Governance Principle
Agile Regulation
Agile regulation is a flexible and responsive approach, enabling policymakers to keep pace with the rapid evolution of digital health technologies.
Why is it important?
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Faster adaptation: It addresses novel challenges of emerging technologies.
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Targeted oversight: It prioritises high-stake areas.
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Reduced uncertainty: It promotes legal clarity and predictability.
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Enhanced innovation: It encourages regulatory learning and experimentation.
How do we make it happen?
For Switzerland to successfully adopt and implement agile regulation, policymakers and decision-makers should:
Think of medical wearables.
Agile regulation would help regulators to quickly approve software and updates, thereby balancing innovation with safety.
Action 1
Create a Digital Health Centre of Competence
Why create a specialised governance body?
The complex and rapidly evolving field of digital health requires domain-specific expertise across technology, ethics, and regulatory processes. However, the skills and knowledge are often fragmented across various government entities, limiting coordination and collaboration.
Switzerland needs a specialised governance body to effectively oversee, monitor, assess, and regulate emerging digital health innovations. This dedicated regulatory body, which we call the Digital Health Centre of Competence (DHCC), would exercise oversight over the licensing of digital health devices (Action 2), foster collaboration (Action 3), set standards (Action 4), provide training and support (Action 7 and Action 8), and monitor and adapt regulatory approaches (Action 2 and Action 5).
What needs to be done?
Policymakers need to take the following concrete steps to establish a Digital Health Centre of Competence within a Swiss regulatory body:
Set the rules
Policymakers should create a legal framework to support the centre's ability to oversee the licensing of digital health tools, set standards for evaluating new technologies, ensure data accuracy, address ethical issues, and monitor technologies in the market (Action 2).
Provide resources
Policymakers should allocate finances and recruit skilled staff to support the centre’s ability to conduct iterative policy assessments and engage with stakeholders.
Ensure diversity
Policymakers should make sure the centre has experts from different domains like technology, AI, privacy, cybersecurity, ethics, and law. The Hub should also talk to patients, industry experts, and researchers (Action 3).
Creating a Digital Health Center of Competence will allow Switzerland to strengthen its response to the dynamic and fast-moving environment of digital health innovation whilst safeguarding patient interests and maintaining public trust.
Action 2
Enable Agile regulation
Why build the legal basis for agile regulation?
Current regulations can struggle to keep pace with rapid technological advancements in healthcare, resulting in delayed the implementation of innovation and reduced capacity to avert risks.
A legal basis for agile regulation is needed to foster a more dynamic and adaptive regulatory environment that can address new technologies and their challenges. This framework should support Regulatory Experimentation (testing new technologies and regulatory approaches in controlled settings) and Planned Adaptation (regularly reviewing regulations so that they align with evolving technologies and societal needs).
What needs to be done?
Switzerland must implement legal changes to support agile regulation. This involves creating a regulatory environment that is flexible, adaptable, and responsive to the dynamic nature of digital health.
Assess laws
Policymakers should evaluate whether existing sandboxing and piloting mechanisms can be applied to new digital health tools.
Develop & adapt regulations
Policymakers should establish mechanisms to enable planned adaptation and regulatory experimentation in the governance of digital health innovation.
Early dialogue
Regulatory bodies such as the DHCC should create mechanisms to to engage with innovators early on and continuously throughout the innovation cycle (Action 3).
Grant oversight
Policymakers should grant capacity to specific authorities, such as a Digital Health Centre of Competence (Action 1) to initiate, monitor and evaluate regulatory experiments.