Responsible innovation in health (RIH) takes the ideas of responsible research and innovation (RRI) and applies them to the health sector. This comment takes its point of departure from Lehoux et al which describes a structured literature review to determine the system-level challenges that health systems in countries at different levels of human development face. This approach offers interesting insights from the perspective of RRI, but it also raises the question whether and how RRI can be steered and achieved across healthcare systems. This includes the question who, if anybody, is responsible for responsible innovation and which insights can be drawn from the systemic nature RIH.

Background: Responsible innovation in health (RIH) emphasizes the importance of developing technologies that are responsive to system-level challenges and support equitable and sustainable healthcare. To help decision-makers identify whether an innovation fulfills RIH requirements, we developed and validated an evidence-informed assessment tool comprised of 4 inclusion and exclusion criteria, 9 assessment attributes and a scoring system. Methods: We conducted an inter-rater reliability assessment to establish the extent to which 2 raters agree when applying the RIH Tool to a diversified sample of health innovations (n = 25). Following the Tool's 3-step process, sources of information were collected and cross-checked to ensure their clarity and relevance. Ratings were reported independently in a spreadsheet to generate the study's database. To measure inter-rater reliability, we used: a non-adjusted index (percent agreement), a chance-adjusted index (Gwet's AC) and the Pearson's correlation coefficient. Results of the Tool’ s application to the whole sample of innovations are summarized through descriptive statistics. Results: Our findings show complete agreement for the screening criteria, "almost perfect" agreement for 7 assessment attributes, "substantial" agreement for 2 attributes and "almost perfect" agreement for the RIH overall score. A large portion of the sample obtained high scores for 6 attributes (health relevance, health inequalities, responsiveness, level and intensity of care and frugality) and low scores for 3 attributes (ethical, legal, and social issues [ELSIs], inclusiveness and eco-responsibility). At the rating step, 88% of the innovations had a sufficient number of attributes documented (≥ 7/9), but the assessment was based on sources of moderate to high quality (mean score ≥ 2 points) for 36% of the sample. While “ Almost all RIH features" were present for 24% of the innovations (RIH mean score between 4. 1-5. 0 points), "Many RIH features” were present for 52% of the sample (3. 1-4. 0 points) and "Few RIH features" were present for 24% of the innovations (2. 1-3. 0 points). Conclusion: By confirming key aspects of the RIH Tool's reliability and applicability, our study brings its development to completion. It can be jointly put into action by innovation stakeholders who want to foster innovations with greater social, economic and environmental value.

The insights from an international scoping review provided by Lehoux et al challenge health policy-makers, entrepreneurs/innovators and users of healthcare, worldwide, to be aware of equity and sustainability challenges at system-level when appraising responsible innovation in health (RIH) – purposefully designed to better support health systems. The authors manage to extract no less than 1391 health system challenges with those mostly cited pertaining to service delivery, human resources, leadership and governance. Countries were classified according to the Human Development Index (HDI), while the authors decided not to classify according to the types of health systems justifying this on the basis that the articles reviewed studied a specific setting within a broader national or regional health system. The article presents highly powerful and discerning viewpoints, indeed providing numerous standpoints, yet in a comprehensive manner, thereby putting structure to a somewhat highly complex and multidimensional subject. This commentary brings forth several considerations that are perceived on reading this article. First, although innovation strategies are important for the dynamicity of health systems, one should discuss whether or not RIH can adequately address equity and sustainability on a global scale. Secondly, RIH across countries should also be debated in the context of the principles garnered by the type of health system, thereby identifying whether or not the prevailing political goals support equity and sustainability, and whether or not policy-makers are adequately supported to translate system-level demand signals into innovation development opportunities. As key messages, the commentary reiterates the emphasis made by the authors of the need for international policy-oriented fora as learning vehicles on RIH that also address system-level challenges, albeit the need to acknowledge cultural differences. In addition, the public has not only the right for transparency on how equity and sustainability challenges are addressed in innovation decisions, but also the responsibilities to contribute to overcome these challenges.

In this commentary on the exercise of Lehoux et al (this volume) I argue that in discussions on the current challenges of health systems, a better diagnosis of the health system is required. The cause of responsible innovation in health (RIH) requires a better understanding of the dynamics of health systems, in particular how innovation, demand, and responsibility are manifested. Innovation brings its own dynamic to the health system; demands are linked to historical and social developments; responsibility brings contestations about what counts as good healthcare. Any attempt of RIH should include such reflections.