Background Issues:
Healthcare is essential for individuals and society, but faces challenges such as diseases, aging populations, financial burdens, and fair distribution of services. Regenerative medicine, which aims to replace or regenerate human cells, tissues, or organs, offers promising solutions but encounters difficulties in transitioning from research to clinical practice. This transition requires societal changes including political, regulatory, and public acceptance.

Regenerative Medicine in Japan:
Japan’s healthcare system is strained by an aging population and other health issues. To address this, Japan has implemented unique regulations over the past decade to promote regenerative medicine. These regulations allow hospitals to provide regenerative treatments without extensive scientific assessments and enable pharmaceutical companies to market products with conditional approval before full scientific validation. Although these measures aim to expedite access and industry growth, they also raise concerns about safety and standardization.

Research Question:
This research investigates how ethical considerations can be incorporated into the translation of regenerative medicine in Japan. Using an interdisciplinary approach, the study examines key processes and actors involved, ethical issues, and potential solutions through literature review, actor analysis, thematic analysis, conceptual synthesis, and an online questionnaire with supplementary interviews.

Results and Conclusion:
Key processes and influential actors in the translation of regenerative medicine in Japan were identified, including the Ministry of Health, Labour and Welfare (MHLW), the Ministry of Education, Culture, Sports, Science and Technology (MEXT), large hospitals, and universities/national research institutions. Current and potential ethical issues were explored, with suggested approaches derived from literature and comparative analysis with other countries.

Recommendations include:

MHLW should clearly define terms like “unproven,” “innovative,” “research,” and “treatment.”
Hospitals should refine their practices and guidelines, collaborating with MHLW and MEXT.
MHLW and MEXT should gather feedback from practitioners to update ethical guidelines.
Doctors and researchers should contribute to policy-making and practical guideline reflections.
Public discussion should be encouraged to gain societal acceptance and contribute to policy formation.

The research proposes a framework for incorporating ethical considerations into regenerative medicine in Japan, offering insights for policy refinement and further research in emerging technologies both in Japan and globally.

The aim of this research is to gain an understanding of the balance between guideline standardisation and professional autonomy. This includes its impact on the safety and quality of healthcare. These are crucial aspects of providing good care as they can contribute to an overall healthcare system that is effective, reliable, and patient-centered. The reason for performing this research is the difficulty of finding a balance between guideline standardisation and professional autonomy. While guideline standardisation is crucial to ensure a structured approach to uniform care of high quality, professional autonomy is necessary to individualise this care for each patient. At times, the tension between these aspects arises as medical practitioners feel limited in their professional autonomy, but healthcare organisations require a structural set-up of healthcare systems to provide equal care.

By performing interviews with guideline developers, doctors, and patients, this tension and possible contributing factors were explored through a technical, human, and organisational perspective. The identification of a need for the inclusion of the psychosocial elements, research regarding sensitivity around professional autonomy, and structural changes is beneficial to get to a point where it is possible to identify a balance between guideline standardisation and professional autonomy and its impact on the safety and quality of care. While multiple points for further research are indicated in this study, these three factors contribute to improving the situation of both the tension itself and the discussions around it.

The Dutch first-line healthcare domain faces challenges arising from an ageing population and resource limitations, accentuating the need for an effective IT domain. Inadequate interoperability and data portability between information systems used by healthcare organisations in daily processes hinder patient treatment and innovation. This study explores a platform-based information system as a solution to enhance innovation and interoperability. Previous research focused on the IS supplier perspectives, but this research aimed to examine patients and healthcare professionals' needs considering the development of a platform-based information system.

The study is conducted within a socio-technical context, guided by the Design Science Research Methodology (DSRM). This study centers around five sub-research questions distributed across design cycles within DSRM. The preliminary research (including a focus group, semi-structured interviews and expert talks) revealed inefficiencies in communication regarding care around the medication process. The statements gathered during this research phase were validated on a bigger scale by conducting a survey. The statements resulted in a number of requirements, which were formalised and categorised using a System Requirement Structure (SRS) design. The SRS resulted in five main areas: supporting healthcare professional participation, regulating access, enabling clear and concise content, supporting agreements, and supporting patient participation. The low-level requirements of each of these areas were used to construct the platform modules and platform architecture, using a layered approach (showing the business, information and technology layer). The platform architecture was developed through iterative evaluations with domain experts, enhancing quality and detail. The evaluations also resulted in a new perspective on the platform-based information system, rather seeing it as a platform-based ecosystem solution.

The practical contribution of this research lies in two areas. Firstly, the designed platform addresses the need to improve communication within the healthcare domain, offering a communication service that can significantly enhance efficiency and collaboration among healthcare providers and patients. The insights and requirements from various perspectives can also be applied to enhance communication practices in other healthcare lines and countries. Secondly, the platform-based ecosystem design provides valuable insights into the roles, responsibilities, and interactions among different stakeholders, serving as a blueprint for developing similar ecosystems in other domains. The design also aligns with the Communication Platform as a Service (CPaaS) concept, offering the potential for further exploration in other industries.

Additionally, the research contributes to the scientific literature by addressing the research agenda on digital platforms by providing a comprehensive overview of how platform-based ecosystems can be conceptualised and designed in the healthcare sector. The findings can guide further research on feasibility, financial implications, and governance in platform-based ecosystems. The study’s value also extends to other domains, such as education and government, where ISs play a crucial role. Moreover, this study found that the interoperability layers can be applied and adapted within the healthcare context and potentially in other IS ecosystems, providing strong guidance and support for designing platforms and services. The research design demonstrates the relevance and applicability of interoperability layers, and with further experimentation, these layers may have broader applicability across different domains. Overall, the study’s positioning in Design Science Research (DSR) places it as an improvement for communication and an exaptation for the platform-based ecosystem, with potential for reuse and further research in various domains and contexts. The academic contribution also entails identifying knowledge gaps that must be explored in the future: the next steps.

Several areas need further research to enhance the development of the platform-based ecosystem and communication service. Firstly, understanding the patient’s perspective through focus groups or interviews can provide valuable insights into communication preferences and platforms. Secondly, detailed research on communication variety in healthcare and specifying platform content and user details will ensure successful implementation. Thirdly, following the Architecture Development Method (ADM) cycle can optimise the business, information, and technology architecture, cost-sharing decisions and stakeholder governance. Additionally, exploring governance frameworks like the Institutional Analysis and Development (IAD) framework will facilitate feasible implementation. Lastly, developing new design principles and guidelines for digital platform (ecosystem) design will better support the platform-based ecosystem’s growth and refinement.

This research provides a performance measurement framework for Reverse Innovation (RI) within the healthcare sector. In order to design this performance measurement framework, literature analysis was combined with data from current practices that was obtained by interviewing product managers from multination companies (MNCs) in the healthcare sector that have produced RIs. Within the performance measurement framework four categories are used: financial performance, product innovation performance, sustainability performance and customer satisfaction performance. This performance measurement framework can be used to assess the performance of RIs and MNCs pursuing RIs which can help managers in their decision making and daily business management.