Going Germline: Mitochondrial Replacement as a Guide to Genome Editing.

Mitochondrial replacement (MR) serves as a crucial test case and learning guide for the scientific, ethical, and regulatory challenges of future reproductive breakthroughs. The lessons learned from the regulatory review process of MR over the last decade promise to enrich the emerging dialog over genome editing.

Medicare Advantage Under Fire: Public Criticism and Implications.

Congressional hearings and public reports have drawn attention to problems afflicting Medicare Advantage (MA), the privatized version of Medicare. Private plans became a staple of Medicare through the passage of the Tax Equity and Fiscal Responsibility Act of 1982 (TEFRA). Congress passed this law during a furor of privatization, when think tanks and powerful financial interests emphasized the power of corporations' profit incentive to improve the efficiency and quality of social enterprise. Yet the surging criticism of MA suggests a misalignment between the financial interest of some MA plans and the well-being of their patient populations. The criticisms range from deceptive marketing, ghost networks, and patient cherry-picking to unethical prior authorization denials and defrauding the government. In total, MA plans cost the federal government 22% more per patient than if these patients in question were enrolled in traditional Medicare. Moreover, it is not clear that this additional funding is producing proportional benefits. These developments raise questions about the presence of a profit incentive in Medicare, and perhaps health care more broadly.

The Mifepristone Litigation: Untangling the Implications of the Fifth Circuit's Decision for Abortion Access and the U.S. Food and Drug Administration.

In August 2023, a federal appeals court issued an opinion in Alliance for Hippocratic Medicine v FDA, a case wherein a group of antiabortion medical organizations and physicians have challenged U.S. Food and Drug Administration (FDA) approval and regulation of mifepristone. This opinion contained some good news for the FDA, drug makers, and patients: the appeals court declined to halt the marketing of mifepristone altogether (as the trial court judge would have). But the court also decided that the FDA's 2016 and 2021 actions expanding the indication for mifepristone, lowering the drug's dose, and loosening restrictions on its distribution and use were likely unlawful, and it thus affirmed the trial court's order staying these actions. In this article, we explain key aspects of the opinion to health care professionals and consider the ways in which the appeals court's reasoning and conclusions, if followed by the Supreme Court, could undermine abortion access and public health going forward.

Therapeutic Germline Editing: Sense and Sensibility.

Safe and effective heritable editing of the human genome is years away from the clinic because of formidable technical, statutory, regulatory, and societal challenges. In particular, we note the fledgling state of the science, the imperatives of editing efficiency, specificity, and uniformity, and the extant legal roadblock.

The Regulation of Mitochondrial Replacement Techniques Around the World.

Mitochondrial replacement techniques (MRTs, also referred to as mitochondrial replacement therapies) have given hope to many women who wish to have genetically related children but have mitochondrial DNA mutations in their eggs. MRTs have also spurred deep ethical disagreements and led to different regulatory approaches worldwide. In this review, we discuss the current regulation of MRTs across several countries. After discussing the basics of the science, we describe the current law and policy directions in seven countries: the United Kingdom, the United States, Canada, Australia, Germany, Israel, and Singapore. We also discuss the emerging phenomenon of medical tourism (also called medical travel) for MRTs to places like Greece, Spain, Mexico, and Ukraine. We then pull out some key findings regarding similarities and differences in regulatory approaches around the world.

Persistent Inpatient Harm: the Unremitting Challenge of Patient Safety.

The sobering realization that little has changed in the scope of inpatient harm makes it plain that efforts intent on improving patient safety must be redoubled if the status quo is to be reversed. Living up to the recommendations of the iconic Institute of Medicine (IOM) Report (To Err Is Human: Building a Safer Health System) must remain top of mind. Much can and must be done to assure to the degree possible the safety of the inpatient population.

Traveling Across States for Prohibited Treatments: Medical Aid in Dying and Looming Battles Over Abortion.

This JGIM Perspective discusses new and emerging challenges with accessing controversial medical therapies like medical aid in dying and abortion. While some states permit these therapies for only their residents, other states prohibit these therapies for their own residents. We summarize recent developments and growing challenges for clinicians treating "medical tourism" patients from other jurisdictions.

The misplaced embryo: legal parenthood in 'embryo mix-up' cases.

Recently in Israel, a woman was mistakenly implanted with an embryo that is genetically related to another couple. Unfortunately, this case is not an isolated occurrence, as other cases of embryo mix-ups have been reported in several countries, including the USA, China, the UK and various other countries within the European Union. Cases of mixed-up embryos are ethically and legally complex: the woman who carried the pregnancy and the woman who is genetically related to the resulting child-both of whom endured emotionally and physically demanding infertility treatments-along with their partners, may be unwilling to relinquish parental rights over the child.This article explores four possible approaches, found in numerous common law jurisdictions, which can be used to address cases involving embryo mix-ups. Our analysis reveals several avenues through which legal parentage can be established. It can be done through gestation and the marital presumption, genetic connections, by adhering to the principle of the best interests of the child, or by recognising multiple individuals as legal parents. We review the advantages and disadvantages of each approach, but we have one clear recommendation: resolving embryo mix-up cases should be done proactively through the establishment of legislation and guidelines, rather than relying on post hoc individual court decisions. Such legislation and guidelines should guarantee the consistency of values throughout diverse reproductive contexts and mandate that fertility clinics and medical professionals provide individuals with comprehensive information regarding the potential risks associated with assisted reproductive treatments.

What Should ChatGPT Mean for Bioethics?

In the last several months, several major disciplines have started their initial reckoning with what ChatGPT and other Large Language Models (LLMs) mean for them - law, medicine, business among other professions. With a heavy dose of humility, given how fast the technology is moving and how uncertain its social implications are, this article attempts to give some early tentative thoughts on what ChatGPT might mean for bioethics. I will first argue that many bioethics issues raised by ChatGPT are similar to those raised by current medical AI - built into devices, decision support tools, data analytics, etc. These include issues of data ownership, consent for data use, data representativeness and bias, and privacy. I describe how these familiar issues appear somewhat differently in the ChatGPT context, but much of the existing bioethical thinking on these issues provides a strong starting point. There are, however, a few "new-ish" issues I highlight - by new-ish I mean issues that while perhaps not truly new seem much more important for it than other forms of medical AI. These include issues about informed consent and the right to know we are dealing with an AI, the problem of medical deepfakes, the risk of oligopoly and inequitable access related to foundational models, environmental effects, and on the positive side opportunities for the democratization of knowledge and empowering patients. I also discuss how races towards dominance (between large companies and between the U.S. and geopolitical rivals like China) risk sidelining ethics.

Hospital-at-Home: Multistakeholder Considerations for Program Dissemination and Scale.

Policy Points Hospital-at-Home (HaH) is a home-based alternative for acute care that has expanded significantly under COVID-19 regulatory flexibilities. The post-pandemic policy agenda for HaH will require consideration of multistakeholder perspectives, including patient, caregiver, provider, clinical operations, technology, equity, legal, quality, and payer. Key policy challenges include reaching a consensus on program standards, clarifying caregivers' issues, creating sustainable reimbursement mechanisms, and mitigating potential equity concerns. Key policy prescriptions include creating a national surveillance system for quality and safety, clarifying legal standards for care in the home, and deploying payment reforms through value-based models.

"I'd feel like someone was watchin' me watching for a good reason": perceptions of data privacy, access, and sharing in the context of real-time PrEP adherence monitoring among HIV-negative MSM with substance use.

Once-daily oral tenofovir/emtricitabine is highly effective as pre-exposure prophylaxis (PrEP) against HIV but is dependent on adherence, which may be challenging for men who have sex with men (MSM) and use substances. Digital pill systems (DPS) permit the direct, real-time measurement of adherence, though user perceptions of data privacy in this context are unknown. Thirty prospective DPS users - HIV-negative MSM with non-alcohol substance use - completed in-depth qualitative interviews exploring preferences around privacy, access, and sharing of DPS adherence data. Participants discussed some concerns about the impact of DPS use on personal privacy, and emphasized the need for robust data protections in the technology. Participants were interested in having on-demand access to their adherence data, and were most willing to share data with primary care providers and long-term relationship partners. Future investigations exploring bioethical frameworks around DPS use are warranted, and user preferences should inform best practices for protecting DPS data.

Artificial Intelligence and Liability in Medicine: Balancing Safety and Innovation.

Policy Points With increasing integration of artificial intelligence and machine learning in medicine, there are concerns that algorithm inaccuracy could lead to patient injury and medical liability. While prior work has focused on medical malpractice, the artificial intelligence ecosystem consists of multiple stakeholders beyond clinicians. Current liability frameworks are inadequate to encourage both safe clinical implementation and disruptive innovation of artificial intelligence. Several policy options could ensure a more balanced liability system, including altering the standard of care, insurance, indemnification, special/no-fault adjudication systems, and regulation. Such liability frameworks could facilitate safe and expedient implementation of artificial intelligence and machine learning in clinical care.

Ethical and Legal Implications of Remote Monitoring of Medical Devices.

Policy Points Millions of life-sustaining implantable devices collect and relay massive amounts of digital health data, increasingly by using user-downloaded smartphone applications to facilitate data relay to clinicians via manufacturer servers. Our analysis of health privacy laws indicates that most US patients may have little access to their own digital health data in the United States under the Health Insurance Portability and Accountability Act Privacy Rule, whereas the EU General Data Protection Regulation and the California Consumer Privacy Act grant greater access to device-collected data. Our normative analysis argues for consistently granting patients access to the raw data collected by their implantable devices. CONTEXT: Millions of life-sustaining implantable devices collect and relay massive amounts of digital health data, increasingly by using user-downloaded smartphone applications to facilitate data relay to clinicians via manufacturer servers. Whether patients have either legal or normative claims to data collected by these devices, particularly in the raw, granular format beyond that summarized in their medical records, remains incompletely explored. METHODS: Using pacemakers and implantable cardioverter-defibrillators (ICDs) as a clinical model, we outline the clinical ecosystem of data collection, relay, retrieval, and documentation. We consider the legal implications of US and European privacy regulations for patient access to either summary or raw device data. Lastly, we evaluate ethical arguments for or against providing patients access to data beyond the summaries presented in medical records. FINDINGS: Our analysis of applicable health privacy laws indicates that US patients may have little access to their raw data collected and held by device manufacturers in the United States under the Health Insurance Portability and Accountability Act Privacy Rule, whereas the EU General Data Protection Regulation (GDPR) grants greater access to device-collected data when the processing of personal data falls under the GDPR's territorial scope. The California Consumer Privacy Act, the "little sister" of the GDPR, also grants greater rights to California residents. By contrast, our normative analysis argues for consistently granting patients access to the raw data collected by their implantable devices. Smartphone applications are increasingly involved in the collection, relay, retrieval, and documentation of these data. Therefore, we argue that smartphone user agreements are an emerging but potentially underutilized opportunity for clarifying both legal and ethical claims for device-derived data. CONCLUSIONS: Current health privacy legislation incompletely supports patients' normative claims for access to digital health data.