Introducing a Regulatory Sandbox Into the Indonesian Health System Using e-Malaria as a Use Case: Participatory Action Study

Introduction

Background

Regulatory sandboxes have been widely implemented in the financial sector to facilitate adoption of disruptive technologies. More than 50 countries, including Indonesia, have adopted this framework [1]. The COVID-19 pandemic has further underscored the importance of regulatory sandboxes, as evidenced by the use of emergency authorization for COVID-19 vaccines [2,3]. Although regulatory sandboxes have been used in a number of health sectors in high-income countries [4,5], their adoption remains very limited in low- and middle-income countries, including Indonesia.

Regulatory sandboxes in the health sector strike a balance between disruptive innovation and public health [2]. They created a safe testing ground in which new regulatory processes and technologies can be evaluated in real-world settings. By providing a real-world testing environment, regulatory sandboxes can provide valuable evidence on the effectiveness and feasibility of digital health interventions. This allows for the cautious relaxation of certain regulations to foster innovation, while ensuring that new technologies undergo validation before widespread implementation. Ultimately, regulatory sandboxes enable the scale-up of proven digital healthtech [3,4].

Although a framework exists for policymakers to implement a regulatory sandbox [1], there is currently no specific framework tailored to health policymakers. However, the health sector actively advocates for the implementation of digital healthtech to enhance health systems. The World Health Organization (WHO) has been at the forefront of publishing guidelines on digital health interventions, including the recent release of digital adaptation kits for specific health programs and diseases, such as WHO smart guidelines for antenatal care, family planning, and HIV [6,7]. Furthermore, an increasing number of innovative health solutions have been developed for the treatment of various diseases.

Indonesia is a thriving digital ecosystem hub in Southeast Asia, with a robust millennial population and numerous unicorn start-ups. The country has witnessed remarkable growth in the digital technology sector [8]. Notably, during the pandemic, the Indonesian Ministry of Health (MoH) collaborated with 17 start-ups to deliver teleconsultation services to COVID-19 self-isolated patients. According to the Indonesian Telemedicine Alliance, telemedicine providers have conducted a staggering 17.9 million teleconsultations during the pandemic [9]. Unfortunately, the regulatory framework for these emerging businesses remains inadequately defined, as the MoH currently lacks specific regulations governing health care start-ups. Instead, these entities primarily fall under the regulatory purview of the Ministry of Communication and Informatics as electronic system providers. This regulatory discrepancy raises concerns regarding oversight of safety and quality control for health care start-ups operating within the country.

Objectives

This study aimed to explore stakeholders’ perspectives on this issue by introducing a regulatory sandbox approach. Unlike studies that have primarily focused on well-known health issues, our investigation focused specifically on malaria, a persistent public health issue in Indonesia, particularly in the eastern region. Although there has been significant progress in reducing malaria cases over the past decade [10], advancements have stagnated since 2014 because of limited resources, funding, regulations, and challenging geographic conditions. Embracing digital technology is crucial for effective malaria elimination, aligned with the WHO Global Technical Strategy for Malaria 2016-2030 [11-13]. However, the lack of adaptive regulation of disruptive technologies poses a potential threat to the effective elimination of malaria.

The regulatory sandbox concept is relatively new to the health sector, requiring a thorough understanding and compelling use cases that present clear opportunities for involving digital innovators to join the safe testing experiment [4]. In this study, we introduced e-malaria, encompassing various digital innovations that can contribute to malaria programs, including prevention, control, diagnostics, treatment, and surveillance. Recognizing the importance of stakeholder engagement in health policymaking and regulation [14], this study aimed to explore stakeholders’ comprehension and expectations regarding the introduction of a regulatory sandbox to facilitate the adoption of disruptive technologies in the context of e-malaria.

This study is expected to contribute to the understanding of regulatory sandboxes in the global health context. Several publications have mentioned pilot projects, their limited sustainability, and their use as an alternative method to healthtech assessment [4,15]. By exploring stakeholders’ perspectives and involvement in introducing a regulatory sandbox into the Indonesian health system, specifically using e-malaria as a use case, this study aimed to provide valuable insights and contribute to the broader discourse on regulatory sandboxes in health care.

Methods

Study Setting

This study was conducted in the context of the Indonesian health system, which faces challenges related to the limited understanding of a regulatory sandbox as an example of a progressive law approach. In the Indonesian health system, there are an increasing number of healthtech companies operating without specific regulations and supervision from the MoH. Instead, these companies are primarily regulated by the Ministry of Communication and Informatics regarding the registration of electronic service providers.

To gain a comprehensive understanding of stakeholders’ perspectives on regulatory sandboxes within the Indonesian health system, we used a participatory action research approach with qualitative data collection methodology. This approach, which has been practiced elsewhere, allows for active engagement and buy-in of the stakeholders [16].

Data were collected through 7 focus group discussions (FGDs) and 2 in-depth interviews, all of which were conducted online because of the constraints imposed by the COVID-19 pandemic. This web-based format allowed remote participation and ensured the safety and convenience of participants. Data collection was conducted between April 2020 and December 2021, allowing a comprehensive exploration of stakeholder perspectives over an extended period.

By conducting this study within the specific context of the Indonesian health system, where the understanding of regulatory sandboxes is limited, we aimed to provide valuable insights that can inform policy development and decision-making processes related to health sector regulation and supervision.

Study Design

To achieve the objective of this study, we used a participatory action research approach using a qualitative methodology. Participatory action research is grounded in theoretical frameworks and previous studies that emphasize the collaboration, engagement, and active participation of stakeholders throughout the research process. It aims to generate knowledge and bring about social change by involving stakeholders at every stage of the study [17-19].

This study consisted of a series of stages, including a preliminary study, exploration of stakeholders’ understanding, introduction of the regulatory sandbox concept, and completion of the preparatory phase of regulatory sandbox trials in e-malaria (Figure 1). The involvement and contribution of stakeholders in these stages ensures that their perspectives and experiences are central to the research process. This approach also demonstrates the value of engaging stakeholders in research processes [19].

The identification of participants and stakeholders was a crucial aspect of the study design. Various stakeholders, including regulators from the MoH, innovators, academics, practitioners, and implementers or users were involved. These stakeholders were selected based on their expertise, involvement in the malaria program, familiarity with disruptive healthtech, and regulatory expertise. Their diverse perspectives and roles ensured a comprehensive understanding of the subject matter and enriched the quality of the findings.

‎

Data Collection

The data collection process involved in-depth interviews and FGDs to gather comprehensive insights into stakeholders’ perspectives regarding the introduction of a regulatory sandbox for e-malaria. The collected data were systematically coded and organized according to the topics discussed to facilitate analysis and interpretation.

The main points and concerns of stakeholders regarding the implementation of the regulatory sandbox were identified and described. These FGDs and seminars were virtually held. In addition, we held a talk show at the launch of the e-malaria regulatory sandbox guidelines, which was attended by stakeholders and the media.

All sessions, including FGDs, interviews, and talk shows, were recorded and transcribed to ensure accuracy during the data analysis phase. These transcriptions serve as valuable resources for capturing the nuances and details of stakeholders’ perspectives of this new approach. Guidelines for FGDs and interviews were developed to ensure consistency and facilitate gathering of perspectives from diverse groups of stakeholders. These guidelines served as a framework for the data collection process, ensuring that key topics were explored and enabling a thematic analysis of the collected data.

To provide a comprehensive overview of the study, Table 1 outlines the role of stakeholders at various stages of the research process, whereas Tables 2 and 3 present the themes and participants involved in FGDs, virtual seminars, and talk shows. These tables offer a clear snapshot of the data collection methods and participants involved in each phase of the study, aiding in the organization and interpretation of the findings.

In addition to the primary data collection methods, a desk review of the relevant Indonesian policies and regulations related to digital health and malaria was conducted. This review provides a contextual understanding of the existing landscape of various disruptive healthtech, especially those in malaria, and an analysis of stakeholders’ perspectives.

For in-depth interviews and FGDs, the interviews and FGD instruments are available in Multimedia Appendix 1, with detailed information on the questions and prompts used to elicit stakeholder responses. The number of FGD respondents is presented in Table 2, demonstrating the size and diversity of the participants involved in FGDs. In cases where opinions were not homogenous within an FGD, in-depth interviews were conducted to capture a more nuanced understanding of stakeholders’ perspectives. To ensure ethical considerations, all the informants who participated in the FGDs and interviews received compensation for transportation costs or internet quotas, acknowledging their time and contribution to the research process.

Data Analysis

Thematic analysis was used to analyze the collected qualitative data. The research team members collaborated to develop the research protocol and identify thematic issues. A total of 2 researchers (AT and RAK) took the lead in developing probes and interview questions for in-depth interviews and FGDs, respectively. To verify the results, team members evaluated and discussed the theme analysis. This iterative procedure provides many perspectives and interpretations that improve the reliability of findings. Thematic analysis began in Indonesian, the data collection language. The analysis was translated into English to publish the findings. For further inquiries or access to qualitative data, interested parties may contact the research team directly.

Ethical Considerations

This study was approved by the Ethics Committee of the Faculty of Medicine, Public Health, and Nursing at Universitas Gadjah Mada (KE/FK/0644/EC/2020). This ensured that the research was conducted in accordance with established ethical standards, thus safeguarding the rights and risks of the participants.

Results

Overview

This section presents the findings that explain the 4 stages of the study: the preliminary, exploration, introduction, and preparatory phases of the regulatory sandbox for e-malaria. To provide a clear and comprehensive description, 4 tables, 2 figures, and 4 textboxes are included to illustrate the perspectives of the stakeholders and their involvement in this study.

The findings discussed in this section include the roles of stakeholders, the detailed activities of FGDs and virtual seminars, and tables that provide an in-depth analysis of the issues and concerns raised by stakeholders in each phase (Tables 1-4 and Textboxes 1-3). In addition, a selection of quotes from the respondents is presented to reinforce the themes summarized in the tables.

The perspectives of stakeholders and their involvement in the development of the regulatory sandbox are reflected in the stages of this study as well as in activities such as FGDs, virtual seminars, and talk shows. Several findings were identified through these activities, including the challenges and limitations faced by stakeholders as well as positive aspects that could potentially support the development of a regulatory sandbox. The exploration, introduction, and preparation of the e-malaria regulatory sandbox trial were informed by a sequence of FGDs that covered diverse themes, objectives, and participants (Table 2).

In addition to FGDs aimed at exploring stakeholder perspectives, this study also conducted virtual seminars open to the public. The seminars aimed at knowledge exchange and featured speakers from the MoH of Singapore and a Singaporean start-up. The speakers shared valuable insights and experiences regarding the implementation of the regulatory sandbox, specifically discussing the Licensing Experimentation and Adaptation Programme for telemedicine in Singapore, which has been in operation since 2018. Local speakers from the Financial Services Authority of Indonesia contributed to the seminar by sharing their experiences in implementing a regulatory sandbox for financial technologies. A list of virtual seminars, participants, and their respective topics is presented in Table 3.

After the preliminary study was completed, the FGDs and in-depth interviews were divided into 3 phases: exploration, introduction, and preparation. The exploration phase determines the extent to which stakeholders recognize, are familiar with, and are receptive to the various digital technologies used to support the malaria program. In the introduction phase, the concept of a regulatory sandbox is introduced to stakeholders. In this phase, stakeholders’ acceptance of the regulatory sandbox is examined from a legal standpoint. In the preparatory phase, the research team solicited inputs from stakeholders regarding the regulatory sandbox model for e-malaria.

Preliminary Study

During the initial phase of the study, fundamental tasks were conducted to determine subsequent phases. To facilitate future progress, we acknowledge the need to draft a memorandum of understanding with the MoH. Our team had previously received a letter of support from the Malaria Program of the MoH. Although beneficial, it was insufficient to establish a firm working relationship with the MoH. In response, Universitas Gadjah Mada and the MoH signed a memorandum of understanding. Following this, a memorandum of agreement was signed between the Faculty of Medicine, Public Health, and Nursing and the MoH’s Directorate of Vector-borne Disease and Zoonosis to ensure a comprehensive program and activities. Approximately 5 months were required to establish this legal binding, during which the team investigated numerous initiatives that could be incorporated into the development of the regulatory sandbox.

Exploration Phase

This phase aimed to explore the opportunities and challenges associated with adopting various disruptive digital innovations to strengthen the malaria program through a regulatory sandbox. It involved discussions on potential digital technologies to support the malaria program as well as barriers to their implementation, particularly in terms of regulations. This phase took place between August 2020 and December 2020. Initially, the research team planned to conduct 3 offline FGDs; however, because of the pandemic, FGDs were eventually conducted virtually. Virtual seminars were organized as part of this phase. The summary of the FGDs conducted in this program includes an overview of the opportunities and challenges, technical considerations, and legal and social aspects, which are presented in Textbox 1.

During the exploration phase, stakeholders expressed doubts and concerns about the regulatory sandbox approach. Although not exhaustive, these concerns highlight the complexities and challenges associated with implementing a regulatory sandbox for e-malaria. Some notable quotes from stakeholders during this phase further illustrated these important reflections:

How do we ensure that the regulatory sandbox maintains the quality and safety of e-malaria innovations? It is crucial to strike a balance between promoting innovation and protecting public health.
[FGD 3, health practitioner]

There are legitimate concerns about data privacy and security when implementing digital health solutions. A regulatory sandbox should adequately address these issues.
[FGD 6, privacy advocate]

We need clear criteria for selecting healthtech startups to participate in the regulatory sandbox. This ensures that only promising and qualified innovations are tested.
[FGD 1, innovation expert]

These quotes signify the apprehensions and considerations raised by the stakeholders during the exploration phase. They highlighted the need for careful attention to quality assurance, data privacy, security, and a robust selection process for participation in health care start-ups. Addressing these concerns is crucial for successful implementation of regulatory sandboxes in the e-malaria domain.

Introduction Phase

This phase marked the launch of regulatory sandbox guidelines for malaria. Following an in-depth exploration of regulatory barriers and opportunities associated with implementing disruptive digital innovations, the concept of a regulatory sandbox was introduced. The introduction phase encompassed a comprehensive discussion involving the MoH and representatives from various health care start-ups in the presence of the media. The key outcome of this phase was the official release of e-malaria regulatory sandbox guidelines that underwent an open and collaborative review process.

This phase was characterized by the culmination of various issues, including technological and legal considerations, as well as stakeholder expectations, shaping the development of regulatory sandbox guidelines (Textbox 2). Discussions and deliberations during this phase addressed a range of complex issues with the goal of producing regulatory sandbox guidelines in the health sector for the first time.

The regulatory sandbox, within the context of Indonesia as an archipelagic nation, is significant as telemedicine emerges as a supportive tool in the malaria program for enhancing external quality assurance. This is expressed in the following quote:

In island areas, telemedicine is useful. Quality assurance [for malaria microscopy] can be supported by telemedicine.
[FGD 2, user of the malaria program]

Preparatory Phase

The final phase of this study involved preparation of a regulatory sandbox model for malaria. In this phase, the research team had extensive interactions with the MoH, including the malaria program, the Center for Data and Information, and the Digital Transformation Office, to prepare a team that would implement the regulatory sandbox and infrastructure required for participant registration. Input from all stakeholders was accommodated in the form of a regulatory sandbox guideline book (Textbox 3).

Throughout this study, various statements have been expressed by stakeholders reflecting the diverse perspectives and concerns held by stakeholders involved in the study. In addition to the summarized findings presented in the tables, several notable quotes highlight these perspectives. The following quotes, specifically from this phase, serve as illustrative examples:

How the Center for Data and Information MOH do start and supervise?
[FGD 7, law expert]

To protect the validity of e-malaria in the field, a legal base is needed. The principles of justice and humanity should form the basis of regulation.
[FGD 2, user of the malaria program]

Several regulations in the Ministry of Health have provided space and flexibility to adopt digital technology in supporting health programs/services. However, specific regulations and technical details have not yet been established.
[FGD 5, regulator]

These quotes exemplify the range of perspectives and concerns expressed by stakeholders throughout the study, highlighting the need for clear regulations, effective supervision, and the importance of aligning digital health initiatives with existing legal frameworks.

Buy-in of the Regulator (MoH)

As a formal demonstration of buy-in, the MoH appointed a review team to oversee the e-malaria regulatory sandbox. The review team consisted of representatives from various stakeholder groups including regulatory bodies, research teams, partners, and experts in relevant fields. Their primary role was to review and assess the quality and safety of products proposed in each cluster throughout the trial. The appointment of the reviewer’s team members and delineation of their responsibilities were officially documented in decree number HK.02.02/I/3090/2021 issued by the Director General of Disease Prevention and Control of the MoH.

The MoH’s further buy-in was shown by establishing a dedicated website for the sandbox under the domain of the existing MoH website. This website serves as a centralized platform for disseminating crucial information regarding the regulatory sandbox in healthtech communities. Furthermore, the website streamlined the registration process, ensuring convenient and efficient access to interested participants to participate in the regulatory sandbox trial. The provision of this website strongly reflects the MoH’s commitment to supporting and facilitating the regulatory sandbox initiative, demonstrating its recognition of the importance of providing an accessible and user-friendly platform for stakeholder engagement.

Key Terms of the Regulatory Sandbox

This section provides a concise explanation of the general concept of the regulatory sandbox, specifically in the context of e-malaria (Textbox 4). The key definitions of the regulatory sandbox, e-malaria, the regulatory sandbox for e-malaria, and the parties involved are provided in Textbox 4.

The definitions presented in Textbox 4 were derived from the e-malaria regulatory sandbox guidelines officially launched during the introductory phase. In alignment with the consensus reached among all stakeholders, the regulatory sandbox consists of 4 distinct clusters: external quality assurance, telehealth, surveillance, and supporting technologies. Numerous healthtech start-ups are expected to actively engage in successive regulatory sandbox phases, delineating distinct testing stages, as illustrated in Figure 2. This framework was designed to facilitate the advancement and assessment of disruptive technologies within the e-malaria domain, thereby guaranteeing their efficacy and adherence to the quality standards.

‎

Stakeholders’ Perspectives: Pros and Cons

This section highlights the achievements of the research team in involving stakeholders and discusses the pros and cons of the regulatory sandbox, as expressed by different stakeholder groups. Overall, stakeholder perspectives on the proposed regulatory sandbox for e-malaria are largely positive.

Throughout the various stages of regulatory sandbox preparation, active engagement with stakeholders enables comprehensive understanding of the regulatory sandbox concept. This collaborative process resulted in the development of guidelines and establishment of a regulatory sandbox testing team. Such participatory approaches fostered stakeholder buy-in and support for integrating disruptive technologies into the malaria program despite the absence of clear legal and regulatory frameworks.

To provide a comprehensive overview of stakeholder opinions, we documented stakeholder representatives’ viewpoints on the initiative to implement an e-malaria regulatory sandbox. These perspectives, along with their respective advantages and disadvantages, are summarized in Table 4.

Discussion

Principal Findings

This study marks a pioneering milestone in the Indonesian health sector, with the introduction of a regulatory sandbox. In the era of digital transformation, this initiative is particularly significant, as it aligns with the MoH’s vision of implementing a regulatory sandbox for disruptive healthtech. The rapid emergence of disruptive innovations poses a profound challenge to our health care system as it empowers a broader population with limited expertise and resources to access convenient and cost-effective health care services that may harbor unknown risks [20]. By implementing a regulatory sandbox, we created a safe testing environment that allows innovators to explore and refine their technologies, whereas regulators gain invaluable insights into effectively governing these transformative advancements, as mandated by the MoH’s strategic plan [21].

However, the adoption of a regulatory sandbox encounters unique challenges in the health sector of a country that adheres to positive laws despite successful implementation in the financial sector. To ensure the successful integration of disruptive digital technologies in malaria programs, it is crucial to establish a secure space where private sector entities, including healthtech start-ups and incubators, can test their innovations under regulatory supervision [20].

Recognizing the significance of stakeholder buy-in [14], this study undertook a phased exploration to understand regulators’ perspectives and concerns regarding the regulatory sandbox approach. Our approach addresses crucial aspects such as safety, appropriateness, and potential conflicts among users, innovators, and regulators. It is worth noting that incorporating malaria, given its epidemiological change [22], into the regulatory sandbox presents its own set of challenges because the current national malaria program is solely government managed and does not involve external innovative disruptions. Therefore, the introduction of a regulatory sandbox can be viewed as a democratic endeavor aimed at creating responsive and adaptable regulations that meet the growing demand for digital health services from both the community and national programs.

According to the study by Abbot [23], regulators face 4 major challenges when dealing with disruptive technologies: the pace of scientific and technological advancements, governance of risks in the face of uncertainty, effective stakeholder engagement, and coordination within a complex regulatory system. This study has witnessed the dilemmas faced by regulators in choosing between swiftly adopting promising yet unvalidated technologies to protect populations or exercising caution and awaiting robust evidence while the contagion continues to spread [4]. Throughout our research, we fostered meaningful dialogue between regulators and innovators, recognizing that in diverse populations with varying socioeconomic, cultural, and behavioral backgrounds, this approach proves to be more effective than rigid adherence to ideology.

Our study observed the successful development of dialectical collaboration among regulators, users, and providers of digital health innovations from the exploratory phase to the preparation of the e-malaria regulatory sandbox. This collaborative effort has yielded a robust framework for regulating healthtech innovations. As such, this approach represents a more democratic step toward constructing responsive and adaptable regulations for digital health service technology. Satjipto Raharjo, a prominent law expert in Indonesia, contends that progressive law enforcement involves interpreting the underlying spirit and meaning of statutes, moving beyond literal interpretation. This approach recognizes that laws are created for the betterment of humanity and should continuously evolve to achieve justice within society. Law enforcement officials must engage in philosophical thinking to liberate knowledge, engage in theoretical discourse, and apply their insights to practice [24].

The concept of testing policy changes before enforcement aligns with sociological jurisprudence, which delves into legal studies beyond written rules to consider the practical effects and consequences of law enforcement. The elimination of malaria poses social and humanitarian challenges. Relying solely on existing positive law regulations may impede progress, as laws often lag behind current realities. Embracing a more flexible and liberal framework, such as the progressive law approach, empowers regulators to address this challenge effectively [25].

This study introduced a regulatory sandbox to facilitate contributions from external stakeholders, including innovators, civil societies, and industry professionals who are eager to contribute to malaria elimination efforts. However, these contributions would be in vain if regulators were unwilling to create a regulatory system that would nurture and embrace technological growth and innovation. Therefore, the regulatory sandbox provides an enabling environment where regulators can explore new innovations, such as digital interventions for malaria, while granting innovators the freedom to develop and advance their technologies within the boundaries of the law [26].

This study provides valuable insights into stakeholders’ perspectives on the regulatory sandbox approach in the health care sector. This adds to the existing literature on regulatory sandboxes, particularly in low- and middle-income countries, by examining the specific context of malaria. The findings reveal stakeholders’ positive expectations of this innovative regulatory approach in managing disruptive technologies. Furthermore, a comparison can be made with regulatory sandbox initiatives in other countries, such as Singapore’s Licensing Experimentation and Adaptation Programme and Malaysia’s Online Health Service Regulatory Lab [5,27]. This study opens new avenues for future research and the implementation of regulatory sandboxes in public health, offering potential solutions to the challenges of malaria elimination and other health care issues.

Conclusions

In conclusion, the successful introduction of new innovations such as the regulatory sandbox relies heavily on the active involvement of stakeholders. Our study, which encompasses several phases of exploration, introduction, and conceptualization of the regulatory sandbox for the relatively unfamiliar domain of malaria, demonstrates the efficacy of a participatory approach. Through active engagement and collaboration with stakeholders representing diverse interests, we successfully developed the first-ever model of a regulatory sandbox for the Indonesian health sector. Future publications will delve into the challenges encountered during e-malaria regulatory sandbox trials and will provide a detailed account of the implementation process.