“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
Article [Accepted Manuscript]
Abstract(s)
Background Open do-it-yourself (DIY) health
innovations raise new dilemmas for patient-oriented
and service-oriented scholars and healthcare providers.
Our study aimed to generate practical insights into
quality and safety issues to patient care raised by two
volunteer-run, open DIY solutions: Nightscout Project
(patient-driven, open-source software for type 1 diabetes
management) and e-NABLE (volunteers who design and
three-dimensionally print upper-limb assistive devices).
To this end, we examined the views of health innovators
who are knowledgeable about medical devices standards
and regulations.
Methods We applied a multimedia-based, dataelicitation technique to conduct indepth interviews with
a diversified sample of 31 health innovators practising
in two Canadian provinces (Quebec and Ontario). An
exploratory thematic analysis approach was used to
identify respondents’ reasoning processes and compare
their overall judgements of Nightscout and e-NABLE.
Results Respondents pondered the following quality
and safety issues: importance of the need addressed;
accessibility; volunteers’ ability to develop and maintain
a safe solution of good quality; risks involved for users;
consequences of not using the solution; and liability.
Overall, innovators see Nightscout as a high-risk DIY
solution that requires expert involvement and e-NABLE
as a low-risk one that fills a hard-to-meet gap.
Conclusion Health innovators generally support
patient-driven initiatives but also call for the involvement
of professionals who possess complementary skills
and knowledge. Our findings provide a list of issues
healthcare providers may discuss with patients during
clinical consultations to document potential risks and
benefits of open DIY solutions. To inform new policy
approaches, we propose the development of publicly
funded umbrella organisations to act as intermediaries
between open DIY solutions and regulatory bodies to
help them meet quality and safety standards
Other location(s)
Collections
This document disseminated on Papyrus is the exclusive property of the copyright holders and is protected by the Copyright Act (R.S.C. 1985, c. C-42). It may be used for fair dealing and non-commercial purposes, for private study or research, criticism and review as provided by law. For any other use, written authorization from the copyright holders is required.