News & Comment

Navigating contemporary healthcare, wearable technology and smartphones are marking the dawn of a transformative era in patient observation and personalised care. Wearables, equipped with various sensing technologies (e.g., accelerometer for movement, optics for heart rate), are increasingly being recognised for their expansive potential in (remote) patient monitoring, diagnostics, and therapeutic applications which suggests a plausible move towards a more decentralised healthcare system. This shift is evident as healthcare providers and patients alike are becoming increasingly accepting of wearable-driven tools, as they enable continuous health monitoring outside of traditional clinical settings. Equally, the ubiquitous nature of smartphones, now more than mere communication tools, is being harnessed to serve as pivotal health monitoring instruments. Their added sensing capabilities with Internet of Things (IoT) driven connectivity enable a (relatively) seamless transition from conventional health practices to a more interconnected, digital age. However, this evolving landscape is not without its challenges, with concerns surrounding data privacy, security, and ensuring equitable access to digital advances. As we delve deeper into digital healthcare, we must harness the full potential of those technologies and ensure their ethical and equitable implementation, envisioning a future where healthcare is not just hospital-centric but is part of our daily lives.

The integration of Quality Management System (QMS) principles into the life cycle of development, deployment, and utilization of machine learning (ML) and artificial intelligence (AI) technologies within healthcare settings holds the potential to close the AI translation gap by establishing a robust framework that accelerates the safe, ethical, and effective delivery of AI/ML in day-to-day patient care. Healthcare organizations (HCOs) can implement these principles effectively by embracing an enterprise QMS analogous to those in regulated industries. By establishing a QMS explicitly tailored to health AI technologies, HCOs can comply with evolving regulations and minimize redundancy and rework while aligning their internal governance practices with their steadfast commitment to scientific rigor and medical excellence.

As result of the pandemic-related increase in telehealth and the 21st Century Cures Act, technology is playing an increasing role in healthcare. This has led to organizational investments in the “digital front door” of healthcare. The promise that these technologies can revolutionize care by better connecting us to our patients, overcoming analog barriers to care, and addressing health disparities is grounded in “techno-optimism.” We advocate for organizational leaders to inform their digital health equity strategies with a balanced measure of “techno-skepticism”, grounded in implementation science, that can ensure alignment between health technology and health equity.

At a time of diminishing clinical skills and diagnostic endeavours for clinicians worldwide, a method of rapid automated microscopy coupled with pH measurement is introduced with early clinical success results in women with common vulvovaginal symptoms facilitating rapid diagnosis and enhanced therapeutic measures.

Sleep recordings are visually classified in stages by experts in the field, based on consensus international criteria. This procedure is expensive and time-consuming. Automatic sleep scoring systems have, progressively over the years, demonstrated good levels of accuracy. Although the performance of these algorithms is believed to be high, however, there remains widespread skepticism in their daily use in clinical and scientific practice. In this comment to a recent publication of NPJ Digital Medicine, we express the reasons why we think the sleep expert should remain the central pivot in the pendulum between visual and automatic methodology, trying to find a new balance in the scientific debate.

Contemporary wearables like smartwatches are often equipped with advanced sensors and have associated algorithms to aid researchers monitor physiological outcomes like physical activity levels, sleep patterns or heart rate in free-living environments. But here’s the catch: all that valuable data is often collected separately because the sensors don’t always play nice with each other, and it’s a real challenge to put all the data together. To get the full picture, we may often need to combine different data streams. It’s like putting together a puzzle of our health, instead of just looking at individual pieces. This way, we can gather more useful info and better understand health (it’s called digital twinning). Yet, to do so requires robust sensor/data fusion methods at the signal, feature, and decision levels. Selecting the appropriate techniques based on the desired outcome is crucial for successful implementation. An effective data fusion framework along with the right sensor selection could contribute to a more holistic approach to health monitoring that extends beyond clinical settings.

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.

Digital health technologies (DHTs) enable remote data collection, support a patient-centric approach to drug development, and provide real-time data in real-world settings. With increasing use of DHTs in clinical care and development, we expect a growing body of evidence supporting use of DHTs to capture endpoint data in clinical trials. As the body of evidence grows, it will be critical to ensure that available prior work can be leveraged. We propose a framework to reuse analytical and clinical validation, as well as verification data, generated for existing DHTs. We apply real life case studies to illustrate our proposal aimed at leveraging prior work, while applying the V3 framework (verification, analytical validation, clinical validation) and avoiding duplication. Utilizing our framework will enable stakeholders to share best practices and consistent approaches to employing these tools in clinical studies, build on each other’s work, and ultimately accelerate evidence generation demonstrating the reproducibility and value add of these new tools.

AI-based prediction models demonstrate equal or surpassing performance compared to experienced physicians in various research settings. However, only a few have made it into clinical practice. Further, there is no standardized protocol for integrating AI-based physician support systems into the daily clinical routine to improve healthcare delivery. Generally, AI/physician collaboration strategies have not been extensively investigated. A recent study compared four potential strategies for AI model deployment and physician collaboration to investigate the performance of an AI model trained to identify signs of acute respiratory distress syndrome (ARDS) on chest X-ray images. Here we discuss strategies and challenges with AI/physician collaboration when AI-based decision support systems are implemented in the clinical routine.

Artificial Intelligence-supported digital applications (AI applications) are expected to transform radiology. However, providers need the motivation and incentives to adopt these technologies. For some radiology AI applications, the benefits of the application itself may sufficiently serve as the incentive. For others, payers may have to consider reimbursing the AI application separate from the cost of the underlying imaging studies. In such circumstances, it is important for payers to develop a clear set of criteria to decide which AI applications should be paid for separately. In this article, we propose a framework to help serve as a guide for payers aiming to establish such criteria and for technology vendors developing radiology AI applications. As a rule of thumb, we propose that radiology AI applications with a clinical utility must be reimbursed separately provided they have supporting evidence that the improved diagnostic performance leads to improved outcomes from a societal standpoint, or if such improved outcomes can reasonably be anticipated based on the clinical utility offered.

Artificial intelligence systems are increasingly being applied to healthcare. In surgery, AI applications hold promise as tools to predict surgical outcomes, assess technical skills, or guide surgeons intraoperatively via computer vision. On the other hand, AI systems can also suffer from bias, compounding existing inequities in socioeconomic status, race, ethnicity, religion, gender, disability, or sexual orientation. Bias particularly impacts disadvantaged populations, which can be subject to algorithmic predictions that are less accurate or underestimate the need for care. Thus, strategies for detecting and mitigating bias are pivotal for creating AI technology that is generalizable and fair. Here, we discuss a recent study that developed a new strategy to mitigate bias in surgical AI systems.

Health and wellness/well-being are multifaceted topics further complicated when trying to understand the environmental impact. Typically, there has been a one size fits all approach when trying to understand the 3-way interaction, but that is a limited approach. Equally, measurement (of each) has often used a limited set of outcomes during short periods to provide insight. A more robust understanding of health and well-being within environments may require longitudinal/continuous assessment that holistically targets individuals. Therefore, there is a growing requirement for careful data management, individual-first methodologies, scalable research designs and new analytical approaches, e.g., artificial intelligence. That presents many challenges but interesting research opportunities for the field of digital medicine.

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 generalizability of predictive algorithms is of key relevance to application in clinical practice. We provide an overview of three types of generalizability, based on existing literature: temporal, geographical, and domain generalizability. These generalizability types are linked to their associated goals, methodology, and stakeholders.

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.

Digital tools are transforming mental health care. The promise of this transformation to improve outcomes has not yet been realized fully. While some have become skeptical, this article argues that we are just at the end of Act 1, with several opportunities and challenges ahead.