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Physicians’ fear of criminal prosecution for prescribing opioid analgesics is a major reason why many chronic pain patients are having an increasingly difficult time obtaining medically appropriate pain relief. In Ruan v. United States, 142 S. Ct. 2370 (2022), the Supreme Court unanimously vacated two federal convictions under the Controlled Substances Act. The Court held that the government must prove that the defendant knowingly or intentionally acted in an unauthorized manner.

The Occupational Safety and Health Administration (OSHA) issued an emergency temporary standard (ETS) for COVID-19 applicable to private sector employers with 100 or more employees. Among other things, the ETS required employers either to mandate employee vaccination or weekly testing and wearing masks.

Translational science attempts to accelerate and increase the significance of research progressing from bench to bedside. Support from the NIH through its institutional grant program has increased the prominence and importance of translational science. The inclusion of a broadly based bioethics component to translational science presents an opportunity for bioethics scholars to address fundamental social issues, including the effects of translational science on public health, health equity, and human flourishing. Large-scale bioethical inquiries could examine research priorities, unintended consequences of research, and access to and uptake of research discoveries.

The Occupational Safety and Health Administration (OSHA) issued an emergency temporary standard (ETS) for COVID-19 applicable to private sector employers with 100 or more employees. Among other things, the ETS required employers either to mandate employee vaccination or weekly testing and wearing masks.

The new NIH data sharing policy, effective January 2023, requires researchers to submit a data management and data sharing plan in their grant application. Expanded data sharing, encouraged by NIH to facilitate secondary research, will require informed consent documents to explain data sharing plans, limitations, and procedures.

New technologies, including genomics and precision medicine, are expanding the range of predictive health information. Employers interested in assessing the future health risks of prospective or current employees can gain access to information in an individual’s clinical record or can use algorithms to make their own predictions. When individuals have sub-clinical markers of future serious impairments, neither of the two main laws prohibiting discrimination in employment based on health status, the Americans with Disabilities Act (ADA) nor the Genetic Information Nondiscrimination Act (GINA) applies. The ADA does not apply to physical or mental impairments that are not currently a substantial limitation of a major life activity. GINA does not apply to conditions that have “manifested,” including physical changes detectable by a trained professional. Both statutes should be amended to prohibit forms of discrimination that were not contemplated when the legislation was enacted.

The United States is known for valuing personal independence and individualism. With such societal values, would the American people respond to the coronavirus pandemic by complying with quarantines, social distancing, and other measures in which group interests are placed ahead of individual ones? With a relatively small number of exceptions, the American people, including health care providers, have demonstrated an extraordinary degree of community-oriented behavior. Unfortunately, a lack of public health preparedness and a series of blunders by elected officials have increased the peril for all Americans.

The precipitous and medically contraindicated reduction or “tapering” of opioids for patients with chronic pain due to serious medical conditions has caused needless suffering and, increasingly, suicide. Physicians could be liable for wrongful death based on negligent tapering of opioids.

Surveillance capitalism companies, such as Google and Facebook, have substantially increased the amount of information collected, analyzed, and monetized, including health information increasingly used in precision medicine research, thereby presenting great challenges for health privacy.

Banning Genetic Discrimination in Life Insurance Fear of discrimination by life insurance companies has been an obstacle to progress in the use of genetic technologies in medicine and research. A n...

Single-site review means protection and efficiency

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.

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.

Genomic research, especially on rare disorders, has been facilitated by the online recruitment of potential participants. Through cooperative arrangements with disease-specific patient organizations and internet postings, it has become a more efficient way to attract interested patients and their caregivers than traditional recruitment through physicians and hospitals. Eligible participants from remote locations can participate in genomic research by supplying a sample for genome sequencing along with their electronic health records. International direct-to-participant research promises to greatly increase the number and diversity of participants for research on rare diseases, but recruitment across borders is often thwarted by laws prohibiting research participation without ethics review in each country. Such a process, an essential part of traditional research, becomes burdensome and infeasible to enroll only a few participants in many countries. Thus, although global recruitment is a promising strategy, much work remains to be done on devising methods that are legally compliant and ethically acceptable for this novel research.

Workplace exposure to SARS-CoV-2 has been a source of morbidity and mortality from COVID-19, especially for “essential workers,” such as those employed in health care and meatpacking. Many family members of these workers also have become infected and died. If the employee’s exposure was the result of the employer’s negligence, the family member or the family member’s estate might be able to recover from the employer using the “take-home” liability theory first developed in asbestos cases. This article discusses the elements of these cases and how they relate to workers’ compensation, OSHA enforcement, and other aspects of workplace safety and health protections.

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.

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).

We explored cardiologists' attitudes and prescribing patterns specific to the use of generic isosorbide dinitrate and hydralazine hydrochloride, and the fixed-dose patented drug, BiDil.Since the Food and Drug Administration approved BiDil in 2005 with an indication for self-identified black patients, disagreement about the appropriateness of race-based drugs has intensified and led to calls for providers and researchers to abandon race-based delimitations. This paper reports empirical evidence of cardiologists' views on BiDil's race-based indication and their ongoing inertia with respect to the debate about BiDil.We conducted a 2010 cross-sectional online survey of members of the Association of Black Cardiologists.Fifty-nine cardiologists responded to the survey. Most participants (62.7%) prescribed BiDil to their patients. More than 40% of respondents did not prescribe BiDil to any non-African Americans. When considering whether to prescribe BiDil, a patient's race determined by physician assessment was the third most important factor considered by participants. The majority of participants (72.7%) selected symptoms as the most important factor. Most participants (59.2%) perceived race as defining biologically distinct individuals. Respondents prescribed BiDil more often to African American patients than non-African American patients. However, they prescribed the generic components that makeup BiDil to African Americans and non-African American patients similarly.The survey provides useful findings that, when viewed within the context of ongoing debates about race-based medicine, show little progress toward appropriately utilizing BiDil to maximize health outcomes, yet, might inform the development of practical and effective guidelines concerning the use of race in medicine.

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.

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.

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.

The proposed interoperability rules for electronic health records (EHRs) issued on March 4, 2019, by the Centers for Medicare and Medicaid Services address the last major element of the nation’s system of EHRs. The ability of health care providers and other users to supplement, exchange, and access comprehensive EHRs is essential to achieve efficient and high quality medical care. Interoperability, however, also increases the privacy risks of EHRs by enabling the unnecessary disclosure of sensitive health information to individuals and entities without a need to access them. This article reviews some leading proposals to protect health privacy within an interoperable system, highlighting the proposal from the National Committee on Vital and Health Statistics to permit patients to segment certain fields of sensitive information from the main body of their EHRs.

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.

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.

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.

In both the popular media and scholarly literature, breaches of health privacy, confidentiality, and security are often associated with unlawful or unethical actions that result in disclosures of health information to individuals or entities with no right to access them. Although it is important to address wrongful access, disclosure, and use of health information, the focus on wrongful acts frequently overlooks the significant threat to health privacy posed by lawful disclosure of health information to individuals and entities with the economic or other leverage to require individuals to sign authorizations for the disclosure of their health information. We have termed this common practice "compelled disclosures" or "compelled authorizations." It includes instances in which individuals are required to sign an authorization as well as the times in which individuals are required to obtain and submit directly their own health records.

The opioid crisis presents significant challenges to the physician-patient relationship. Although physicians are still writing far too many prescriptions for opioid analgesics, many physicians are undertreating their patients who have severe acute or chronic pain. Physicians have dual ethical responsibilities to provide adequate pain management and to assist their patients who have developed opioid use disorder.

Numerous state laws and the federal Genetic Information Nondiscrimination Act (GINA) have been enacted to prevent or redress genetic discrimination in employment and health insurance, but laws protecting against genetic discrimination in life insurance have been less common and weak. Consequently, some individuals with a genetic risk of a serious illness have declined presymptomatic genetic testing, thereby decreasing their prevention and treatment options and increasing their mortality risk. In 2020, Florida became the first state to prohibit life insurance companies from using the results of presymptomatic genetic tests in underwriting. Although the law was "only" intended to prevent genetic discrimination, a possible or even likely consequence of the law will be to encourage timely genetic testing by at-rick individuals and thereby save lives.

May 21, 2018, marks the tenth anniversary of the signing into law of the Genetic Information Nondiscrimination Act. The Congressional deliberations for GINA were long and difficult. The original bill was introduced in 1995, and for many years, it did not look as if the bill would ever emerge from committee. Several of its provisions raised concerns for insurers, employers, and other stakeholders. After thirteen years, the controversial provisions were either deleted, revised, or clarified. At this ten-year mark, it is appropriate to take stock of GINA. In light of GINA's glacial legislative history, it is reasonable to start thinking about the necessity, wisdom, and feasibility of amending GINA or enacting new legislation to address unresolved or emerging issues of genetic discrimination and trends in genetics, genomics, precision medicine, and related technologies.

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.

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.

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 (Common Rule), awaiting final regulatory action, would weaken the privacy protections for research. If these measures are adopted, the HIPAA Privacy Rule would have so little value that it might not be worth the aggravation and burden.