Artificial intelligence in digital mental health technology: Considerations for regulation.

The World Health Organization (WHO) defines health innovation as the development or refinement of policies, systems, technologies, and delivery methods that enhance health and wellbeing []. Embedding innovations such as a new malaria vaccine into existing routine healthcare is inherently complex, context-specific and presents several potential operational pitfalls, such as inadequate integration with existing health infrastructure, supply chains and workflows, [] inadequate capacity and poor training of healthcare workers. Supply chain weaknesses can compromise vaccine availability and efficacy. Additionally, poor community engagement may lead to mistrust, low acceptance, and vaccine hesitancy. Misalignment between innovation timelines and national health planning cycles can hinder institutional adoption and sustainability. Finally, limited coordination between stakeholders - including government agencies, donors, and implementing partners - can result in fragmented efforts and resource inefficiencies. Addressing these pitfalls requires realistic planning, inclusive stakeholder engagement and adaptive implementation strategies. Typically, the introduction of health innovations follows a phased approach, which not only supports the creation of solutions but also addresses critical factors necessary for sustainable implementation and scale-up. The example of malaria vaccine illustrates the substantial delays and pitfalls in the process of translating evidence into policy and practices []. The Ghana malaria vaccine introduction plan was developed in 2018 and the pilot started in May 2019 []. The planning processes around a malaria vaccine embedment in routine health services must actively engage a diverse range of stakeholders - those who influence, are affected by, or have a vested interest in the innovation. Incorporating their insights and experiences ensures that innovations are contextually relevant, ethically grounded, and more likely to be adopted in practice. Stakeholder analysis is thus a critical tool [, ].