Returning Individual Research Results from Digital Phenotyping in Psychiatry.

Psychiatry is rapidly adopting digital phenotyping and artificial intelligence/machine learning tools to study mental illness based on tracking participants' locations, online activity, phone and text message usage, heart rate, sleep, physical activity, and more. Existing ethical frameworks for return of individual research results (IRRs) are inadequate to guide researchers for when, if, and how to return this unprecedented number of potentially sensitive results about each participant's real-world behavior. To address this gap, we convened an interdisciplinary expert working group, supported by a National Institute of Mental Health grant. Building on established guidelines and the emerging norm of returning results in participant-centered research, we present a novel framework specific to the ethical, legal, and social implications of returning IRRs in digital phenotyping research. Our framework offers researchers, clinicians, and Institutional Review Boards (IRBs) urgently needed guidance, and the principles developed here in the context of psychiatry will be readily adaptable to other therapeutic areas.

"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.

Criminal Justice or Public Health: A Comparison of the Representation of the Crack Cocaine and Opioid Epidemics in the Media.

CONTEXT: The opioid epidemic is a major US public health crisis. Its scope prompted significant public outreach, but this response triggered a series of journalistic articles comparing the opioid epidemic to the crack cocaine epidemic. Some authors claimed that the political response to the crack cocaine epidemic was criminal justice rather than medical in nature, motivated by divergent racial demographics. METHODS: We examine these assertions by analyzing the language used in relevant newspaper articles. Using a national sample, we compare word frequencies from articles about crack cocaine in 1988-89 and opioids in 2016-17 to evaluate media framings. We also examine articles about methamphetamines in 1992-93 and heroin throughout the three eras to distinguish between narratives used to describe the crack cocaine and opioid epidemics. FINDINGS: We find support for critics' hypotheses about the differential framing of the two epidemics: articles on the opioid epidemic are likelier to use medical terminology than criminal justice terminology while the reverse is true for crack cocaine articles. CONCLUSIONS: Our analysis suggests that race and legality may influence policy responses to substance-use epidemics. Comparisons also suggest that the evolution of the media narrative on substance use cannot alone account for the divergence in framing between the two epidemics.

Increasing Telehealth Access Through Licensure Exceptions.

This Viewpoint explains how exceptions can be used to connect patients via telehealth with a physician in another state, why this is a more practical and effective strategy, and what needs to happen for this to be a feasible solution.

Whose Responsibility Is It to Define Exceptions in Abortion Bans?

This Viewpoint evaluates Texas' proposals to define the scope of the life exception for the state's abortion ban and argues that these approaches do not allow physicians to follow the national standards of care, avoid criminal liability, or have sufficient notice of what the law permits.

Prevention of Bias and Discrimination in Clinical Practice Algorithms.

This Viewpoint discusses a proposed DHHS rule to address discrimination in clinical algorithms and the need for additional considerations to ensure the burden of liability for biased algorithms is not disproportionately placed on health care professionals.

Providing Responsible Health Care for Out-of-State Patients.

This Viewpoint discusses why the legality of calling patients located in another state has suddenly been called into question.

Pulse Oximeters and Violation of Federal Antidiscrimination Law.

This Viewpoint discusses how some pulse oximeters can provide incorrect oxygen saturation data for dark-skinned patients compared with light-skinned patients, describes the reasons that biased oximeters remained in use, and highlights why a rule recently proposed by the US Department of Health and Human Services may bring about needed change in the use of pulse oximetry for patients with dark skin.

Abortion Miscoding-Legal Risks for Clinicians and Hospital Systems.

This Viewpoint discusses the legal risks physicians and health care facilities may incur by miscoding a surgical or chemical abortion as a miscarriage to conceal an abortion procedure.

Pediatric Drug and Other Shortages in the Age of Supply Chain Disruption.

This Viewpoint lists the top 3 pediatric drugs and product shortages, considers the federal government's and manufacturers' ethical duty to protect children, reviews the causes for the shortages, and suggests policy changes that could help fill in the gap.

Unsettled Liability Issues for "Prediagnostic" Wearables and Health-Related Products.

This Viewpoint examines the murky legal treatment of various health-related wearable or other general wellness products for patients, physicians, and manufacturers, and recommends solutions.

Using digital technologies to diagnose in the home: recommendations from a Delphi panel.

Rapid advances in digital technology have expanded the availability of diagnostic tools beyond traditional medical settings. Previously confined to clinical environments, these many diagnostic capabilities are now accessible outside the clinic. This study utilized the Delphi method, a consensus-building approach, to develop recommendations for the development and deployment of these innovative technologies. The study findings present the 29 consensus-based recommendations generated through the Delphi process, providing valuable insights and guidance for stakeholders involved in the implementation and utilization of these novel diagnostic solutions. These recommendations serve as a roadmap for navigating the complexities of integrating digital diagnostics into healthcare practice outside traditional settings like hospitals and clinics.