This introductory chapter briefly outlines the main theme of this volume, namely, to review the new opportunities and risks of digital healthcare from various disciplinary perspectives. These perspectives include law, public policy, organisational studies, and applied ethics. Based on this interdisciplinary approach, we hope that effective strategies may arise to ensure that benefits of this ongoing revolution are deployed in a responsible and sustainable manner. The second part of the chapter comprises a brief review of the four parts and fourteen substantive chapters that make up this volume.

The emergence of Facebook’s suicide prevention algorithm has prompted discussion around whether social media platforms have a role to play in public health surveillance. Concerns have been raised about an entity that is not a public interest health authority collecting and acting on the private health information of its users, particularly sensitive data like an individual’s mental health status. Mental illnesses are still heavily stigmatised, despite continued efforts to normalise these conditions in some regions of the world. Depending on a user’s geographic location, the ramifications of the suicide detection algorithms generating false positives for suicide risk could have severe consequences. The present chapter continues this discourse by examining the ethical implications of Facebook’s suicide prevention algorithm from the privacy, legal, and cultural perspectives.

The use of digital technologies in healthcare is changing how medical treatments are developed by researchers, delivered by medical professionals and experienced by patients. This chapter argues that a defining feature of this disruption is the emergence of medical apps that leverage algorithm-based AI systems. As the use of such apps and AI wearables goes mainstream and new players – notably ‘Super Platforms’ with digital rather than medical expertise – enter the healthcare sector, traditional medical services will be transformed.

These developments pose several challenges for regulators and policymakers, most obviously in terms of privacy and data protection. Here, we examine how the emerging field of Legal Design can provide a more transparent infrastructure that embeds relevant legal protections in the user interfaces of healthcare products and services. A Privacy-by-Design approach focused on the user interface (UI) offers several advantages, most obviously greater transparency, accountability and human choice. The chapter offers real-world examples of design patterns that illustrate the value of UI-focused Privacy-by-Design in protecting sensitive information, enabling people to retain control of their personal data. The chapter concludes with some examples and reflects on the challenges in implementing Legal Design in an eHealth context.

The rules on de-identification and research exemptions in the GDPR help companies to use personal data for scientific research with fewer restrictions compared to data collections for other purposes. Under these exemptions, companies in the EU might collect and process data for a secondary purpose without consent. However, the requirements and exemptions for scientific research vary among EU Member States, which might result in forum shopping. They might also hinder the review of the input data in medical devices since the new regulations on medical devices in the EU (Regulations 2017/745 and 2017/746) require compliance with the GDPR. These combined implications might result in safety risks. Focusing on the research exemption and de-identification rules of the GDPR in a medical device setting, the authors discuss to what extent scientific research with public interest should benefit from the research exemption of the GDPR. Harmonized rules would also be necessary on the expected level of de-identification, to balance the data subjects’ rights and safety of medical devices. This chapter will examine how the input data is reviewed by medical device authorities and notified bodies in the EU and how this may affect the US, following recently released guidelines and discussion papers.