Driving Activity Recognition Using UWB Radar and Deep Neural Networks.

In-car activity monitoring is a key enabler of various automotive safety functions. Existing approaches are largely based on vision systems. Radar, however, can provide a low-cost, privacy-preserving alternative. To this day, such systems based on the radar are not widely researched. In our work, we introduce a novel approach that uses the Doppler signal of an ultra-wideband (UWB) radar as an input to deep neural networks for the classification of driving activities. In contrast to previous work in the domain, we focus on generalization to unseen persons and make a new radar driving activity dataset (RaDA) available to the scientific community to encourage comparison and the benchmarking of future methods.

Harnessing the potential of microalgae-bacteria interaction for eco-friendly wastewater treatment: A review on new strategies involving machine learning and artificial intelligence.

In the pursuit of effective wastewater treatment and biomass generation, the symbiotic relationship between microalgae and bacteria emerges as a promising avenue. This analysis delves into recent advancements concerning the utilization of microalgae-bacteria consortia for wastewater treatment and biomass production. It examines multiple facets of this symbiosis, encompassing the judicious selection of suitable strains, optimal culture conditions, appropriate media, and operational parameters. Moreover, the exploration extends to contrasting closed and open bioreactor systems for fostering microalgae-bacteria consortia, elucidating the inherent merits and constraints of each methodology. Notably, the untapped potential of co-cultivation with diverse microorganisms, including yeast, fungi, and various microalgae species, to augment biomass output. In this context, artificial intelligence (AI) and machine learning (ML) stand out as transformative catalysts. By addressing intricate challenges in wastewater treatment and microalgae-bacteria symbiosis, AI and ML foster innovative technological solutions. These cutting-edge technologies play a pivotal role in optimizing wastewater treatment processes, enhancing biomass yield, and facilitating real-time monitoring. The synergistic integration of AI and ML instills a novel dimension, propelling the fields towards sustainable solutions. As AI and ML become integral tools in wastewater treatment and symbiotic microorganism cultivation, novel strategies emerge that harness their potential to overcome intricate challenges and revolutionize the domain.

Probabilistic modeling of personalized drug combinations from integrated chemical screen and molecular data in sarcoma.

BACKGROUND: Cancer patients with advanced disease routinely exhaust available clinical regimens and lack actionable genomic medicine results, leaving a large patient population without effective treatments options when their disease inevitably progresses. To address the unmet clinical need for evidence-based therapy assignment when standard clinical approaches have failed, we have developed a probabilistic computational modeling approach which integrates molecular sequencing data with functional assay data to develop patient-specific combination cancer treatments. METHODS: Tissue taken from a murine model of alveolar rhabdomyosarcoma was used to perform single agent drug screening and DNA/RNA sequencing experiments; results integrated via our computational modeling approach identified a synergistic personalized two-drug combination. Cells derived from the primary murine tumor were allografted into mouse models and used to validate the personalized two-drug combination. Computational modeling of single agent drug screening and RNA sequencing of multiple heterogenous sites from a single patient's epithelioid sarcoma identified a personalized two-drug combination effective across all tumor regions. The heterogeneity-consensus combination was validated in a xenograft model derived from the patient's primary tumor. Cell cultures derived from human and canine undifferentiated pleomorphic sarcoma were assayed by drug screen; computational modeling identified a resistance-abrogating two-drug combination common to both cell cultures. This combination was validated in vitro via a cell regrowth assay. RESULTS: Our computational modeling approach addresses three major challenges in personalized cancer therapy: synergistic drug combination predictions (validated in vitro and in vivo in a genetically engineered murine cancer model), identification of unifying therapeutic targets to overcome intra-tumor heterogeneity (validated in vivo in a human cancer xenograft), and mitigation of cancer cell resistance and rewiring mechanisms (validated in vitro in a human and canine cancer model). CONCLUSIONS: These proof-of-concept studies support the use of an integrative functional approach to personalized combination therapy prediction for the population of high-risk cancer patients lacking viable clinical options and without actionable DNA sequencing-based therapy.

A Systematic Review of Artificial Intelligence Used to Predict Loneliness, Social Isolation, and Drug Use During the COVID-19 Pandemic.

This systematic literature review evaluates the role of machine learning, artificial intelligence (AI), and social determinants of health (SDOH) in identifying loneliness during the COVID-19 pandemic. By examining various studies and articles through a comprehensive search of databases EBSCOhost, Medline Complete, Academic Search Complete, Directory of Open Access Journals, and Complementary Index, the research team sought to discern consistent themes and patterns. We identified four constructs central to understanding the impact of the pandemic on societal well-being: (1) the prediction of compliance with COVID-19 measures, (2) the prediction of loneliness and its effects, (3) the prediction of well-being and social inclusion, and (4) the prediction of drug use. Within these constructs, prevalent themes related to opioid overdose, stress levels, mental health, well-being, and cognitive decline emerged. The adherence to the PRISMA 2020 checklist has resulted in a PRISMA flow diagram that categorizes the selected literature. The findings of this review, including the proportion of studies predicting various attributes related to loneliness, demonstrate the critical intersections between machine learning, AI, SDOH, and the psychosocial phenomenon of loneliness amidst a global health crisis. The review results provide a summary of the occurrences and predictive percentages of each construct as determined by the literature, contributing to a nuanced understanding of the pandemic's multifaceted impact on loneliness, social isolation, and drug use. Using AI to predict these constructs has remarkable capabilities in identifying individuals at risk and facilitating timely interventions to mitigate adverse outcomes and promote mental health resilience in the face of challenges such as the COVID-19 pandemic. Moving forward, future research is warranted to refine AI algorithms, validate predictive models and utilize AI-based interventions in healthcare and mental health services while ensuring data security, and individuals' privacy.

Improving newborn screening in India: Disease gaps and quality control.

In India, newborn screening (NBS) is essential for detecting health problems in infants. Despite significant progress, significant gaps and challenges persist. India has made great strides in genomics dueto the existence of the National Institute of Biomedical Genomics in West Bengal. The work emphasizes the challenges NBS programs confront with technology, budgetary constraints, insufficient counseling, inequality in illness panels, and a lack of awareness. Advancements in technology, such as genetic testing and next-generation sequencing, are expected to significantly transform the process. The integration of analytical tools, artificial intelligence, and machine learning algorithms could improve the efficiency of newborn screening programs, offering a personalized healthcare approach. It is critical to address gaps in information, inequities in illness incidence, budgetary restrictions, and inadequate counseling. Strengthening national NBS programs requires increased public awareness and coordinated efforts between state and central agencies. Quality control procedures must be used at every level for implementation to be successful. Additional studies endeavor to enhance NBS in India through public education, illness screening expansion, enhanced quality control, government incentive implementation, partnership promotion, and expert training. Improved neonatal health outcomes and the viability of the program across the country will depend heavily on new technology and counseling techniques.

Carbon capture, utilization and sequestration systems design and operation optimization: Assessment and perspectives of artificial intelligence opportunities.

Carbon capture, utilization, and sequestration (CCUS) is a promising solution to decarbonize the energy and industrial sectors to mitigate climate change. An integrated assessment of technological options is required for the effective deployment of CCUS large-scale infrastructure between CO2 production and utilization/sequestration nodes. However, developing cost-effective strategies from engineering and operation perspectives to implement CCUS is challenging. This is due to the diversity of upstream emitting processes located in different geographical areas, available downstream utilization technologies, storage sites capacity/location, and current/future energy/emissions/economic conditions. This paper identifies the need to achieve a robust hybrid assessment tool for CCUS modeling, simulation, and optimization based mainly on artificial intelligence (AI) combined with mechanistic methods. Thus, a critical literature review is conducted to assess CCUS technologies and their related process modeling/simulation/optimization techniques, while evaluating the needs for improvements or new developments to reduce overall CCUS systems design and operation costs. These techniques include first principles- based and data-driven ones, i.e. AI and related machine learning (ML) methods. Besides, the paper gives an overview on the role of life cycle assessment (LCA) to evaluate CCUS systems where the combined LCA-AI approach is assessed. Other advanced methods based on the AI/ML capabilities/algorithms can be developed to optimize the whole CCUS value chain. Interpretable ML combined with explainable AI can accelerate optimum materials selection by giving strong rules which accelerates the design of capture/utilization plants afterwards. Besides, deep reinforcement learning (DRL) coupled with process simulations will accelerate process design/operation optimization through considering simultaneous optimization of equipment sizing and operating conditions. Moreover, generative deep learning (GDL) is a key solution to optimum capture/utilization materials design/discovery. The developed AI methods can be generalizable where the extracted knowledge can be transferred to future works to help cutting the costs of CCUS value chain.

Smart laser Sintering: Deep Learning-Powered powder bed fusion 3D printing in precision medicine.

Medicines remain ineffective for over 50% of patients due to conventional mass production methods with fixed drug dosages. Three-dimensional (3D) printing, specifically selective laser sintering (SLS), offers a potential solution to this challenge, allowing the manufacturing of small, personalized batches of medication. Despite its simplicity and suitability for upscaling to large-scale production, SLS was not designed for pharmaceutical manufacturing and necessitates a time-consuming, trial-and-error adaptation process. In response, this study introduces a deep learning model trained on a variety of features to identify the best feature set to represent drugs and polymeric materials for the prediction of the printability of drug-loaded formulations using SLS. The proposed model demonstrates success by achieving 90% accuracy in predicting printability. Furthermore, explainability analysis unveils materials that facilitate SLS printability, offering invaluable insights for scientists to optimize SLS formulations, which can be expanded to other disciplines. This represents the first study in the field to develop an interpretable, uncertainty-optimized deep learning model for predicting the printability of drug-loaded formulations. This paves the way for accelerating formulation development, propelling us into a future of personalized medicine with unprecedented manufacturing precision.

Can Whole-Body Baseline CT Radiomics Add Information to the Prediction of Best Response, Progression-Free Survival, and Overall Survival of Stage IV Melanoma Patients Receiving First-Line Targeted Therapy: A Retrospective Register Study.

BACKGROUND: The aim of this study was to investigate whether the combination of radiomics and clinical parameters in a machine-learning model offers additive information compared with the use of only clinical parameters in predicting the best response, progression-free survival after six months, as well as overall survival after six and twelve months in patients with stage IV malignant melanoma undergoing first-line targeted therapy. METHODS: A baseline machine-learning model using clinical variables (demographic parameters and tumor markers) was compared with an extended model using clinical variables and radiomic features of the whole tumor burden, utilizing repeated five-fold cross-validation. Baseline CTs of 91 stage IV malignant melanoma patients, all treated in the same university hospital, were identified in the Central Malignant Melanoma Registry and all metastases were volumetrically segmented (n = 4727). RESULTS: Compared with the baseline model, the extended radiomics model did not add significantly more information to the best-response prediction (AUC [95% CI] 0.548 (0.188, 0.808) vs. 0.487 (0.139, 0.743)), the prediction of PFS after six months (AUC [95% CI] 0.699 (0.436, 0.958) vs. 0.604 (0.373, 0.867)), or the overall survival prediction after six and twelve months (AUC [95% CI] 0.685 (0.188, 0.967) vs. 0.766 (0.433, 1.000) and AUC [95% CI] 0.554 (0.163, 0.781) vs. 0.616 (0.271, 1.000), respectively). CONCLUSIONS: The results showed no additional value of baseline whole-body CT radiomics for best-response prediction, progression-free survival prediction for six months, or six-month and twelve-month overall survival prediction for stage IV melanoma patients receiving first-line targeted therapy. These results need to be validated in a larger cohort.

Open Data and transparency in artificial intelligence and machine learning: A new era of research.

Artificial Intelligence (AI) and machine learning are the current forefront of computer science and technology. AI and related sub-disciplines, including machine learning, are essential technologies which have enabled the widespread use of smart technology, such as smart phones, smart home appliances and even electric toothbrushes. It is AI that allows the devices used day-to-day across people's personal lives, working lives and in industry to better anticipate and respond to our needs. However, the use of AI technology comes with a range of ethical questions - including issues around privacy, security, reliability, copyright/plagiarism and whether AI is capable of independent, conscious thought. We have seen several issues related to racial and sexual bias in AI in the recent times, putting the reliability of AI in question. Many of these issues have been brought to the forefront of cultural awareness in late 2022, early 2023, with the rise of AI art programs (and the copyright issues arising from the deep-learning methods employed to train this AI), and the popularity of ChatGPT alongside its ability to be used to mimic human output, particularly in regard to academic work. In critical areas like healthcare, the errors of AI can be fatal. With the incorporation of AI in almost every sector of our everyday life, we need to keep asking ourselves- can we trust AI, and how much? This Editorial outlines the importance of openness and transparency in the development and applications of AI to allow all users to fully understand both the benefits and risks of this ubiquitous technology, and outlines how the Artificial Intelligence and Machine Learning  Gateway on F1000Research meets these needs.

A Delphi Process to Identify Relevant Outcomes That May Be Associated With a Predictive Analytic Tool to Detect Hemodynamic Deterioration in the Intensive Care Unit.

Background The critical care literature has seen an increase in the development and validation of tools using artificial intelligence for early detection of patient events or disease onset in the intensive care unit (ICU). The hemodynamic stability index (HSI) was found to have an AUC of 0.82 in predicting the need for hemodynamic intervention in the ICU. Future studies using this tool may benefit from targeting those outcomes that are more relevant to clinicians and most achievable. Methods A three-round Delphi study was conducted with a panel of 10 critical care physicians and three nurses in the United States to identify outcomes that may be most relevant and achievable with the HSI when evaluated for use in the ICU. To achieve criteria for relevance, at least 65% of panelists had to rate an outcome as a 4 or 5 on a 5-point scale. Results Nineteen of 24 outcomes that may be associated with the HSI achieved consensus for relevance. The Kemeny-Young approach was used to develop a matrix depicting the distribution of outcomes considering both relevance and achievability. "Reduces time spent in hemodynamic instability" and "reduces times to recognition of hemodynamic instability" were the highest-ranking outcomes considering both relevance and achievability. Conclusion This Delphi study was a feasible method to identify relevant outcomes that may be associated with an appropriate predictive analytic tool in the ICU. These findings can provide insight to researchers looking to study such tools to impact outcomes relevant to critical care practitioners. Future studies should test these tools in the ICU that target the most clinically relevant and achievable outcomes, such as time spent hemodynamically unstable or time until actionable nursing assessment or treatment.

AI/ML combined with next-generation sequencing of VHH immune repertoires enables the rapid identification of de novo humanized and sequence-optimized single domain antibodies: a prospective case study.

Introduction: In this study, we demonstrate the feasibility of yeast surface display (YSD) and nextgeneration sequencing (NGS) in combination with artificial intelligence and machine learning methods (AI/ML) for the identification of de novo humanized single domain antibodies (sdAbs) with favorable early developability profiles. Methods: The display library was derived from a novel approach, in which VHH-based CDR3 regions obtained from a llama (Lama glama), immunized against NKp46, were grafted onto a humanized VHH backbone library that was diversified in CDR1 and CDR2. Following NGS analysis of sequence pools from two rounds of fluorescence-activated cell sorting we focused on four sequence clusters based on NGS frequency and enrichment analysis as well as in silico developability assessment. For each cluster, long short-term memory (LSTM) based deep generative models were trained and used for the in silico sampling of new sequences. Sequences were subjected to sequence- and structure-based in silico developability assessment to select a set of less than 10 sequences per cluster for production. Results: As demonstrated by binding kinetics and early developability assessment, this procedure represents a general strategy for the rapid and efficient design of potent and automatically humanized sdAb hits from screening selections with favorable early developability profiles.

Colonic drug delivery: Formulating the next generation of colon-targeted therapeutics.

Colonic drug delivery can facilitate access to unique therapeutic targets and has the potential to enhance drug bioavailability whilst reducing off-target effects. Delivering drugs to the colon requires considered formulation development, as both oral and rectal dosage forms can encounter challenges if the colon's distinct physiological environment is not appreciated. As the therapeutic opportunities surrounding colonic drug delivery multiply, the success of novel pharmaceuticals lies in their design. This review provides a modern insight into the key parameters determining the effective design and development of colon-targeted medicines. Influential physiological features governing the release, dissolution, stability, and absorption of drugs in the colon are first discussed, followed by an overview of the most reliable colon-targeted formulation strategies. Finally, the most appropriate in vitro, in vivo, and in silico preclinical investigations are presented, with the goal of inspiring strategic development of new colon-targeted therapeutics.

Evidence-Based Surgery: What Can Intra-Operative Images Contribute?

Evidence-based medicine integrates results from randomized controlled trials (RCTs) and meta-analyses, combining the best external evidence with individual clinical expertise and patients' preferences. However, RCTs of surgery differ from those of medicine in that surgical performance is often assumed to be consistent. Yet, evaluating whether each surgery is performed to the same standard is quite challenging. As a primary issue, the novelty of this review is to emphasize-with a focus on orthopedic trauma-the advantage of having complete intra-operative image documentation, allowing the direct evaluation of the quality of the intra-operative technical performance. The absence of complete intra-operative image documentation leads to the inhomogeneity of case series, yielding inconsistent results due to the impossibility of a secondary analysis. Thus, comparisons and the reproduction of studies are difficult. Access to complete intra-operative image data in surgical RCTs allows not only secondary analysis but also comparisons with similar cases. Such complete data can be included in electronic papers. Offering these data to peers-in an accessible link-when presenting papers facilitates the selection process and improves publications for readers. Additionally, having access to the full set of image data for all presented cases serves as a rich resource for learning. It enables the reader to sift through the information and pinpoint the details that are most relevant to their individual needs, allowing them to potentially incorporate this knowledge into daily practice. A broad use of the concept of complete intra-operative image documentation is pivotal for bridging the gap between clinical research findings and real-world applications. Enhancing the quality of surgical RCTs would facilitate the equalization of evidence acquisition in both internal medicine and surgery. Joint effort by surgeons, scientific societies, publishers, and healthcare authorities is needed to support the ideas, implement economic requirements, and overcome the mental obstacles to its realization.

Simple Detection of Unstained Live Senescent Cells with Imaging Flow Cytometry.

Cellular senescence is a hallmark of aging and a promising target for therapeutic approaches. The identification of senescent cells requires multiple biomarkers and complex experimental procedures, resulting in increased variability and reduced sensitivity. Here, we propose a simple and broadly applicable imaging flow cytometry (IFC) method. This method is based on measuring autofluorescence and morphological parameters and on applying recent artificial intelligence (AI) and machine learning (ML) tools. We show that the results of this method are superior to those obtained measuring the classical senescence marker, senescence-associated beta-galactosidase (SA-ß-Gal). We provide evidence that this method has the potential for diagnostic or prognostic applications as it was able to detect senescence in cardiac pericytes isolated from the hearts of patients affected by end-stage heart failure. We additionally demonstrate that it can be used to quantify senescence "in vivo" and can be used to evaluate the effects of senolytic compounds. We conclude that this method can be used as a simple and fast senescence assay independently of the origin of the cells and the procedure to induce senescence.

Combination of Whole-Body Baseline CT Radiomics and Clinical Parameters to Predict Response and Survival in a Stage-IV Melanoma Cohort Undergoing Immunotherapy.

BACKGROUND: This study investigated whether a machine-learning-based combination of radiomics and clinical parameters was superior to the use of clinical parameters alone in predicting therapy response after three months, and overall survival after six and twelve months, in stage-IV malignant melanoma patients undergoing immunotherapy with PD-1 checkpoint inhibitors and CTLA-4 checkpoint inhibitors. METHODS: A random forest model using clinical parameters (demographic variables and tumor markers = baseline model) was compared to a random forest model using clinical parameters and radiomics (extended model) via repeated 5-fold cross-validation. For this purpose, the baseline computed tomographies of 262 stage-IV malignant melanoma patients treated at a tertiary referral center were identified in the Central Malignant Melanoma Registry, and all visible metastases were three-dimensionally segmented (n = 6404). RESULTS: The extended model was not significantly superior compared to the baseline model for survival prediction after six and twelve months (AUC (95% CI): 0.664 (0.598, 0.729) vs. 0.620 (0.545, 0.692) and AUC (95% CI): 0.600 (0.526, 0.667) vs. 0.588 (0.481, 0.629), respectively). The extended model was not significantly superior compared to the baseline model for response prediction after three months (AUC (95% CI): 0.641 (0.581, 0.700) vs. 0.656 (0.587, 0.719)). CONCLUSIONS: The study indicated a potential, but non-significant, added value of radiomics for six-month and twelve-month survival prediction of stage-IV melanoma patients undergoing immunotherapy.

Connected healthcare: Improving patient care using digital health technologies.

Now more than ever, traditional healthcare models are being overhauled with digital technologies of Healthcare 4.0 increasingly adopted. Worldwide, digital devices are improving every stage of the patient care pathway. For one, sensors are being used to monitor patient metrics 24/7, permitting swift diagnosis and interventions. At the treatment stage, 3D printers are under investigation for the concept of personalised medicine by allowing patients access to on-demand, customisable therapeutics. Robots are also being explored for treatment, by empowering precision surgery, rehabilitation, or targeted drug delivery. Within medical logistics, drones are being leveraged to deliver critical treatments to remote areas, collect samples, and even provide emergency aid. To enable seamless integration within healthcare, the Internet of Things technology is being exploited to form closed-loop systems that remotely communicate with one another. This review outlines the most promising healthcare technologies and devices, their strengths, drawbacks, and opportunities for clinical adoption.

Let's talk about sex: Differences in drug therapy in males and females.

Professor Henry Higgins in My Fair Lady said, 'Why can't a woman be more like a man?' Perhaps unintended, such narration extends to the reality of current drug development. A clear sex-gap exists in pharmaceutical research spanning from preclinical studies, clinical trials to post-marketing surveillance with a bias towards males. Consequently, women experience adverse drug reactions from approved drug products more often than men. Distinct differences in pharmaceutical response across drug classes and the lack of understanding of disease pathophysiology also exists between the sexes, often leading to suboptimal drug therapy in women. This review explores the influence of sex as a biological variable in drug delivery, pharmacokinetic response and overall efficacy in the context of pharmaceutical research and practice in the clinic. Prospective recommendations are provided to guide researchers towards the consideration of sex differences in methodologies and analyses. The promotion of disaggregating data according to sex to strengthen scientific rigour, encouraging innovation through the personalisation of medicines and adopting machine learning algorithms is vital for optimised drug development in the sexes and population health equity.

Roadmap for Developing Complex Virtual Reality Simulation Scenarios: Subpial Neurosurgical Tumor Resection Model.

BACKGROUND: Advancement and evolution of current virtual reality (VR) surgical simulation technologies are integral to improve the available armamentarium of surgical skill education. This is especially important in high-risk surgical specialties. Such fields including neurosurgery are beginning to explore the utilization of virtual reality simulation in the assessment and training of psychomotor skills. An important issue facing the available VR simulation technologies is the lack of complexity of scenarios that fail to replicate the visual and haptic realities of complex neurosurgical procedures. Therefore there is a need to create more realistic and complex scenarios with the appropriate visual and haptic realities to maximize the potential of virtual reality technology. METHODS: We outline a roadmap for creating complex virtual reality neurosurgical simulation scenarios using a step-wise description of our team's subpial tumor resection project as a model. RESULTS: The creation of complex neurosurgical simulations involves integrating multiple modules into a scenario-building roadmap. The components of each module are described outlining the important stages in the process of complex VR simulation creation. CONCLUSIONS: Our roadmap of a stepwise approach for the creation of complex VR-simulated neurosurgical procedures may also serve as a guide to aid the development of other VR scenarios in a variety of surgical fields. The generation of new VR complex simulated neurosurgical procedures, by surgeons for surgeons, with the help of computer scientists and engineers may improve the assessment and training of residents and ultimately improve patient care.

Artificial Intelligence and Machine Learning Applied at the Point of Care.

INTRODUCTION: The increasing availability of healthcare data and rapid development of big data analytic methods has opened new avenues for use of Artificial Intelligence (AI)- and Machine Learning (ML)-based technology in medical practice. However, applications at the point of care are still scarce. OBJECTIVE: Review and discuss case studies to understand current capabilities for applying AI/ML in the healthcare setting, and regulatory requirements in the US, Europe and China. METHODS: A targeted narrative literature review of AI/ML based digital tools was performed. Scientific publications (identified in PubMed) and grey literature (identified on the websites of regulatory agencies) were reviewed and analyzed. RESULTS: From the regulatory perspective, AI/ML-based solutions can be considered medical devices (i.e., Software as Medical Device, SaMD). A case series of SaMD is presented. First, tools for monitoring and remote management of chronic diseases are presented. Second, imaging applications for diagnostic support are discussed. Finally, clinical decision support tools to facilitate the choice of treatment and precision dosing are reviewed. While tested and validated algorithms for precision dosing exist, their implementation at the point of care is limited, and their regulatory and commercialization pathway is not clear. Regulatory requirements depend on the level of risk associated with the use of the device in medical practice, and can be classified into administrative (manufacturing and quality control), software-related (design, specification, hazard analysis, architecture, traceability, software risk analysis, cybersecurity, etc.), clinical evidence (including patient perspectives in some cases), non-clinical evidence (dosing validation and biocompatibility/toxicology) and other, such as e.g. benefit-to-risk determination, risk assessment and mitigation. There generally is an alignment between the US and Europe. China additionally requires that the clinical evidence is applicable to the Chinese population and recommends that a third-party central laboratory evaluates the clinical trial results. CONCLUSIONS: The number of promising AI/ML-based technologies is increasing, but few have been implemented widely at the point of care. The need for external validation, implementation logistics, and data exchange and privacy remain the main obstacles.