Antitrust as a Guardrail for Socially Responsible Neurotechnology Design.

The neurotechnology sector is likely to develop under pressure towards commercialized, nonmedical products and may also undergo market consolidation. This possibility raises ethical, social, and policy concerns about the future responsibility of neurotechnology innovators and companies for high-consequence design decisions. Present-day internet technology firms furnish an instructive example of the problems that arise when providers of communicative technologies become too big for accountability. As a guardrail against the emergence of similar problems, concerned neurotechnologists may wish to draw inspiration from antitrust law and direct efforts, where appropriate, against undue consolidation in the commercial neurotechnology market.

International Legal Approaches to Neurosurgery for Psychiatric Disorders.

Neurosurgery for psychiatric disorders (NPD), also sometimes referred to as psychosurgery, is rapidly evolving, with new techniques and indications being investigated actively. Many within the field have suggested that some form of guidelines or regulations are needed to help ensure that a promising field develops safely. Multiple countries have enacted specific laws regulating NPD. This article reviews NPD-specific laws drawn from North and South America, Asia and Europe, in order to identify the typical form and contents of these laws and to set the groundwork for the design of an optimal regulation for the field. Key challenges for this design that are revealed by the review are how to define the scope of the law (what should be regulated), what types of regulations are required (eligibility criteria, approval procedures, data collection, and oversight mechanisms), and how to approach international harmonization given the potential migration of researchers and patients.

Availability, readability, and content of privacy policies and terms of agreements of mental health apps.

OBJECTIVE: To assess the availability, readability, and privacy-related content of the privacy policies and terms of agreement of mental health apps available through popular digital stores. MATERIALS AND METHODS: Popular smartphone app stores were searched using combinations of keywords "track" and "mood" and their synonyms. The first 100 apps from each search were evaluated for inclusion and exclusion criteria. Apps were assessed for availability of a privacy policy (PP) and terms of agreement (ToA) and if available, these documents were evaluated for both content and readability. RESULTS: Most of the apps collected in the sample did not include a PP or ToA. PPs could be accessed for 18% of iOS apps and 4% of Android apps; whereas ToAs were available for 15% of iOS and 3% of Android apps. Many PPs stated that users' information may be shared with third parties (71% iOS, 46% Android). DISCUSSION: Results demonstrate that information collection is occurring with the majority of apps that allow users to track the status of their mental health. Most of the apps collected in the initial sample did not include a PP or ToA despite this being a requirement by the store. The majority of PPs and ToAs that were evaluated are written at a post-secondary reading level and disclose that extensive data collection is occurring. CONCLUSION: Our findings raise concerns about consent, transparency, and data sharing associated with mental health apps and highlight the importance of improved regulation in the mobile app environment.

Legal Regulation of Psychosurgery: A Fifty-State Survey.

Following the rise and fall of lobotomy, a majority of U.S. states took legislative aim at psychosurgical procedures. This article canvasses, organizes, and analyzes the existing body of United States statutes and regulations mentioning psychosurgery. Many states regulate psychosurgery without defining the term; existing definitions are imprecise, but many would arguably apply to contemporary procedures like deep brain stimulation. Common to many states are restrictions on surrogate consent to psychosurgery, codifications of patients' consent or refusal rights, and situation-specific bans on the practice targeting certain contexts of vulnerability. Many states have only a handful of scattered laws bearing on psychosurgery, but a few have wide-ranging and well-integrated regulatory regimes. In reviewing these laws we perceive much room for harmonization and modernization. Greater consistency in protecting vulnerable persons from troubling uses of psychosurgery is achievable even alongside an effort to remove undue legal obstacles impeding patient access to potentially therapeutic procedures. Our hope in surveying current psychosurgery law is to inaugurate a conversation on how best to shape its future.

Physician attitudes towards pharmacological cognitive enhancement: safety concerns are paramount.

The ethical dimensions of pharmacological cognitive enhancement have been widely discussed in academic circles and the popular media, but missing from the conversation have been the perspectives of physicians - key decision makers in the adoption of new technologies into medical practice. We queried primary care physicians in major urban centers in Canada and the United States with the aim of understanding their attitudes towards cognitive enhancement. Our primary hypothesis was that physicians would be more comfortable prescribing cognitive enhancers to older patients than to young adults. Physicians were presented with a hypothetical pharmaceutical cognitive enhancer that had been approved by the regulatory authorities for use in healthy adults, and was characterized as being safe, effective, and without significant adverse side effects. Respondents overwhelmingly reported increasing comfort with prescribing cognitive enhancers as the patient age increased from 25 to 65. When asked about their comfort with prescribing extant drugs that might be considered enhancements (sildenafil, modafinil, and methylphenidate) or our hypothetical cognitive enhancer to a normal, healthy 40 year old, physicians were more comfortable prescribing sildenafil than any of the other three agents. When queried as to the reasons they answered as they did, the most prominent concerns physicians expressed were issues of safety that were not offset by the benefit afforded the individual, even in the face of explicit safety claims. Moreover, many physicians indicated that they viewed safety claims with considerable skepticism. It has become routine for safety to be raised and summarily dismissed as an issue in the debate over pharmacological cognitive enhancement; the observation that physicians were so skeptical in the face of explicit safety claims suggests that such a conclusion may be premature. Thus, physician attitudes suggest that greater weight be placed upon the balance between safety and benefit in consideration of pharmacological cognitive enhancement.