Corporate report

Agile Nations: 2020-2022 progress report

Published 30 March 2022

Introduction and background

The Agile Nations is an intergovernmental network bringing governments and industry together to collaborate on creating a global regulatory environment that allows innovation to flourish. The network focuses on practical collaboration to share learning and explore new ways to support businesses to introduce and scale innovations across different markets.

The initiative was championed by the UK, who led the network’s first term after it was created in December 2020 together with Canada, Denmark, Italy, Japan, Singapore, and the United Arab Emirates (UAE), along with support from the World Economic Forum (WEF) and the Organisation for Economic Co-operation and Development (OECD).

This report provides a summary of the first term of the network, including an update on the progress made on the Agile Nations Work Programme, first published in October 2021. It’s worth noting that the first half of the UK’s term was spent establishing the foundation for collaboration – through the creation of its governance structure, developing the operating model and the first workplan. The network is beginning to implement the first 10 international collaboration projects.

The Agile Nations is making real progress in connecting governments and regulators to explore new avenues to cooperate - providing innovators with a landscape to scale ideas across borders and find solutions to regulatory barriers. The UK has proudly served as the network’s first chair – showcasing our commitment to an innovation-led economy. We are excited to work with the UAE (the network’s new Chair) and fellow member states to drive forward our ambition to unleash the fantastic benefits of emerging technologies.

Lord Callanan, Minister for Business, Energy and Corporate Responsibility

Highlights

• December 2020: The Agile Nations Charter is signed by the 7 founding members
• May 2021: Introductory workshops are conducted bringing together innovators, regulators and government agencies from across the member states to devise proposals
• October 2021: The first Agile Nations annual plenary takes place, involving:
  • the first meeting of the Agile Nations Ministerial Council, where ministers and their delegates from the member states meet to agree the network’s work programme
  • Agile Nations delegates participate in a Ministerial Roundtable hosted by the WEF considering the question: How can governments embrace innovation to navigate a disrupted world?
• October 2021 and beyond: over 100 officials and regulators begin implementing a diverse set of projects seeking to harness the benefits of emerging technologies. For example:
  • the UK’s Solicitors Regulation Authority are leading a project aimed at advancing the use of lawtech across global legal markets by helping innovators navigate regulatory barriers
  • officials from UK, Canada and Singapore are collaborating to unlock the benefits of the Internet of Things (IoT) whilst protecting consumers from potential cyber-security harms
  • the Danish Business Authority are leading a project to explore and investigate regulatory frameworks that help innovators test, develop, and launch new technologies and businesses models

Work programme report

The 10 projects that make up the Agile Nations’ current work programme have been grouped against the network’s 6 priority workstreams.

Pro-innovation Approaches to Regulation

Data and Communications

Mobility

Green Tech

Medical Devices and Treatments

Professional Services

Projects are in the initial stages of implementation (beginning October 2021) and are set to continue across the year and beyond.

1. Coordinating the National Standards Bodies of the Agile Nations

This is a multilateral project led by Canada and supported by Denmark and the UK.

Project objectives

The goal of this project is to ensure the National Standards Bodies (NSBs) of the Agile Nations Participants are aligned in support of the Agile Nations Charter. Under this goal there are 3 objectives:

• Objective 1: Awareness - promote awareness of the Agile Nations Charter and work programme amongst NSBs
• Objective 2: Inventory - create an inventory of initiatives under the Agile Nations work programme that can be supported by standardisation resources
• Objective 3: Linkages - broker interaction between NSBs and Agile Nations participants to share best practice at a national level and identify collaborative opportunities in support of international standards development where mutual support is feasible

Achievements so far

The working group has collaborated on developing and executing an outreach strategy for NSBs by pooling information about how NSBs across the Agile Nations approach standardisation and regulation. Some NSBs are part of government entities, while others exist outside of government but have agreements to provide standardisation advice and solutions.

Having outlined the variability in NSB relationships within regulatory systems, the working group members were better positioned to draft communication to NSBs about the broader initiative. Working group members also devised the outreach strategy to leverage pre-existing bilateral relations between NSBs on the working group and those that might be brought in. Once the outreach strategy was optimised, the team carried out engagement with NSBs. Of the 7 NSBs involved, 3 of them sit directly on the working group and the other 4 have been invited to participate.

Promoting an innovative and competitive regulatory environment is key to supporting business growth. By working with the national standards bodies of the Agile Nations and leveraging standards and conformity assessment, we can help achieve this on a global scale.

Chantal Guay, CEO, Standards Council of Canada

Next steps

• Spring 2022 - the working group will begin engaging NSBs representatives about the nature of their work and its alignment with the Agile Nations Charter and work programme
• Summer 2022 - the working group will design and host a workshop for project leads of the Agile Nations work programme. This event will facilitate knowledge sharing about standards and conformity assessment tools as they support agile rulemaking

2. Experimental Approaches

This is a multilateral project led by Denmark, supported by Canada, Italy, the UAE and the UK, and observed by Singapore.

Project objectives

The overall objectives of the project are to:

• explore different methods of experimentation, and in particular the detailed implementation of regulatory sandboxes, testbeds, and similar initiatives with a view to drawing out lessons learned and best practice
• investigate other tools that can be used to create good regulatory framework conditions, where start-ups and innovative business are encouraged, and able to test, develop and launch new technologies and business models

Achievements so far

Achievements so far include:

• we have conducted a survey on experimental approaches in the Agile Nations
• the survey has shown that members of the Agile Nations are using sandboxes and other tools to promote innovation friendly regulation in areas such as artificial intelligence, data protection, finTech and other financial services, biotechnology, health, energy and mobility
• the survey results will be gathered in a short report and shared among members and observers of the Agile Nations

Next steps

• Spring 2022 - Denmark will host webinars and coffee meetings on selected areas of interest, inviting members and observers of the Agile Nations and other interested parties to join
• the overall purpose is to promote knowledge sharing on how to create innovation friendly regulation for emerging technologies, which can benefit our societies and the environment

3. Anticipatory Regulation

This is a multilateral project led by the UK, supported by Canada and Denmark, and observed by Italy, the UAE, and the World Economic Forum.

Project objectives

This working group is exploring 2 components of anticipatory regulation:

• horizon scanning
• cross cutting principles for regulation

Achievements so far

Horizon scanning

A key component of putting anticipatory regulation in practice is being able to have a sense of possible forthcoming technological innovations but also focusing on innovations where regulation is a key enabler for ensuring that countries can extract value for their economy, society and environment. The Regulatory Horizons Council (RHC) has undertaken a horizon scanning and prioritisation exercise, and the working group has provided a forum to exchange learnings and best practice. Working group discussions have informed the RHC’s future approach to horizon scanning which will be used to identify its next priority areas.

Cross cutting principles for regulation

The RHC has undertaken a project to reflect on the existing literature on regulatory principles for innovation and draw out the main themes that have arisen. The Council has worked with regulators, industry, government, and other stakeholders to highlight where there are gaps between these good regulatory principles and current practice. The report is supplemented with several case studies to highlight how some of these identified gaps can be closed.

The development of the report has benefited from, and been informed by, the expertise and networks of the working group. Working group members have provided case studies to support the project. Emerging findings from the report have been shared with working group members to encourage international join-up on key challenges.

The report will be published in Spring 2022.

Next steps

Horizon scanning

• the working group will continue to provide a forum to share international expertise around horizon scanning. The RHC will collaborate with the group to share updates on the revised approaches on horizon scanning

Cross cutting principles for regulation

• the RHC will publish its report in Spring 2022, identifying gaps between good regulatory principles and current practice
• this report aims to provide useful prompts for discussion with regulators and policymakers, including holding them to account for following good practice and considering the impacts of their work on innovation. It could also help innovators and civil society groups to better understand the concerns and approaches of regulators and policymakers
• the report and learnings identified throughout its development will be shared with the working group, recognising that these are international challenges. Maintaining an ongoing dialogue on this topic will improve the regulatory process for innovative technologies

4. Agile Governance Guidebook

This is a bilateral project led by Japan and supported by the UAE.

Project objectives

The objectives of this project are as follows:

• to present an overall picture of ‘agile governance’, which combines regulation, corporate governance, and democratic systems
• to show the process of implementing agile governance
• to present the institutions and incentive designs for implementing agile governance, with specific examples from Japan and abroad

Achievements so far

The research project will present an overall picture of ‘agile governance’, which combines regulation, corporate governance, and democratic systems to make innovation truly beneficial for society. It also summarises the processes of agile governance in practice, as well as some institutional suggestions to incentivise stakeholders to conduct agile governance. The framework will provide a theoretical background for the agile governance initiatives taken by member states and facilitate mutual understanding among them.

Next steps

• March 2022 – publish the Agile Governance Update draft report and call for public comments
• April 2022 - close the call for public comments and seek input from Agile Nations members
• Summer 2023 - publish the final Agile Governance Guidebook

5. Digital Credentials and Digital Trust Services

This is a multilateral project led by Canada, supported by the UK, and observed by Italy and Singapore.

Project objectives

The overall objectives of the project are:

• to establish a common understanding of the digital credentials model and how it could be applied to use cases of interest to Agile Nations members
• to jointly undertake a digital credentials use case involving participating Agile Nations members, in the form of a proof of concept or a pilot. The goal is to explore and test the use case end-to-end, from the issuance of the digital credentials to a user’s digital wallet, to the use of those digital credentials to obtain services and/or complete transactions
• to identify and document the gaps in interoperability and mutual support between participating Agile Nations members regarding digital credentials and digital trust services. Once the gaps are identified, the goal is to specify the implications, document possible mitigations, and propose next steps

Achievements so far

The working group has explored and tested the regulatory and technology implications of a digital credentials use case involving participating Agile Nations members, in the form of a proof of concept or a pilot.

It has met and conducted 4 workshops, enabling the development of a common understanding of digital credentials and the exploration of possible use cases for collaboration. The working group has identified and examined 4 use cases with one selected for deeper exploration.

The Group will continue working to identify the regulatory and technology gaps and challenges involved in digital credentials and providing recommendations for addressing those gaps and challenges, whilst also enabling cross-border interoperability and mutual support for digital credentials and digital trust services.

Next steps

Joint proofs of concepts and/or pilots for digital credential use cases

By spring 2022 the working group will have:

• refined digital credentials use case, detailing the agreed upon approach, scope, activities, and stakeholders for the proof of concept or pilot
• produced a summary report for the digital credentials proof of concept or pilot, detailing the journey, lessons learned, recommendations and possible next steps

This will provide the following benefits:

• exploration and testing of the regulatory and technology implications of a digital credentials use case involving participating Agile Nations members, in the form of a proof of concept or a pilot
• provide a roadmap to enable other use cases to foster interoperability and mutual support for digital credentials more broadly

Technical and policy workshop series

• November 2022 - the working group will produce a summary report that will include key findings and recommendations from the workshop series for enabling interoperability and mutual support for digital credentials and digital trust services between participating Agile Nations

6. Cyber Security for Consumer Connected Products

This is a multilateral project led by the UK and supported by Canada and Singapore.

Project objectives

Connected products offer tremendous economic and social benefits, but appropriate cyber security requirements must be built into these products by design, rather than placing this burden on consumers.

The UK, Canada and Singapore are working together to promote and support the development of international standards and industry guidance, to foster innovation, and to explore schemes or programs that incorporate internationally recognised security requirements.

Achievements so far

The Agile Nations has provided an opportunity to collaborate closely and share respective views and insights on to how to encourage international alignment and continued recognition of the need to address these risks.

The project hosted a roundtable event, attended by Agile Nations members beyond our working group. This raised awareness of the issues presented by insecure consumer connected devices, and we learned about consumer opinions internationally from an expert from the UK consumer group, Which?.

The working group are continuing to develop a shared Statement of Intent. This Statement will make clear our commitment to continued collaboration and emphasise that we will all continue to promote global alignment on best practices and encourage the recognition of aligned schemes to reduce unnecessary barriers to trade and industry.

Next steps

The project is working towards publishing a Statement of Intent – the aim is to publish this by Spring 2022.

7. Joint Air Cargo Targeting

This is a multilateral project led by Canada, supported by the UK, and observed by the International Air Transportation Association.

Project objectives

The objective of the project is to develop a harmonised approach to Pre-loading Advance Cargo Information (PLACI) risk assessment including a proposed international risk referral protocol.

A harmonised risk assessment and risk referral protocol can enable risk decisions and mitigation actions to accompany shipments, reducing redundant security actions and focus on high-risk cargo.

Achievements so far

• the Joint Air Cargo Targeting (JACT) working group has met on 7 occasions including holding an industry engagement meeting with stakeholders
• the International Air Transportation Association and other government agencies have been invited as observers on the working group
• the working group has outlined the concept of joint targeting between Pre-Loading Advance Cargo Information (PLACI) programs and carried out data analysis to identify air routings and carriers that represent the best measure for success
• the main success to date has been in receiving the support and agreement from industry representatives that harmonised approaches to pre-load data and risk assessments are important and that there is value in pursuing the concept of joint targeting and risk referral between PLACI programs

Next steps

• Data Acquisition Agreement - this will allow industry stakeholders to share air cargo information with working group teams
• Joint Targeting Standard Operating Procedures (22 April 2022) - this will be a working draft on how each country can collaborate on targeting, which can also be tested in subsequent phases
• initial targeting and review results (31 May 2022) - this will provide a resultant dataset that performance measures can be applied to
• proposed international framework for joint targeting and risk referrals (31 May 2022) - this will be a drafted and evidenced proposal for collaboration between PLACI programs
• high risk cargo referral tabletop exercise (10 June 2022) - this is a venue in which the working group and key stakeholders can review proposed framework and the resultant dataset to refine referral and response protocols

8. Agri-Tech

This is a multilateral project led by the UAE, supported by the UK, and observed by Singapore.

Project objectives

The project aims to develop a national policy on utilising treated sewage effluent (TSE) and biosolids in Controlled Environment Agriculture (CEA) to enhance food and nutrition security in the UAE and internationally. The development and application of the UAE national policy on the utilisation of TSE and biosolids in CEA will achieve the following objectives:

• enhance the safe usage of treated wastewater in agricultural and food production in CEA
• minimise risks of treated wastewater use to public health and the environment
• maximise the economic benefits of treated wastewater usage in food production in CEA

Achievements so far

• an assessment of the technologies to be employed for TSE use in CEA has taken place – including the analysis of the characteristics of TSE and its suitability for CEA
• an evaluation of TSE technologies in CEA is in progress – including a review of the most suitable irrigation and fertigation technologies. An experimental proposal has been written and discussions have commenced on testing this proposal
• an optimisation exercise on TSE use in CEA to improve food production in UAE is in progress, involving the mapping of wastewater treatment plants in different emirates
• economic analysis of TSE use in CEA has been undertaken, including field surveys as well as cost-benefit analysis to assess the economic feasibility of TSE in CEA production. A draft economic model/tool on the potential analytical framework has been designed and shared with partners for review and feedback
• there is ongoing work on the assessment of safe use of TSE and food safety with existing federal and Emirate standards and guidelines are under review
• an assessment of public acceptance and awareness on the use of TSE in agricultural production is ongoing

Next steps

• by July 2022, the policy will be formulated, involving the preparation of a policy report that describes key technologies, standards, and guidelines that can encourage the safe use of TSE in the CEA
• once the project is completed, the outcome will be presented in a technical standard/guideline for TSE water in CEA application. The standard can be adopted by partners, countries, and international organisations

9. Digital Health Software Medical Devices

This is a multilateral project led by Singapore and supported by Canada and the UK.

Project objectives

As digital health technology is increasingly adopted to meet evolving clinical needs globally, cooperation between Agile Nations member nations can help ensure appropriate governance and timely patient access across markets.

The working group’s aims are as follows:

• to explore information-sharing and work-sharing processes to facilitate cooperation and timely access of innovative digital health devices to multiple markets
• to leverage each agency’s expertise and experience to enhance evaluation quality, while minimising work duplication for the review of the same device

Achievements so far

The working group set aside time to explore, share and understand:

• each nation’s processes and regulations for digital medical devices
• areas of interests in the digital medical devices foray, including AI and regulating medical devices that incorporate machine learning

Despite the ongoing fight against the pandemic, I am heartened that health regulators found it useful to use this platform to discuss their interests and concerns with regard to Digital Health Medical Devices. As digital health technology is increasingly adopted to meet evolving clinical needs globally, cooperation between member nations will help ensure appropriate governance and timely patient access in our markets.

John Nehemiah Samuel, Director, Enterprise Development Division, Ministry of Trade and Industry (MTI), Singapore

Next steps

Moving forward, the working group aspires to explore the following topics on an ad hoc basis:

• pre- and post-market reconciliation or collaboration such as joint review or seeking pre- or post-market synergies
• sharing best practices to ensure safety and quality of trained AI software devices or Machine Learning Medical devices
• expedited tracks and best practices to support novel digital health medical devices
• information-sharing via case studies of medical devices recently approved or novel medical device

10. Agile Nations Lawtech Network (ANLIN)

This is a multilateral project led by the Solicitors Regulation Authority (UK) (SRA), supported by agencies in Dubai and Canada, and observed by Singapore.

Project objectives

ANLIN is a collaborative initiative aimed at sharing knowledge and regulatory insights in key areas, including lawtech ethical standards, increasing access to justice and consumer protection, and advancing competition and innovation in the global legal market. This is achieved through regulators sharing experiences and working to help innovators navigate potential barriers by facilitating cross-border experimentation.

Its objectives are:

• to act as a collective group to co-operate and share data on innovation in respective markets and to promote lawtech globally
• to provide a forum for international collaboration on joint lawtech development work
• to develop the necessary frameworks and/or principles for co-operation with the aim of helping lawtech innovators scale across jurisdictions
• to provide an environment to help firms to understand and operate within different jurisdictions’ regulations, trial and test cross-border lawtech solutions, and explore practical lawtech issues

Achievements so far

The network has started by building working relationships with government officials, legal representative organisations, innovators, and others. This initial stage has been about understanding how legal technology is used in the respective jurisdictions. This knowledge is being used to encourage UK lawtech innovators to explore business opportunities in other markets.

The SRA has led the network to identify what types of lawtech can be universally applied and are not greatly affected by local conditions. This is aligned with existing work the SRA is carrying out. The network are interested in how lawtech can improve access to justice and outcomes for those seeking legal support, and have collated examples of this [taking place in the UAE and in Singapore.

Each legal services market in Agile Nations states are at different stages of development. Therefore, the network is looking at challenges facing lawtech adoption and potential regulatory adaptations. The network is drafting a set of principles that can be applied to innovators when approaching government departments or regulators.

A key output is identifying the role that government, their agencies, and regulators can play in creating a conducive environment for lawtech introduction and encouraging its wider application. The SRA is drawing together a series of examples from the UAE, Singapore and the UK. Recent research carried out in conjunction with Oxford University highlighted the impact lawtech skills are starting to have on employability in the legal sector, both regulated and unregulated.

There are considerable benefits in developing international cooperation to understand the application of legal technology. Its introduction is having an impact in all jurisdictions, and it is important for us to work together to develop an understanding of how legal services regulation needs to develop and create an environment for the appropriate use of lawtech.

We look forward to continuing to work together through the Agile Nations Lawtech Innovation Network and learning from each other.

Frederica Wilson, Executive Director, Policy and Public Affairs and Deputy CEO of the Federation of the Law Societies of Canada

There are huge opportunities to employ innovation and technology in professional services. Amplified Global is focused on delivering an AI-led approach to solve a universal problem; the fact that consumers struggle to read and understand legal and regulated documents.

Cutting edge AI and machine learning can provide solutions that make legal drafting processes more efficient for firms, more effective for consumers, and deliver better outcomes. And by finding new ways to make complex information simpler to understand and engage with, innovative technology can remove a major barrier to delivering access to justice. The work of the SRA has been vital in helping Lawtechs like Amplified to understand the challenges, and to shape innovation in the sector. Initiatives like Agile Nations will help to take that important work further.

Ewan Willars, Regulatory Lead at Amplified Global

The Agile Nations work provides international input to the work we, at the Solicitors Regulation Authority, are carrying out on innovation and technology. In our corporate strategy we have a specific objective to support the adoption of legal technology to increase access to justice. We believe technology has the potential to help better meet the needs of the public and businesses, as well as bringing broader economic benefits.

At this stage of our work, we are building our understanding of technology, its impact on the legal services sector and on our regulation, as well as the benefits and risks for the users of legal services. The Agile Nations Lawtech Innovation Network provides the opportunity to share ideas and collaborate, which has helped us develop our thinking.

We look forward to the next phase of the collaboration as the UK passes the chairing of the network over to the UAE in April, and more nations take part.

Anna Bradley, Solicitors Regulation Authority Chair

Next steps

By October 2022, the ANLIN will:

• develop an approach to information sharing through a portal and encourage other international partners to share knowledge. This will encourage lawtech innovators to expand into new markets by improving the initial approach
• work on how to overcome any regulatory processes that may inadvertently be inhibiting lawtech development
• build on our own access to justice project and other evidence from the UAE and Singapore, to show how lawtech can offer tangible improvements in access to justice outcomes
• showcase examples where governments and regulators are creating a favourable environment for lawtech to develop – for example, lawtech sandboxes tech and data friendly legal structures, online court processes, trials, and pilots
• identify the benefits that lawtech skills and training bring to the sector and provide case studies of how it is working successfully

Next steps for the network

The UAE will commence Chairmanship of the Agile Nations from April 2022 for the next 12 months. The UK is working closely with the UAE to handover the Chair and welcomes the UAE’s strong ambition to bring together regulators, innovators, and business leaders to find solutions to the challenges facing our economies.

Under the UAE’s Chair, the network will pursue the following priorities:

• creating a knowledge sharing platform to support agile governance
• collaborating on new and agile regulation for the New Economy
• collaborating on innovation friendly regulation to govern the metaverse and related concepts

With thanks to the following partners for their work in leading Agile Nations Projects and for their contributions to this report:

• Danish Business Authority
• Department for Digital, Culture, Media & Sport (UK)
• Health Science Authority (Singapore)
• Innovation, Science and Economic Development Canada
• Ministry of Climate Change & Environment (UAE)
• Ministry of Economy, Trade and Industry (Japan)
• Ministry of Trade and Industry (Singapore)
• Solicitors Regulation Authority (UK)
• Standards Council of Canada
• Transport Canada