Sync fast and solve things-best practices for responsible digital health.

Digital health innovation is expected to transform healthcare, but it also generates ethical and societal concerns, such as privacy risks, and biases that can compound existing health inequalities. While such concerns are widely recognized, existing regulatory principles, oversight methods and ethical frameworks seem out of sync with digital health innovation. New governance and innovation best practices are thus needed to bring such principles to bear with the reality of business, innovation, and regulation.To grant practical insight into best practices for responsible digital health innovation, we conducted a qualitative study based on an interactive engagement methodology. We engaged key stakeholders (n = 46) operating at the translational frontier of digital health. This approach allowed us to identify three clusters of governance and innovation best practices in digital health innovation: i) inclusive co-creation, ii) responsive regulation, and iii) value-driven innovation. Our study shows that realizing responsible digital health requires diverse stakeholders' commitment to adapt innovation and regulation practices, embracing co-creation as the default modus operandi for digital health development. We describe these collaborative practices and show how they can ensure that innovation is neither slowed by overregulation, nor leads to unethical outcomes.

Talking Ethics Early in Health Data Public Private Partnerships.

Data access and data sharing are vital to advance medicine. A growing number of public private partnerships are set up to facilitate data access and sharing, as private and public actors possess highly complementary health data sets and treatment development resources. However, the priorities and incentives of public and private organizations are frequently in conflict. This has complicated partnerships and sparked public concerns around ethical issues such as trust, justice or privacy-in turn raising an important problem in business and data ethics: how can ethical theory inform the practice of public and private partners to mitigate misaligned incentives, and ensure that they can deliver societally beneficial innovation? In this paper, we report on the development of the Swiss Personalized Health Network's ethical guidelines for health data sharing in public private partnerships. We describe the process of identifying ethical issues and engaging core stakeholders to incorporate their practical reality on these issues. Our report highlights core ethical issues in health data public private partnerships and provides strategies for how to overcome these in the Swiss health data context. By agreeing on and formalizing ethical principles and practices at the beginning of a partnership, partners and society can benefit from a relationship built around a mutual commitment to ethical principles. We present this summary in the hope that it will contribute to the global data sharing dialogue.

Stuck in translation: Stakeholder perspectives on impediments to responsible digital health.

Spurred by recent advances in machine learning and electronic hardware, digital health promises to profoundly transform medicine. At the same time, however, it raises conspicuous ethical and regulatory issues. This has led to a growing number of calls for responsible digital health. Based on stakeholder engagement methods, this paper sets out to identify core impediments hindering responsible digital health in Switzerland. We developed a participatory research methodology to access stakeholders' fragmented knowledge of digital health, engaging 46 digital health stakeholders over a period of five months (December 2020-April 2021). We identified ineffective stakeholder collaboration, lack of ethical awareness among digital health innovators, and lack of relevant regulation as core impediments to responsible digital health. The stakeholders' accounts indicate that ethical concerns may considerably slow the pace of digital health innovation - implying that responsible innovation is a core catalyst for the progress of digital health overall.

Beyond high hopes: A scoping review of the 2019-2021 scientific discourse on machine learning in medical imaging.

Machine learning has become a key driver of the digital health revolution. That comes with a fair share of high hopes and hype. We conducted a scoping review on machine learning in medical imaging, providing a comprehensive outlook of the field's potential, limitations, and future directions. Most reported strengths and promises included: improved (a) analytic power, (b) efficiency (c) decision making, and (d) equity. Most reported challenges included: (a) structural barriers and imaging heterogeneity, (b) scarcity of well-annotated, representative and interconnected imaging datasets (c) validity and performance limitations, including bias and equity issues, and (d) the still missing clinical integration. The boundaries between strengths and challenges, with cross-cutting ethical and regulatory implications, remain blurred. The literature emphasizes explainability and trustworthiness, with a largely missing discussion about the specific technical and regulatory challenges surrounding these concepts. Future trends are expected to shift towards multi-source models, combining imaging with an array of other data, in a more open access, and explainable manner.

Digital Mental Health for Young People: A Scoping Review of Ethical Promises and Challenges.

Mental health disorders are complex disorders of the nervous system characterized by a behavioral or mental pattern that causes significant distress or impairment of personal functioning. Mental illness is of particular concern for younger people. The WHO estimates that around 20% of the world's children and adolescents have a mental health condition, a rate that is almost double compared to the general population. One approach toward mitigating the medical and socio-economic effects of mental health disorders is leveraging the power of digital health technology to deploy assistive, preventative, and therapeutic solutions for people in need. We define "digital mental health" as any application of digital health technology for mental health assessment, support, prevention, and treatment. However, there is only limited evidence that digital mental health tools can be successfully implemented in clinical settings. Authors have pointed to a lack of technical and medical standards for digital mental health apps, personalized neurotechnology, and assistive cognitive technology as a possible cause of suboptimal adoption and implementation in the clinical setting. Further, ethical concerns have been raised related to insufficient effectiveness, lack of adequate clinical validation, and user-centered design as well as data privacy vulnerabilities of current digital mental health products. The aim of this paper is to report on a scoping review we conducted to capture and synthesize the growing literature on the promises and ethical challenges of digital mental health for young people aged 0-25. This review seeks to survey the scope and focus of the relevant literature, identify major benefits and opportunities of ethical significance (e.g., reducing suffering and improving well-being), and provide a comprehensive mapping of the emerging ethical challenges. Our findings provide a comprehensive synthesis of the current literature and offer a detailed informative basis for any stakeholder involved in the development, deployment, and management of ethically-aligned digital mental health solutions for young people.