scholarly journals The Ethics of Emergent Health Technologies: Implications of the 21st Century Cures Act for Nursing

2020 ◽  
Vol 21 (4) ◽  
pp. 195-201
Author(s):  
Margaret Martin
Keyword(s):  
21St Century ◽  
Digital Health ◽  
Public Awareness ◽  
Health Technology ◽  
The United States ◽  
Practice Research ◽  
Health Technologies ◽  
Ethical Implications ◽  
Systems Research ◽  
21St Century Cures Act

The 21st Century Cures Act, passed in December 2016 by the United States Congress, is a public law aimed at accelerating the time it takes to get pharmaceutical drugs and medical devices into the market, in addition to shifting connected review processes from randomized controlled trials to real-world efficacy tests. As of December 2019, efforts are underway to introduce a “Cures Act 2.0” bill, with particular attention to the implementation of digital health within health systems. Research on the development of emergent health technologies is nascent; research examining health technology implications of 21st Century Cures Act for the health care workforce is nonexistent. This article fills a crucial gap in public awareness, discussing ethical implications of the 21st Century Cures Act and centering nursing. Nursing is a profession frequently acknowledged as practicing on “the front lines of care” and frequently responsible for the trialing of products in clinical settings. The article summarizes and evaluates key components of the 21st Century Cures Act related to health technology development. Discrete health technologies addressed are (a) breakthrough devices, (b) digital health software, and (c) combination products. It then connects these provisions to ethical considerations for nursing practice, research, and policy. The article concludes by discussing the relevance of emerging digital health technologies to the crafting of a “Cures 2.0” bill, with particular attention to this moment in light of digital care precedents set during the COVID-19 pandemic.

Six Digital Health Technologies That Will Transform Diabetes

2021 ◽  
pp. 193229682110434
Author(s):  
Alexander N. Klonoff ◽  
Wei-An (Andy) Lee ◽  
Nicole Y. Xu ◽  
Kevin T. Nguyen ◽  
Ashley DuBord ◽  
...  
Keyword(s):  
Diabetes Care ◽  
Digital Health ◽  
Health Technology ◽  
The United States ◽  
Digital Data ◽  
Sensor Data ◽  
Communication Tools ◽  
Health Technologies ◽  
The People ◽  
Key Questions

The digital health revolution is transforming the landscape of medicine through innovations in sensor data, software, and wireless communication tools. As one of the most prevalent chronic diseases in the United States, diabetes is particularly impactful as a model disease for which to apply innovation. As with any other newly developed technologies, there are three key questions to consider: 1) How can the technology benefit people with diabetes?, 2) What barriers must be overcome to further advance the technology?, and 3) How will the technology be applied in the future?. In this article, we highlight six areas of innovation that have the potential to reduce the burden of diabetes for individuals living with the condition and their families as well as provide measurable benefits for all stakeholders involved in diabetes care. The six technologies which have the potential to transform diabetes care are (i) telehealth, (ii) incorporation of diabetes digital data into the electronic health record, (iii) qualitative hypoglycemia alarms, (iv) artificial intelligence, (v) cybersecurity of diabetes devices, and (vi) diabetes registries. To be successful, a new digital health technology must be accessible and affordable. Furthermore, the people and communities that would most likely benefit from the technology must be willing to use the innovation in their management of diabetes.

scholarly journals The 21st Century Cures Act: A Competitive Apps Market and the Risk of Innovation Blocking

10.2196/24824 ◽  
2020 ◽  
Vol 22 (12) ◽  
pp. e24824
Author(s):  
William J Gordon ◽  
Kenneth D Mandl
Keyword(s):  
21St Century ◽  
Health Care Organizations ◽  
The United States ◽  
Business Practices ◽  
Hospital System ◽  
Final Rule ◽  
Application Programming ◽  
Innovation Blocking ◽  
Programming Interfaces ◽  
21St Century Cures Act

The 21st Century Cures Act and the recently published “final rule” define standardized methods for obtaining electronic copies of electronic health record (EHR) data through application programming interfaces. The rule is meant to create an ecosystem of reusable, substitutable apps that can be built once but run at any hospital system “without special effort.” Yet, despite numerous provisions around information blocking in the final rule, there is concern that the business practices that govern EHR vendors and health care organizations in the United States could still stifle innovation. We describe potential app ecosystems that may form. We caution that misaligned incentives may result in anticompetitive behavior and purposefully limited functionality. Closed proprietary ecosystems may result, limiting the value derived from interoperability. The 21st Century Cures Act and final rule are an exciting step in the direction of improved interoperability. However, realizing the vision of a truly interoperable app ecosystem is not predetermined.

OP348 Assessing The Potential Value Of Wearable Digital Health Technologies In Chronic Kidney Disease Using Early Health Technology Assessment Methods

2021 ◽  
Vol 37 (S1) ◽  
pp. 15-16
Author(s):  
Vijay S. Gc ◽  
Andrea Manca ◽  
Alexander J. Casson ◽  
Steven Antrobus ◽  
Cynthia Iglesias
Keyword(s):  
Blood Pressure ◽  
Chronic Kidney Disease ◽  
Digital Health ◽  
Qualitative Interviews ◽  
Cost Effective ◽  
Health Technology ◽  
Self Management ◽  
Health Technologies ◽  
Early Health Technology Assessment ◽  
Early Health

IntroductionWearable digital health technologies (WDHTs) offer several solutions in terms of disease monitoring, management and delivery of specific interventions. In chronic conditions, WDHTs can be used to support individuals’ self-management efforts, potentially improving adherence to (and outcomes resulting from) interventions. Early health technology assessment (HTA) methods can inform considerations about the potential clinical and economic benefits of technology in the initial phases of the product's lifecycle, facilitating identification of those Research & Development (R&D) investments with the greatest potential stakeholders’ payoff. We report our experience of using early HTA methods to support R&D decisions relating to novel WDHT being designed to support self-management of chronic kidney disease (CKD).MethodsWe performed a literature review, focus-group interviews with patients, and qualitative interviews with the prototype development team to understand the relevant characteristics of WDHTs, quantify relevant clinical indications and existing technological constraints. An early economic evaluation was used to identify the key drivers of value for money, and a discrete choice experiment shed light onto patient preferences towards what key features the WDHT should have for the users to adopt it. Then a model-based cost-effectiveness analysis was undertaken incorporating headroom analysis, return on investment, one-way sensitivity analysis and scenario analyses using data from secondary sources.ResultsThe review of the literature, focus groups with CKD patients, and qualitative interviews with technology developers helped to understand relevant characteristics of WDHT and user preferences helped inform the next R&D iteration. Compared to the standard care, WDHT that support stage ≥3 CKD patients self-management at home by measuring blood pressure and monitor mobility has the potential to be cost-effective at conventional cost-effectiveness threshold levels. From the headroom analysis, novel WDHT can be priced up to GBP280 (EUR315, USD360) and still be cost-effective compared to standard home blood pressure monitoring.ConclusionsOur study provides valuable information for the further development of the WDHT, such as defining a go/no-go decision, as well as providing a template for performing early HTA of Digital Health Interventions.

scholarly journals The Digital Health Revolution and People with Disabilities: Perspective from the United States

2020 ◽  
Vol 17 (2) ◽  
pp. 381 ◽  
Author(s):  
Mike Jones ◽  
Frank DeRuyter ◽  
John Morris
Keyword(s):  
United States ◽  
Mobile Health ◽  
Chronic Conditions ◽  
Digital Health ◽  
Wearable Sensors ◽  
Healthcare Delivery ◽  
People With Disabilities ◽  
The United States ◽  
Models Of Care ◽  
Health Technologies

This article serves as the introduction to this special issue on Mobile Health and Mobile Rehabilitation for People with Disabilities. Social, technological and policy trends are reviewed. Needs, opportunities and challenges for the emerging fields of mobile health (mHealth, aka eHealth) and mobile rehabilitation (mRehab) are discussed. Healthcare in the United States (U.S.) is at a critical juncture characterized by: (1) a growing need for healthcare and rehabilitation services; (2) maturing technological capabilities to support more effective and efficient health services; (3) evolving public policies designed, by turns, to contain cost and support new models of care; and (4) a growing need to ensure acceptance and usability of new health technologies by people with disabilities and chronic conditions, clinicians and health delivery systems. Discussion of demographic and population health data, healthcare service delivery and a public policy primarily focuses on the U.S. However, trends identified (aging populations, growing prevalence of chronic conditions and disability, labor shortages in healthcare) apply to most countries with advanced economies and others. Furthermore, technologies that enable mRehab (wearable sensors, in-home environmental monitors, cloud computing, artificial intelligence) transcend national boundaries. Remote and mobile healthcare delivery is needed and inevitable. Proactive engagement is critical to ensure acceptance and effectiveness for all stakeholders.

scholarly journals A new hope for early psychosis care: the evolving landscape of digital care tools

2019 ◽  
Vol 214 (5) ◽  
pp. 269-272 ◽  
Author(s):  
John Torous ◽  
Jessica Woodyatt ◽  
Matcheri Keshavan ◽  
Laura M. Tully
Keyword(s):  
Predictive Models ◽  
Global Mental Health ◽  
Digital Health ◽  
Treatment Options ◽  
Health Technology ◽  
Early Interventions ◽  
Clinical Heterogeneity ◽  
Health Technologies ◽  
Early Course ◽  
Advance Care

SummaryImproving understanding of and outcomes for early-course psychosis (ECP) is a recognised global mental health priority. We argue digital health technologies can advance care for ECP by better accounting for clinical heterogeneity, offering better predictive models, increasing access to early interventions and enhancing existing treatment options.Declaration of interestL.M.T. owns shares in Safari Health Inc – a digital health technology company.

scholarly journals Exploring digital health care: eHealth, mHealth, and librarian opportunities

2021 ◽  
Vol 109 (3) ◽  
Author(s):  
Janet Chan
Keyword(s):  
Health Care ◽  
Health Literacy ◽  
Health Information ◽  
Digital Health ◽  
The United States ◽  
Security And Privacy ◽  
Care Providers ◽  
Vast Number ◽  
Health Technologies ◽  
Technology Advances

Technology advances in eHealth and mHealth are changing the way that health care consumers and providers communicate, receive and deliver care, and access health information. As electronic health records and smartphones have become ubiquitous in the United States, opportunities and applications for the integration of eHealth and mHealth have increased. In addition to technology advances, the changing health care model is simultaneously adapting to and driving initiatives in digital health care. With these digital initiatives have come challenges, including data overload, security and privacy concerns, deficits in technological and health literacy skills, and sorting through the vast number of choices of digital applications. Navigating this changing landscape can be overwhelming and time consuming for both health care providers and consumers. Librarians are uniquely positioned to assist providers and consumers to break down barriers within the digital health care landscape through data management initiatives, technology and health literacy instruction, and finding and evaluating health information and digital health technologies.

scholarly journals Academia–industry digital health collaborations: A cross-cultural analysis of barriers and facilitators

2019 ◽  
Vol 5 ◽  
pp. 205520761987862 ◽  
Author(s):  
Chelsea Liu ◽  
Shuai Shao ◽  
Chang Liu ◽  
Gary G. Bennett ◽  
Janet Prvu Bettger ◽  
...  
Keyword(s):  
Digital Health ◽  
The United States ◽  
Cultural Analysis ◽  
High Income ◽  
Barriers And Facilitators ◽  
Communication Styles ◽  
Middle Income ◽  
Business Outcomes ◽  
Health Technologies ◽  
Middle Income Countries

Background Development and uptake of digital health technologies benefit from cross-sectoral efforts from academia and industry. Our study aims to identify the barriers and facilitators associated with academia–industry collaborations in digital health in middle- and high-income countries. Methods Trained personnel conducted semi-structured interviews with 23 stakeholders who were active in industry, academia or both. Stakeholders were based in middle-income countries (including China) and high-income countries (including the United States) as defined by the World Bank. Interviews were conducted in the stakeholder’s language of choice (Chinese, n = 12; English, n = 11). Qualitative interview questions elicited perspectives on stakeholders’ experience with academia–industry collaboration, challenges faced, and factors that facilitated the process. Interviews were audiotaped, transcribed verbatim, thematically coded by bilingual coders and analyzed using inductive content analysis. Results Stakeholders in both academia and industry identified complementary roles, authentic communication between partners, and clearly outlined goals or expectations prior to the collaboration as primary facilitators for success. Misaligned goals or expectations, differences in timelines for productivity and difficulties balancing expectations for business outcomes versus generation of scientific evidence were identified as primary barriers. Stakeholders in high-income countries reported inauthentic communication as a significant barrier to collaboration, whereas those in middle-income countries did not. Conclusion Outlining and communicating openly about goals and expectations for timeline and priorities as well as establishing complementary roles will facilitate fruitful academia–industry collaborations in the future. Best practices for communication styles may be dependent on the cultural setting, and thus should be adopted accordingly.

Understanding Decision Making in the Adoption of Digital Health Technology: The Role of Behavioural Economics’ Prospect Theory (Preprint)

2021 ◽  
Author(s):  
Waqas Ullah Khan ◽  
Aviv Shachak ◽  
Emily Seto
Keyword(s):  
Decision Making ◽  
Prospect Theory ◽  
Digital Health ◽  
Health Technology ◽  
Behavioural Economics ◽  
Individual Level ◽  
Health Technologies ◽  
Research Article ◽  
The Individual

UNSTRUCTURED The decision to accept or reject new digital health technologies remains an ongoing discussion. Over the past few decades, interest in understanding the choice to adopt technology has led to the development of numerous theories and models. In 1979, however, psychologists Kahneman and Tversky published their seminal research article that has pioneered the field of behavioural economics. They named their model the “prospect theory” and used it to explain decision making behaviours under conditions of risk and uncertainty as well as to provide an understanding of why individuals may make irrational or inconsistent decisions. Although the prospect theory has been used to explain decision making in economics, law, political science, and clinically at the individual level, its application to understanding choice in the adoption of digital health technology has not been explored.

Computer incursion in psychiatry via e-mental health: Innovation and implications to keep in mind

2020 ◽  
pp. 33-44
Author(s):  
Sally Hardy ◽  
Fabian Van Essen ◽  
Luca Pingani
Keyword(s):  
Mental Health ◽  
Digital Health ◽  
Evidence Base ◽  
Outcome Data ◽  
Mental Wellbeing ◽  
Discussion Paper ◽  
Health Technologies ◽  
Ethical Implications ◽  
Published Evidence ◽  
The Subject

The digital health technologies have gained dramatic levels of interest and offer potential for self-managed, at scale, cost effective e-mental health. In this discussion paper, we aim to outline some of the contemporary issues arising from the computer's incursion in the field of psychiatry, as the global demand for improved mental wellbeing advances. The authors bring their personal reflections and areas of interest on the subject of e-mental health, taking into consideration both potential pitfalls and therapeutic possibilities. The paper outlines as an introduction what is meant by e-mental health and explores how it is being utilized in areas such as depression, anxiety management, alongside emergent outcome data on, for example, rates of admissions to hospital, as an initial measure of e-mental health's success. Having undertaken a review of the published evidence from the past five years, it can be seen how the subject is gaining attention, yet results are as yet limited to small numbers, and thus there is a limited evidence base. However, we also consider the implications for inclusion, through the application of e-health strategies for people living with additional neurological aspects such as intellectual disabilities, which as a population tends to limit uptake and exposure to online digital activity to date. We conclude with consideration of two critical questions on how to monitor, evaluate and regulate e-mental health activities, plus the ethical implications of e-exposure.

Inequities in Healthcare Services caused by the Adoption of Digital Health Technologies: A Systematic Review (Preprint)

2021 ◽  
Author(s):  
Rui Yao ◽  
Wenli Zhang ◽  
Richard Evans ◽  
Guang Cao ◽  
Lining Shen
Keyword(s):  
Systematic Review ◽  
Influencing Factors ◽  
Digital Health ◽  
Health Inequities ◽  
Healthcare Services ◽  
The United States ◽  
Future Research ◽  
Unequal Distribution ◽  
Health Technologies ◽  
Starting Point

BACKGROUND Digital health technologies are rapidly adapting to healthcare contexts to provide improved medical services to citizens. However, contrary to expectations, their rapid adoption appears to have led to health inequities. OBJECTIVE The aim of this study is to systematically review the inequities of healthcare services brought about by the adoption of digital health technologies. The influencing factors of inequities, as well as corresponding countermeasures to ensure the health equity between different groups of citizens, is also studied. METHODS A systematic review of literature published from 1990 to 2020 was completed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) review process, and the electronic databases of Web of Science Core Collection, PubMed, and Scopus. Search, sorting, and data extraction processes were completed by two authors of the paper using Thomson Endnote. RESULTS In total, 1,895 studies were collected during the search process, of which 40 were identified for analysis. The earliest literature identified was published in 1993, with the number remaining below 2 for a long period of time. The number started to increase until 2016, with a peak thereafter being reached in 2020. The United States, the United Kingdom, and Norway ranked as the top three in terms of publication output. Health inequities caused by digital health technologies were mainly reflected by access and availability of digital technologies and the differences in healthcare outcomes. The factors that influenced inequities included: demographic factors (i.e., gender, age, race, region, economy, and education level), health conditions, and eHealth literacy. Finally, government agencies and medical institutions, digital health technology providers, and healthcare service receivers can all take actions to alleviate inequities, in future. CONCLUSIONS Findings provide a comprehensive starting point for future research allowing for further investigation into how digital health technologies may influence the unequal distribution of healthcare services. The interaction between individual subjective factors, as well as social support, and influencing factors should be included in future studies. In particular, access and availability to digital health technologies by vulnerable groups should be of paramount importance.

Sign in / Sign up

Export Citation Format

Share Document