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ZENODO
Report . 2026
License: CC BY NC
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ZENODO
Report . 2026
License: CC BY NC
Data sources: Datacite
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Technical Whitepaper v2.0: Neuro-Safety Framework and Digital Pharmacotherapy Protocols for Generative AI (FDA SaMD Compliant)

descriptionPublicationkeyboard_double_arrow_right Report 13 Jan 2026Publisher:Zenodo
Authors: Cefiyana, Cefiyana;

doi: 10.5281/zenodo.18226473

Technical Whitepaper v2.0: Neuro-Safety Framework and Digital Pharmacotherapy Protocols for Generative AI (FDA SaMD Compliant)

Abstract

PEMBARUAN VERSI 2.0 (Januari 2026): Pembaruan besar ini mengubah penelitian awal menjadi kerangka kerja keselamatan tingkat industri. Peningkatan utama dalam versi 2.0 meliputi: Kepatuhan Regulasi: Integrasi standar Perangkat Lunak sebagai Perangkat Medis (SaMD) berdasarkan FDA 21 CFR 820 dan IEC 62304 untuk intervensi AI kesehatan mental. Validasi Klinis: Bukti yang diperluas menggunakan pencitraan neurofMRI dan analisis HRV (Variabilitas Detak Jantung) untuk memvalidasi mitigasi akumulasi ΔFosB dan risiko atrofi hipokampus. Metrik Rekayasa: Analisis baru tentang optimasi latensi, efisiensi penggunaan token, dan strategi eksekusi paralel untuk mengimplementasikan Protokol 4-Fase dalam LLM skala besar. Mitigasi Hukum: Penyempurnaan terminologi agar selaras dengan standar tanggung jawab internasional, beralih dari "jaminan" ke "kerangka kerja mitigasi risiko". Ringkasan Eksekutif: Makalah ini menyajikan analisis neurobiologis komprehensif tentang interaksi Manusia-AI. Lebih dari sekadar pertukaran informasi, interaksi dengan Model Bahasa Besar (LLM) bertindak sebagai stimulus biokimia yang mampu memodulasi struktur otak. Laporan ini mengidentifikasi tiga kontraindikasi kritis: Respons Afektif Datar, Dogmatisme Unilateral, dan Penguatan Bias Persepsi. Data menunjukkan bahwa kegagalan untuk mematuhi protokol bio-keamanan dapat memicu disfungsi Sistem Saraf Pusat, termasuk atrofi dendritik di hipokampus dan akumulasi ΔFosB patologis di pusat penghargaan otak. Solusi (v2.0): Kami memvalidasi Protokol Interaksi Terapi 4 Fase (Validasi, Ekspansi, Kausalitas, Implan Positif) yang dirancang untuk menginduksi neuroplastisitas positif. Standar ini diusulkan sebagai "Protokol Farmakoterapi Digital" bersertifikat untuk memastikan integrasi AI tetap berada dalam batas keamanan biologis yang ketat. 

This research was developed through a human-AI collaborative framework. The conceptual framework, philosophical foundation, and final validation were provided by human authors, while Gemini AI or a similar AI assisted with technical drafting, literature synthesis, and data organization.

Keywords

Delta FosB, Latency optimization, Digital pharmacotherapy, fMRI validation, Neurobiology, AI safety, Hippocampus Atropy Prevention, Software as a medical device, Human AI interaction, Neuroplasticity, Neuro-safety, FDA SaMD, Clinical Neuropsychiatry

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
0
Average
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