New York’s Hospital Cybersecurity Regulation (10 NYCRR § 405.46) Raised the Bar for Medical Device Security – Here’s What You Need to Know

New York is the first state in the United States to mandate comprehensive cybersecurity programs for hospitals. The regulation, 10 NYCRR § 405.46, was adopted in October 2024 and became fully enforceable on October 2, 2025. It applies to all 195+ general hospitals licensed under Article 28 of the Public Health Law, and it goes well beyond what HIPAA requires.

For hospitals still working toward full compliance, or those treating the regulation as a static checkbox rather than a living program, the requirements have real operational weight. Annual risk assessments, penetration testing, asset inventory, network monitoring, audit trail retention for six years, a designated CISO reporting to the governing body, and incident notification to the Department of Health within 72 hours of a material cybersecurity event.

Connected medical devices sit at the center of nearly every one of those requirements, and they are among the hardest assets to address.

What the Regulation Requires

Section 405.46 covers fifteen distinct areas of cybersecurity policy, from access controls and data governance to vendor management and incident response. Several of those areas have direct implications for how hospitals manage IoT and IoMT devices:

Asset inventory and device management (§ 405.46(d)(iii)). Hospitals must maintain policies covering their full asset footprint. For connected medical devices, many of which were never cataloged by traditional IT asset management tools, this means building an accurate, continuously updated inventory that includes device type, manufacturer, software version, and network behavior.

Systems and network monitoring (§ 405.46(d)(viii)). The regulation requires defensive infrastructure capable of detecting cybersecurity events, including unauthorized access and misuse of information systems. Medical devices that communicate over unencrypted protocols or connect to clinical networks without segmentation create blind spots in that monitoring capability.

Risk assessment (§ 405.46(h)). Hospitals must conduct annual risk assessments that evaluate vulnerabilities to the confidentiality, integrity, and availability of nonpublic information. For medical devices, this means understanding not just which CVEs apply to a given device, but whether those vulnerabilities are actually exploitable in the hospital’s specific network configuration.

Third-party service provider management (§ 405.46(j)). Policies must address the cybersecurity practices of vendors and contractors with access to hospital systems. Medical device manufacturers are squarely in this category, particularly when devices “phone home” for updates or diagnostics.

Testing and vulnerability assessments (§ 405.46(f)). Annual penetration testing and ongoing vulnerability scanning are required. For IoMT devices that cannot be safely scanned with traditional tools, hospitals need passive methods to identify and assess risk without disrupting clinical operations.

Why Medical Devices Are the Hardest Part of Compliance

IT endpoints have mature management tooling. Medical devices do not. Many connected devices in hospital environments run proprietary operating systems, lack endpoint agents, and cannot be patched on a standard cycle without manufacturer involvement. They were designed for clinical function, not for security governance.

That creates a gap between what 405.46 requires on paper and what most hospitals can operationalize for their device fleets. The regulation does not exempt medical devices from any of its requirements. Asset inventory, vulnerability assessment, network monitoring, and incident response: all apply equally to an MRI scanner and a workstation.

Closing that gap manually, across hundreds or thousands of devices from dozens of manufacturers, is a staffing and coordination problem that does not scale with the tools most hospitals already have in place.

How Asimily Addresses the Core Requirements

Asimily was purpose-built to bring IoT, OT, and IoMT devices under the same security governance that hospitals already apply to their IT systems. The platform maps directly to the 405.46 requirements that are hardest to meet for connected devices:

Inventory and categorization. Asimily uses deep packet inspection and passive protocol analysis to safely discover, classify, and de-duplicate every connected device on the network. The result is a continuously updated source of truth that feeds directly into risk assessment, compliance reporting, and operational planning, without requiring agents or active scanning that could disrupt clinical workflows.

Vulnerability detection and prioritization. Rather than generating a flat list of CVEs, Asimily’s patented Attack Vector Analysis evaluates how each vulnerability could be exploited in the hospital’s specific environment. It cross-references device configuration, network context, EPSS scores, and MITRE ATT&CK mappings to surface the vulnerabilities that pose genuine risk and suppress the ones that do not. That kind of contextual prioritization is exactly what 405.46’s risk assessment requirement demands.

Network monitoring and anomaly detection. Asimily continuously analyzes device traffic to detect malware, misconfigurations, indicators of compromise, and policy violations. For the monitoring and audit trail requirements under 405.46, this gives hospitals device-level visibility into network behavior that traditional SIEM and EDR tools were not designed to capture.

Targeted mitigation and segmentation. When a vulnerability cannot wait for a manufacturer patch, Asimily provides over 180 targeted attack prevention techniques that neutralize specific exploit paths without taking a device offline. For broader protection, the platform generates tailored segmentation and microsegmentation policies that integrate with existing NAC and network infrastructure.

Configuration control and compliance documentation. Asimily captures known-good device states and alerts when a device drifts from that baseline, whether the change comes from a manufacturer update, a third-party action, or a compromise. That capability supports multiple 405.46 requirements simultaneously: change detection, audit trails, and incident response readiness.

The Broader Signal

New York’s regulation is the most prescriptive state-level hospital cybersecurity mandate in the country. Texas issued its own directive in March 2026 requiring healthcare facilities to align with FDA cybersecurity guidance. Federal pressure continues to build through the FDA’s Section 524B requirements, the updated QMSR, and HHS cybersecurity performance goals.

Hospitals that build continuous, device-aware security programs now will be positioned to meet the next mandate without starting over. Those who treat 405.46 as a one-time compliance exercise will find themselves repeating the same work every time a new regulation arrives.

Asimily helps hospitals turn regulatory requirements into operational security programs for their connected device fleets. If you are working toward 405.46 compliance or preparing for the next state-level mandate, request a demo to see how the platform works in your environment.