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TABLE OF CONTENTS I. BACKGROUND 775 A. Artificial Intelligence in Medicine 776 B. Medical Device Regulation 778 C. Off-Label Use 781 III. ANALYSIS 784 A. Federal Regulators 785 1. The [...], Through machine learning (ML) developments, medical devices are gaining more autonomous functions and taking on more central roles in medical care. Many scholars believe that artificial intelligence (AI) will revolutionize the healthcare industry, but the technology brings several concerns that implicate data privacy, patient security and safety, and professional responsibility. The Federal Drug Administration (FDA) acknowledged this fact, publishing proposed guidance in 2023 on artificial intelligence and machine learning (AI/ML) medical device approval that would tighten device regulation upfront and enhance supervision throughout the regulatory process. While some have addressed the premarket approval process or tort liability frameworks for artificial intelligence-enabled devices, this Note focuses on the regulatory concerns arising from off-label use of AI/ML-enabled medical devices. This Note agrees with FDA and other scholars that the current legal system does not support the proper use of AI/ML-enabled medical devices. To remedy that lack of systemic support, this Note considers which agencies, if any, have the proper regulatory authority to handle the matter and challenges the idea that nonbinding guidance is the proper regulatory vehicle for enforcement. Ultimately, this Note argues for a multilevel regulatory framework promulgated under the formal rulemaking process, state regulatory procedure, and private regulation.

Background: Gamification represents a promising approach for facilitating positive social interactions among groups of individuals and is increasingly being leveraged in physical activity (PA) interventions to promote enhanced intervention engagement and PA outcomes. Although African American (AA) adults experience disparities associated with health conditions that can be ameliorated with increased PA, little is known about how best to culturally target PA gamification strategies for this population. The purpose of this study was to gather perspectives from AA adults residing in the Southeast United States and subsequently identify themes to help inform the cultural adaptation of an existing electronic and mobile health (e/mHealth) gamification- and theory-based PA intervention for teams of insufficiently active AA adults., Methods: An AA moderator facilitated six online focus groups among AA adults (n=42; 93% female; 45.09±9.77 years; 34.40±57.38 minutes/week of reported moderate-intensity equivalent PA), using a semi-structured focus group guide. Drawing from a content analysis approach, transcripts were coded and salient themes were identified., Results: The focus groups revealed the following seven themes: (I) motivation (team-based gamification motivating); (II) accountability (team-based gamification promotes accountability); (III) competition (competitive elements attractive); (IV) weekly challenges (prefer to choose weekly PA challenges); (V) leaderboard feedback (preference for viewing steps and active minutes via a leaderboard); (VI) cultural relevancy (prefer elements reflective of their race and culture that promote team unity); (VII) teammate characteristics (mixed preferences regarding ideal sociodemographic characteristics and starting PA level of teammates)., Conclusions: Integrating team-based gamification in an e/mHealth-based PA intervention may be acceptable among AA adults. The identification of specific design preferences and perceptions of the value of the social environment points to the need to consider surface-level and deep structure cultural targeting when developing and further exploring best practices regarding gamified PA interventions for insufficiently active AAs., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://mhealth.amegroups.com/article/view/10.21037/mhealth-23-44/coif). All authors report that this project was funded by the Southeast Regional Pilot and Feasibility Program [Vanderbilt University School of Medicine/National Institute of Diabetes and Digestive and Kidney Diseases (No. DK020593 to Principal Investigator: C.M.M.)]. This funding provided monetary support for K.Z. and M.S. to fulfill their role in the proposed work. Effort on this project was provided in-kind by C.M.M., R.E.D., G.D., R.L.N., B.C., and D.S.W. C.M.M. reports receiving travel costs in 2022 from the University of South Carolina to present a portion of this work via a poster at the Society of Behavioral Medicine’s 2022 Annual Meeting. R.L.N. reports receiving NIH funding (R42MD014947) to work with Klein Buendel (a marketing and technology company), to develop a smartphone app to increase physical activity in African American men. The authors have no other conflicts of interest to declare., (2024 mHealth. All rights reserved.)

Background: There is now a rising commitment to acknowledge the role patients and families play in contributing to their safety. This review focuses on one type of involvement in safety - patient and family involvement in escalation of care for serious life-threatening conditions i.e. helping secure a step-up to urgent or emergency care - which has been receiving increasing policy and practice attention. This review was concerned with the negotiation work that patient and family members undertake across the emergency care escalation pathway, once contact has been made with healthcare staff. It includes interventions aiming to improve detection of symptoms, communication of concerns and staff response to these concerns., Objectives: To assess the effects of interventions designed to increase patient and family involvement in escalation of care for acute life-threatening illness on patient and family outcomes, treatment outcomes, clinical outcomes, patient and family experience and adverse events., Search Methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL, MEDLINE (OvidSP), Embase (OvidSP), PsycINFO (OvidSP) ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform from 1 Jan 2000 to 24 August 2018. The search was updated on 21 October 2019., Selection Criteria: We included randomised controlled trials (RCTs) and cluster-randomised controlled trials where the intervention focused on patients and families working with healthcare professionals to ensure care received for acute deterioration was timely and appropriate. A key criterion was to include an interactive element of rehearsal, role play, modelling, shared language, group work etc. to the intervention to help patients and families have agency in the process of escalation of care. The interventions included components such as enabling patients and families to detect changes in patients' conditions and to speak up about these changes to staff. We also included studies where the intervention included a component targeted at enabling staff response., Data Collection and Analysis: Seven of the eight authors were involved in screening; two review authors independently extracted data and assessed the risk of bias of included studies, with any disagreements resolved by discussion to reach consensus. Primary outcomes included patient and family outcomes, treatment outcomes, clinical outcomes, patient and family experience and adverse events. Our advisory group (four users and four providers) ensured that the review was of relevance and could inform policy and practice., Main Results: We included nine studies involving 436,684 patients and family members and one ongoing study. The published studies focused on patients with specific conditions such as coronary artery disease, ischaemic stroke, and asthma, as well as pregnant women, inpatients on medical surgical wards, older adults and high-risk patients with a history of poor self-management. While all studies tested interventions versus usual care, for four studies the usual care group also received educational or information strategies. Seven of the interventions involved face-to-face, interactional education/coaching sessions aimed at patients/families while two provided multi-component education programmes which included components targeted at staff as well as patients/families. All of the interventions included: (1) an educational component about the acute condition and preparedness for future events such as stroke or change in fetal movements: (2) an engagement element (self-monitoring, action plans); while two additionally focused on shared language or communication skills. We had concerns about risk of bias for all but one of the included studies in respect of one or more criteria, particularly regarding blinding of participants and personnel. Our confidence in results regarding the effectiveness of interventions was moderate to low. Low-certainty evidence suggests that there may be moderate improvement in patients' knowledge of acute life-threatening conditions, danger signs, appropriate care-seeking responses, and preparedness capacity between interactional patient-facing interventions and multi-component programmes and usual care at 12 months (MD 4.20, 95% CI 2.44 to 5.97, 2 studies, 687 participants). Four studies in total assessed knowledge (3,086 participants) but we were unable to include two other studies in the pooled analysis due to differences in the way outcome measures were reported. One found no improvement in knowledge but higher symptom preparedness at 12 months. The other study found an improvement in patients' knowledge about symptoms and appropriate care-seeking responses in the intervention group at 18 months compared with usual care. Low-certainty evidence from two studies, each using a different measure, meant that we were unable to determine the effects of patient-based interventions on self-efficacy. Self-efficacy was higher in the intervention group in one study but there was no difference in the other compared with usual care. We are uncertain whether interactional patient-facing and multi-component programmes improve time from the start of patient symptoms to treatment due to low-certainty evidence for this outcome. We were unable to combine the data due to differences in outcome measures. Three studies found that arrival times or prehospital delay time was no different between groups. One found that delay time was shorter in the intervention group. Moderate-certainty evidence suggests that multi-component interventions probably have little or no impact on mortality rates. Only one study on a pregnant population was eligible for inclusion in the review, which found no difference between groups in rates of stillbirth. In terms of unintended events, we found that interactional patient-facing interventions to increase patient and family involvement in escalation of care probably have few adverse effects on patient's anxiety levels (moderate-certainty evidence). None of the studies measured or reported patient and family perceptions of involvement in escalation of care or patient and family experience of patient care. Reported outcomes related to healthcare professionals were also not reported in any studies., Authors' Conclusions: Our review identified that interactional patient-facing interventions and multi-component programmes (including staff) to increase patient and family involvement in escalation of care for acute life-threatening illness may improve patient and family knowledge about danger signs and care-seeking responses, and probably have few adverse effects on patient's anxiety levels when compared to usual care. Multi-component interventions probably have little impact on mortality rates. Further high-quality trials are required using multi-component interventions and a focus on relational elements of care. Cognitive and behavioural outcomes should be included at patient and staff level., (Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)