This aim of this playbook is to help innovators attend to the social, economic, and environmental impacts of their innovations and to guide innovation stakeholders in the scaling of a responsible health innovation ecosystem.

It summarises many of the lessons we have learned from our projects with sixteen small- and medium-sized enterprises involved in developing responsible health innovations, and with a number of social finance actors in Canada and Brazil. It offers action points for entrepreneurs, healthcare managers, managers of innovation incubators and accelerators, and decision-makers involved in health policies and in innovation policies.

• Lehoux, P., Silva, H.P, and Rivard, L. (2024). Responsible Innovation in Health Playbook. Lessons-learned and action points for health innovation stakeholders. The In Fieri Research Program: Montreal, Quebec, Canada.
• Este guia também está disponível em português.

Over the past decade, digital health solutions and those relying on artificial intelligence (hereafter called “D/AI solutions”) have exponentially grown and expanded research and health care practices in ways that were previously unthinkable. As health care providers and health systems worldwide will be on the frontline tackling the health effects of climate change and growing social and economic disparities, our team aimed to develop a rigorous tool that can measure the degree of responsibility of D/AI solutions by adapting the multidimensional and already validated Responsible Innovation in Health (RIH) Tool.

To do so, we conducted a three-phase mixed method study:

1. In Phase 1, we performed a scoping review of practice-oriented tools (n=57) developed since 2015 to support the development and use of responsible and ethical D/AI solutions. We extracted from these tools up to 40 principles that were mapped against the RIH Tool to identify issues that are specific to D/AI solutions and were not covered in the RIH Tool. This mapping process led to a preliminary version of the ‘Responsible D/AI Solutions Assessment Tool.’
2. In Phase 2, an international two-round e-Delphi expert panel rated on a five-level scale the importance, clarity, and appropriateness of the new Tool’s components (i.e., its premises, screening criteria, and assessment attributes).
3. In Phase 3, two raters independently applied the revised Tool to a sample of D/AI solutions (n=25), interrater reliability was measured, and final minor changes were brought to the Tool.

The results of the scoping review were published (see below) and confirmed the need for a comprehensive, valid, and reliable tool to assess the degree of responsibility of D/AI health solutions. Because regulation remains limited in this rapidly evolving field, we believe that the new tool we developed has the potential to change practice towards more equitable as well as economically and environmentally sustainable digital health care.

Publications of interest to this project:

• Alami, H., Lehoux, P., Denis, JL., Motulsky, A., Petitgrand, C., Savoldelli, M., Rouquet, R., Gagnon, MP., Roy, D., Fortin, JP. (2020). Organizational readiness for artificial intelligence in health care: Insights for decision-making and practice. Journal of Health Organization and Management.
• Alami, H., Rivard, L., de Oliveira, R.R., Lehoux, P., Cadeddu, S., Savoldelli, M., Ag Ahmed, M.A., Fortin, J.-P. (2020). Extracting value from the way we live? Guiding health insurance models towards responsible digital innovations. Journal of Participatory Medicine. 12(3), e19586.
• Alami, H., Rivard, L., Lehoux, P., Hoffman, S. J., Cadeddu, SBM., Savoldelli, M., Samri, MA., Ag Ahmed, MA., Fleet, R., Fortin, JP. (2020). Artificial intelligence in health care: Laying the Foundation for Responsible, sustainable, and inclusive innovation in low- and middle-income countries. Globalization and Health. 16(1): 52.
• Lehoux, P. & Rivard, L. (2022). Major public works ahead for a healthy data-centric NHS, The BMJ.
• Lehoux, P., Rivard, L., de Oliveira, R. R., Mörch, C. M., & Alami, H. (2022). Tools to foster responsibility in digital solutions that operate with or without artificial intelligence: A scoping review for health and innovation policymakers. International Journal of Medical Informatics.
• Rivard, L., Lehoux, P. (2023). AI is not ready for the 21st century: What can business leaders do? The European Business Review. January 11, 2023.
• Rivard. L., Lehoux, P., Rocha de Oliveira, R., Alami, H. (2023). Thematic analysis of tools for health innovators and organisation leaders to develop digital health solutions fit for climate change. BMJ Leader.
• Lehoux, P., Rocha de Oliveira, R., Rivard, L., Silva, H. P., Alami, H. Mörch, C.-M., Malas, K. (2023). A comprehensive, valid, and reliable tool to assess the degree of responsibility of digital solutions that operate with or without artificial intelligence. 3-phase mixed methods study. Journal of Medical Internet Research.

Project Team Members: Lysanne Rivard

Robson Rocha de Oliveira

Hassane Alami

Pascale Lehoux

This project aims to clarify the conditions under which social finance provides high-impact enterprises with the resources they need to design, develop and commercialize RIH on a larger scale.

This project involves two sequential data collections. First, social finance experts working in Quebec, Ontario, and the State of Sao Paulo will be recruited to participate in semi-structured interviews. The purpose of the interviews will be to clarify the conditions under which social finance provides innovative enterprises with the resources they need to design and commercialize RIH, the impact measures used to assess their social, economic or environmental impacts, and the milestones that are appropriate for monitoring their progress over the investment life cycle.

Approximately 5 participants per geographical region will be recruited on the basis of their expertise in the field of social finance. Inclusion criteria include: 1) five or more years of experience in the field; and 2) involvement in the full life cycle of an investment (file assessment, project management and “exit”). Diversification criteria include the profile of the investment portfolio for which the respondent is responsible (e.g., more social or technological innovations, health or environmental sector) and the degree of responsibility of the position the respondent holds (senior partner, senior advisor, advisor).

Subsequently, more international social finance experts will be invited to participate in a two-round Delphi prioritization exercise that will take place on a secure web-based platform. The study will build on the results of the interviews. First, the experts will be invited to assess, through a series of closed-ended questions, the level of importance of the resources and conditions that will have been identified through the interviews as being particularly conducive to the design, development, and commercialization of RIH. Free-text response fields will allow them to share comments and propose additional resources or conditions they consider important. In Round 2, the experts will receive the results of the previous round and will be asked to comment on the level of feasibility associated with each of the resources and conditions identified and the risk mitigation strategies they consider appropriate.

Up to 75 participants will be recruited on a non-probability basis to participate in both rounds. Inclusion criteria include mastery of the topic, interest and availability to participate in the study. Diversification criteria include gender, geographic location (to cover five continents) and years of experience. The participation of each expert will be confidential, and the composition of the group will not be revealed to participants.

Project Lead: Hudson Silva

This illustrated booklet produced by In Fieri is intended for innovation ecosystem actors in Quebec and elsewhere in the world. It explains the nine attributes of responsibility that can guide the development of an innovation in health or be used to evaluate the level of responsibility of existing solutions. Eloquent examples and counter-examples are also presented. Download it!

Em defesa da inovação responsável em saúde. Um livreto ilustrado para os atores do ecossistema de inovação no Quebec e em outras partes do mundo está disponível em português.

This project aims to identify how alternative business models and hybrid entrepreneurship can support the design, development and commercialization of RIH.

This project consists of a longitudinal case study of high-impact enterprises developing RIH in Quebec, Ontario and the state of Sao Paulo in Brazil. Sixteen small- and medium-sized enterprises with responsibility features described in the RIH framework were recruited in 2017 and 2018 and have been monitored over a period of 4 years. Diversification criteria included organizational structures and types of innovation developed. An overview of the cohort of enterprises participating in this project can be seen in the following infographics.

This project is based on in-depth interviews with members of the organization’s management team or employees directly involved in the design or development of the innovation. Additional data is collected through a secure web-based platform that allows: 1) to upload public documents related to the organization (financial reports, business plan, etc.) and 2) to complete the organization’s “digital diary” twice a year.

Articles have been published and others are currently under review or in preparation:

• Lehoux, P., Silva, H. P., Rocha de Oliveira, R., Sabio, R. P., & Malas, K. (2021). Responsible innovation in health and health system sustainability: Insights from health innovators’ views and practices, Health Services Management Research.
• Lehoux, P., Silva, H. P., Oliveira, R.R., Rivard, L. (2020). The responsible innovation in health tool and the need to reconcile formative and summative ends in RRI tools for business, Journal of Responsible Innovation.
• Lehoux, P., Silva, H. P., Denis, J-L., , Miller, F. A., Pozelli Sabio, R., Mendell, M. (2021). Moving toward responsible value creation: Business model challenges faced by organizations producing responsible health innovations, Journal of Product Innovation Management.
• Silva, H. P., Lehoux, P. & Sabio, R. P. (2022). Is there a fit between incubators and ventures producing responsible innovations in health?, Health Policy and Technology.
• Lehoux, P., Silva, H.P., Miller, F.A., Denis, J.-L., Sabio, R.P. (2022). How can entrepreneurs’ experience inform responsible health innovation policies? A longitudinal case study in Canada and Brazil. The International Journal of Health Planning and Management.

Project Lead: Hudson Silva

The aim of this project was to take stock of the empirical studies that examined the motivations and processes that led to the development of responsible innovations (RIs) that have implications for health and social care.

An article that provides a synthesis of 17 qualitative studies and develops a model of the goals and processes of responsible innovations was published in the journal Innovations-Revue d’économie et de management.

Responsible Innovation (RI) goals and processes model

According to this model, the context of emergence stimulates the development of RI oriented towards a common good, whether it involves broad collective interests (e.g., wastewater treatment) or those of marginalized groups (e.g., making a building accessible to people with disabilities).

Actors include the leaders of the RI project, i.e., the individuals and organizations that design and develop it, and their partners, who may change according to the stage of innovation development (investors, representatives of municipal, regional or national public authorities, suppliers, potential users, community organizations, etc.).

Actors pursue goals that are not all related to a common good and may include particular interests (establishing one’s own network of contacts, developing a market, increasing a city’s influence, etc.). Anchoring refers to the actions through which leaders and partners manage (or not) to increase the relevance of RI along its development, experimentation and appropriation, and this is achieved by reconciling the goals pursued.

Resource work is characterized by both ideological and material flexibility. This process combines three activities that enable the production of RI by promoting learning, collaborative work within networks and the emergence of a protective “niche.” It is indeed important to create a material and socio-cultural space that allows a RI to develop and establish its place on the market despite —or thanks to— its non-standard character. To the opposite, letting established market forces play out without working on the conditions of the construction and reception of a given RI reduces its possibilities of emergence.

Ultimately, RIs can succeed in occupying a market of their own by remaining a unique case, by being reproduced (for example, a bike-sharing system is set up in another city) or by being more widely and institutionally diffused (a mass-produced electric car captures a market segment). In this way, RI contributes to modifying its context of appropriation, making it more conducive to the deployment of activities that consolidate its anchoring.

Former Project Lead: Geneviève Daudelin

Contact for the project: Pascale Lehoux

In 2018, Palindrome —a magazine bringing together health and literature— concluded its proof of concept phase by successfully publishing two issues.

This magazine combines literary creations and scientific content from a new vantage point, underlining the social and cultural mutations that innovations in health can bring. A palindrome is a word that can be read from left to right as well as from right to left. Likewise, this magazine offers to travel back and forth between literature and health in a fruitful way.

Palindrome is based on an interdisciplinary approach, bringing food for thought to the readers about health innovations so as to strike their imagination. To that end, Palindrome is inviting writers, experts and researchers, both beginners and seasoned, to tell us their story about an innovation in health, whether technological or social, that has changed their life in a meaningful way. Practitioners are also welcome to contribute to the magazine.

Read Palindrome online: magpalindrome.ca

Former Project Lead: Frédérique Dubé

Contact for this project : Pascale Lehoux

Renata Pozelli is currently pursuing her doctoral research project on the responsible production and consumption of food.

Our food is produced, processed and distributed within “food systems.” Currently, the way such systems are organized in most countries is characterized by the presence of “dominant” organizations and practices, developed during the Industrial Revolution, in a context of demographic and economic growth. However, previous studies have already shown the negative effects of these dominant practices on human health and on the environment. To change this situation, a transition to better practices in food systems is currently taking place. Initiatives that incorporate attributes of responsibility are emerging all around the world. They include, for example, rooftop agriculture and organic basket networks, among others. However, the current state of knowledge is limited since little is known about how these innovations are emerging and how a transition to more responsible food systems can be achieved.

To fill this gap, this doctoral thesis aims to better understand food system transitions in the context of an established and an emerging economy: the province of Quebec and the state of São Paulo. These regions face different food security challenges, but both show a high dependency upon the dominant food system and an increased interest in innovative systems. A multiple case study design is applied and combines interviews with organizations in both regions with secondary data analysis. The results of this thesis, which is comprised of four articles, contribute to the consolidation of organizations and food practices that contribute to health and, therefore, responsible food systems.

• Pozelli Sabio, R., & Lehoux, P. (2019). How can alternative food systems contribute to the sustainable development goals? Systèmes alimentaires/Food systems, 2019(4), 209-218.
• Pozelli Sabio, R., Lehoux, P. (2022). How does context contribute to and constrain the emergence of responsible innovation in food systems? Results from a multiple case study. Sustainability. 14(13), 7776.
• Pozelli Sabio, R., Lehoux, P. (2023). Characterizing food systems to better understand their vulnerabilities: A case study in Québec and São Paulo. Renewable Agriculture and Food Systems. 38, E25.
• Pozelli Sabio, R., Lehoux, P. (soumis). The contribution of Responsible Innovation to food systems transition: Results from a multiple case study.

Project Lead : Renata Pozelli

Experimenting and enhancing RIH design tools

How can we help health innovators who wish to work with RIH’s dimensions and attributes to design and develop responsible innovations?

To answer this question, we collaborated with the TransMedTech Institute of Polytechnique Montréal and implemented, in Fall 2019, a co-design project to identify tools that can design responsible innovations in health. Eight teams of health innovators from different professional fields, including rehabilitation, biomedical engineering, communication, design, and management were recruited, for a total of 17 participants. Working with the RIH framework as a design brief, participants conceptually redesigned an existing innovation in order to make it more responsible.

To do so, the 9 RIH attributes were transformed into “responsibility cards” and each team received 5 different cards as their design brief. For example:

To increase the innovation’s degree of responsibility, the teams identified tools (e.g., standards, norms, models, criteria, or processes) to support the design of responsible innovations. Then, they shared what they believed were the best tools to include in our RIH Design Toolbox. The latter was made publicly available to those wishing to develop responsible innovations in health in a book published in 2022:

• Lehoux, P., Rivard, L., & Silva, H. P. (2022). Responsible Innovation in Health: Concepts and Tools for Sustainable Impact. Springer Nature.

Project Lead: Lysanne Rivard

Launched in 2018, the objective of this project was to better understand how innovation developers perceive Responsible Innovation in Health (RIH).

We interviewed 31 participants working in Quebec and Ontario and trained in clinical sciences, engineering, industrial design, and/or entrepreneurship. To stimulate reflections on the topic, participants visited a visual repertoire developed by our team that contains 9 examples of innovations that are potentially responsible and that fall within one of the following categories of healthcare:

Participants also shared their perspective on the RIH conceptual framework, mainly the 5 value domains:

A 1^st article describes how health innovators perceive RIH and underscores how “desirability” and “feasibility” go hand in hand. In other words, the implementation of RIH is first and foremost a pragmatic issue and not only a question of principles or moral sensibility.

• Rivard L., Lehoux P. (2019). When desirability and feasibility go hand in hand: innovators’ perspectives on what is and is not responsible innovation in health, Journal of Responsible Innovation.

A 2^nd article focuses on the systemic obstacles confronting innovators who seek to develop eco-responsible health innovations. Potential solutions are discussed in order to transform what is currently defined as a double burden into a single duty to care.

• Rivard, L., Lehoux, P., Miller, F.A. (2019). Double burden or single duty to care? Health innovators’ perspectives on environmental considerations in health innovation design, BMJ Innovation.

A 3^rd article examines the quality and safety dilemmas raised by open source and Do-It-Yourself health innovations. Policy recommendations are made to help patients safely benefit from these innovations that often meet their needs.

• Rivard, L., Lehoux, P., Alami, H. “It’s not just hacking for the sake of it”: a qualitative study of health innovators’ views on patient-driven open innovations, quality and safety, BMJ Quality & Safety.

A 4th article, guided by Tronto’s (1993) ethic of care framework and Responsible Research and Innovation (RRI), focuses on the ways in which health innovation designers reason around care and responsibility and translate these notions into their work. The exploratory findings provide a novel empirical basis for scholars to conceptualize health innovation designers as ‘care-makers’ and to integrate designers within the care relationship alongside caregivers and care-receivers.

• Rivard, L., Lehoux, P., Hagemeister, N. (2021). Articulating care and responsibility in design: A study on the reasoning processes guiding health innovators’ ‘care-making’ practices, Design Studies.

Project Lead: Lysanne Rivard