Department of Homeland Security AI Risk: Why Should MDMs Care and What Should MDMs Know Continuing the Biohacking Village's dissection of the DHS Roles and Responsibilities Framework for AI in Critical Infrastructure, first let's start with why should MDMs care? 💡 Insight provided by Lacey Harbour Smith MS, RAC, MB(ASCP), volunteer and AI Advisor for the Biohacking Village. ❣️ Important: Don't forget that medical devices fall within Healthcare and Public Health Sector, which is one of the 16 critical infrastructure sectors as defined by the US CISA and the DHS. We are not just subject to FDA's guidance and scrutiny. ❓Navigating Uncertainty: With the evolving US regulatory landscape due to the change in the Administration and emerging risks, the Framework provides a much-needed guide to navigate complexities and ensure secure development that are backed by key industry leaders of major AI products – indicating customer led expectations. The Framework highlights critical risks that manufacturers must address: 💻 1. Attacks Using AI: AI-driven devices can be exploited by cybercriminals to compromise patient safety—like altering treatment algorithms or stealing sensitive data. 🎯 2. Attacks Targeting AI Systems: Vulnerabilities in AI-powered devices can lead to breaches or malfunctions, putting patients’ lives at risk. 🛠️ 3. Design and Implementation Failures: Flaws in AI models or improper deployment could result in device errors, misdiagnoses, or system failures during critical moments. Risk Levels for Medical Devices: 👉 Device-Level Risks: Failures in individual devices impacting patient care. 👉Sector Risks: Disruptions across healthcare networks or hospital systems. 👉Systemic Risks: Widespread issues stemming from interconnected devices and systems. 👉National Risks: Threats to public health on a large scale, e.g., cyberattacks on life-support systems. 🛂 Your Role: MDMs should adopt robust AI safety and security practices is not just smart—it’s essential and it is not going away. -Conduct thorough testing and validation. -Build secure-by-design systems. -Develop incident response plans for potential threats. -Meet Expectations: US Governmental customers and regulators will increasingly expect manufacturers to align with this Framework. 💫 Takeaway: Of course MDMs want to protect their devices and customers (including patients, HCPs, and HDOs) by addressing these AI risks - but there is static when determining the regulatory requirements and expectations regarding how these risks should be analyzed across the ecosystem on a greater scale than FDA's recognized consensus standards. Understanding the expectations of our customers and the tools they will leverage will provide smart MDMs a market advantage in addition to developing safe, secure, and reliable AI enabled products. #MedicalDevices #AI #CyberSecurity #PatientSafety #Innovation #RiskManagement #CriticalInfrastructure
Did you know that the Department of Homeland Security released the “Roles and Responsibilities Framework for Artificial Intelligence in Critical Infrastructure” (“Framework”) on Nov 14th? This is a follow up on the implementation plans for Executive Order 14110 which mark a pivotal step toward ensuring AI is developed and deployed safely, securely, and responsibly, safeguarding privacy and advancing equity, critical for the future of healthcare and cybersecurity. Follow us as we break down this Framework and discuss its implication on the US Healthcare Ecosystems that includes medical devices, biopharma and the hospital systems. This post is shared by Lacey Harbour Smith MS, RAC, MB(ASCP), a dedicated volunteer and AI Advisor for the Biohacking Village. Read Framework: https://lnkd.in/gCPgBdzt #ArtificialIntelligence #AI #EO14110 #Healthcare #Cybersecurity