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  • Regulatory Sandbox: Supporting Digital Health Innovations in the New Habit of Adaptation Era

Regulatory Sandbox: Supporting Digital Health Innovations in the New Habit of Adaptation Era

  • 02 October 2020, 17:06 WIB
  • By: Natasa Adelayanti
  • 717
  • PDF Version
Regulatory sandbox : Solusi Pendukung Inovasi Kesehatan Digital di Era Adaptasi Kebiasaan Baru

The occurrence of the Covid-19 pandemic nowadays has increased the use of telemedicine by the public. This condition is related to President Jokowi's statement that revealed the use of telemedicine through an application in collaboration with the Indonesian Ministry of Health increased from 4 million to 15 million.

Although specific telemedicine regulations guarantee the quality and safety of services for users are not yet available, a circular from the Ministry of Health, which provides flexibility in technology-based health services, is available.

Still, several innovations related to pandemic direction have arisen, one of which is related to a new health regulation approach, namely the regulatory sandbox. Throughout the Financial Services Authority and only focuses on financial technology, Indonesia has implemented this innovation since 2018. Regarding the health sector application, we can see an example from Singapore that has applied it to telemedicine and mobile health.

This regulatory sandbox is highly essential to test regulations based on society's real conditions more quickly and precisely. Moreover, the formation of regulations at the national level requires a long time and considerable resources. The regulatory sandbox can also bridge the needs between developing the digital health industry and health regulators' needs. This condition is due to the process that requires the two sectors to cooperate intensively.

Understanding this, the Malaria Management research team from the UGM Tropical Medicine Center collaborated with the Indonesian Ministry of Health and funding from the Ministry of Finance's LPDP Innovative Research (RISPRO) presented an online seminar entitled "Opportunities and Challenges of Digital Health Regulatory Sandbox to Support Malaria Elimination" on last Thursday (24/9).

In this seminar, Praveen Raj Kumar, a representative of the Ministry of Health Singapore, performed his experience in implementing a regulatory sandbox to protect telemedicine service users' safety and various health startups. Their program is known as the Licensing Experimentation and Adaptation Program (LEAP).

Throughput this way, Praveen said that their regulation was no longer reactionary, but anticipatory. "Even though the law on telemedicine will only be launched in 2022, but the government guarantees consumers' access to quality telemedicine services through this program," he explained.

Lim Wei Mun, CEO of Doctor Anywhere, a startup that successfully passed the regulatory sandbox program, shared its benefits for startups. According to him, investors feel safer when they are investing in startups. "When expanding its business outside Singapore, the licensed label in the regulatory sandbox program also provides added value," he said.

The experience of implementing the regulatory sandbox for Indonesian financial technology was described by Maskum, Digital Financial Innovation advisor at the Financial Services Authority. Through the light touch and safe harbor approach, OJK hopes that rigid regulations will not restrict technological developments. Successful startups undergoing the regulatory sandbox program at the OJK are increasing with various specialties in financial technology.

From a legal perspective, Rimawati, a lecturer at the UGM Faculty of Law, pointed out the importance of progressive law in anticipating disruptive innovations that are often not related to existing (positive) legal regulations. "Regulatory sandbox, as a form of progressive law, is possible to be applied in the health sector as long as it does not harm legal certainty, benefit, and public justice," he explained.

Currently, the UGM Tropical Medicine Center's research team is formulating a regulatory sandbox governance model to support malaria elimination. The research team had previously developed a digital model for malaria diagnostic external quality assurance (PME), which has received IPR (Intellectual Property Rights) recognition.

The malaria program policy expects that 90 percent of health care facilities will be able to complete External Quality Assurance (PME). Only 10 percent can afford it. The existence of regulations that involve various parties (including technology actors such as startups) in supporting the malaria elimination program is expected to increase PME achievement and quality assurance in malaria diagnostics. Good governance in telemedicine could also support the target of full malaria elimination by 2030.

The research team hopes that the competent authorities will immediately take advantage of the regulatory sandbox as a policy invention. This hope aims to support access to quality health services through digital innovation in adapting to new habits today.

Author: Hakam
Photo: Wartaekonomi.co.id
Translator: Natasa A

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