Kerangka Regulasi dan Praktik Klinis untuk Digital Therapeutics (DTx): Analisis Yuridis dan Farmakologis

Authors

  • Afdhillah Wahyu Putra Nugraha Fakultas Farmasi, Universitas Padjajaran, Bandung, Indonesia
  • Gevan Naufal Wala Fakultas Hukum, Universitas Tarumanagara, Jakarta, Indonesia

DOI:

https://doi.org/10.38035/dhps.v2i4.1846

Keywords:

Digital Therapeutics, Kerangka Regulasi, Analisis Farmakologis, Perangkat Lunak Medis, Kebijakan Teknologi Kesehatan

Abstract

Penelitian ini mengkaji kerangka regulasi dan implementasi klinis Digital Therapeutics (DTx) di Indonesia melalui analisis yuridis dan farmakologis. Digital Therapeutics merupakan kategori baru intervensi medis yang disampaikan melalui perangkat lunak untuk mencegah, mengelola, atau mengobati gangguan atau penyakit medis. Penelitian ini bertujuan mengidentifikasi kesenjangan regulasi dalam sistem kesehatan Indonesia terkait DTx dan mengusulkan kerangka regulasi ideal yang selaras dengan standar internasional sambil memenuhi kebutuhan kesehatan lokal. Menggunakan metode yuridis normatif dan komparatif, penelitian ini menganalisis regulasi kesehatan dan digital yang ada di Indonesia bersama dengan pendekatan regulasi internasional dari AS, Jerman, Jepang, dan Korea Selatan. Hasil penelitian menunjukkan adanya kesenjangan regulasi yang signifikan di Indonesia, terutama mengenai klasifikasi DTx, persyaratan bukti klinis, perlindungan privasi data, dan mekanisme penggantian biaya. Penelitian ini mengusulkan kerangka regulasi komprehensif yang mengatasi kesenjangan tersebut melalui pendekatan berbasis risiko, metode evaluasi terstandarisasi, dan model tata kelola multi-pemangku kepentingan. Temuan ini berkontribusi pada pengembangan kebijakan berbasis bukti untuk integrasi kesehatan digital dalam sistem kesehatan Indonesia dan menekankan perlunya harmonisasi regulasi di sektor kesehatan, teknologi, dan perlindungan data.

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Published

2025-04-22

How to Cite

Nugraha, A. W. P., & Wala, G. N. (2025). Kerangka Regulasi dan Praktik Klinis untuk Digital Therapeutics (DTx): Analisis Yuridis dan Farmakologis. Dinasti Health and Pharmacy Science, 2(4), 26–33. https://doi.org/10.38035/dhps.v2i4.1846

Issue

Vol. 2 No. 4 (2025): Dinasti Health and Pharmacy Science (April 2025)

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Copyright (c) 2025 Afdhillah Wahyu Putra Nugraha, Gevan Naufal Wala

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