Enabling Responsible Digital Health Innovation: From Ethical Principles To Innovation And Regulation Practice

Abstract

Digitalization is disrupting the very nature of how people live and how societies operate. While this has led to major gains in welfare and productivity over the last 20 years, digital technologies also raise novel ethical and societal challenges. The importance of these challenges is aggravated by the fact that quickly emerging technologies, in particular artificial intelligence, are hard to predict and thus regulate. In healthcare, one of the ethically most sensitive and regulated sectors of societal life, digitalization is changing how health is conceived of, protected, and managed. Digital health, a broad category encompassing the application of digital technologies across the entire range of healthcare activities, also raises novel ethical issues. In response, ethical frameworks have been formulated and novel regulatory approaches are emerging to enable responsible digital health innovation and ultimately deliver equitable and societally beneficial progress. This thesis seeks to further theoretical and practical understanding of how ethical principles can be translated into innovation and governance practices to attain responsible digital health innovation. As such, it aims to enable multi-directional ethical translation: it furthers research in ethics, policy, and legislation, as well as innovation science by offering the hard-to-access understanding of stakeholders’ practical perspectives on digital health innovation. These insights, in turn, enable the ethical translation of principles into responsible innovation and regulation practices. To attain this, this thesis is split into three sections that each follow a distinct research focus: in section I, literature reviews and case study methodologies help identify and contextualize the main ethical values in dynamic digital health fields, understand the role and responsibilities of core stakeholders, and assess the start-of-the-art of digital health technology. The thesis’ main contributions then consist of utilizing stakeholder engagement methods to a) reveal major stakeholders’ insights on impediments to responsible digital health in Section II, and b) present and develop innovation and regulation practices to further responsible digital health in Section III. Section III further translates these insights into concrete recommendations for Switzerland. Given this thesis’ aim to enhance research, practice, and policy, it delivers a multitude of outputs; while expanding the academic body of knowledge through publications, this thesis also translates its findings into actionable recommendations and ethics guidelines for practitioners and presents the draft for a digital health governance roadmap for Switzerland.