Governance Principle
Inclusive Co-creation
Inclusive co-creation is the early and ongoing involvement of all relevant stakeholders in developing and deploying innovative technologies. This ensures collaboration, equitable representation, and shared ownership of innovation outcomes.
Why is it important?
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Ensures societal alignment: Incorporates societal values through collaboration.
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Improves decision-making: Leverages collective expertise to support ethical innovation that can be adequately regulated.
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Enhances patient outcomes: Ensures the perspectives of healthcare professionals and patients are prioritised, thereby contributing to safer, more effective healthcare.
How do we make it happen?
For Switzerland to successfully adopt and practise inclusive co-creation, policymakers and decision-makers should:
Consider a medical device co-designed with patient, doctors, and citizens.
Inclusive Co-creation would help to improve the user experience, safety, efficacy, patient acceptance, and accelerated time to market.
Action 3
Engage diverse stakeholders
Why do we need diverse stakeholder engagement?
Early and inclusive engagement, particularly among regulators, healthcare professionals, and patients, is needed to ensure that innovations meet societal needs, comply with regulations, and are evaluated comprehensively. Engaging regulators, end-users and patients from the beginning can lead to innovations that better meet the needs of their users, resulting in better societal impact.
What needs to be done?
To implement diverse stakeholder engagement, policymakers and decision-makers in the healthcare system should take the following actions:
Include all actors
Regulatory exchanges and experimentation should involve all relevant actors, including patients and healthcare professionals, to ensure innovations meet societal needs.
Ensure access
Policymakers should ensure that both small and large entities have equal access to early exchanges, priority review and pilot projects.
Prioritise impact
Policymakers should set up priority review mechanisms for technologies that are expected to have a tangible impact on patients’ outcomes or to address unmet medical needs (Action 6).
Enable exchanges
Policymakers should promote data sharing and interoperability standards, and provide clear guidance on product development and testing (Action 4).
Stakeholder engagement promotes innovation that is aligned with societal needs and regulatory requirements, enhancing the legitimacy and adoption of innovations and contributing to improved patient outcomes and societal well-being.
Action 4
Provide guidance and standards
Why promote uniform standards and interoperability?
Switzerland's healthcare system faces interoperability issues that can hinder innovation. In particular, sharing medical and non-medical data is subject to inconsistencies in standards, terminology, data storage and processing mechanisms, and regulation between sectors and institutions.
Standardised terminology and guidance could improve efficiency and effectiveness in healthcare by streamlining workflows, and ensuring that ethical considerations are consistently addressed. This would thus foster collaboration and build public trust in digital health technologies.
What needs to be done?
Regulators and policymakers should implement the following strategies:
Tailor guidance
Regulators should provide clear guidelines to help standardise technology development, tailored to specific medical areas and clinical purposes.
Use what's there
Policymakers should build upon the standardisation and governance work of organisations like the Swiss Personalised Health Network (SPHN) to improve data sharing and access.
Adopt standards
Policymakers should use established standards like IEEE7000 to guide innovation (Action 2). This standard promotes ethics, value-based innovation, and transparency.
Incentivise usage
Regulators should actively promote and incentivise using uniform standards. Examples of incentives include regulatory approval or access to funding for organisations that adhere to emerging standards.