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UNIVERSITAS GADJAH MADA

Regulatory Sandbox: Solution to Support Digital Health Innovation in New Habit Adaptation Era

The Covid-19 pandemic 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 that users’ quality and safety 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. Indonesia has implemented this innovation throughout the Financial Services Authority and has only focused on financial technology 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 essential to test regulations based on society’s actual 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’ demands. 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 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. OJK hopes that rigid regulations will not restrict technological developments through the light touch and safe harbor approach. 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.

The UGM Tropical Medicine Center’s research team is currently 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 help the target of complete 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.

Source: https://ugm.ac.id/id/berita/20160-regulatory-sandbox-solusi-pendukung-inovasi-kesehatan-digital-di-era-adaptasi-kebiasaan-baru

 

 

 

 

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