Innovation continues to evolve at great speed, yet investment in and meaningful action to address healthcare challenges remains fragmented and is decreasing. The AI revolution comes at a time of acute political polarization and dramatic scaling back of funding for development programmes that support some of the most vulnerable people on the planet. Crucial decisions relating to regulation, ethical frameworks and governance structures will shape how both digital health and AI continues to develop and will have long-term repercussions. There is a need for appropriate guardrails.
Digital technologies can offer new health solutions. According to World Bank data, within challenging fiscal environments, people-centered and evidence-based digital investments can help governments save up to 15 percent of health costs. The World Health Organization & International Telecommunication Union ‘Going Digital for Noncommunicable Diseases – The Case for Action‘ shares how investing an additional $0.24/patient/year in telemedicine, mobile messaging and chatbots will save 2 million lives and an additional $199 billion in economic benefits realised.
However, the health sector faces significant challenges ranging from the low adoption of digital tools to inadequate data usage. It is estimated that some countries use less than 5% of health data to improve health. Lack of infrastructure, interoperability and easy access to the right data in one centralised repository and secure storage and access to personal health information is an ongoing challenge for many.
Countries are exploring new ways to foster innovation and deploy digital tech solutions in their public services. Many are looking for spaces where they can both learn about and test new digital health solutions before they commit to adoption at scale. Another imperative is to learn how to create enabling environments for health innovation and support the development of new data governance policies and practices that really speak to the context. Sandboxes are rapidly emerging as useful tools to provide a flexible way to test data-intensive technologies, and catalyze homegrown solutions to address local and cross-border health challenges.
Sandboxes are defined as safe spaces to test new technologies and practices against regulatory frameworks and facilitate experimentation with innovative use of data. Sandboxes were initially used in the FinTech space, and are now being applied to new sectors—from transportation to telecommunications to healthcare, and can be operational, regulatory, or hybrid. Since 2022, the Datasphere Initiative has been researching their potential as tools for responsible data-sharing and testing and iterating regulations for emerging technologies.
Let’s take the example from Indonesia of Kementerian Kesehatan, officially abbreviated to Kemenkes. In 2023, the Ministry of Health launched a regulatory sandbox to support the development of the digital health innovation ecosystem and telemedicine was included. Much like the regulatory sandbox model applied to Fintech, the sandbox was a testing mechanism for digital health innovation led by the Ministry of Health in collaboration with various experts, and included both the public and private sector. The regulatory sandbox assessed the reliability of business processes and models. The sandbox also encouraged service providers and regulators to jointly explore innovative business models and analyze risks to society while allowing the development of regulations that actively support the implementation of these new technologies in the health sector. The test process generated learnings that resulted in solid recommendations for the development of evidence-based regulations in the health sector. The regulatory sandbox approach has supported hospitals to strengthen consumer protection and patient safety, including personal data of service users. The sandbox has also been beneficial to the pharmaceutical industry, especially for health technology developers, as it has allowed for the issuance of temporary regulations in the form of recommendations and guidance for those who pass the supervision process thereby strengthening the industry to test and evolve. The government also prepared recommendations to help the implementation of this mechanism that could develop more specific policies and regulations in the field of data-based health technology.
In the UK, due to regulatory reform and a marked increase in innovative health devices entering the UK market, the Medicines and Healthcare products Regulatory Agency (MHRA) decided to set-up a regulatory sandbox to explore Artificial Intelligence as a Medical Device (AIaMD). The goal of setting up the sandbox was to balance appropriate oversight to protect patient safety with the agility needed to respond to the particular challenges presented by these products to ensure regulation does not present undue barriers to innovation. The MHRA AI Airlock was launched in Spring 2024 and is the MHRA’s first regulatory sandbox for AI as a Medical Device (AIaMD) products. Using real-world products, the AI Airlock brings together expertise from within the MHRA and key partners including the UK Approved Bodies, the NHS and other regulators. The outputs will inform subsequent AI Airlock phases in the short term, and future MHRA guidance and policy in the longer term, while exploring any limitations of existing approaches to demonstrating regulatory compliance.
Cross-border health sandboxes hold immense potential to facilitate international collaboration and data-sharing on health. Investment and support for these initiatives such as the sandbox being explored by Africa Centre for Disease Control and Prevention are crucial to foster health innovation and interoperability of data-driven health solutions.
While these examples are inspiring, knowledge about their more long-term impact and lessons learnt are largely unknown and undocumented. Policymakers, health ministries, health tech innovators, civil society organizations and academia would all benefit from learning about such sandbox examples and exploring their potential to assist with the digital health challenges they face.
The Datasphere Initiative and the Asia eHealth Information Network (AeHIN) are exploring ways to foster knowledge sharing on health sandbox applications, opportunities and identify challenges regulators face when designing a sandbox to tackle a specific health challenge in their country or region. We are looking for partners as we seek to share how a sandbox approach to innovation could equip governments and development agencies with new and innovative ways and means to deliver health services.
Watch the webinar on ‘Exploring Sandboxes in the Health Sector: Why, When, and How to Support Responsible Innovation?’ here. This was organized in partnership with Datasphere Initiative, Asia eHealth Information Network (AeHIN) and the Global Telehealth Community of Practice.
