Abstract
Digital health holds significant promise for transforming healthcare but presents several risks to patients and providers, especially in fragmented regulatory terrains. Experts have articulated the need for clear digital health regulatory frameworks, but there is uncertainty surrounding the design of such frameworks with governments adopting varied models, spanning both formal and informal mechanisms. Using content analysis and a stakeholder dialogue with focus group discussions, we aimed to assess stakeholders' perceptions of the benefits, costs, risks and trade-offs of different forms of regulatory frameworks in low- and middle-income countries, focusing on Kenya, Rwanda and Uganda. Stakeholders consider both formal and informal regulatory approaches to be beneficial, citing regulatory maturity, political will and financial support as key factors to consider. However, the aim of regulatory design should be patient protection, the key concern being how best to protect individuals' and engender trust between citizens and government. Moreover, while stakeholder engagement is crucial, this should be done with a clear aim and is likely best done in the latter stages of regulation to facilitate peer review of initial regulatory efforts. Overall, context-specific, iterative strategies are key for digital health regulatory design, with patient protection, inclusive stakeholder engagement, flexible regulatory tools and enduring political and institutional support being key factors to consider.