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The Health Sector Coordinating Council (HSCC) has released Version 2 of its Model Contract-Language for Medtech Cybersecurity, designed to help healthcare providers and medical device manufacturers better define and share cybersecurity responsibilities in procurement contracts. The updated framework addresses the increasing complexity and connectivity of medical devices, many of which now leverage internet connectivity and artificial intelligence, raising the stakes for robust cybersecurity measures in healthcare environments.
This new version incorporates feedback from stakeholders on the initial 2022 release, clarifies shared risk and accountability between device makers and healthcare delivery organizations, and aligns contract language with evolving regulatory requirements. The revised model aims to reduce ambiguity in contract negotiations, ensuring that cybersecurity considerations are explicitly addressed and that both parties understand their obligations to protect patient safety and sensitive data.
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The Health Sector Coordinating Council released Version 2 of its Model Contract-Language for Medtech Cybersecurity to standardize and clarify cybersecurity responsibilities between healthcare delivery organizations and medical device manufacturers. The update incorporates stakeholder feedback, aligns with evolving regulations and industry standards, and is intended to reduce ambiguity and disputes in medical device procurement negotiations.
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The Health Sector Coordinating Council (HSCC) has released a new, free guidance document called the Health Industry Cybersecurity Sector Mapping and Risk Toolkit (SMART) to assist healthcare organizations in managing third-party risk. The toolkit is designed to address the complex and persistent challenges posed by third-party security and supply-chain risk in the healthcare sector, which faces a vast array of vendors providing mission-critical products and services. Developed over 16 months, the SMART Toolkit involved collaboration among 80 organizations spanning all healthcare subsectors, including patient care providers, insurance companies, laboratories, pharmaceutical and blood services, medical technology firms, public health entities, and health IT providers. The toolkit offers templates and a structured methodology to help organizations visualize, identify, and measure systemic risk associated with third-party technology, software, and communications services. It recognizes that not all vendors pose the same level of risk and provides guidance to help teams prioritize their risk management efforts accordingly. The SMART Toolkit aims to empower healthcare entities of all sizes and types, from small clinics to large hospital systems, to make informed decisions about vendor risk. By mapping and ranking third-party risks, the toolkit supports organizations in allocating resources more effectively and strengthening their overall cybersecurity posture. The guidance is intended to be practical and actionable, enabling healthcare organizations to better understand the interconnectedness of their supply chains and the potential impact of third-party failures. The release of the toolkit comes at a time when healthcare organizations are increasingly targeted by cyberattacks exploiting third-party vulnerabilities. The HSCC emphasizes the importance of cross-sector collaboration in developing robust risk management strategies, as demonstrated by the diverse participation in the toolkit's creation. The SMART Toolkit is freely available, reflecting a commitment to sector-wide improvement in cybersecurity resilience. It also aligns with broader industry efforts to enhance governance and risk management practices in healthcare. The toolkit is expected to become a valuable resource for CISOs, risk managers, and compliance teams seeking to address regulatory requirements and industry best practices. By providing a standardized approach to third-party risk assessment, the SMART Toolkit helps reduce ambiguity and supports more consistent risk mitigation across the sector. The HSCC encourages all healthcare organizations to adopt the toolkit as part of their ongoing risk management programs. The initiative underscores the critical role of third-party risk management in safeguarding patient data and ensuring the continuity of healthcare operations.
Jun 29, 2026
Healthcare sector experts said **medical device cybersecurity** may become more manageable as manufacturers provide more complete **software bills of materials (SBOMs)** and hospitals improve asset visibility. Phil Englert of Health-ISAC said that when vulnerabilities such as **SweynTooth** emerge, organizations with better device component inventories can more quickly identify affected systems, and he pointed to U.S. FDA rules in effect since 2023 that require medical device makers to include SBOMs for commercial, open-source, and off-the-shelf components in premarket submissions for covered "cyber devices." Englert said higher-quality, more consistent SBOM data, combined with evolving **AI-enabled tools**, should help healthcare delivery organizations and manufacturers streamline vulnerability identification and resilience efforts across medical device environments. The reporting is based on the same HIMSS 2026 interview carried by two outlets, while separate commentary on **systemic third-party risk** in healthcare tied to the Change Healthcare ransomware incident addresses a different issue and does not describe the same specific development in medical device security.
Jun 29, 2026
The US Department of Health and Human Services’ **Administration for Strategic Preparedness and Response (ASPR)** released an update to its free, web-based **Risk Identification and Site Criticality (RISC) 2.0 Toolkit** that adds a dedicated **cybersecurity module** to help healthcare and public health organizations assess cyber risk alongside other hazards (e.g., weather and physical disruptions). The module guides users through a questionnaire on policies and practices and scores responses against **NIST Cybersecurity Framework (CSF) 2.0** and **HHS Cybersecurity Performance Goals**, with the stated aim of reducing disruptions to patient care and improving sector resilience. ASPR leadership framed the update as a response to increasingly sophisticated threats and emphasized that “**cyber safety is patient safety**,” warning that cyber incidents can create cascading impacts across the healthcare industry. Reporting also highlighted sector preparedness concerns—particularly around **cloud-related threats**, **quantum computing risks**, and attacks on **connected products**—and noted that the RISC toolkit is already in use across thousands of health systems; the cyber module is intended to help organizations identify gaps, prioritize investments, and support risk management discussions, including risks introduced by third-party providers in the wake of high-profile incidents such as the **Change Healthcare** attack.
Jun 29, 2026