Insights From a Clinically Orientated Workshop on Health Care Cybersecurity and Medical Technology: Observational Study and Thematic Analysis.

BACKGROUND: Health care professionals receive little training on the digital technologies that their patients rely on. Consequently, practitioners may face significant barriers when providing care to patients experiencing digitally mediated harms (eg, medical device failures and cybersecurity exploits). Here, we explore the impact of technological failures in clinical terms. OBJECTIVE: Our study explored the key challenges faced by frontline health care workers during digital events, identified gaps in clinical training and guidance, and proposes a set of recommendations for improving digital clinical practice. METHODS: A qualitative study involving a 1-day workshop of 52 participants, internationally attended, with multistakeholder participation. Participants engaged in table-top exercises and group discussions focused on medical scenarios complicated by technology (eg, malfunctioning ventilators and malicious hacks on health care apps). Extensive notes from 5 scribes were retrospectively analyzed and a thematic analysis was performed to extract and synthesize data. RESULTS: Clinicians reported novel forms of harm related to technology (eg, geofencing in domestic violence and errors related to interconnected fetal monitoring systems) and barriers impeding adverse event reporting (eg, time constraints and postmortem device disposal). Challenges to providing effective patient care included a lack of clinical suspicion of device failures, unfamiliarity with equipment, and an absence of digitally tailored clinical protocols. Participants agreed that cyberattacks should be classified as major incidents, with the repurposing of existing crisis resources. Treatment of patients was determined by the role technology played in clinical management, such that those reliant on potentially compromised laboratory or radiological facilities were prioritized. CONCLUSIONS: Here, we have framed digital events through a clinical lens, described in terms of their end-point impact on the patient. In doing so, we have developed a series of recommendations for ensuring responses to digital events are tailored to clinical needs and center patient care.

Digital health technologies and inequalities: A scoping review of potential impacts and policy recommendations.

Digital health technologies hold promises for reducing health care costs, enhancing access to care, and addressing labor shortages. However, they risk exacerbating inequalities by disproportionately benefitting a subset of the population. Use of digital technologies accelerated during the Covid-19 pandemic. Our scoping review aimed to describe how inequalities related to their use were conceptually assessed during and after the pandemic and understand how digital strategies and policies might support digital equity. We used the PRISMA Extension for scoping reviews, identifying 2055 papers through an initial search of 3 databases in 2021 and complementary search in 2022, of which 41 were retained. Analysis was guided by the eHealth equity framework. Results showed that digital inequalities were reported in the U.S. and other high-income countries and were mainly assessed through differences in access and use according to individual sociodemographic characteristics. Health disparities related to technology use and the interaction between context and technology implementation were more rarely documented. Policy recommendations stressed the adoption of an equity lens in strategy development and multilayered and intersectoral collaboration to align interventions with the needs of specific subgroups. Finally, findings suggested that evaluations of health and wellbeing distribution related to the use of digital technologies should inform digital strategies and health policies.

Behavioral Engagement and Activation Model Study (BEAMS): A latent class analysis of adopters and non-adopters of digital health technologies among people with Type 2 diabetes.

Many people with Type 2 diabetes (T2D) who could benefit from digital health technologies (DHTs) are either not using DHTs or do use them, but not for long enough to reach their behavioral or metabolic goals. We aimed to identify subgroups within DHT adopters and non-adopters and describe their unique profiles to better understand the type of tailored support needed to promote effective and sustained DHT use across a diverse T2D population. We conducted latent class analysis of a sample of adults with T2D who responded to an internet survey between December 2021 and March 2022. We describe the clinical and psychological characteristics of DHT adopters and non-adopters, and their attitudes toward DHTs. A total of 633 individuals were characterized as either DHT "Adopters" (n = 376 reporting any use of DHT) or "Non-Adopters" (n = 257 reporting never using any DHT). Within Adopters, three subgroups were identified: 21% (79/376) were "Self-managing Adopters," who reported high health activation and self-efficacy for diabetes management, 42% (158/376) were "Activated Adopters with dropout risk," and 37% (139/376) were "Non-Activated Adopters with dropout risk." The latter two subgroups reported barriers to using DHTs and lower rates of intended future use. Within Non-Adopters, two subgroups were identified: 31% (79/257) were "Activated Non-Adopters," and 69% (178/257) were "Non-Adopters with barriers," and were similarly distinguished by health activation and barriers to using DHTs. Beyond demographic characteristics, psychological, and clinical factors may help identify different subgroups of Adopters and Non-Adopters.

In this study, we characterized subgroups of adopters and non-adopters of digital health technologies (DHTs) for managing Type 2 diabetes, such as apps to track nutrition, continuous glucose monitors, and activity monitors like Fitbit. Self-efficacy for diabetes management, health activation, and perceived barriers to use DHT emerged as characteristics that distinguished subgroups. Notably, subgroups of adopters differed in their interest to use these technologies in the next 3 months; groups with low levels of self-efficacy and health activation were least interested in using them and thus at risk of discontinuing use. The ability to identify these subgroups can inform strategies tailored to each subgroup that motivate adoption of DHTs and promote long-term engagement.

Health policy and regulatory authorities: challenges of technology regulation in Public Health Emergencies. / Política de saúde e Autoridades Reguladoras: desafios da regulação de tecnologias nas Emergências em Saúde Pública.

Public Health Emergencies (PHE) have had repercussions on health systems on a global scale, and timely access to new health technologies is a challenge for health policy. The national regulatory authorities (NRA) play a key role in the evaluation and regulation of these technologies. The present study aims to analyze the main strategies and regulatory instruments used to deal with the challenges of regulating new technologies necessary for the health system's effective response during a PHE. This research, based on WHO and Brazilian NRA norms and documents, considered dimensions related to strategies for strengthening regulatory activities and regulatory instruments used to accelerate access to technologies, especially during PHEs. International cooperation between the NRA and the WHO were important strategies for strengthening the NRA, with emphasis on the use of reliance, regionalization, accelerated assessments, and work/information sharing, as well as the processes of regulatory harmonization and convergence. In addition to the use of existing regulatory instruments, efforts were also identified in order to implement new ones.

As Emergências em Saúde Pública (ESP) têm repercutido nos sistemas de saúde em escala global. O acesso às novas tecnologias em saúde em tempo oportuno é um desafio para a política de saúde. As autoridades reguladoras nacionais (ARN) têm papel fundamental na avaliação e regulação dessas tecnologias. O estudo objetiva analisar as principais estratégias e instrumentos regulatórios utilizados para lidar com os desafios da regulação de novas tecnologias necessárias à resposta do sistema de saúde durante as ESP. Trata-se de uma pesquisa normativa e documental, tendo como fonte a OMS e a ARN brasileira. Foram consideradas as dimensões relacionadas às estratégias para o fortalecimento das atividades regulatórias e os instrumentos regulatórios utilizados para acelerar o acesso às tecnologias, especialmente durante as ESP. A cooperação e a colaboração internacional entre as ARN e com a OMS foram importantes estratégias para o fortalecimento das ARN, com destaque para o uso de confiança, regionalização, avaliações aceleradas e compartilhamento de trabalho/informações, bem como os processos de harmonização e convergência regulatória. Identificou-se, além da utilização de instrumentos regulatórios já existentes, esforços na implementação de novos, com destaque para Autorização de Uso Emergencial.

The participation of hard-to-reach older people in the research and development process of health technologies from the perspective of multipliers-A qualitative analysis.

Introduction: The participation of older people in research and development processes has long been called for but has not been sufficiently put into practice. In addition, participation is often late and not particularly intensive, so that certain older groups of people are underrepresented in the development of health technologies (HT). Heterogeneity, e.g., between urban and rural populations, in access to and motivation for participation is also rarely taken into account. The aim of this study was to investigate form and phases of participation for hard-to-reach older people in the research and development process of HT. Methods: The qualitative study among multipliers was conducted using focus groups and telephone interviews and took place in a city and an adjacent rural area in northwestern Lower Saxony, Germany. A content analysis of the data was undertaken using deductive-inductive category formation. Results: Seventeen participants (13 female) took part in the study (median age 61, 33-73). Participants from both areas identified particular forms and phases of participation in the research and development process. Longer forms of participation for hard-to-reach groups and the development process of technologies for older people from the rural area were viewed as challenges. Passive and active access strategies are needed to achieve sufficient heterogeneity in the research and development process. Trusted multipliers can play an important role in gaining access to hard-to-reach older people, but also during the research process. Apart from facilitating factors (e.g., age-specific study materials), inhibiting factors such as contact anxieties are also indicated. Only urban participants mention financial/material incentives and community as possible motivations. Conclusions: The results provide important insights from the perspective of multipliers. They show specificities in access and participation for rural areas and for hard-to-reach older people. Many older people may have uncertainties about research projects and HT. Multipliers can assume a key role to help reduce these uncertainties in the future.

Leveraging sensor-based functional outcomes to enhance understanding of the patient experience: challenges and opportunities.

INTRODUCTION: Sensor-based digital health technology (DHT) has emerged as a promising means to assess patient functioning within and outside clinical trials. Sensor-based functional outcomes (SBFOs) provide valuable insights that complement other measures of how a patient feels or functions to enhance understanding of the patient experience to inform medical product development. AREAS COVERED: This perspective paper provides recommendations for defining SBFOs, discusses the core evidence required to support SBFOs to inform decision-making, and considers future directions for the field. EXPERT COMMENTARY: The clinical outcome assessment (COA) development process provides an important starting point for developing patient-centered SBFOs; however, given the infancy of the field, SBFO development may benefit from a hybrid approach to evidence generation by merging exploratory data analysis with patient engagement in measure development. Effective SBFO development requires combining unique expertise in patient engagement, measurement and regulatory science, and digital health and analytics. Challenges specific to SBFO development include identifying concepts of interest, ensuring measurement of meaningful aspects of health, and identifying thresholds for meaningful change. SBFOs are complementary to other COAs and, as part of an integrated evidence strategy, offer great promise in fostering a holistic understanding of patient experience and treatment benefits, particularly in real-world settings.

What happens when the tasks dry up? Exploring the impact of medical technology on workforce planning.

Increasing evidence suggests that new technologies tend to substitute for low skilled labour and complement highly skilled labour. This paper considers the manner in which new technology impacts on two distinct groups of highly skilled health care labour, cardiologists and cardiac surgeons. We consider the diffusion impact of PCI as it replaces CABG in the treatment of cardiovascular disease in the English NHS, and explicitly estimate the degree to which the cardiac surgical workforce reacts to this newer technology. Using administrative data we trace the complementarity between CABG and PCI during the mature phase of technology adoption, mapped against an increasing employment of cardiologists as they replace cardiothoracic surgeons. Our findings show evidence of growing employment of cardiologists, as PCI is increasingly expanded to older and sicker patients. While in cardiothoracic surgery, surgeons compensate falling CABG rates in a manner consistent with undertaking replacement activity and redeployment. While for cardiologists this reflects the general findings in the literature, that new technology enhances rather than substitutes for skilled labour, for the surgeons the new technology leads to redeployment rather than a downsizing of their labour.

The WHO Pandemic Agreement should be more specific about when and how to enable global access to technology.

Timeliness is repeatedly referenced in the World Health Organization (WHO) Pandemic Agreement negotiation draft, published in March 2024. However, the draft remains vague with regard to what is considered timely. Health policymaking should be much more conscious of the time scales it evokes and implements in order to support global equity and solidarity. The Pandemic Agreement negotiation draft could be made more specific to foster global synchronicity by: (1) replacing 'best endeavor' language with enforceable timelines, particularly for benefit sharing mechanisms, (2) mandating an automatically triggered time-bound IP waiver for pandemic health technologies to accelerate manufacturing and distribution scale-up to global levels, and (3) strengthening the pandemic fund and debt relief mechanisms to safeguard financial resources to enable global synchronicity for future pandemic prevention, preparedness, and response. In summary, global solidarity during a pandemic requires more attention to synchronicity by ensuring the simultaneous implementation and rollout of measures to prevent, contain, or end a pandemic in different countries or regions.

Breaking down the Digital Fortress: The Unseen Challenges in Healthcare Technology-Lessons Learned from 10 Years of Research.

Healthcare is undergoing a fundamental shift in which digital health tools are becoming ubiquitous, with the promise of improved outcomes, reduced costs, and greater efficiency. Healthcare professionals, patients, and the wider public are faced with a paradox of choice regarding technologies across multiple domains. Research is continuing to look for methods and tools to further revolutionise all aspects of health from prediction, diagnosis, treatment, and monitoring. However, despite its promise, the reality of implementing digital health tools in practice, and the scalability of innovations, remains stunted. Digital health is approaching a crossroads where we need to shift our focus away from simply looking at developing new innovations to seriously considering how we overcome the barriers that currently limit its impact. This paper summarises over 10 years of digital health experiences from a group of researchers with backgrounds in physical therapy-in order to highlight and discuss some of these key lessons-in the areas of validity, patient and public involvement, privacy, reimbursement, and interoperability. Practical learnings from this collective experience across patient cohorts are leveraged to propose a list of recommendations to enable researchers to bridge the gap between the development and implementation of digital health tools.

Scalp surface estimation and head registration using sparse sampling and 3D statistical models.

Registering the head and estimating the scalp surface are important for various biomedical procedures, including those using neuronavigation to localize brain stimulation or recording. However, neuronavigation systems rely on manually-identified fiducial head targets and often require a patient-specific MRI for accurate registration, limiting adoption. We propose a practical technique capable of inferring the scalp shape and use it to accurately register the subject's head. Our method does not require anatomical landmark annotation or an individual MRI scan, yet achieves accurate registration of the subject's head and estimation of its surface. The scalp shape is estimated from surface samples easily acquired using existing pointer tools, and registration exploits statistical head model priors. Our method allows for the acquisition of non-trivial shapes from a limited number of data points while leveraging their object class priors, surpassing the accuracy of common reconstruction and registration methods using the same tools. The proposed approach is evaluated in a virtual study with head MRI data from 1152 subjects, achieving an average reconstruction root-mean-square error of 2.95 mm, which outperforms a common neuronavigation technique by 2.70 mm. We also characterize the error under different conditions and provide guidelines for efficient sampling. Furthermore, we demonstrate and validate the proposed method on data from 50 subjects collected with conventional neuronavigation tools and setup, obtaining an average root-mean-square error of 2.89 mm; adding landmark-based registration improves this error to 2.63 mm. The simulation and experimental results support the proposed method's effectiveness with or without landmark annotation, highlighting its broad applicability.

Healthcare personnel's perspectives on health technology in home-based pediatric palliative care: a qualitative study.

BACKGROUND: In the context of pediatric palliative care, where the quality of life of children with life-limiting or life-threatening conditions is of utmost importance, the integration of health technology must support the provision of care. Research has highlighted the role of healthcare personnel when utilizing health technology in home-based pediatric palliative care, but specific knowledge of healthcare personnel's views on the technological relevance remains limited. Therefore, our study has explored potentials and limitations of health technology in home-based pediatric palliative care from the perspectives of healthcare personnel. METHODS: Our study utilized a qualitative, descriptive, and exploratory design, including five focus groups with a total of 22 healthcare personnel. The participants were selected from various health regions in Norway and were experienced in providing home-based pediatric palliative care. Using reflexive thematic analysis, we interpreted data obtained from focus groups, identified patterns, and developed themes. RESULTS: The analysis resulted in the development of three intersecting themes: balancing in-person interaction and time in home-based pediatric palliative care; exchange of information can improve timely and appropriate care; and the power of visual documentation in pediatric palliative care. The healthcare personnel acknowledged difficulties in fully replacing in-person interaction with health technology. However, they also emphasized potentials of health technology to facilitate information sharing and the ability to access a child's health record within interdisciplinary teams. CONCLUSION: The results underscored that technology can support pediatric palliative care but must be thoughtfully integrated to ensure an individualized patient-centered approach. To maximize the benefits of health technology in enhancing home-based pediatric palliative care, future research should address the limitations of current health technology and consider the opinions for information sharing between relevant healthcare team members, the child, and their family.

Fritz Kahn and the Centenary of The Doctor of the Future.

This JAMA Arts and Medicine feature describes ways in which Fritz Kahn shared a prescient and nuanced vision of technology's role in the patient-physician interaction, a topic of continued interest and relevance today, through his illustrations.

Unlocking the full potential of digital endpoints for decision making: a novel modular evidence concept enabling re-use and advancing collaboration.

INTRODUCTION: Over the last decade increasing examples indicate opportunities to measure patient functioning and its relevance for clinical and regulatory decision making via endpoints collected through digital health technologies. More recently, we have seen such measures support primary study endpoints and enable smaller trials. The field is advancing fast: validation requirements have been proposed in the literature and regulators are releasing new guidances to review these endpoints. Pharmaceutical companies are embracing collaborations to develop them and working with academia and patient organizations in their development. However, the road to validation and regulatory acceptance is lengthy. The full value of digital endpoints cannot be unlocked until better collaboration and modular evidence frameworks are developed enabling re-use of evidence and repurposing of digital endpoints. AREAS COVERED: This paper proposes a solution by presenting a novel modular evidence framework -the Digital Evidence Ecosystem and Protocols (DEEP)- enabling repurposing of measurement solutions, re-use of evidence, application of standards and also facilitates collaboration with health technology assessment bodies. EXPERT OPINION: The integration of digital endpoints in healthcare, essential for personalized and remote care, requires harmonization and transparency. The proposed novel stack model offers a modular approach, fostering collaboration and expediting the adoption in patient care.

Digital health technologies in enhancing patient and caregiver engagement in heart failure management: Opportunities and challenges.

The management of heart failure has undergone significant evolution, advancing from the initial utilization of digitalis and diuretics to the contemporary practice of personalized medicine and sophisticated device therapy. Despite these advancements, the persistent challenge of high hospitalization and readmission rates underscores an urgent need for innovative solutions. This manuscript explores how the integration of digital health technologies into interventional cardiology marks a paradigm shift in the management of heart failure. These technologies are no longer mere adjuncts but have become foundational to a modern approach, providing tools for continuous monitoring, patient education, and improved outcomes post-intervention. Through an examination of current trends, this perspective article highlights the transformative impact of wearable technologies, telehealth platforms, and advanced analytical tools in reshaping patient engagement and enabling proactive care strategies. Case studies illustrate the practical advantages, including enhanced medication adherence, early detection of heart failure signs, and a reduction in healthcare facility burdens. Central to this new digital health landscape is the Information Technology Management (ITM) system, a framework poised to revolutionize patient and caregiver engagement and pave the way for the future of interventional cardiology. This manuscript delineates the ITM system's innovative architecture and its consequential role in refining current and prospective cardiological interventions.

HCI-modelling for improving the clinical usability of digital health technologies.

INTRODUCTION: Digital Health Technologies (DHTs) have been shown to have variable usability as measured by efficiency, effectiveness and user satisfaction despite large-scale government projects to regulate and standardise user interface (UI) design. We hypothesised that Human-Computer Interaction (HCI) modelling could improve the methodology for DHT design and regulation, and support the creation of future evidence-based UI standards and guidelines for DHTs. METHODOLOGY: Using a Design Science Research (DSR) framework, we developed novel UI components that adhered to existing standards and guidelines (combining the NHS Common User Interface (CUI) standard and the NHS Design System). We firstly evaluated the Patient Banner UI component for compliance with the two guidelines and then used HCI-modelling to evaluate the "Add New Patient" workflow to measure time to task completion and cognitive load. RESULTS: Combining the two guidelines to produce new UI elements is technically feasible for the Patient Banner and the Patient Name Input components. There are some inconsistencies between the NHS Design System and the NHS CUI when implementing the Patient Banner. HCI-modelling successfully quantified challenges adhering to the NHS CUI and the NHS Design system for the "Add New Patient" workflow. DISCUSSION: We successfully developed new design artefacts combing two major design guidelines for DHTs. By quantifying usability issues using HCI-modelling, we have demonstrated the feasibility of a methodology that combines HCI-modelling into a human-centred design (HCD) process could enable the development of standardised UI elements for DHTs that is more scientifically robust than HCD alone. CONCLUSION: Combining HCI-modelling and Human-Centred Design could improve scientific progress towards developing safer and more user-friendly DHTs.