual with a serious clinical problem and the results returned related to the disorder. At the American College of Medical Genetics and Genomics (ACMG) meeting in Phoenix (AZ, USA) in March 2013, the ACMG presented new recommendations on the return of incidental findings in clinical care. It recommended that incidental findings be sought out and reported regardless of age and that the results be reported to patients (or surrogates), regardless of their preferences. These recommendations were made despite the drafting Working Group’s acknowledgement “that there was insufficient evidence about benefits, risks and costs of disclosing incidental findings to make evidence-based recommendations” [1]. It is our opinion that the ACMG recommendations clearly contravene respect for patients and shared decision-making at the clinical level and represent a setback to evidence-based medicine and the responsible development of societal policy. This article addresses five related issues: Guideline development; ‘Incidental’ findings; Informed consent; The ‘best interest of the child’ standard; The wider implications of the recommendations.
- Published
- 2013
- Full Text
- View/download PDF
28. The Moral Challenge of Ebola
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Mark A. Rothstein
- Subjects
Ebola virus ,business.industry ,viruses ,Public Health, Environmental and Occupational Health ,virus diseases ,Disease ,Public relations ,medicine.disease_cause ,humanities ,Editorial ,medicine ,Decision-making ,business ,health care economics and organizations - Abstract
The author reflects on the moral challenge of the Ebola virus and its management. He suggests that the Ebola virus poses a moral challenge to individuals and societies and that moral considerations should play a role in the decision making process which is used to bring the Ebola virus under control. He argues that the only effective and humane strategy to use when attempting to manage the Ebola virus is to attack the disease where it arises.
- Published
- 2015
- Full Text
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29. The Opioid Crisis and the Need for Compassion in Pain Management
- Author
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Mark A. Rothstein
- Subjects
medicine.medical_specialty ,030505 public health ,media_common.quotation_subject ,Public Health, Environmental and Occupational Health ,Alternative medicine ,Opioid abuse ,Empathy ,Compassion ,Pain management ,03 medical and health sciences ,0302 clinical medicine ,Treatment Refusal ,Opioid ,medicine ,030212 general & internal medicine ,Prescription Drug Monitoring Program ,0305 other medical science ,Psychiatry ,Psychology ,media_common ,medicine.drug - Abstract
An editorial is presented which addresses the author's views about an opioid abuse epidemic in America and the need for compassion in pain management as of 2017. Prescription drug monitoring programs and state laws in the U.S. are addressed, along with the therapeutic use of opioids. The potential impacts that no opioid policies could have on patients are examined, along with physician-patient relations in America and problems such as the over-prescribing of opioids.
- Published
- 2017
- Full Text
- View/download PDF
30. Doubling down on forensic twin studies
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Scott M. Williams, Gregory P. Copenhaver, Hua Tang, Bruce S. Weir, Gregory S. Barsh, and Mark A. Rothstein
- Subjects
0301 basic medicine ,Cancer Research ,MEDLINE ,QH426-470 ,Biology ,Criminology ,Criminal investigation ,Twin study ,Forensic science ,03 medical and health sciences ,030104 developmental biology ,Genetics ,media_common.cataloged_instance ,European union ,Molecular Biology ,Genetics (clinical) ,Ecology, Evolution, Behavior and Systematics ,media_common - Published
- 2018
- Full Text
- View/download PDF
31. Is Deidentification Sufficient to Protect Health Privacy in Research?
- Author
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Mark A. Rothstein
- Subjects
Research Subjects ,Health information technology ,Internet privacy ,Health records ,Trust ,Article ,Specimen Handling ,Codes of Ethics ,Electronic Health Records ,Humans ,Medicine ,Confidentiality ,American Medical Association ,Health policy ,Protected health information ,Ethical code ,HRHIS ,business.industry ,Health Policy ,Commerce ,Research Personnel ,United States ,Issues, ethics and legal aspects ,Deidentification ,Human Experimentation ,Privacy ,Personal Autonomy ,InformationSystems_MISCELLANEOUS ,business - Abstract
The revolution in health information technology has enabled the compilation and use of large data sets of health records for genomic and other research. Extensive collections of health records, esp...
- Published
- 2010
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32. The Hippocratic Bargain and Health Information Technology
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Mark A. Rothstein
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Health information technology ,Internet privacy ,Pharmacist ,0603 philosophy, ethics and religion ,Masking (Electronic Health Record) ,Article ,03 medical and health sciences ,0302 clinical medicine ,Electronic Health Records ,Humans ,Medicine ,Confidentiality ,030212 general & internal medicine ,Reproductive health ,Physician-Patient Relations ,Information Dissemination ,business.industry ,Health Policy ,Medical record ,06 humanities and the arts ,General Medicine ,Mental health ,United States ,Issues, ethics and legal aspects ,Information sensitivity ,Hippocratic Oath ,060301 applied ethics ,business - Abstract
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.
- Published
- 2010
- Full Text
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33. Currents in Contemporary Bioethics
- Author
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Mark A. Rothstein
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Medical malpractice ,0603 philosophy, ethics and religion ,Article ,Defensive medicine ,03 medical and health sciences ,0302 clinical medicine ,Malpractice ,Health care ,Patient Protection and Affordable Care Act ,Humans ,030212 general & internal medicine ,health care economics and organizations ,Actuarial science ,business.industry ,Health Policy ,06 humanities and the arts ,General Medicine ,Physician supply ,United States ,Issues, ethics and legal aspects ,060301 applied ethics ,Health care reform ,Business ,Health care quality - Abstract
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.1 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.2 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 (PPACA),3 it is especially appropriate to consider what effect, if any, the new law will have on the rate of medical malpractice claims. When fully implemented, PPACA will increase the number of individuals with health care coverage by approximately 32 million.4 As a result, there will be many millions of additional patient encounters each year. If the rate of adverse events arguably attributable to medical malpractice remains constant, then it might be assumed that the total number of medical malpractice claims will increase. In addition, with a physician work force of roughly the same size, there will be more patients per physician, and likely less time per patient visit. Thus, it might be assumed that more expedited medical care will increase the likelihood of medical errors and resulting medical malpractice claims. Several counter-arguments are possible, and health care reform might actually reduce adverse events and medical malpractice claims because of superior care. It can be asserted that better coordination through continuity of care and “medical homes” will improve outcomes and decrease adverse events; electronic health records, including clinical decision support, will provide physicians with comprehensive and timely patient health information, as well as messages about potential drug interactions and other problems; expansion of outcomes research and greater emphasis on evidence-based medicine will improve health care quality; and lifelong assessment, recertification, remediation, and more intensive licensing review will improve physicians’ clinical knowledge and skills, and remove the licenses of physicians unfit to practice medicine. There is a complicated and nonlinear relationship between medical malpractice events, medical malpractice claims, and medical malpractice costs.5 Changes in one of these measures will likely affect the others, but not necessarily in quantifiable or predictable ways. This article focuses exclusively on medical malpractice claims — and specifically the number of medical malpractice lawsuits initiated.6 It concludes that one of the leading reasons why individuals bring medical malpractice claims is to ensure the availability of funds for future medical care. Because health care coverage at affordable rates will be accessible in the public or private sector without regard to preexisting conditions, and annual and lifetime caps will be prohibited, significant numbers of injured patients are likely to forego medical malpractice claims. Consequently, even with more patient visits, the total number of medical malpractice claims is unlikely to rise and might even decline.
- Published
- 2010
- Full Text
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34. Health Risk Reduction Programs in Employer-Sponsored Health Plans: Part I—Efficacy
- Author
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Heather L. Harrell and Mark A. Rothstein
- Subjects
medicine.medical_specialty ,Actuarial science ,business.industry ,Public health ,Public Health, Environmental and Occupational Health ,Psychological intervention ,Efficiency, Organizational ,Article ,Variety (cybernetics) ,Health Benefit Plans, Employee ,Incentive ,Health promotion ,Health care ,medicine ,Humans ,Moral responsibility ,Business ,Risk Reduction Behavior ,Occupational Health ,health care economics and organizations ,Anecdotal evidence ,Program Evaluation - Abstract
Objective: We sought to determine whether workplace health risk reduction programs (HRRPs) using health risk assessments (HRAs), individually focused risk reduction, and financial incentives succeeded in improving employee health and reducing employer health benefit costs. Methods: We reviewed the proprietary HRA available to us and conducted a literature review to determine the efficacy of HRRPs using HRAs, individualized employee interventions, and financial incentives for employee participation. Results: There is some evidence that HRRPs in employer-sponsored programs improve measures of employee health, but the results of these studies are somewhat equivocal. Conclusion: Employer-sponsored HRRPs may have some benefits, but problems in plan design and in the studies assessing their efficacy complicate drawing conclusions. (J Occup Environ Med. 2009;51:943–950) V irtually, every employer faced with substantial increases in employee health benefits expenses has been exploring ways to reduce costs without drastically cutting benefits or excessively shifting costs to employees. At the same time, there has been an increased awareness of the role of lifestyle in health risk and a growing sense of need to increase personal responsibility in health care utilization and outcomes. Employer sponsors of health plans have adopted a variety of activities to improve employee health measures and reduce costs. Some of these initiatives have been aggressively marketed by vendors using proprietary health risk assessments (HRAs), individual health risk reduction programs (HRRPs), and other related services. Besides vendor-produced studies and anecdotal evidence of improved employee health and lower employer costs, is there conclusive evidence that HRRPs are effective in achieving their goals?
- Published
- 2009
- Full Text
- View/download PDF
35. Currents in Contemporary Ethics
- Author
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Mark A. Rothstein
- Subjects
National Academies of Science, Engineering, and Medicine, U.S., Health and Medicine Division ,Research ethics ,Informed Consent ,business.industry ,Health Policy ,Internet privacy ,General Medicine ,Reference Standards ,United States ,Article ,Ethics, Research ,Federal policy ,Issues, ethics and legal aspects ,Informed consent ,Political science ,Common Rule ,Humans ,Confidentiality ,business ,Privacy rule ,Human services ,Contemporary ethics - Abstract
The report is based on formal presentations, commissioned and in-vited surveys and papers, a literature review, and deliberations by the Com-mittee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule. The Commit-tee was charged with addressing the often-expressed concern of research-ers that the Privacy Rule burdens re-search without adequately protecting the privacy interests of patients and subjects.There is much to commend in the report. Among other things, it recom-mends the following: (1) privacy pro-tections should apply to all research regardless of the funding source; (2) the Department of Health and Human Services (HHS) should take steps to harmonize the requirements of the Federal Policy for the Protec-tion of Research Subjects (Common Rule)
- Published
- 2009
- Full Text
- View/download PDF
36. Confidentiality, privacy, and security of genetic and genomic test information in electronic health records: points to consider
- Author
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John Glaser, Rebecca Fisher, Stephen Matteson, Paul Cusenza, Deven McGraw, Douglas E. Henley, Mark A. Rothstein, Kathy Hudson, and Amy L. McGuire
- Subjects
Medical Records Systems, Computerized ,medicine.diagnostic_test ,business.industry ,Genetic exceptionalism ,Health Policy ,Internet privacy ,Environmental resource management ,Health information exchange ,Personal Health Services ,United States ,Information protection policy ,Health care ,medicine ,Humans ,Confidentiality ,Genetic Testing ,Genetic Privacy ,business ,Computer Security ,Genetics (clinical) ,Health policy ,Protected health information ,Genetic testing - Abstract
As clinical genetics evolves, and we embark down the path toward more personalized and effective health care, the amount, detail, and complexity of genetic/genomic test information within the electronic health record will increase. This information should be appropriately protected to secure the trust of patients and to support interoperable electronic health information exchange. This article discusses characteristics of genetic/genomic test information, including predictive capability, immutability, and uniqueness, which should be considered when developing policies about information protection. Issues related to "genetic exceptionalism"; i.e., whether genetic/genomic test information should be treated differently from other medical information for purposes of data access and permissible use, are also considered. These discussions can help guide policy that will facilitate the biological and clinical resource development to support the introduction of this information into health care.
- Published
- 2008
- Full Text
- View/download PDF
37. Currents in Contemporary Ethics
- Author
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Mark A. Rothstein
- Subjects
Presidential system ,Health Policy ,media_common.quotation_subject ,Genetic Information Nondiscrimination Act ,Legislative history ,Legislation ,06 humanities and the arts ,General Medicine ,0603 philosophy, ethics and religion ,03 medical and health sciences ,Issues, ethics and legal aspects ,0302 clinical medicine ,Political science ,Law ,060301 applied ethics ,030212 general & internal medicine ,Privacy law ,Genetic discrimination ,Prejudice ,Underwriting ,media_common - Abstract
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 (GINA)1 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. GINA is a fatally flawed bill, whose chances of achieving its noble goal of genetic nondiscrimination were doomed from the start by a health finance system in which individual health insurance is medically underwritten and by employment laws that fail to protect the privacy of employee health information. This article puts GINA into perspective by reviewing the need for legislation, the bill's key provisions, and its likely consequences. The article also discusses the essential issues of discrimination and disclosure of genetic information in health insurance and employment that GINA does not address. It observes that the shortcomings of GINA stem from the health finance system of the United States and the absence of effective health privacy legislation. Upon closer inspection, discrimination based on “genetic information” is not a discrete and singular issue; it is a case study for the broader issue of the permissible uses and disclosures of predictive health information.
- Published
- 2008
- Full Text
- View/download PDF
38. Licensing and Physician Mental Health: Problems and Possibilities
- Author
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Barbara S Schneidman, James N. Thompson, Steven I. Altchuler, Mark A. Rothstein, Herbert Hendin, Luis Sanchez, Laura Rothstein, Dan Fox, Phillip Rodgers, Peter A. Mansky, and Charles F. Reynolds
- Subjects
medicine.medical_specialty ,business.industry ,Medical license ,010102 general mathematics ,Mental illness ,medicine.disease ,01 natural sciences ,Physician health ,Medical care ,Mental health ,Help-seeking ,03 medical and health sciences ,0302 clinical medicine ,Misrepresentation ,medicine ,030212 general & internal medicine ,0101 mathematics ,Psychiatry ,business ,License - Abstract
A number of factors appear to discourage physicians from seeking help for mental illness. This reluctance may be exacerbated by fears – well-founded or imagined – that by seeking help, physicians may put their medical license in jeopardy. To examine this risk, an analysis of all state medical board (SMB) license applications was followed by a seven-item survey mailed to SMB executive directors, and 70 percent responded. Follow up interviews were conducted with a sample of those not responding and also with a small group of directors whose responses were problematic. Thirteen of the 35 SMBs responding indicated that the diagnosis of mental illness by itself was sufficient for sanctioning physicians. The same states indicated that they treat physicians receiving psychiatric care differently than they do physicians receiving medical care. In follow-up interviews all 13 indicated that without evidence of impairment or misrepresentation any such sanctioning was likely to be temporary. A significant percentage (37 percent) of states sanction or have the ability to sanction physicians on the basis of information revealed on the licensing application about the presence of a psychiatric condition rather than on the basis of impairment. The same percentage state they treat physicians receiving psychiatric care differently than they do those receiving medical care. Physicians’ perceptions of this apparent discrimination is likely to play a role in their reluctance to seek help for mental health-related conditions. Suggestions are made for how SMBs and state physician health programs and state and county medical societies might collaborate in ways that while protecting patients decreases barriers to physicians help seeking.
- Published
- 2007
- Full Text
- View/download PDF
39. Encouraging Compliance With Quarantine: A Proposal to Provide Job Security and Income Replacement
- Author
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Mark A. Rothstein and Meghan K. Talbott
- Subjects
Employment ,Actuarial science ,Public economics ,Human influenza ,business.industry ,Public Health, Environmental and Occupational Health ,Public policy ,Public Policy ,Government, Politics, and Law ,Limiting ,United States ,Disease Outbreaks ,Compliance (psychology) ,law.invention ,Job security ,law ,Influenza, Human ,Quarantine ,Pandemic ,Income ,Humans ,Medicine ,business - Abstract
A human influenza virus is considered the most likely source of a pandemic in the near future. Quarantine has the potential to be the most effective measure for limiting the spread of infection. The major obstacles to compliance for those asked to enter quarantine include loss of income during quarantine and loss of employment after quarantine. We discuss current antidiscrimination and compensation laws, as well as options to expand coverage for quarantined individuals to encourage public cooperation by guaranteeing job security and providing income replacement.
- Published
- 2007
- Full Text
- View/download PDF
40. Compelled Authorizations for Disclosure of Health Records: Magnitude and Implications
- Author
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Mark A. Rothstein and Meghan K. Talbott
- Subjects
Employment ,Medical Records Systems, Computerized ,Interoperability ,Disclosure ,Health records ,Medical Records ,Insurance ,Insurance, Long-Term Care ,Humans ,Medicine ,Disabled Persons ,Health Insurance Portability and Accountability Act ,Insurance, Health ,Actuarial science ,Scope (project management) ,business.industry ,Health Policy ,Authorization ,United States ,Issues, ethics and legal aspects ,Insurance, Life ,Insurance, Disability ,Workers' Compensation ,Health information ,InformationSystems_MISCELLANEOUS ,business ,Confidentiality - Abstract
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.
- Published
- 2007
- Full Text
- View/download PDF
41. Returning a Research Participant's Genomic Results to Relatives: Analysis and Recommendations
- Author
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Brian G Van Ness, Conrad V. Fernandez, Robert C. Green, Susan M. Wolf, Mary B. Daly, Laura M. Beskow, Gloria M. Petersen, P. Pearl O'Rourke, Barbara A. Koenig, Susan A. Berry, Mark A. Rothstein, Carmen Radecki Breitkopf, Bonnie S. LeRoy, Noralane Morey Lindor, Benjamin S. Wilfond, and Rebecca Branum
- Subjects
0301 basic medicine ,Adult ,Research Subjects ,Genomic research ,MEDLINE ,Disclosure ,030105 genetics & heredity ,Article ,03 medical and health sciences ,Informed consent ,Research participant ,Humans ,Family ,Child ,Health implications ,Medical education ,Informed Consent ,Health Policy ,General Medicine ,Genomics ,Issues, ethics and legal aspects ,030104 developmental biology ,Consensus analysis ,Privacy for research participants ,Psychology ,Return of results ,Social psychology - Abstract
The debate about how to manage individual research results and incidental findings in genetic and genomic research has focused primarily on what information, if any, to offer back to research participants. However, increasing controversy surrounds the question of whether researchers have any responsibility to offer a participant’s results (defined here to include both individual research results and incidental findings) to the participant’s relatives, including after the participant’s death. This question arises in multiple contexts, including when researchers discover a result with potentially important health implications for genetic relatives, when a participant’s relatives ask a researcher whether any research results about the participant have implications for their own health or reproductive planning, when a participant’s relative asks whether any of the participant’s results have implications for a child’s health, and when the participant is deceased and the participant’s relatives seek information about the participant’s genetic results in order to address their own health or reproductive concerns.
- Published
- 2015
42. Genetic Exceptionalism & Legislative Pragmatism
- Author
-
Mark A. Rothstein
- Subjects
Pragmatism ,Health (social science) ,medicine.diagnostic_test ,Genetic exceptionalism ,Health Policy ,media_common.quotation_subject ,Legislation ,Legislature ,General Medicine ,Philosophy ,Issues, ethics and legal aspects ,Political science ,medicine ,Spite ,Health policy ,Prejudice (legal term) ,Law and economics ,Genetic testing ,media_common - Abstract
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.
- Published
- 2005
- Full Text
- View/download PDF
43. Risk of re-identification of epigenetic methylation data: a more nuanced response is needed
- Author
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Tomi Pastinen, Stephanie O.M. Dyke, Warren A. Cheung, Yann Joly, and Mark A. Rothstein
- Subjects
Letter to the editor ,Computational biology ,Bioinformatics ,Re identification ,03 medical and health sciences ,Epigenome ,0302 clinical medicine ,Genetics ,Epigenetics ,Molecular Biology ,Letter to the Editor ,Genetics (clinical) ,030304 developmental biology ,Protected health information ,0303 health sciences ,Methylation ,Human genetics ,3. Good health ,Data sharing ,Policy ,Privacy ,Psychology ,030217 neurology & neurosurgery ,Developmental Biology - Abstract
In this letter to the editor, we respond to the recent publication by Philibert et al. Methylation array data can simultaneously identify individuals and convey protected health information: an unrecognized ethical concern (Clinical Epigenetics 2014, 6:28). Further discussion of the issues raised by the risk of re-identification of epigenetic methylation data is needed, and a more nuanced approach should be taken with respect to its implications for data sharing policy than the one provided.
- Published
- 2015
44. Epigenome data release: a participant-centered approach to privacy protection
- Author
-
Tomi Pastinen, Maxime Caron, Paul Flicek, Stephan Busche, Stephan Beck, Mark A. Rothstein, Jörn Walter, Martin Hirst, Yann Joly, Reiner Siebert, Guillaume Bourque, Henk Stunnenberg, Ole Ammerpohl, Stephanie O.M. Dyke, Warren A. Cheung, Lars Rönnblom, and Pavlo Lutsik
- Subjects
Epigenomics ,Opinion ,Biology ,ENCODE ,Epigenesis, Genetic ,03 medical and health sciences ,0302 clinical medicine ,Life insurance ,Data Anonymization ,Humans ,International HapMap Project ,Genetic discrimination ,Genetic Privacy ,Molecular Biology ,GeneralLiterature_REFERENCE(e.g.,dictionaries,encyclopedias,glossaries) ,030304 developmental biology ,Rheumatology and Autoimmunity ,0303 health sciences ,Reumatologi och inflammation ,Data anonymization ,Genetic Variation ,High-Throughput Nucleotide Sequencing ,Epigenome ,Sequence Analysis, DNA ,DNA Methylation ,Data science ,Identification (information) ,Evolutionary biology ,030220 oncology & carcinogenesis - Abstract
Large-scale epigenome mapping by the NIH Roadmap Epigenomics Project, the ENCODE Consortium and the International Human Epigenome Consortium (IHEC) produces genome-wide DNA methylation data at one base-pair resolution. We examine how such data can be made open-access while balancing appropriate interpretation and genomic privacy. We propose guidelines for data release that both reduce ambiguity in the interpretation of open-access data and limit immediate access to genetic variation data that are made available through controlled access. Electronic supplementary material The online version of this article (doi:10.1186/s13059-015-0723-0) contains supplementary material, which is available to authorized users.
- Published
- 2015
- Full Text
- View/download PDF
45. Public Health Planning for Pets
- Author
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Mark A. Rothstein
- Subjects
medicine.medical_specialty ,030505 public health ,Public health ,Public Health, Environmental and Occupational Health ,Pets ,AJPH Research ,Disasters ,Health Planning ,03 medical and health sciences ,Environmental health ,medicine ,Animals ,Public Health ,Business ,0305 other medical science - Abstract
During a disaster, many pet owners want to evacuate their pets with them, only to find that evacuation and sheltering options are limited or nonexistent. This disregard for companion animal welfare during a disaster can have public health consequences. Pet owners may be stranded at home, unwilling to leave their pets behind. Others refuse evacuation orders or attempt to reenter evacuation sites illegally to rescue their animals. Psychopathologies such as grief, depression, and posttraumatic stress disorder are associated with pet abandonment during an evacuation. Health care workers may refuse to work if their animals are in danger, leaving medical facilities understaffed during crises. Zoonotic disease risk increases when pets are abandoned or left to roam, where they are more likely to encounter infected wildlife or unowned animals than they would if they were safely sheltered with their owners. These sequelae are not unique to the United States, nor to wealthy countries. Emergency planning for companion animals during disasters is a global need in communities with a significant pet population, and will increase resilience and improve public health.
- Published
- 2017
- Full Text
- View/download PDF
46. Promoting public health in health care facilities
- Author
-
Mark A. Rothstein
- Subjects
medicine.medical_specialty ,business.industry ,Public health ,media_common.quotation_subject ,Public Health, Environmental and Occupational Health ,Physical activity ,Editorials ,Health Promotion ,Motor Activity ,medicine.disease ,Obesity ,Health promotion ,Promotion (rank) ,Nursing ,Influenza Vaccines ,Health care ,medicine ,Humans ,Health Facilities ,Public Health ,business ,media_common - Abstract
The author reflects on public health promotion in U.S. health care facilities. He suggests that health care facilities can increase health promotion by controlling the types of food and drink that are publicly available in an effort to help reduce obesity. He argues that health care facilities should make physical activity opportunities available to patients, visitors and employees to improve their health.
- Published
- 2014
47. Ethical Research and Minorities
- Author
-
Mark A. Rothstein
- Subjects
Editor's Choice ,Ethical issues ,Law ,education ,Public Health, Environmental and Occupational Health ,Humans ,Sociology ,Inclusion (education) ,Minority Groups ,United States ,Ethics, Research - Abstract
In this article the author reflects on the 20th anniversary of the National Institutes of Health (NIH) Revitalization Act of 1993 and on a provision of the law that directed the NIH to establish guidelines for the inclusion of women and members of minority groups in clinical research. In the article the author offers his opinions on the ethical issues associated with research and minorities and on the challenges that are associated with conducting ethically responsible research with minorities.
- Published
- 2013
48. Ethical, legal, and social implications of incorporating genomic information into electronic health records
- Author
-
Ribhi Hazin, Kyle B. Brothers, Bradley A. Malin, Barbara A. Koenig, Saskia C. Sanderson, Mark A. Rothstein, Marc S. Williams, Ellen W. Clayton, and Iftikhar J. Kullo
- Subjects
media_common.quotation_subject ,Internet privacy ,Health literacy ,Context (language use) ,Social issues ,Duty to warn ,Clinical decision support system ,Literacy ,Article ,Environmental health ,Medicine ,Electronic Health Records ,Humans ,Confidentiality ,Precision Medicine ,Genetic Privacy ,Genetics (clinical) ,Computer Security ,media_common ,Incidental Findings ,Patient Access to Records ,business.industry ,Genomics ,Precision medicine ,Decision Support Systems, Clinical ,Health Literacy ,Health Records, Personal ,business - Abstract
The inclusion of genomic data in the electronic health record raises important ethical, legal, and social issues. In this article, we highlight these challenges and discuss potential solutions. We provide a brief background on the current state of electronic health records in the context of genomic medicine, discuss the importance of equitable access to genome-enabled electronic health records, and consider the potential use of electronic health records for improving genomic literacy in patients and providers. We highlight the importance of privacy, access, and security, and of determining which genomic information is included in the electronic health record. Finally, we discuss the challenges of reporting incidental findings, storing and reinterpreting genomic data, and nondocumentation and duty to warn family members at potential genetic risk.
- Published
- 2013
49. Harmonizing Privacy Laws to Enable International Biobank Research
- Author
-
Mark A. Rothstein and Bartha Maria Knoppers
- Subjects
Issues, ethics and legal aspects ,business.industry ,Health Policy ,Political science ,Internet privacy ,Privacy laws of the United States ,Confidentiality ,Biological Specimen Banks ,General Medicine ,business ,Biobank ,Article - Published
- 2015
- Full Text
- View/download PDF
50. The future of public health ethics
- Author
-
Mark A. Rothstein
- Subjects
medicine.medical_specialty ,Sanitation ,business.industry ,Public health ,Health Policy ,Public Health, Environmental and Occupational Health ,Public relations ,Disaster response ,Public Health Ethics ,Editor's Choice ,Political science ,Well-being ,medicine ,Humans ,Public Health ,business ,Health policy ,Forecasting - Abstract
For those of us who practice, administer, research, study, or teach public health, two aspects of the field inspire and motivate us-the importance of public health measures to the well being os society and the constantly evolving nature of public health issues. Besides traditional public health concerns such as sanitation, environmental health, and infectious diseases, contemporary public health also focuses on - among other things - newly emerging pathogens, bioterriorism, and disaster response.
- Published
- 2011
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