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Background: The evolution of eHealth development has shifted from standalone tools to comprehensive digital health environments, fostering data exchange among diverse stakeholders and systems. Nevertheless, existing research and implementation frameworks have primarily emphasized technological and organizational aspects of eHealth implementation, overlooking the intricate legal, ethical, and financial considerations. It is essential to discover what legal, ethical, financial, and technological challenges should be considered to ensure successful and sustainable implementation of eHealth. Objective: This review aims to provide insights into barriers and facilitators of legal, ethical, financial, and technological aspects for successful implementation of complex eHealth technologies, which impacts multiple levels and multiple stakeholders. Methods: A scoping review was conducted by querying PubMed, Scopus, Web of Science, and ACM Digital Library (2018-2023) for studies describing the implementation process of eHealth technologies that facilitate data exchange. Studies solely reporting clinical outcomes or conducted outside Europe were excluded. Two independent reviewers selected the studies. A conceptual framework was constructed through axial and inductive coding, extracting data from literature on legal, ethical, financial, and technological aspects of eHealth implementation. This framework guided systematic extraction and interpretation. Results: The search resulted in 7.308 studies that were screened for eligibility, of which 35 (0.48%) were included. Legal barriers revolve around data confidentiality and security, necessitating clear regulatory guidelines. Ethical barriers span consent, responsibility, liability, and validation complexities, necessitating robust frameworks. Financial barriers stem from inadequate funding, requiring (commercial) partnerships and business models. Technological issues include interoperability, integration, and malfunctioning, necessitating strategies for enhancing data reliability, improving accessibility, and aligning eHealth technology with existing systems for smoother integration. Conclusions: This research highlights the multifaceted nature of eHealth implementation, encompassing legal, ethical, financial, and technological considerations. Collaborative stakeholder engagement is paramount for effective decision-making and aligns with the transition from standalone eHealth tools to integrated digital health environments. Identifying suitable stakeholders and recognizing their stakes and values enriches implementation strategies with expertise and guidance across all aspects. Future research should explore the timing of these considerations and practical solutions for regulatory compliance, funding, navigation of responsibility and liability, and business models for reimbursement strategies. [ABSTRACT FROM AUTHOR]

Trustworthy medical AI requires transparency about the development and testing of underlying algorithms to identify biases and communicate potential risks of harm. Abundant guidance exists on how to achieve transparency for medical AI products, but it is unclear whether publicly available information adequately informs about their risks. To assess this, we retrieved public documentation on the 14 available CE-certified AI-based radiology products of the II b risk category in the EU from vendor websites, scientific publications, and the European EUDAMED database. Using a self-designed survey, we reported on their development, validation, ethical considerations, and deployment caveats, according to trustworthy AI guidelines. We scored each question with either 0, 0.5, or 1, to rate if the required information was "unavailable", "partially available," or "fully available." The transparency of each product was calculated relative to all 55 questions. Transparency scores ranged from 6.4% to 60.9%, with a median of 29.1%. Major transparency gaps included missing documentation on training data, ethical considerations, and limitations for deployment. Ethical aspects like consent, safety monitoring, and GDPR-compliance were rarely documented. Furthermore, deployment caveats for different demographics and medical settings were scarce. In conclusion, public documentation of authorized medical AI products in Europe lacks sufficient public transparency to inform about safety and risks. We call on lawmakers and regulators to establish legally mandated requirements for public and substantive transparency to fulfill the promise of trustworthy AI for health. [ABSTRACT FROM AUTHOR]