Recent attempts to develop and apply digital ethics principles to address the challenges of the digital transformation leave organisations with an operationalisation gap. To successfully implement such guidance, they must find ways to translate high-level ethics frameworks into practical methods and tools that match their specific workflows and needs. Here, we describe the development of a standardised risk assessment tool, the Principle-at-Risk Analysis (PaRA), as a means to close this operationalisation gap for a key level of the ethics infrastructure at (...) many organisations – the work of an interdisciplinary ethics panel. The PaRA tool serves to guide and harmonise the work of the Digital Ethics Advisory Panel at the multinational science and technology company Merck KGaA in alignment with the principles outlined in the company’s Code of Digital Ethics. We examine how such a tool can be used as part of a multifaceted approach to operationalise high-level principles at an organisational level and provide general requirements for its implementation. We showcase its application in an example case dealing with the comprehensibility of consent forms in a data-sharing context at Syntropy, a collaborative technology platform for clinical research. (shrink)

Background The principles of dynamic consent are based on the idea of safeguarding the autonomy of individuals by providing them with personalized options to choose from regarding the sharing and utilization of personal health data. To facilitate the widespread introduction of dynamic consent concepts in practice, individuals must perceive these procedures as useful and easy to use. This study examines the user experience of a dynamic consent-based application, in particular focusing on personalized options, and explores whether this approach may be (...) useful in terms of ensuring the autonomy of data subjects in personal health data usage. Methods This study investigated the user experience of MyHealthHub, a dynamic consent-based application, among adults aged 18 years or older living in South Korea. Eight tasks exploring the primary aspects of dynamic consent principles–including providing consent, monitoring consent history, and managing personalized options were provided to participants. Feedback on the experiences of testing MyHealthHub was gathered via multiple-choice and open-ended questionnaire items. Results A total of 30 participants provided dynamic consent through the MyHealthHub application. Most participants successfully completed all the provided tasks without assistance and regarded the personalized options favourably. Concerns about the security and reliability of the digital-based consent system were raised, in contrast to positive responses elicited in other aspects, such as perceived usefulness and ease of use. Conclusions Dynamic consent is an ethically advantageous approach for the sharing and utilization of personal health data. Personalized options have the potential to serve as pragmatic safeguards for the autonomy of individuals in the sharing and utilization of personal health data. Incorporating the principles of dynamic consent into real-world scenarios requires remaining issues, such as the need for powerful authentication mechanisms that bolster privacy and security, to be addressed. This would enhance the trustworthiness of dynamic consent-based applications while preserving their ethical advantages. (shrink)