I. Glenn Cohen

FDA Regulation of Mobile Health Technologies

Mobile health (“mHealth”) is the use of portable devices such as smartphones and tablets to improve health. This report discusses the public health benefits and risks of mHealth and the challenges facing the FDA in regulating this technology.

The Legal And Ethical Concerns That Arise From Using Complex Predictive Analytics In Health Care

Predictive analytics, or the use of electronic algorithms to forecast future events in real time, makes it possible to harness the power of big data to improve the health of patients and lower the cost of health care. However, this opportunity raises policy, ethical, and legal challenges. In this article we analyze the major challenges to implementing predictive analytics in health care settings and make broad recommendations for overcoming challenges raised in the four phases of the life cycle of a predictive analytics model: acquiring data to build the model, building and validating it, testing it in real-world settings, and disseminating and using it more broadly. For instance, we recommend that model developers implement governance structures that include patients and other stakeholders starting in the earliest phases of development. In addition, developers should be allowed to use already collected patient data without explicit consent, provided that they comply with federal regulations regarding research on human subjects and the privacy of health information.

Ethical and legal implications of the risks of medical tourism for patients: A qualitative study of Canadian health and safety representatives' perspectives

Objectives Medical tourism involves patients’ intentional travel to privately obtain medical care in another country. Empirical evidence regarding health and safety risks facing medical tourists is limited. Consideration of this issue is dominated by speculation and lacks meaningful input from people with specific expertise in patient health and safety. We consulted with patient health and safety experts in the Canadian province of British Columbia to explore their views concerning risks that medical tourists may be exposed to. Herein, we report on the findings, linking them to existing ethical and legal issues associated with medical tourism. Design We held a focus group in September 2011 in Vancouver, British Columbia with professionals representing different domains of patient health and safety expertise. The focus group was transcribed verbatim and analysed thematically. Participants Seven professionals representing the domains of tissue banking, blood safety, health records, organ transplantation, dental care, clinical ethics and infection control participated. Results Five dominant health and safety risks for outbound medical tourists were identified by participants: (1) complications; (2) specific concerns regarding organ transplantation; (3) transmission of antibiotic-resistant organisms; (4) (dis)continuity of medical documentation and (5) (un)informed decision-making. Conclusions Concern was expressed that medical tourism might have unintended and undesired effects upon patients’ home healthcare systems. The individual choices of medical tourists could have significant public consequences if healthcare facilities in their home countries must expend resources treating postoperative complications. Participants also expressed concern that medical tourists returning home with infections, particularly antibiotic-resistant infections, could place others at risk of exposure to infections that are refractory to standard treatment regimens and thereby pose significant public health risks.

Using Social Media as a Research Recruitment Tool: Ethical Issues and Recommendations

The use of social media as a recruitment tool for research with humans is increasing, and likely to continue to grow. Despite this, to date there has been no specific regulatory guidance and there has been little in the bioethics literature to guide investigators and institutional review boards (IRBs) faced with navigating the ethical issues such use raises. We begin to fill this gap by first defending a nonexceptionalist methodology for assessing social media recruitment; second, examining respect for privacy and investigator transparency as key norms governing social media recruitment; and, finally, analyzing three relatively novel aspects of social media recruitment: (i) the ethical significance of compliance with website “terms of use”; (ii) the ethics of recruiting from the online networks of research participants; and (iii) the ethical implications of online communication from and between participants. Two checklists aimed at guiding investigators and IRBs through the ethical issues are included as appendices.

Transatlantic Lessons in Regulation of Mitochondrial Replacement Therapy

The UK has approved MRT for clinical use, but the discussion has just begun in the U.S. Mutant mitochondrial DNA (mtDNA) gives rise to a broad range of heritable clinical syndromes (1). A cure for those affected remains out of reach (1). However, recently developed mitochondrial replacement therapy (MRT) has raised the prospect of disease-free progeny for women carriers (2–4). Moreover, the feasibility of replacing mutant oocytic or zygotic mtDNA with a donated wild-type counterpart in humans has now been firmly established (2–4). In the United Kingdom, legislation regulating the clinical application of MRT, now 10 years in the making, has recently been approved by the House of Commons (5) and the House of Lords (6). The regulatory vetting of MRT in the United States, under way for a year, remains a work in progress (7). Here, we compare and contrast the regulatory history of MRT in the United Kingdom and the United States and examine potential lessons learned.

How to Regulate Medical Tourism (and Why it Matters for Bioethics)

A growing literature examines descriptive and normative questions about medical tourism such as: How does it operate? What are its effects? Are home country patients or their governments failing in moral duties by engaging in or permitting medical tourism? By contrast, much less has been written on the regulatory dimension: What might be done about medical tourism if we were convinced that it posed ethical issues and were motivated to act? I shall argue that this kind of regulatory analysis is essential for bioethical analysis of medical tourism. This article focuses on these regulatory questions more directly, evaluating available methods, restrictions, costs, and benefits of home and destination country unilateral regulatory moves. This article also discusses more briefly multilateral treaty and private sector responses.

The Ethics of Smart Pills and Self-Acting Devices: Autonomy, Truth-Telling, and Trust at the Dawn of Digital Medicine

Digital medicine is a medical treatment that combines technology with drug delivery. The promises of this combination are continuous and remote monitoring, better disease management, self-tracking, self-management of diseases, and improved treatment adherence. These devices pose ethical challenges for patients, providers, and the social practice of medicine. For patients, having both informed consent and a user agreement raises questions of understanding for autonomy and informed consent, therapeutic misconception, external influences on decision making, confidentiality and privacy, and device dependability. For providers, digital medicine changes the relationship where trust can be verified, clinicians can be monitored, expectations must be managed, and new liability risks may be assumed. Other ethical questions include direct third-party monitoring of health treatment, affordability, and planning for adverse events in the case of device malfunction. This article seeks to lay out the ethical landscape for the implementation of such devices in patient care.

Disruptive reproductive technologies

In vitro gametogenesis raises new possibilities for reproductive and regenerative medicine as well as vexing policy challenges. In vitro gametogenesis raises new possibilities for reproductive and regenerative medicine as well as vexing policy challenges.

The FDA is prohibited from going germline

Full stop: U.S. Congress precludes human germline modification A potentially renewable provision of the Consolidated Appropriation Act of 2016 forestalling the prospect of human germline modification was signed into law on 18 December 2015 (1). The provision, also known as a rider (an amendment extraneous to the main purpose of the bill to which it is attached), stipulates that “none of the funds made available by this Act [to the FDA] may be used to review or approve an application for an exemption for investigational use of a drug or biological product… in which a human embryo is intentionally created or modified to include a heritable genetic modification” (1). Destined to expire at the conclusion of this fiscal year (30 September 2016), the rider has since been incorporated yet again into the House and Senate appropriation bills for the fiscal year ending 30 September 2017 (2, 3). Subject to ongoing annual renewal, this congressionally legislated ban undermines ongoing conversations on the possibility of human germline modification, its likely distant time horizon notwithstanding (4). Also affected are ongoing efforts of the FDA to review the prevention of mitochondrial DNA diseases through germline modification of human zygotes or oocytes at risk (5).

Consensus Statement on Electronic Health Predictive Analytics: A Guiding Framework to Address Challenges

Context: The recent explosion in available electronic health record (EHR) data is motivating a rapid expansion of electronic health care predictive analytic (e-HPA) applications, defined as the use of electronic algorithms that forecast clinical events in real time with the intent to improve patient outcomes and reduce costs. There is an urgent need for a systematic framework to guide the development and application of e-HPA to ensure that the field develops in a scientifically sound, ethical, and efficient manner. Objectives: Building upon earlier frameworks of model development and utilization, we identify the emerging opportunities and challenges of e-HPA, propose a framework that enables us to realize these opportunities, address these challenges, and motivate e-HPA stakeholders to both adopt and continuously refine the framework as the applications of e-HPA emerge. Methods: To achieve these objectives, 17 experts with diverse expertise including methodology, ethics, legal, regulation, and health care delivery systems were assembled to identify emerging opportunities and challenges of e-HPA and to propose a framework to guide the development and application of e-HPA. Findings: The framework proposed by the panel includes three key domains where e-HPA differs qualitatively from earlier generations of models and algorithms (Data Barriers, Transparency, and Ethics) and areas where current frameworks are insufficient to address the emerging opportunities and challenges of e-HPA (Regulation and Certification; and Education and Training). The following list of recommendations summarizes the key points of the framework: Data Barriers: Establish mechanisms within the scientific community to support data sharing for predictive model development and testing. Transparency: Set standards around e-HPA validation based on principles of scientific transparency and reproducibility. Ethics: Develop both individual-centered and society-centered risk-benefit approaches to evaluate e-HPA. Regulation and Certification: Construct a self-regulation and certification framework within e-HPA. Education and Training: Make significant changes to medical, nursing, and paraprofessional curricula by including training for understanding, evaluating, and utilizing predictive models.