Lesson Learned from Digital Health Innovation Regulatory Sandbox �towards Health Innovation Sandbox

Lesson Learned from Digital Health Innovation Regulatory Sandbox towards Health Innovation Sandbox - MOH Indonesia Regulatory Sandbox Team: Can a regulation help to solve the challenge in harnessing the benefit of health technology innovation?

1. May 2024 By Regulatory Sandbox Team MoH Indonesia Lesson Learned from Digital Health Innovation Regulatory Sandbox towards Health Innovation Sandbox

2. Back ground

3. Urgency of Regulation in Managing Disruptive Innovation in Indonesia Telehealth E-Pharmacy Biotechnology Artificial Intelligence Benefit Improving accessibility and quality of healthcare service regardless physical and geographical barrier Prohibition of cross border consultation Challenge Health Technology Improving convenience for patient to order medicine from pharmacy Standard of KYC mechanism for digital medical receipt Creating precise and personalized medicine or supplement for optimum health benefit Regulation to protect sensitive human genomic data Potential improvement for health data analysis Ethical issues regarding the failure or error of an AI Can a regulation help to solve the challenge in harnessing the benefit of health technology innovation?

4. Cross country comparative & national desk study on the practice & regulation of telehealth provided by development partner The ministry of health learn about the regulatory comparison through Tony Blair institute (TBI) ’s desk study on Indonesia Telemedicine Regulation Mapping and Benchmark in the presented graphic. Furthermore, UNDP conduct a series of telehealth webinar an policy brief on telehealth, that emphasize: Research will be held by Thinkwell in the practice of telehealth in Indonesia. The need to organize a multi-stakeholder platform for the development of telemedicine regulation to create comprehensive telemedicine regulation. The importance to Address the needs of marginalized and vulnerable populations and align future regulations with telemedicine’s intended and legally established purpose to prioritize these populations. Clarify the scope and standards of telemedicine implementation in Indonesia and ensuring data storage, ownership, and security governance associated with telemedicine. 3 2 1 Case study: Telehealth

5. Pilot Regulatory Sandbox for eMalaria Health Technology (1) Regulatory Sandbox for eMalaria : is an implementation research, a collaboration from Gadjah Mada University, the Ministry of Health, and other partners to test the feasibility of regulatory sandbox model for adopting disruptive technologies in the malaria program . Four cluster of technologies were chosen : a) telemedicine, b) external quality assurance , c) survellance and d) other supporting technologies for malaria Name of technology: Lorem ipsum dolor sit amet, consectetur adipiscing elit. Lorem ipsum dolor sit amet, consectetur adipiscing elit. Lorem ipsum dolor sit amet, consectetur adipiscing elit.Lorem ipsum dolor sit amet, consectetur. Scenario & Live Test - Simple user acceptance test - Medical scenario test - Security assessment test - Technology assessment test - Live testing Result: There are 2 out 5 technology that was passing the scenario & live test standard Challenge on telemedicine technology implementation: 1. Direct to patient telemedicine regulation is unavailable 2. A subject of debate among clinician 3. Limited support from the health industry Telemedicine Cluster X Image or Icon of technology provider 1 2 3 4 Source: University of Gadjah Mada - Researcher for Pilot Regulatory Sandbox for Malaria

6. Pilot Regulatory Sandbox for eMalaria Health Technology (2)

7. An option of regulatory approach in managing disruptive health innovation Practice of regulatory sandbox across the globes as a mechanism to regulate disruptive innovation in health & finance technology sector The option to use regulatory sandbox as mechanism to oversee and coach Health Technology Innovation in indonesia (including the prioritized telehealth regulation) New Regulation on particular health tech Learning on Disruptive Health Tech Innovation Through Identifying cluster of health technology & Regulatory Sandbox Mechanism 1 2 3 4 inspired learning & adopting inspired learning & adopting learning & adopting learning & future partnership 5 6 7 Cross country comparative & national desk study on the practice & regulation of telehealth. Inter-organizational collaborative learning process through piloting of regulatory sandbox for malaria related health technology in Indonesia Success story of regulating the disruptive financial technology sector through regulatory sandbox implementation In Indonesia

8. Digital Health Innovation Regulatory sandbox Implementation

9. About Regulatory Sandbox Digital Health Innovation Disruption Regulatory Sandbox Disruption Risks Learned and Mitigated through Testing Environment & Recommendation Scheme Evidence-Based Regulatory Development Recommendations Without Regulatory Sandbox With Regulatory Sandbox Unmitigated Disruption Risks Regulatory Sandbox is a testing mechanism for health digital innovation providers conducted by the Ministry of Health Indonesia to assess the reliability of business processes and models, technology, governance. Lessons learned during the testing process can become recommendations for the development of evidence-based regulations.

10. 10 Legally, the existing regulation of telehealth during the COVID-19 pandemic (the minister decree no 4829 0f 2021) will not be applicable after the pandemic ends. Therefore, the post-pandemic regulation for telehealth should be prepared. To expand the existing telehealth services, improve regulation of telemedicine ( Ministry Health Regulation No 20 of 2019 ) , and regulate the telehealth cluster . Regulatory Sandbx …

11. The procedures for implementing the regulatory sandbox have been determined by the Minister of Health based on the Decree of the Minister of Health of the Republic of Indonesia Number HK.01.01/MENKES/1280/2023 on Developing a Digital Health Innovation Ecosystem Through the Regulatory Sandbox Governance substance supervisor Regulation and Ethics Clinical Licensing Financing Industrial substance supervisor Telehealth Telepharmacy On-demand marketplace Other health digital innovations Regulatory Sandbox Team: Protector: Minister of Health Director Chairman Technical Supervision Team Supervisor of Industrial Substances Governance Substance Supervisor Sandbox Regulatory Secretariat Team Sandbox Regulatory Panel Team Regulatory sandbox panelists are facilitated by the secretariat and appointed in a separate Decree (at the level of Head of Centre of Data and Information Technology/Secretary General). REGULATORY SANDBOX GUIDELINE MINISTRY OF HEALTH INDONESIA Regulatory Sandbox Guideline

12. Digital Health Innovation Regulatory sandbox Implementation 2023 Registrant Innovator Regulatory Sandbox Registration Monitoring, Participatory Supervision (Parallel to Pilot - Coaching Phase) Calon Peserta Rekomendasi Record Testing Trial Verification & Validation Recorded Innovators Innovators are Selected and Categorized According to Clusters Deepening Business Models Scenario Trials Live Test Passed Live Test Recommendation Assistance Not Passed/Needs Further Improvement Revision Recommendation Given Coaching Status Recorded Supervised Assisted Socialization Repeat Process Extended Recommendations Recommendation Revocation 2 months 6 months - 1 year 1 year Result Review Recommended The Role of the Sandbox Regulatory Panel Team P P P P P P

13. AVAILABILITY QUALITY ACCEPTABILITY ACCESSIBILITY AAAQ Policies and innovations continue to change and adapt to each other, but fulfilling people's rights must be the main goal The regulatory sandbox for digital health innovation is organized using AAAQ principles Accessibility Physical access : Financial access ; Bureaucratic / administrative access : Social access ; Information access. Availability Are services adequate in terms of quantity and type? Acceptability ethical standards and professionalism social and cultural factors satisfactory or well received by customers or provider Quality Effective , safe , human/ user centered , timely , standardized and consistent , efficient and integrated with other services

14. What do we get from the regulatory sandbox process for digital health innovation?

15. Organization and business The maturity levels and scales of the Digital Maturity Index vary The number of employees ranges from 11 people to 1400 people The composition/structure of a company team varies depending on the business model Until mid-2023, all companies will experience positive YoY growth in the range of 20%-350% Product/ Service The services offered are varied: telemedicine, telemonitoring, tele-KIE, telepharmacy , health market, teleconsultation and wellness Most of the services can be accessed via the website, iOS and Android Anticipating internet network limitations, some companies provide chat-based services, low bandwidth video calls, and lite versions of applications. Most companies use bank transfer to e-wallet payment methods Users Companies with a B2C business model have a user range from 2700 people to 20 million users; partners with 2 to 76 thousand doctors; collaborates with 30 to 3000 health facilities; collaborates with 188 to 5000 pharmacies The company with a B2B business model collaborates with dozens of companies and around 2000 workers Regulatory sandbox provides insight into the business models of various digital health innovations

16. Definition and scope Registration, supervision, coaching Quality of service and user safety Data Security Bentuk inovasi dan model bisnis beragam, mempersulit pengelompokan dan pengaturannya Pendaftaran dan pencatatan belum dilakukan di sektor kesehatan . Belum terdapat mekanisme pengawasan dan pembinaan . Pendaftaran dan pencatatan belum dilakukan di sektor kesehatan . Belum terdapat mekanisme pengawasan dan pembinaan . Belum semua penyelenggara melakukan penyaringan pasien sesuai kriteria kelayakan. Belum semua memiliki batasan kondisi medis yang boleh dilayani. Service Output Pengkodean diagnosis sulit mengikuti ICD-10. Peresepan elektronik belum terstandar . Kebanyakan layanan tidak terintegrasi dengan sistem rujukan . Competence and qualifications of service providers Service provider's license and practice schedule Jadwal praktik daring tidak sesuai dengan SIP. Penyelenggara layanan bermitra langsung dengan tenaga kesehatan , tanpa melalui fasilitas kesehatan . Cross country service Belum ada aturan jelas mengenai penyelenggaraan layanan yang melibatkan tenaga medis atau kesehatan asing . Terdapat isu akses data kesehatan lintas negara. Personal data and medical records Belum semua informasi kesehatan individu dikelola dengan standar rekam medis . Belum ada standar interoperabilitas . Accessibility and inclusivity Financing Belum ada mekanisme pembiayaan dengan JKN. Pembiayaan terutama lewat OOP dan asuransi swasta, lewat pihak ketiga. Prosedur keamanan data belum sesuai standar , termasuk pengujian keamanan dan ketahanan siber . Beberapa layanan menggunakan aplikasi pihak ketiga . Layanan sulit diakses penyandang disabilitas . Kebanyakan layanan belum sensitif gender atau kondisi psikososial pengguna . Patient eligibility Perlu penyesuaian kompetensi di ranah digital. Belum semua penyelenggara layanan memberikan pelatihan terstandar . Regulatory sandbox maps potential risks and policy issues in providing telehealth

17. Definition and scope Registration, supervision, coaching Quality of service and user safety Data Security Mengkaji kembali definisi dan ruang lingkup . Dapat mengatur aktivitas tanpa mengkategorikan layanan digital. Harmonisasi kebijakan lintas kementerian . Mewajibkan kemitraan dengan fasilitas kesehatan . Mewajibkan penyelenggara memiliki kerangka mutu . Menyusun pedoman dan standar layanan . Membuat pedoman dan mewajibkan adanya mekanisme penyaringan kelayakan. Service Output Competence and qualifications of service providers Service provider's license and practice schedule Mewajibkan penyelenggara melaksanakan kredensial. Penyesuaian jadwal praktik daring dengan SIP. Cross country service Menyusun aturan yang jelas terkait layanan lintas negara, sesuai dengan aturan-aturan lain yang sudah ada (mis. izin praktik dokter asing ). Personal data and medical records Accessibility and inclusivity Menetapkan ruang lingkup rekam medis serta standar penyelenggaraannya dalam layanan teleksehatan . Financing Mengkaji kemungkinan pembiayaan dengan skema JKN. Melakukan pengawasan terhadap aspek pembiayaan layanan telekesehatan . Menetapkan standar keamanan dan mewajibkan penerapan kebijakan & prosedur standar keamanan data sebagai syarat izin usaha . Membuat pedoman aksesibilitas dan inklusivitas. Patient eligibility Membuat mekanisme dan menunjuk lembaga /unit yang menjalankan fungsi tersebut . Edukasi masyarakat untuk memilih layanan yang telah dibina . Mewajibkan penyelenggara menyediakan orientasi . Mempertimbangkan standar kompetensi dan pelatihan khusus layanan telekesehatan . Mempertimbangkan sistem pengkodean lain, misalnya ICPC. Membuat standar peresepan elektronik . Mengintegrasikan layanan ke sistem rujukan nasional . Regulatory sandbox produces policy recommendations for the implementation of telehealth

18. After following the regulatory sandbox, service providers will receive a recommendation for a corrective action plan . In the live testing process , organizers can also interact directly with testers to get feedback , including with people with disabilities who provide input regarding aspects of service accessibility . . Regulatory sandbox provide recommendations for service improvements for telehealth service providers

19. Regulatory Sandbox Recommendation Mei 2024

20. In 2023, there are 15 digital health innovations that participate in the Regulatory Sandbox

21. Regulatory Sandbox recommendation Digital Health Innovation Initial Recommendation Status (December 2023) Recommendation status after making adjustments (April 2024) Good Doctor Conditional Recommendation Full Recommendation Halodoc Conditional Recommendation Full Recommendation Alodokter Conditional Recommendation Full Recommendation SIRKA Conditional Recommendation Full Recommendation Sehati TeleCTG Conditional Recommendation Full Recommendation Naluri Conditional Recommendation Full Recommendation

22. Providers of Digital Health Innovation who are fully recommended and then receive the status of ' Discovered by the Indonesian Ministry of Health ' will receive : Guidance from the Indonesian Ministry of Health , and Has the right to use the logo ' Developed by the Indonesian Ministry of Health ' in accordance with the provisions of applicable laws and regulations

23. Health sector sandbox development plan

24. Health sector sandbox development plan Innovation Lab Development of innovation before use Industrial Lab Expanding the utilization of innovative products / services that have been used Regulatory Sandbo x Formation and testing of innovation-based regulations There are already regulations There are no regulations yet i Clusters that have not been accommodated * Health Management Solutions Health Services Search Insur Tech Medical Diagnosis Patient Solutions Medical Education Online Health Communities Online Marketplace Population Health Management Safety & Securities Remote Monitoring Research Veterinarian Wellness Healthcare Logistics Others * from Gallen Growth Sandbox Development Indicators : National Priority Health Program Implementation of innovation in society Investment and industrial development at Indonesia and abroad ✅ ✅

25. Sandbox Implementation Plan in 2024 INNOVATION SANDBOX INDUSTRIAL SANDBOX REGULATORY SANDBOX Create an innovation sandbox guidelines Create an industrial sandbox guidelines Create an regulatory sandbox guidelines 2024 No Implementation in 2024 ( piloting only ) No Implementation in 2024 ( piloting only ) Supervision of regulatory sandbox batch 1 Implementation of the regulatory sandbox batch 2 uses the 2023 Regulatory Sandbox guidelines Supported by USAID-CHISU Supported by Thinkwell Supported by British Embassy Jakarta Expert Panel, Implementing Partner 1.0, and Regulatory Sandbox Team

26. Characteristics of the Digital Innovation Sandbox based on the level of maturity and the goals of the sandbox program INNOVATION SANDBOX INDUSTRIAL SANDBOX REGULATORY SANDBOX Innovation maturity the early stages of innovation the initial stage of innovation towards development expansion of innovation implementation the initial stage of innovation towards development Medium and high maturity levels Program Objectives Proof of Concept innovation from various aspects Development of ideal integration business processes Integration Process Testing with existing systems Standard integration testing from various aspects Strengthening Public Private Partnerships Focuses on strengthening systems at subnational levels Testing for gap analysis between innovation and policy Testing existing regulations and gaps in the field Program Duration 6 – 12 months 6 – 12 months 6 – 12 months Output targets Proof of concept and piloting test results Standardization of technical aspects and business processes Development of standard operating procedures Expanding integration with existing health systems and health information systems Strengthening Public Private Partnerships Policy recommendations for developing regulations based on aspects of test results Harmonization of existing regulation

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