Digital Health technologies (DHTs) are IT applications in medicine that focus, among others, on functions of prevention, diagnostics, monitoring and treatment of diseases and other conditions – areas that have been regulated heavily based on past mistakes leading to harm. With the increasing prevalence of such technologies come shifts in roles of physicians, patients, and other stakeholders in healthcare delivery. Increasingly, the level of technological maturity is also moving from systems informing physicians to currently augmenting and potentially replacing physicians – leading to technology-patient interaction without the level of physician supervision that patients are used to. This new reality is met with no to little specific regulation that would ensure relevant ethical principles are upheld – foremost safety & efficacy but also additional ethical needs such as privacy, transparency, and accountability. There has often been a gap between innovative technologies and their regulation – with the latter catching up to the former only after years. In the era of digital health technologies, the pace of innovation has picked up considerably – while it typically takes up to 10-15 years to bring a novel drug to market, digital health interventions - such as in the form of a mobile health app - can be designed and rolled out within months – aggregating the problem of the “regulatory gap”.
Under ideal circumstances, there would be no time gap between availability of a new technology and its appropriate regulation. This dissertation is concerned with providing insights into this gap and potential solutions enabling societies and individuals to benefit from DHTs and avoid their harms. In a series of papers, it first describes the regulatory gap and additional ways to bridge it in the short-term. Second, it attempts to anticipate ethical-regulatory challenges from the emerging metaverse technology of “digital twins” in medicine and thereby permit an early start to developing appropriate regulation in the case of this particular technology. Third, an explorative study along the example of a cardiology machine learning application formulates hypotheses as to the standard required for healthcare provider-patient briefings as an already established safety-related practice in medicine and the last safeguard before the employment of some digital health technologies on a patient.