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The U.S. Food and Drug Administration’s (FDA) recent authorization of DermaSensor, an AI-enabled device for skin cancer detection in primary care, marks a pivotal moment in digital health innovation. Clinically, the authorization of the first AI-enabled device for use by non-specialists for detecting skin cancer reinforces the feasibility of digital health technologies to bridge gaps in access and expertise in medical practice. The authorization also establishes a new regulatory precedent for FDA authorization of medical devices incorporating AI and machine learning (ML) technologies within dermatology. Together, this article uses the DermaSensor authorization to examine the clinical evidence and regulatory implications of emerging AI-enabled technologies in dermatology.

Generative AI is designed to create new content from trained parameters. Learning from large amounts of data, many of these models aim to simulate human conversation. Generative AI is being applied to many different sectors. Within healthcare there has been innovation specifically towards generative AI models trained on electronic medical record data. A recent review characterizes these models, their strengths, and weaknesses. Inspired by that work, we present our evaluation checklist for generative AI models applied to electronic medical records.

We explore the evolving landscape of diagnostic artificial intelligence (AI) in dermatology, particularly focusing on deep learning models for a wide array of skin diseases beyond skin cancer. We critically analyze the current state of AI in dermatology, its potential in enhancing diagnostic accuracy, and the challenges it faces in terms of bias, applicability, and therapeutic recommendations.

The utilization of artificial intelligence (AI) in diabetes care has focused on early intervention and treatment management. Notably, usage has expanded to predict an individual’s risk for developing type 2 diabetes. A scoping review of 40 studies by Mohsen et al. shows that while most studies used unimodal AI models, multimodal approaches were superior because they integrate multiple types of data. However, creating multimodal models and determining model performance are challenging tasks given the multi-factored nature of diabetes. For both unimodal and multimodal models, there are also concerns of bias with the lack of external validations and representation of race, age, and gender in training data. The barriers in data quality and evaluation standardization are ripe areas for developing new technologies, especially for entrepreneurs and innovators. Collaboration amongst providers, entrepreneurs, and researchers must be prioritized to ensure that AI in diabetes care is providing quality and equitable patient care.

Even as innovation occurs within digital medicine, challenges around equity and racial health disparities remain. Golden et al. evaluate structural racism in their recent paper focused on reproductive health. They recommend a framework to Remove, Repair, Restructure, and Remediate. We propose applying the framework to three areas within digital medicine: artificial intelligence (AI) applications, wearable devices, and telehealth. With this approach, we can continue to work towards an equitable future for digital medicine.

Gregoor et al. evaluated the healthcare implications and costs of an AI-enabled mobile health app for skin cancer detection, involving 18,960 beneficiaries of a Netherlands insurer. They report a 32% increase in claims for premalignant and malignant skin lesions among app users, largely attributed to benign skin lesions and leading to higher annual costs for app users (€64.97) compared to controls (€43.09). Cost-effectiveness analysis showed a comparable cost to dermatologist-based diagnosis alone. This editorial emphasizes the balance in AI-based dermatology between increased access and increased false positives resulting in overutilization. We suggest refining the diagnostic schemas with new referral pathways to capitalize on potential savings. We also discuss the importance of econometric analysis to evaluate the adoption of new technologies, as well as adapting payment models to mitigate the risk of overutilization inherent in AI-based diagnostics such as skin cancer detection.

Abstract Telehealth use for primary care has skyrocketed since the onset of the COVID-19 pandemic. Enthusiasts have praised this new medium of delivery as a way to increase access to care while potentially reducing spending. Over two years into the pandemic, the question of whether telehealth will lead to an increase in primary care utilization and spending has been met with contradictory answers. Some evidence suggests that telehealth may be used as an addition to in-person visits. Others like Dixit et al. have found that telehealth can actually substitute for in-person care rather than contribute to overutilization. As telehealth continues to evolve, outcomes, utilization, and quality of care should be closely monitored.

Abstract With the increasing number of FDA-approved artificial intelligence (AI) systems, the financing of these technologies has become a primary gatekeeper to mass clinical adoption. Reimbursement models adapted for current payment schemes, including per-use rates, are feasible for early AI products. Alternative and complementary models may offer future payment options for value-based AI. A successful reimbursement strategy will align interests across stakeholders to guide value-based and cost-effective improvements to care.

Digital health technologies (DHTs) have brought several significant improvements to clinical trials, enabling real-world data collection outside of the traditional clinical context and more patient-centered approaches. DHTs, such as wearables, allow the collection of unique personal data at home over a long period. But DHTs also bring challenges, such as digital endpoint harmonization and disadvantaging populations already experiencing the digital divide. A recent study explored the growth trends and implications of established and novel DHTs in neurology trials over the past decade. Here, we discuss the benefits and future challenges of DHT usage in clinical trials.

The usage of digital devices in clinical and research settings has rapidly increased. Despite their promise, optimal use of these devices is often hampered by low adherence. The relevant factors predictive of long-term adherence have yet to be fully explored. A recent study investigated device usage over 12 months in a cohort of the electronic Framingham Heart Study. It identified sociodemographic and health-related factors associated with the long-term use of three digital health components: a smartphone app, a digital blood pressure cuff, and a smartwatch. The authors found that depressive symptoms and lower self-rated health were associated with lower smartwatch usage. Female sex and higher education levels were associated with higher app-based survey completion. Here, we discuss factors predictive for adherence and personalized strategies to promote adherence to digital tools.

Artificial intelligence (AI) and natural language processing (NLP) have found a highly promising application in automated clinical coding (ACC), an innovation that will have profound impacts on the clinical coding industry, billing and revenue management, and potentially clinical care itself. Dong et al. recently analyzed the technical challenges of ACC and proposed future directions. Primary challenges for ACC exist at the technological and implementation levels; clinical documents are redundant and complex, code sets like the ICD-10 are rapidly evolving, training sets are not comprehensive of codes, and ACC models have yet to fully capture the logic and rules of coding decisions. Next steps include interdisciplinary collaboration with clinical coders, accessibility and transparency of datasets, and tailoring models to specific use cases.

Abstract Innovations in robotics, virtual and augmented reality, and artificial intelligence are being rapidly adopted as tools of “digital surgery”. Despite its quickly emerging role, digital surgery is not well understood. A recent study defines the term itself, and then specifies ethical issues specific to the field. These include privacy and public trust, consent, and litigation.

Abstract The importance of infection risk prediction as a key public health measure has only been underscored by the COVID-19 pandemic. In a recent study, researchers use machine learning to develop an algorithm that predicts the risk of COVID-19 infection, by combining biometric data from wearable devices like Fitbit, with electronic symptom surveys. In doing so, they aim to increase the efficiency of test allocation when tracking disease spread in resource-limited settings. But the implications of technology that applies data from wearables stretch far beyond infection monitoring into healthcare delivery and research. The adoption and implementation of this type of technology will depend on regulation, impact on patient outcomes, and cost savings.

Abstract Health digital twins are defined as virtual representations (“digital twin”) of patients (“physical twin”) that are generated from multimodal patient data, population data, and real-time updates on patient and environmental variables. With appropriate use, HDTs can model random perturbations on the digital twin to gain insight into the expected behavior of the physical twin—offering groundbreaking applications in precision medicine, clinical trials, and public health. Main considerations for translating HDT research into clinical practice include computational requirements, clinical implementation, as well as data governance, and product oversight.

Abstract Parkinson’s disease (PD) lacks sensitive, objective, and reliable measures for disease progression and response. This presents a challenge for clinical trials given the multifaceted and fluctuating nature of PD symptoms. Innovations in digital health and wearable sensors promise to more precisely measure aspects of patient function and well-being. Beyond research trials, digital biomarkers and clinical outcome assessments may someday support clinician-initiated or closed-loop treatment adjustments. A recent study from Verily Life Sciences presents results for a smartwatch-based motor exam intended to accelerate the development and evaluation of therapies for PD.

Due to its enormous capacity for benefit, harm, and cost, health care is among the most tightly regulated industries in the world. But with the rise of smartphones, an explosion of direct-to-consumer mobile health applications has challenged the role of centralized gatekeepers. As interest in health apps continue to climb, national regulatory bodies have turned their attention toward strategies to protect consumers from apps that mine and sell health data, recommend unsafe practices, or simply do not work as advertised. To characterize the current state and outlook of these efforts, Essén and colleagues map the nascent landscape of national health app policies and raise several considerations for cross-border collaboration. Strategies to increase transparency, organize app marketplaces, and monitor existing apps are needed to ensure that the global wave of new digital health tools fulfills its promise to improve health at scale.

As clinicians and scientists gather more data on the clinical trajectory of COVID-19 and the biology of its causative agent, the SARS-CoV-2 virus, novel strategies are needed to integrate these data to inform new therapies. A recent study by Howell et al. introduces a network model of viral-host interactions to produce explainable and testable predictions for treatment effects. Their model was consistent with experimental data and recommended treatments, and one of its predicted drug combinations was validated through in vitro assays. These findings support the utility of computational strategies for leveraging the vast literature on COVID-19 to generate insights for drug repurposing.

Generative AI is designed to create new content from trained parameters. Learning from large amounts of data, many of these models aim to simulate human conversation. Generative AI is being applied to many different sectors. Within healthcare there has been innovation specifically towards generative AI models trained on electronic medical record data. A recent review characterizes these models, their strengths, and weaknesses. Inspired by that work, we present our evaluation checklist for generative AI models applied to electronic medical records. [ABSTRACT FROM AUTHOR]