Harnessing Digital Health Technologies During and After the COVID-19 Pandemic: Context Matters.

A common development observed during the COVID-19 pandemic is the renewed reliance on digital health technologies. Prior to the pandemic, the uptake of digital health technologies to directly strengthen public health systems had been unsatisfactory; however, a relentless acceleration took place within health care systems during the COVID-19 pandemic. Therefore, digital health technologies could not be prescinded from the organizational and institutional merits of the systems in which they were introduced. The Italian National Health Service is strongly decentralized, with the national government exercising general stewardship and regions responsible for the delivery of health care services. Together with the substantial lack of digital efforts previously, these institutional characteristics resulted in delays in the uptake of appropriate solutions, territorial differences, and issues in engaging the appropriate health care professionals during the pandemic. An in-depth analysis of the organizational context is instrumental in fully interpreting the contribution of digital health during the pandemic and providing the foundation for the digital reconstruction of what is to come after.

Psychosis, vulnerability, and the moral significance of biomedical innovation in psychiatry. Why ethicists should join efforts.

The study of the neuroscience and genomics of mental illness are increasingly intertwined. This is mostly due to the translation of medical technologies into psychiatry and to technological convergence. This article focuses on psychosis. I argue that the convergence of neuroscience and genomics in the context of psychosis is morally problematic, and that ethics scholarship should go beyond the identification of a number of ethical, legal, and social issues. My argument is composed of two strands. First, I argue that we should respond to technological convergence by developing an integrated, patient-centred approach focused on the assessment of individual vulnerabilities. Responding to technological convergence requires that we (i) integrate insights from several areas of ethics, (ii) translate bioethical principles into the mental health context, and (iii) proactively try to anticipate future ethical concerns. Second, I argue that a nuanced understanding of the concept of vulnerability might help us to accomplish this task. I borrow Florencia Luna's notion of 'layers of vulnerability' to show how potential harms or wrongs to individuals who experience psychosis can be conceptualised as stemming from different sources, or layers, of vulnerability. I argue that a layered notion of vulnerability might serve as a common ground to achieve the ethical integration needed to ensure that biomedical innovation can truly benefit, and not harm, individuals who suffer from psychosis.

'Fit-for-purpose?' - challenges and opportunities for applications of blockchain technology in the future of healthcare.

Blockchain is a shared distributed digital ledger technology that can better facilitate data management, provenance and security, and has the potential to transform healthcare. Importantly, blockchain represents a data architecture, whose application goes far beyond Bitcoin - the cryptocurrency that relies on blockchain and has popularized the technology. In the health sector, blockchain is being aggressively explored by various stakeholders to optimize business processes, lower costs, improve patient outcomes, enhance compliance, and enable better use of healthcare-related data. However, critical in assessing whether blockchain can fulfill the hype of a technology characterized as 'revolutionary' and 'disruptive', is the need to ensure that blockchain design elements consider actual healthcare needs from the diverse perspectives of consumers, patients, providers, and regulators. In addition, answering the real needs of healthcare stakeholders, blockchain approaches must also be responsive to the unique challenges faced in healthcare compared to other sectors of the economy. In this sense, ensuring that a health blockchain is 'fit-for-purpose' is pivotal. This concept forms the basis for this article, where we share views from a multidisciplinary group of practitioners at the forefront of blockchain conceptualization, development, and deployment.

Negotiating commissioning pathways for the successful implementation of innovative health technology in primary care.

BACKGROUND: Commissioning innovative health technologies is typically complex and multi-faceted. Drawing on the negotiated order perspective, we explore the process by which commissioning organisations make their decisions to commission innovative health technologies. The empirical backdrop to this discussion is provided by a case study exploring the commissioning considerations for a new photoplethysmography-based diagnostic technology for peripheral arterial disease in primary care in the UK. METHODS: The research involved an empirical case study of four Clinical Commissioning Groups (CCGs) involved in the commissioning of services in primary and secondary care. Semi-structured in-depth interviews (16 in total) and two focus groups (a total of eight people participated, four in each group) were conducted with key individuals involved in commissioning services in the NHS including (i) senior NHS clinical leaders and directors (ii) commissioners and health care managers across CCGs and (iii) local general practitioners. RESULTS: Commissioning of a new diagnostic technology for peripheral arterial disease in primary care involves high levels of protracted negotiations over funding between providers and commissioners, alliance building, conflict resolution and compromise of objectives where the outcomes of change are highly contingent upon interventions made across different care settings. Our evidence illustrates how reconfigurations of inter-organisational relations, and of clinical and related work practices required for the successful implementation of a new technology could become the major challenge in commissioning negotiations. CONCLUSIONS: Innovative health technologies such as the diagnostic technology for peripheral arterial disease are commissioned in care pathways where the value of such technology is realised by those delivering care to patients. The detail of how care pathways are commissioned is complex and involves high degrees of uncertainty concerning such issues as prioritisation decisions, patient benefits, clinical buy-in, value for money and unintended consequences. Recent developments in the new care models and integrated care systems (ICSs) in the UK offer a unique opportunity for the successful commissioning arrangements of innovative health technologies in primary care such as the new diagnostic technology for peripheral arterial disease.

A long-term plan for embracing digital healthcare technology.

Emeritus Professor Alan Glasper, from the University of Southampton, discusses the recently published NHS Long Term Plan's proposals for developing the use of digital technology to enhance patient care.

Estimating the value of implementing reimbursement decisions: What can payers and manufacturers learn from economics?

Implementation of reimbursement decisions is important to payers and manufacturers, however, evidence shows that it is highly variable. An economic framework is available to assess its value that has been successfully applied and which has developed over time to produce a more realistic representation of the real world. The framework incorporates the value of information, technology diffusion, and the interaction between the two, to generate a value of implementation. While potentially complex to apply, simple analyses are possible and qualitative lessons identified from its associated literature. Six lessons are identified which highlight the importance of considering pricing, population size, technology diffusion, evidence generation, and cost-effectiveness. Consideration of these issues would help payers and manufacturers to work together in a combined effort to increase the implementation of new technologies and generate greater value to society.

Innovation in cardiovascular disease in Europe with focus on arrhythmias: current status, opportunities, roadblocks, and the role of multiple stakeholders.

The European Heart Rhythm Association (EHRA) held an Innovation Forum in February 2016, to consider issues around innovation. The objective of the forum was to extend the innovation debate outside of the narrow world of arrhythmia specialists and cardiology in general, and seek input from all stakeholders including regulators, strategists, technologists, industry, academia, health providers, medical societies, payers, and patients. Innovation is indispensable for a continuing improvement in health care, preferably at higher efficacy and lower costs. It requires people who have been trained in a good scientific environment, high-quality research for achieving ground breaking inventions and the certainty of return on innovation investments. In the context of cardiovascular disease, innovation can imply better risk assessment and stratification, device technology, drug development, and process design. Several areas of promising developments were identified as well as several roadblocks to innovation. To drive innovation forward all stakeholders need to play a significant role. In a globalized and extremely competitive world, the leading role of Europe in medical innovation can only be achieved through a combined and well-coordinated effort from all involved parties.

Facilitating the implementation of clinical technology in healthcare: what role does a national agency play?

BACKGROUND: Accelerating the implementation of new technology in healthcare is typically complex and multi-faceted. One strategy is to charge a national agency with the responsibility for facilitating implementation. This study examines the role of such an agency in the English National Health Service. In particular, it compares two different facilitation strategies employed by the agency to support the implementation of insulin pump therapy. METHODS: The research involved an empirical case study of four healthcare organisations receiving different levels of facilitation from the national agency: two received active hands-on facilitation; one was the intended recipient of a more passive, web-based facilitation strategy; the other implemented the technology without any external facilitation. The primary method of data collection was semi-structured qualitative interviews with key individuals involved in implementation. The integrated-PARIHS framework was applied as a conceptual lens to analyse the data. RESULTS: The two sites that received active facilitation from an Implementation Manager in the national agency made positive progress in implementing the technology. In both sites there was a high level of initial receptiveness to implementation. This was similar to a site that had successfully introduced insulin pump therapy without facilitation support from the national agency. By contrast, a site that did not have direct contact with the national agency made little progress with implementation, despite the availability of a web-based implementation resource. Clinicians expressed differences of opinion around the value and effectiveness of the technology and contextual barriers related to funding for implementation persisted. The national agency's intended roll out strategy using passive web-based facilitation appeared to have little impact. CONCLUSIONS: When favourable conditions exist, in terms of agreement around the value of the technology, clinician receptiveness and motivation to change, active facilitation via an external agency can help to structure the implementation process and address contextual barriers. Passive facilitation using web-based implementation resources appears less effective. Moving from initial implementation to wider scale-up presents challenges and is an issue that warrants further attention.

Moving low value care lists into action: prioritizing candidate health technologies for reassessment using administrative data.

BACKGROUND: Active management of existing health technologies (e.g., devices, diagnostic, and/or medical procedures) to ensure the delivery of high value care is increasingly recognized around the world. A number of initiatives have raised awareness of technologies that may be overused, mis-used, or potentially harmful by compiling them into lists of low value care. However, despite the growing number of lists, changes to local healthcare practices remain challenging for many systems. The objective of this study was to develop and implement a process, leveraging existing initiatives and data assets, to produce a list of prioritized low value technologies for health technology reassessment (HTR). METHODS: An expert advisory committee comprised of clinical experts and health system decision-makers was convened to determine key process requirements. Once developed, the process was piloted to assess feasibility in the Canadian province of British Columbia (BC). RESULTS: The expert advisory committee identified five required attributes for the process: data-driven, routine and replicable, actionable, stakeholder collaboration, and high return on investment. Guided by these attributes, a 5-step process was developed. First, over 1300 published low value technologies (i.e., from the National Institute for Health and Care Excellence [NICE] "do not do" recommendations, low value technologies in the Australian Medical Benefits Schedule, and Choosing Wisely "Top 5" lists) were identified. Using appropriate coding systems for BC's administrative health data (e.g., International Classification of Diseases [ICD]), the low value technologies were queried to examine frequencies and costs of technology use. This information was used to rank potential candidates for reassessment based on high annual budgetary impact. Lastly, clinical experts reviewed the ranked technologies prior to broad dissemination and stakeholder action. Pilot testing of the process in BC resulted in the prioritization of 9 initial candidate technologies for reassessment. CONCLUSIONS: This is the first account of a systematic approach to move a collective body of low value technology recommendations into action in a healthcare setting. This work demonstrates the feasibility and strength of using administrative data to identify and prioritize low value technologies for HTR at a population-level.

What maximizes the effectiveness and implementation of technology-based interventions to support healthcare professional practice? A systematic literature review.

BACKGROUND: Technological support may be crucial in optimizing healthcare professional practice and improving patient outcomes. A focus on electronic health records has left other technological supports relatively neglected. Additionally, there has been no comparison between different types of technology-based interventions, and the importance of delivery setting on the implementation of technology-based interventions to change professional practice. Consequently, there is a need to synthesise and examine intervention characteristics using a methodology suited to identifying important features of effective interventions, and the barriers and facilitators to implementation. Three aims were addressed: to identify interventions with a technological component that are successful at changing professional practice, to determine if and how such interventions are theory-based, and to examine barriers and facilitators to successful implementation. METHODS: A literature review informed by realist review methods was conducted involving a systematic search of studies reporting either: (1) behavior change interventions that included technology to support professional practice change; or (2) barriers and facilitators to implementation of technological interventions. Extracted data was quantitative and qualitative, and included setting, target professionals, and use of Behaviour Change Techniques (BCTs). The primary outcome was a change in professional practice. A thematic analysis was conducted on studies reporting barriers and facilitators of implementation. RESULTS: Sixty-nine studies met the inclusion criteria; 48 (27 randomized controlled trials) reported behavior change interventions and 21 reported practicalities of implementation. The most successful technological intervention was decision support providing healthcare professionals with knowledge and/or person-specific information to assist with patient management. Successful technologies were more likely to operationalise BCTs, particularly "instruction on how to perform the behavior". Facilitators of implementation included aligning studies with organisational initiatives, ensuring senior peer endorsement, and integration into clinical workload. Barriers included organisational challenges, and design, content and technical issues of technology-based interventions. CONCLUSIONS: Technological interventions must focus on providing decision support for clinical practice using recognized behavior change techniques. Interventions must consider organizational context, clinical workload, and have clearly defined benefits for improving practice and patient outcomes.

Medicine and technology. Remarks on the notion of responsibility in the technology-assisted health care.

The introduction of the modern diagnostic and therapeutic procedures to the medical practice provided a new challenge for the medicine. The art of medicine, with its default purpose of acting for the benefit of health, is therefore required to derive from technological progress effectively and rationally. As a result, the medical ethics has been engaged with the rules of economy and management of deficit medical procedures as well as their rational and fair distribution. The above suggests, that medics, given these recourses, should approach each patient with a consideration to their therapeutic rights. However, the physicians cannot just concentrate on the good of one particular patient, but must take into account joint responsibility for the good of a potential patient. This makes medical ethical dilemmas similar to the ethical issues of business. The notion of responsibility is the key for discriminating these two kinds of ethics.

Use of Simulation-Based Training to Aid in Implementing Complex Health Technology.

Clinicians are adult learners in a complex environment that historically does not invest in training in a way that is conducive to these types of learners. Adult learners are independent, self-directed, and goal oriented. In today's fast-paced clinical setting, a practical need exists for nurses and clinicians to master the technology they use on a daily basis, especially as medical devices have become more interconnected and complex. As hospitals look to embrace new technologies, medical device companies must provide clinical end-user training. This should be a required part of the selection process when considering the purchase of any complex medical technology. However, training busy clinicians in a traditional classroom setting can be difficult and costly. A simple, less expensive solution is online simulation training. This interactive training provides a virtual, "hands-on" end-user experience in advance of implementing new equipment. Online simulation training ensures knowledge retention and comprehension and, most importantly, that the training leads to end-user satisfaction and the ability to confidently operate new equipment. A review of the literature revealed that online simulation, coupled with the use of adult learning principles and experiential learning, may enhance the experience of clinical end users.

Early Experience with Technology-Based Eye Care Services (TECS): A Novel Ophthalmologic Telemedicine Initiative.

PURPOSE: The aging population is at risk of common eye diseases, and routine eye examinations are recommended to prevent visual impairment. Unfortunately, patients are less likely to seek care as they age, which may be the result of significant travel and time burdens associated with going to an eye clinic in person. A new method of eye-care delivery that mitigates distance barriers and improves access was developed to improve screening for potentially blinding conditions. We present the quality data from the early experience (first 13 months) of Technology-Based Eye Care Services (TECS), a novel ophthalmologic telemedicine program. DESIGN: With TECS, a trained ophthalmology technician is stationed in a primary care clinic away from the main hospital. The ophthalmology technician follows a detailed protocol that collects information about the patient's eyes. The information then is interpreted remotely. Patients with possible abnormal findings are scheduled for a face-to-face examination in the eye clinic. PARTICIPANTS: Any patient with no known ocular disease who desires a routine eye screening examination is eligible. METHODS: Technology-Based Eye Care Services was established in 5 primary care clinics in Georgia surrounding the Atlanta Veterans Affairs hospital. MAIN OUTCOME MEASURES: Four program operation metrics (patient satisfaction, eyeglass remakes, disease detection, and visit length) and 2 access-to-care metrics (appointment wait time and no-show rate) were tracked. RESULTS: Care was rendered to 2690 patients over the first 13 months of TECS. The program has been met with high patient satisfaction (4.95 of 5). Eyeglass remake rate was 0.59%. Abnormal findings were noted in 36.8% of patients and there was >90% agreement between the TECS reading and the face-to-face findings of the physician. TECS saved both patient (25% less) and physician time (50% less), and access to care substantially improved with 99% of patients seen within 14 days of contacting the eye clinic, with a TECS no-show rate of 5.2%. CONCLUSIONS: The early experience with TECS has been promising. Tele-ophthalmology has the potential to improve operational efficiency, reduce cost, and significantly improve access to care. Although further study is necessary, TECS shows potential to help prevent avoidable vision loss.

Increasing the Capacity of Primary Care Through Enabling Technology.

Primary care is the foundation of effective and high-quality health care. The role of primary care clinicians has expanded to encompass coordination of care across multiple providers and management of more patients with complex conditions. Enabling technology has the potential to expand the capacity for primary care clinicians to provide integrated, accessible care that channels expertise to the patient and brings specialty consultations into the primary care clinic. Furthermore, technology offers opportunities to engage patients in advancing their health through improved communication and enhanced self-management of chronic conditions. This paper describes enabling technologies in four domains (the body, the home, the community, and the primary care clinic) that can support the critical role primary care clinicians play in the health care system. It also identifies challenges to incorporating these technologies into primary care clinics, care processes, and workflow.

The Role of Healthcare Technology Management in Facilitating Medical Device Cybersecurity.

This article discusses the role of healthcare technology management (HTM) in medical device cybersecurity and outlines concepts that are applicable to HTM professionals at a healthcare delivery organization or at an integrated delivery network, regardless of size. It provides direction for HTM professionals who are unfamiliar with the security aspects of managing healthcare technologies but are familiar with standards from The Joint Commission (TJC). It provides a useful set of recommendations, including relevant references for incorporating good security practices into HTM practice. Recommendations for policies, procedures, and processes referencing TJC standards are easily applicable to HTM departments with limited resources and to those with no resource concerns. The authors outline processes from their organization as well as best practices learned through information sharing at AAMI, National Health Information Sharing and Analysis Center (NH-ISAC), and Medical Device Innovation, Safety, and Security Consortium (MDISS) conferences and workshops.

Bringing Medicine to the Digital Age via Hackathons and Beyond.

Health care technology and innovation is a rapidly growing industry with great potential. Hackathons have become an increasingly popular venue for institutions to generate ideas and enthusiasm for innovation. These events can inspire change and eventual improvement in medical systems. However, alongside developers and business-savvy entrepreneurs, the ongoing participation by health care providers and researchers is essential for the careful development, implementation and evaluation of any technological intervention.

Designing Technology to Decrease Pneumonia in Intubated Trauma Patients.

Trauma patients are at increased risk for developing ventilator-associated pneumonia. Sixty adult trauma intensive care unit patients were audited 3 months prepractice change, and 30 were audited postpractice change. Quality improvement interventions included staff education of a redesigned electronic medical record ventilator bundle and chlorhexidine gluconate administration timing practice change. Postpractice change audits revealed 2-hour chlorhexidine gluconate documentation increased from 38.3% to 73.3% and incidence of pneumonia in intubated patients decreased by 62%. Early initiation of chlorhexidine gluconate mouth care utilizing electronic medical record technology may help reduce pneumonia in intubated patients, hospital length of stay, overall health costs, and improve documentation.

Health Technology Assessment in the UK.

In this Review, we discuss the UK's Health Technology Assessment programme, which is 20 years old in 2013. We situate the programme in the context of the UK landscape for evidence-based medicine, including in relation to the National Institute for Health and Care Excellence and as guidance to the National Health Service. We identify features that might be of value to other health systems as they confront the challenges of rapid innovation and rising costs. We use examples of recent studies to show the strengths and weaknesses of the programme.

Improving the contribution of regulatory assessment reports to health technology assessments--a collaboration between the European Medicines Agency and the European network for Health Technology Assessment.

In response to a recommendation from the Pharmaceutical Forum, the European Medicines Agency and the European network for Health Technology Assessment initiated a collaboration with the aim to improve the contribution regulatory assessment reports can make to the assessment of relative effectiveness of medicinal products by health technology assessment bodies. This collaboration on improving European Public Assessment Reports (EPARs) started in February 2010 and was performed over 2 years. As a result, the templates for preparing EPARs were revised to better address the needs of heath technology organizations. The better understanding of information needs was a key outcome of the collaboration. To ascertain whether these template changes led to the inclusion of relevant information, a review of a small set of EPARs for recently approved medicinal products was carried out in parallel by both the European network for Health Technology Assessment and the European Medicines Agency. This report provides an account of this project on improving EPARs, which is part of the ongoing dialogue between regulators and health technology assessment bodies on a European level to support policymaker decisions in the future.