# Integral Security Pillars for Medical Devices:
## 1 Introduction  
In the current context of the digital revolution, cybersecurity has become a fundamental pillar for ensuring the security, integrity, and reliability of healthcare systems globally [1]. The widespread adoption of advanced technologies, such as interconnected medical devices, has brought numerous benefits, but it has also increased the exposure of healthcare institutions to a broader range of cyber risks and vulnerabilities. The integration of these devices into interconnected networks presents significant opportunities to improve patient care but also poses critical challenges in terms of protecting information and the underlying technological infrastructure [2].  
One of the main issues facing the healthcare community is the fragmentation of information related to the security of medical devices. Relevant data sources are scattered, making it difficult to build a coherent framework that can systematically identify and address the vulnerabilities of these devices. In this context, it is necessary to have an integrated security model that not only consolidates existing knowledge but also integrates and applies effective protection measures based on international security standards [3].  
The goal of this study is to establish a clear set of fundamental pillars for the security of medical devices. Through an exhaustive analysis, the main threats and most common vulnerabilities are identified, and the security approaches used in different environments and healthcare systems are compared [4,5]. This analysis is complemented by a comprehensive review of the existing literature, covering the latest studies and international regulations, allowing for the identification of security gaps and the proposal of effective solutions.  
The primary purpose of this research is to develop a practical support tool for implementing security strategies in medical devices. The study aims to provide a model that not only strengthens the security infrastructure of healthcare environments but also serves as a foundation for continuous and adaptive audits in response to emerging threats. This model is based on the principles of systematic auditing and designed to integrate effectively with Information Security Management Systems (ISMS) and align with international standards, such as the HITRUST Framework [6,7].  
Finally, this work aims not only to address the current security gaps in medical devices but also to offer a broader perspective that enables its implementation in various international contexts, adapting to the specificities of each healthcare system. In this way, it is expected that this model will act as a global benchmark in risk management and cybersecurity within healthcare, contributing to the strengthening of trust and reliability in interconnected healthcare systems.  
Building upon this context, the present study introduces a comprehensive methodology that integrates the analysis of international regulatory frameworks, a systematic review of the scientific literature, and a comparative evaluation of security standards applicable to medical devices. The results present an integral model grounded in conceptual pillars, designed to systematically structure the critical components of protection and to enable a coherent assessment of the most significant vulnerabilities. The discussion section further examines the distinctions between this holistic approach and conventional models focused primarily on device connectivity (IoMT), underscoring the necessity of a broader perspective that addresses the entire life cycle of medical devices and their seamless integration within healthcare systems. Finally, the conclusions emphasize the practical relevance of the proposed model as a foundational tool to support the implementation of cybersecurity strategies in clinical environments, while also highlighting its potential to inform future research aimed at the standardization and continuous enhancement of security across interconnected healthcare infrastructures.