# Integral Security Pillars for Medical Devices:
## 9 Who
### Development of the Security Pillars Model  
As a result of the development of the Integral Security Pillars for Medical Devices: A Comprehensive Analysis, a simplified and abstract representation of the design was created. This was performed to select the critical elements and define their relationships. Various attributes were established for each element to visualize the structure and connections of the model derived from the review process, ensuring clarity and coherence. This representation was accompanied by information that facilitates its understanding and application. The results were developed based on pillars and an integral approach to ensure both structural clarity and comprehensive coverage. From an engineering perspective, pillars refer to foundational components that support the integrity and functionality of a system, enabling modular analysis and targeted improvements. The term integral emphasizes the unification and concentration of information, allowing the model to aggregate and centralize critical aspects of security into a coherent framework that facilitates holistic assessment and implementation. As a result, four essential elements that compose the Pillars of Security model were identified, as shown in Figure 6.  
**Description of the Elements of the Four Security Pillars**  
* **Regulations:**  
Regulations are an essential component of the security model for medical device infrastructure, as they provide a normative framework that guides the implementation of data protection measures. These standards and procedures help organizations identify, prevent, and mitigate risks derived from cyber threats, ensuring the confidentiality, integrity, and availability of information. In the context of medical devices, regulations are crucial not only for setting protection standards but also for monitoring and regulating the use and operation of the devices, which is vital for protecting them against current and emerging threats. National regulations, best practices, and internal laws play a central role in ensuring that devices operate safely and are protected from unauthorized or malicious access, fostering a reliable environment for healthcare delivery. **Model vs. Manufacturer:**  
Medical device manufacturers are tasked with innovating and solving technological challenges to improve healthcare and developing advanced technologies such as connected systems for diagnosis and monitoring (e.g., magnetic resonance imaging). However, it is essential to recognize that a wide range of devices has shown vulnerabilities in their software systems or communication protocols, which puts information security at risk. This element of the model emphasizes the importance of periodic updates and continuous support, providing a valuable complement to prevent and detect issues in the medical device infrastructure, enhancing protection against potential cyber threats. **Vulnerability and Threat Analysis:**  
Proactive vulnerability and threat analysis is key to strengthening the cybersecurity posture of organizations, particularly those managing medical device infrastructures. Identifying and understanding the specific vulnerabilities of each device allows organizations to correct weaknesses before they are exploited. This analysis enables periodic and systematic protection of sensitive information, helping mitigate risks and ensuring that medical device systems operate safely in an increasingly interconnected environment. The ability to prevent security breaches is a crucial component for protecting both technological infrastructure and the confidentiality of data. **Trends and Emerging Technologies:**  
Emerging technological trends and scientific advancements can have a significant impact on the landscape of cyber threats. The research and development of new technologies can not only facilitate the identification of vulnerabilities but also influence the adoption of new attack techniques and the improvement of cybersecurity measures.