Eight Strategies to Engineer Acceptance of Human Germline Modifications.

Until recently, scientific consensus held firm that genetically manipulated embryos created through methods including Mitochondrial Replacement Therapy or human germline genome editing should not be used to initiate a pregnancy. In countries that have relevant laws pertaining to heritable human germline modifications, the vast majority prohibit or restrict this practice. In the last several years, scholars have observed a transformation of scientific and policy restrictions with insistent calls for creating a regulatory pathway. Multiple stakeholders highlight the role of social consensus and public engagement for governance of heritable human germline modifications. However, in the drive to gain public acceptance and lift restrictions, some proponents provide distorted or misleading narratives designed to influence public perception and incrementally shift the consensus. This article describes eight discrete strategies that proponents employ to influence framing, sway public opinion, and revise policymaking of human germline modifications in a manner that undermines honest engagement.

AI and machine learning ethics, law, diversity, and global impact.

Artificial intelligence (AI) and its machine learning (ML) algorithms are offering new promise for personalized biomedicine and more cost-effective healthcare with impressive technical capability to mimic human cognitive capabilities. However, widespread application of this promising technology has been limited in the medical domain and expectations have been tampered by ethical challenges and concerns regarding patient privacy, legal responsibility, trustworthiness, and fairness. To balance technical innovation with ethical applications of AI/ML, developers must demonstrate the AI functions as intended and adopt strategies to minimize the risks for failure or bias. This review describes the new ethical challenges created by AI/ML for clinical care and identifies specific considerations for its practice in medicine. We provide an overview of regulatory and legal issues applicable in Europe and the United States, a description of technical aspects to consider, and present recommendations for trustworthy AI/ML that promote transparency, minimize risks of bias or error, and protect the patient well-being.

The Problem with Using Medical Boards to Regulate Misinformation.

Some stakeholders called on medical boards to sanction physicians for spreading misinformation during COVID-19 and discussing off-label medications. In 2022, California passed AB 2098, which classifies physician dissemination of misinformation as unprofessional conduct subject to discipline by the state medical board. This article describes the purpose and function of state medical boards, the law relating to off-label prescribing, and why using medical boards to discipline physicians for discussing controversial opinions exceeds the traditional role of state medical boards. Though physicians do have a duty to provide accurate information to the public, defining misinformation is difficult and poses five distinct problems. Although California's law was repealed, this article asserts that disciplining physicians for disseminating misinformation could pose Constitutional concerns, hinder physicians' ability to practice medicine, or suppress information that is important to the public interest.

What Should Health Care Organizations Do to Reduce Billing Fraud and Abuse?

Whether physicians are being trained or encouraged to commit fraud within corporatized organizational cultures through contractual incentives (or mandates) to optimize billing and process more patients is unknown. What is known is that upcoding and misrepresentation of clinical information (fraud) costs more than $100 billion annually and can result in unnecessary procedures and prescriptions. This article proposes fraud mitigation strategies that combine organizational cultural enhancements and deployment of transparent compliance and risk management systems that rely on front-end data analytics.

Geneva Statement on Heritable Human Genome Editing: The Need for Course Correction.

As public interest advocates, policy experts, bioethicists, and scientists, we call for a course correction in public discussions about heritable human genome editing. Clarifying misrepresentations, centering societal consequences and concerns, and fostering public empowerment will support robust, global public engagement and meaningful deliberation about altering the genes of future generations.

The Nuffield Council's green light for genome editing human embryos defies fundamental human rights law.

In July 2018, the Nuffield Council on Bioethics released the report Genome editing and human reproduction: Social and ethical issues, concluding that human germline modification of human embryos for implantation is not 'morally unacceptable in itself' and could be ethically permissible in certain circumstances once the risks of adverse outcomes have been assessed and the procedure appears 'reasonably safe'. The Nuffield Council set forth two main principles governing anticipated uses and envisions applications that may include health enhancements as a public health measure. This essay provides a critique of three aspects in the Nuffield Council's Report: its presumption of therapeutic efficacy, its inflation of parental rights to create a certain type of child, and its reliance on a specially commissioned report that appears to distort key definitions in international law.

Patient attitudes toward genotyping in an urban women's health clinic.

OBJECTIVE: To estimate willingness of women to donate specimens for DNA analysis by needlestick compared with collection of saliva. METHODS: This study was a cross-sectional survey given to women attending clinic appointments asked about their knowledge and attitudes toward genetics research and genotyping. RESULTS: The majority of the 279 women surveyed would give DNA specimens by needlestick (68.3%) but more would be willing to donate saliva (75.7%), P=.003. An ethnic difference was seen in the replies about needlesticks but not regarding saliva donation. Multivariable analysis demonstrated that women who were likely to donate specimens rated themselves more knowledgeable about genes and DNA (odds ratio 2.43, 95% confidence interval 1.12-5.28) and had graduated from college or higher (odds ratio 6.74, 95% confidence interval 1.98-22.86). CONCLUSION: More women are willing to donate DNA specimens by saliva than by needlestick. Knowledge and higher education predict a willingness to donate. LEVEL OF EVIDENCE: III.

Ethics, law, and commercial surrogacy: a call for uniformity.

In the United States at this time, no uniform federal law exists regarding commercial surrogacy, and state statutory schemes vary vastly, ranging from criminalization to legal recognition with contract enforcement. The authors examine how commercial surrogacy agencies utilize the Internet as a means for attracting parents and surrogates by employing emotional cultural rhetoric. By inducing both parents and surrogates to their jurisdiction, agencies circumvent vast discrepancies in state statutory regulative schemes and create a distinct interstate business, absent an efficient regulatory framework or legal recourse in some circumstances. The authors propose a uniform federal regulatory scheme premised upon regulating interstate business transactions to create accountability and legal remedies for both the parents and the surrogate.