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. (shrink)

Under the umbrella of the burgeoning neurotransdisciplines, scholars are using the principles and research methodologies of their primary and secondary fields to examine developments in neuroimaging, neuromodulation and psychopharmacology. The path for advanced scholarship at the intersection of law and neuroscience may clear if work across the disciplines is collected and reviewed and outstanding and debated issues are identified and clarified. In this article, I organize, examine and refine a narrow class of the burgeoning neurotransdiscipline scholarship; that is, scholarship at (...) the interface of law and functional magnetic resonance imaging (fMRI). (shrink)

In the early 1970s, Congress considered enacting comprehensive privacy legislation, but it was unable to do so. In 1974, it passed the Privacy Act, applicable only to information in the possession of the federal government. In the intervening years, other information privacy laws enacted by Congress, such as the Health Insurance Portability and Accountability Act, have been weak and sector specific. With the explosion of information technology and the growing concerns about an absence of effective federal privacy laws, the legal (...) focus has shifted to the states. Signaling a new direction in state data privacy and consumer protection law, the California Consumer Privacy Act establishes important rights and protections for California residents with regard to the collection, use, disclosure, and sale of their personal information. The CCPA is certain to spur similar legislation and to affect national and international businesses that collect data from California's residents. Understanding the new law is important for all data‐driven industries, including health care. (shrink)

This article examines the privacy and security issues associated with mobile application-mediated health research, concentrating in particular on research conducted or participated in by independent scientists, citizen scientists, and patient researchers. Building on other articles in this issue that examine state research laws and state data protection laws as possible sources of privacy and security protections for mobile research participants, this article focuses on the lack of application of federal standards to mobile application-mediated health research. As discussed in more detail (...) below, the voluminous and diverse data collected by some independent scientists who use mobile applications to conduct health research may be at risk for unregulated privacy and security breaches, leading to dignitary, psychological, and economic harms for which participants have few legally enforceable rights or remedies under current federal law. Federal lawmakers may wish to consider enacting new legislation that would require otherwise unregulated health data holders to implement reasonable data privacy, security, and breach notification measures. (shrink)

Advances in science and technology frequently raise new ethical, legal, and social issues, and developments in neuroscience and neuroimaging technology are no exception. Within the field of neuroethics, leading scientists, ethicists, and humanists are exploring the implications of efforts to image, study, treat, and enhance the human brain.This article focuses on one aspect of neuroethics: the confidentiality and privacy implications of advances in functional magnetic resonance imaging. Following a brief orientation to fMRI and an overview of some of its current (...) and proposed uses, this article highlights key confidentiality and privacy issues raised by fMRI in the contexts of health care, research, employment, insurance, criminal justice, litigation, and cognitive privacy. (shrink)

Advances in neuroscience have implications for criminal law as well as civil and regulatory law, including health, disability, and benefit law. The role of the behavioral and brain sciences in health insurance claims, the mental health parity debate, and disability proceedings is examined.