Decentralised clinical trials: ethical opportunities and challenges.

Fuelled by adaptations to clinical trial implementation during the COVID-19 pandemic, decentralised clinical trials are burgeoning. Decentralised clinical trials involve many digital tools to facilitate research without physical contact between research teams and participants at various stages, such as recruitment, enrolment, informed consent, administering study interventions, obtaining patient-reported outcome measures, and safety monitoring. These tools can provide ways of ensuring participants' safety and research integrity, while sometimes reducing participant burden and trial cost. Research sponsors and investigators are interested in expanding the use of decentralised clinical trials. The US Food and Drug Administration and other regulators worldwide have issued guidance on how to implement such adaptations. However, there has been little focus on the distinct ethical challenges these trials pose. In this Health Policy report, which is informed by both traditional research ethics and digital ethics frameworks, we group the related ethical issues under three areas requiring increased ethical vigilance: participants' safety and rights, scientific validity, and ethics oversight. Our aim is to describe these issues, offer practical means of addressing them, and prompt the delineation of ethical standards for decentralised trials.

Early evidence of effectiveness of digital contact tracing for SARS-CoV-2 in Switzerland.

In the wake of the pandemic of coronavirus disease 2019 (COVID-19), contact tracing has become a key element of strategies to control the spread of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). Given the rapid and intense spread of SARS-CoV-2, digital contact tracing has emerged as a potential complementary tool to support containment and mitigation efforts. Early modelling studies highlighted the potential of digital contact tracing to break transmission chains, and Google and Apple subsequently developed the Exposure Notification (EN) framework, making it available to the vast majority of smartphones. A growing number of governments have launched or announced EN-based contact tracing apps, but their effectiveness remains unknown. Here, we report early findings of the digital contact tracing app deployment in Switzerland. We demonstrate proof-of-principle that digital contact tracing reaches exposed contacts, who then test positive for SARS-CoV-2. This indicates that digital contact tracing is an effective complementary tool for controlling the spread of SARS-CoV-2. Continued technical improvement and international compatibility can further increase the efficacy, particularly also across country borders.

Assessing the Governance of Digital Contact Tracing in Response to COVID-19: Results of a Multi-National Study.

This paper describes the results of a multi-country survey of governance approaches for the use of digital contact tracing (DCT) in response to the COVID-19 pandemic. We argue that the countries in our survey represent two distinct models of DCT governance, both of which are flawed. The "data protection model" emphasizes privacy protections at the expense of public health benefit, while the "emergency response model" sacrifices transparency and accountability, prompting concerns about excessive governance surveillance. The ethical and effective use of DCT in the future requires a new governance approach that is better suited to this novel use of mobile phone data to promote public health."

In the shadow of privacy: Overlooked ethical concerns in COVID-19 digital epidemiology.

The COVID-19 pandemic witnessed a surge in the use of health data to combat the public health threat. As a result, the use of digital technologies for epidemic surveillance showed great potential to collect vast volumes of data, and thereby respond more effectively to the healthcare challenges. However, the deployment of these technologies raised legitimate concerns over risks to individual privacy. While the ethical and governance debate focused primarily on these concerns, other relevant issues remained in the shadows. Leveraging examples from the COVID-19 pandemic, this perspective article aims to investigate these overlooked issues and their ethical implications. Accordingly, we explore the problem of the digital divide, the role played by tech companies in the public health domain and their power dynamics with the government and public research sector, and the re-use of personal data, especially in the absence of adequate public involvement. Even if individual privacy is ensured, failure to properly engage with these other issues will result in digital epidemiology tools that undermine equity, fairness, public trust, just distribution of benefits, autonomy, and minimization of group harm. On the contrary, a better understanding of these issues, a broader ethical and data governance approach, and meaningful public engagement will encourage adoption of these technologies and the use of personal data for public health research, thus increasing their power to tackle epidemics.

Revolutionizing Medical Data Sharing Using Advanced Privacy-Enhancing Technologies: Technical, Legal, and Ethical Synthesis.

Multisite medical data sharing is critical in modern clinical practice and medical research. The challenge is to conduct data sharing that preserves individual privacy and data utility. The shortcomings of traditional privacy-enhancing technologies mean that institutions rely upon bespoke data sharing contracts. The lengthy process and administration induced by these contracts increases the inefficiency of data sharing and may disincentivize important clinical treatment and medical research. This paper provides a synthesis between 2 novel advanced privacy-enhancing technologies-homomorphic encryption and secure multiparty computation (defined together as multiparty homomorphic encryption). These privacy-enhancing technologies provide a mathematical guarantee of privacy, with multiparty homomorphic encryption providing a performance advantage over separately using homomorphic encryption or secure multiparty computation. We argue multiparty homomorphic encryption fulfills legal requirements for medical data sharing under the European Union's General Data Protection Regulation which has set a global benchmark for data protection. Specifically, the data processed and shared using multiparty homomorphic encryption can be considered anonymized data. We explain how multiparty homomorphic encryption can reduce the reliance upon customized contractual measures between institutions. The proposed approach can accelerate the pace of medical research while offering additional incentives for health care and research institutes to employ common data interoperability standards.

Digital Contact Tracing Against COVID-19 in Europe: Current Features and Ongoing Developments.

The SARS-CoV-2 pandemic is a public health challenge of unprecedented scale. In the midst of the first wave of the pandemic, governments worldwide introduced digital contact tracing systems as part of a strategy to contain the spread of the virus. In Europe, after intense discussion about privacy-related risks involving policymakers, technology experts, information technology companies, and-albeit to a limited extent-the public at large, technical protocols were created to support the development of privacy-compatible proximity tracing apps. However, as the second wave of SARS-CoV-2 sweeps the continent, digital contact tracing in Europe is evolving in terms of both technological and governance features. To enable policymakers to harness the full potential of digital health tools against SARS-CoV-2, this paper examines the evolution of digital contact tracing in eight European countries. Our study highlights that while privacy and data protection are at the core of contact tracing apps in Europe, countries differ in their technical protocols, and in their capacity to utilize collected data beyond proximity tracing alone. In particular, the most recently released apps tend to offer users more granular information about risk in specific locations, and to collect data about user whereabouts, in order to enhance retrospective contact tracing capacity. These developments signal a shift from a strict interpretation of data minimization and purpose limitation toward a more expansive approach to digital contact tracing in Europe, calling for careful scrutiny and appropriate oversight.

Mobile apps for travel medicine and ethical considerations: A systematic review.

BACKGROUND: The advent of mobile applications for health and medicine will revolutionize travel medicine. Despite their many benefits, such as access to real-time data, mobile apps for travel medicine are accompanied by many ethical issues, including questions about security and privacy. METHODS: A systematic literature review as conducted following PRISMA guidelines. Database screening yielded 1795 results and seven papers satisfied the criteria for inclusion. Through a mix of inductive and deductive data extraction, this systematic review examined both the benefits and challenges, as well as ethical considerations, of mobile apps for travel medicine. RESULTS: Ethical considerations were discussed with varying depth across the included articles, with privacy and data protection mentioned most frequently, highlighting concerns over sensitive information and a lack of guidelines in the digital sphere. Additionally, technical concerns about data quality and bias were predominant issues for researchers and developers alike. Some ethical issues were not discussed at all, including equity, and user involvement. CONCLUSION: This paper highlights the scarcity of discussion around ethical issues. Both researchers and developers need to better integrate ethical reflection at each step of the development and use of health apps. More effective oversight mechanisms and clearer ethical guidance are needed to guide the stakeholders in this endeavour.

Qualitative analysis of visual risk communication on twitter during the Covid-19 pandemic.

BACKGROUND: The Covid-19 pandemic is characterized by uncertainty and constant change, forcing governments and health authorities to ramp up risk communication efforts. Consequently, visuality and social media platforms like Twitter have come to play a vital role in disseminating prevention messages widely. Yet to date, only little is known about what characterizes visual risk communication during the Covid-19 pandemic. To address this gap in the literature, this study's objective was to determine how visual risk communication was used on Twitter to promote the World Health Organisations (WHO) recommended preventative behaviours and how this communication changed over time. METHODS: We sourced Twitter's 500 most retweeted Covid-19 messages for each month from January-October 2020 using Crowdbreaks. For inclusion, tweets had to have visuals, be in English, come from verified accounts, and contain one of the keywords 'covid19', 'coronavirus', 'corona', or 'covid'. Following a retrospective approach, we then performed a qualitative content analysis of the 616 tweets meeting inclusion criteria. RESULTS: Our results show communication dynamics changed over the course of the pandemic. At the start, most retweeted preventative messages came from the media and health and government institutions, but overall, personal accounts with many followers (51.3%) predominated, and their tweets had the highest spread (10.0%, i.e., retweet count divided by followers). Messages used mostly photographs and images were found to be rich with information. 78.1% of Tweets contained 1-2 preventative messages, whereby 'stay home' and 'wear a mask' frequented most. Although more tweets used health loss framing, health gain messages spread more. CONCLUSION: Our findings can inform the didactics of future crisis communication. The results underscore the value of engaging individuals, particularly influencers, as advocates to spread health risk messages and promote solidarity. Further, our findings on the visual characteristic of the most retweeted tweets highlight factors that health and government organisations should consider when creating visual health messages for Twitter. However, that more tweets used the emotive medium of photographs often combined with health loss framing raises concerns about persuasive tactics. More research is needed to understand the implications of framing and its impact on public perceptions and behaviours.

Digital contact-tracing during the Covid-19 pandemic: An analysis of newspaper coverage in Germany, Austria, and Switzerland.

Governments around the globe have started to develop and deploy digital contact tracing apps to gain control over the spread of the novel coronavirus (Covid-19). The appropriateness and usefulness of these technologies as a containment measure have since sparked political and academic discussions globally. The present paper contributes to this debate through an exploration of how the national daily newspapers in Germany, Austria, and Switzerland reported on the development and adoption of digital contact-tracing apps during early and after stages of the lockdown. These countries were among the first in Europe to develop apps and were critical voices in the debate of decentralized vs. centralized data processing. We conducted thematic analysis on news coverage published between January and May 2020 in high-circulation national daily newspapers from Germany, Austria, and Switzerland. A total of 148 articles from nine newspaper companies were included in the final analysis. From our analysis emerged six core themes of the development and adoption of digital contact tracing apps: 1) data governance; 2) role of IT giants; 3) scientific rigor; 4) voluntariness; 5) functional efficacy; 6) role of the app. These results shed light on the different facets of discussion regarding digital contact tracing as portrayed in German-speaking media. This study complements emerging survey data on public perceptions of digital contact tracing apps by providing a better understanding of the ideas circulating in the media ecosystem.

Tracking the debate on COVID-19 surveillance tools

Contact-tracing apps could help keep countries open before a vaccine is available. But do we have a sufficient understanding of their efficacy, and can we balance protecting public health with safeguarding civil rights? We interviewed five experts, with backgrounds in digital health ethics, internet law and social sciences.

Digital tools against COVID-19: taxonomy, ethical challenges, and navigation aid.

Data collection and processing via digital public health technologies are being promoted worldwide by governments and private companies as strategic remedies for mitigating the COVID-19 pandemic and loosening lockdown measures. However, the ethical and legal boundaries of deploying digital tools for disease surveillance and control purposes are unclear, and a rapidly evolving debate has emerged globally around the promises and risks of mobilising digital tools for public health. To help scientists and policy makers to navigate technological and ethical uncertainty, we present a typology of the primary digital public health applications that are in use. These include proximity and contact tracing, symptom monitoring, quarantine control, and flow modelling. For each, we discuss context-specific risks, cross-sectional issues, and ethical concerns. Finally, recognising the need for practical guidance, we propose a navigation aid for policy makers and other decision makers for the ethical development and use of digital public health tools.