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PROSES DAN TANTANGAN PERSETUJUAN IZIN EDAR ALAT KESEHATAN BARU DI INDONESIA: STUDI LITERATUR ATAS PERMENKES NO. 62 TAHUN 2017 DAN UU KESEHATAN 2023 Gunawan Widjaja; Wagiman; Dyah Ersita Yustanti; Hotmaria Hertawaty Sijabat; Handojo Dhanudibroto
Jurnal Kesehatan Vol. 3 No. 2 (2025): JULI
Publisher : CV. Adiba Aisha Amira

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The approval process for new medical devices in Indonesia is a strategic step to ensure the safety, quality, and usefulness of products circulating in the community. This study aims to critically analyse the administrative and technical licensing process for medical devices based on Permenkes No. 62 of 2017 and the Health Law of 2023 through a literature review. Primary data were obtained from an in-depth review of regulations, policy documents, and other relevant research findings. The study findings indicate that although regulations and licensing governance have significantly improved with the support of an online system and stricter evaluation procedures, implementation on the ground still faces various challenges. Key challenges include inefficient bureaucracy, disruptions caused by technological adaptation, limitations in laboratories and human resources, and harmonisation of standards with global regulations. It was also found that businesses, particularly MSMEs in the medical device sector, still face obstacles in understanding and meeting administrative and technical requirements for marketing authorisation. This study recommends strengthening socialisation, training, and integration of the monitoring system to support the independence and resilience of national medical devices, while ensuring consumer protection and public safety as users of medical devices.

IMPLEMENTASI PERLINDUNGAN DATA PRIBADI PASIEN DALAM LAYANAN TELEMEDICINE DI INDONESIA: ANALISIS REGULASI DAN TANTANGAN PRAKTIS Gunawan Widjaja; Wagiman; Dyah Ersita Yustanti; Hotmaria Hertawaty Sijabat; Handojo Dhanudibroto
Jurnal Kesehatan Vol. 3 No. 2 (2025): JULI
Publisher : CV. Adiba Aisha Amira

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Digital transformation in Indonesia's health sector has accelerated the adoption of telemedicine services as an alternative to remote medical services, especially since the COVID-19 pandemic. Telemedicine provides easy access and efficiency of health services for the community, but at the same time increases challenges related to the protection of patients' personal data stored and processed digitally. This study employs a normative legal method with a literature review to analyse regulations governing the protection of patient personal data in telemedicine services in Indonesia, as well as to identify practical challenges in their implementation in the field. The results of the study indicate that although there is a fairly comprehensive legal basis, such as Law No. 27 of 2022 on Personal Data Protection and various other health sector regulations, implementation at the operational level still faces obstacles. These challenges include weak data security infrastructure, low digital literacy among medical personnel and patients, lack of specific technical guidelines, and limited oversight and enforcement of data protection violations. Collaborative efforts between the government, healthcare providers, and the public are needed to strengthen the personal data protection ecosystem, thereby ensuring safe, inclusive, and trustworthy telemedicine services in Indonesia.

PERAN RUMAH SAKIT SEBAGAI PENGENDALI DATA DALAM MENJAMIN KEAMANAN DATA PRIBADI PASIEN PADA SISTEM KESEHATAN DIGITAL Gunawan Widjaja; Wagiman; Dyah Ersita Yustanti; Hotmaria Hertawaty Sijabat; Handojo Dhanudibroto
Jurnal Kesehatan Vol. 3 No. 2 (2025): JULI
Publisher : CV. Adiba Aisha Amira

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Digital transformation in the health sector has brought various conveniences and efficiencies in patient data management, but it has also posed new challenges related to data security and privacy. Hospitals play an important role as data controllers responsible for ensuring that every process of collecting, storing, processing, and distributing patient data remains in accordance with the principles of security and confidentiality. This study aims to analyse the role of hospitals as data controllers in ensuring the protection of patient personal data in digital health systems, as well as to identify challenges and control strategies. The study was conducted through a literature review of various journals, regulations, and reliable documents, using a descriptive-qualitative approach. The results of the study indicate that data protection requires collaboration between the implementation of security technologies (encryption, two-factor authentication, audit trails), compliance with regulations, standardisation of operational procedures, and improvement of digital literacy among human resources. The main challenges include cyber threats, infrastructure and human resource limitations, and suboptimal data security culture. Systematic and continuous efforts in strengthening policies, education, and internal supervision are key to the success of hospitals as data controllers in the evolving era of digital health.

EVALUASI IMPLEMENTASI KEBIJAKAN JAMINAN KESEHATAN NASIONAL (JKN) DALAM MENINGKATKAN AKSES LAYANAN KESEHATAN MASYARAKAT DI INDONESIA Gunawan Widjaja; Wagiman; Dyah Ersita Yustanti; Hotmaria Hertawaty Sijabat; Handojo Dhanudibroto
Jurnal Kesehatan Vol. 3 No. 2 (2025): JULI
Publisher : CV. Adiba Aisha Amira

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The National Health Insurance (JKN) is a strategic policy of the Indonesian government to improve access to health services for the entire population through a social insurance mechanism. This study aims to evaluate the implementation of the JKN policy in expanding access and improving the quality of health services in Indonesia. The research method used a literature review with an analysis of literature related to the implementation of JKN, supporting and inhibiting factors, and the impact on access to public health services. The findings indicate that JKN has successfully increased coverage, patient visits to healthcare facilities, and reduced financial barriers, particularly for vulnerable groups and the poor. However, challenges remain in the form of disparities in healthcare infrastructure, issues with inactive coverage, and quality disparities in services between urban and rural areas. The evaluation of JKN implementation underscores the need for policy updates, service innovations, and strengthened infrastructure and outreach to achieve the goal of Universal Health Coverage in a sustainable manner.

KEPASTIAN HUKUM DALAM INOVASI LAYANAN KESEHATAN BERBASIS TEKNOLOGI: STUDI PUSTAKA ATAS REGULASI TELEMEDICINE DI INDONESIA Gunawan Widjaja; Wagiman; Dyah Ersita Yustanti; Hotmaria Hertawaty Sijabat; Handojo Dhanudibroto
Jurnal Kesehatan Vol. 3 No. 2 (2025): JULI
Publisher : CV. Adiba Aisha Amira

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The development of digital technology has brought significant transformations in healthcare services, particularly through the implementation of telemedicine in Indonesia. This innovation opens up enormous opportunities to expand access, improve efficiency, and support the equitable distribution of medical services, especially in remote areas. However, it should be noted that regulations governing telemedicine in Indonesia are still sectoral and partial in nature, dominated by Minister of Health Regulation No. 20 of 2019, the Health Law, and the Personal Data Protection Law. These regulations have not fully addressed challenges related to legal certainty, patient data protection, and the legal responsibilities of healthcare professionals and service providers. This literature review analyses the legal framework for telemedicine in Indonesia, identifies regulatory challenges, and highlights the need for harmonisation and the development of more comprehensive regulations to ensure that digital health service innovations can operate safely, fairly, and provide optimal protection for all parties. It is hoped that the findings of this study will contribute to policy development and strengthen the legal system in addressing the rapid development of telemedicine in Indonesia.

PERLINDUNGAN HUKUM BAGI PASIEN DAN TENAGA MEDIS DALAM INOVASI KESEHATAN DIGITAL: TINJAUAN LITERATUR TERHADAP PERATURAN PERUNDANG-UNDANGAN DI INDONESIA Gunawan Widjaja; Wagiman; Dyah Ersita Yustanti; Hotmaria Hertawaty Sijabat; Handojo Dhanudibroto
Jurnal Kesehatan Vol. 3 No. 2 (2025): JULI
Publisher : CV. Adiba Aisha Amira

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Digital transformation in Indonesia's health sector has driven the adoption of innovations such as telemedicine, electronic medical records, and online health applications. These innovations improve service efficiency and access, but also raise challenges related to legal protection for patients and medical personnel. This study aims to analyse the forms of legal protection regulated in various laws and regulations in Indonesia, including the Health Law, the Personal Data Protection Law, and technical regulations from the Ministry of Health. The method used is a literature review with a normative legal approach to regulations and previous research findings. The findings indicate that although various legal instruments have been issued, there are still fragmentation and gaps in the regulations, particularly regarding the protection of patients' personal data and the legal certainty of healthcare professionals' liability in digital healthcare services. Implementation challenges include infrastructure limitations, low digital literacy, and the suboptimal mechanisms for complaints and dispute resolution. Recommendations are aimed at harmonising regulations, strengthening digital literacy, and improving the effectiveness of oversight to create a safe and equitable digital health ecosystem.

ANALISIS REGULASI UJI KLINIS ALAT KESEHATAN DI INDONESIA: TINJAUAN TERHADAP PERATURAN MENTERI KESEHATAN NOMOR 63 TAHUN 2017 Gunawan Widjaja; Wagiman; Dyah Ersita Yustanti; Hotmaria Hertawaty Sijabat; Handojo Dhanudibroto
Jurnal Kesehatan Vol. 3 No. 2 (2025): JULI
Publisher : CV. Adiba Aisha Amira

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The development of medical device technology in Indonesia has prompted the need for strict supervision to ensure the safety, quality, and usefulness of products before they are distributed. Minister of Health Regulation No. 63 of 2017 serves as the legal basis for conducting clinical trials of medical devices, which aims to standardise the testing process and ensure the protection of test subjects. This study analyses the provisions and implementation of the regulation, identifying challenges related to human resources, facilities, bureaucracy, and inter-sectoral coordination that remain major obstacles in the field. Using a normative method and a descriptive qualitative approach, the study examines the substance of the regulation, its implementation mechanisms, and its effectiveness in supporting innovation and protecting the public. The findings indicate that the effectiveness of Permenkes 63/2017 is highly dependent on enhancing the capacity of implementing personnel, harmonising regulations with international standards, and strengthening oversight and inter-institutional coordination. Strategic recommendations are proposed for regulatory reform, human resource capacity building, and optimising the management of clinical trial data to make Indonesia's medical device oversight system more credible and adaptive to technological advancements.

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