In healthcare cybersecurity, vendors (e.g., EHR providers, medical device manufacturers) and HDOs (hospitals, health systems) must work together to protect patient data and clinical systems. However, their differing approaches to security requirements often create gaps that can lead to vulnerabilities.
Key Points:
- Accountability Gap: HDOs are responsible for security compliance under HIPAA, but vendors often control critical technology, creating weak links.
- Vendor Challenges: Vendors prioritize regulatory compliance and scalability but struggle with custom requests, outdated devices, and high questionnaire demands.
- HDO Challenges: HDOs focus on patient safety and risk diagnosis but face resource constraints, staffing shortages, and ongoing oversight difficulties.
- Misalignments: Vendors aim for efficiency, while HDOs demand rigorous, continuous validation, leading to friction in collaboration.
Solutions:
- Shared security frameworks (e.g., NIST CSF, HIPAA).
- Joint threat modeling to identify risks early.
- Lifecycle management with regular reviews and clear responsibilities.
- Governance tools like Censinet RiskOps™ to centralize assessments and evidence.
By aligning goals, establishing clear processes, and leveraging technology, vendors and HDOs can close security gaps and protect patient data effectively.
Vendor Perspective: How Vendors Approach Security Requirements Collaboration
Vendors have the challenging task of scaling security measures across hundreds - or even thousands - of customers. This means every security decision needs to work universally, rather than being tailored to the specific needs of a single hospital.
Key Vendor Priorities
For most vendors, regulatory compliance is the leading priority. They must adhere to FDA pre-market and post-market cybersecurity guidance, HIPAA security rules, and NIST frameworks. But compliance alone isn’t enough - they also aim to embed security into the Software Development Life Cycle (SDLC) without delaying product releases.
Scalability is another major focus. When healthcare delivery organizations (HDOs) request custom security configurations, vendors often resist. This is because custom setups can complicate updates and maintenance down the road. Standardization, therefore, becomes essential for long-term efficiency.
To meet these priorities, vendors rely heavily on standardized documentation. However, this approach comes with its own set of challenges.
Common Documentation Practices
To communicate their security posture effectively, vendors provide standardized artifacts. A key example is the Software Bill of Materials (SBOM), typically shared in machine-readable formats like SPDX or CycloneDX. This has become even more important since the FDA’s Section 524B requirements took effect in March 2023, mandating SBOMs for new "cyber device" submissions. Vendors also share certifications like ISO 27001 and SOC 2 Type II, along with penetration test summaries and vulnerability disclosure policies.
Contracts now include specific details such as vulnerability notification timelines (e.g., 24 hours for critical issues), patching responsibilities, and audit rights. Additionally, the Quality Management System Regulation (QMSR), effective February 2026, has made cybersecurity supplier oversight a required purchasing control. This shift encourages vendors to integrate security documentation into their Quality Management Systems rather than treating it as a separate IT task.
"A static SBOM sitting in a SharePoint folder is paper compliance. A live, monitored SBOM connected to your vulnerability management workflow is an actual control." - Priya Mehta, Compliance Lead, Safeguard [1]
Challenges Vendors Face
Despite their efforts, vendors face several hurdles that create misalignment with HDO security expectations. One major issue is the overwhelming demand for security questionnaires. Large vendors often receive dozens of these questionnaires, each with slight variations in format and requirements. Manually addressing each one consumes significant resources, slows sales cycles, and doesn’t always lead to better security outcomes.
Legacy medical devices pose another significant challenge. Many older devices can’t produce an SBOM or receive necessary patches once support ends. In these cases, vendors are expected to document alternative controls, such as network segmentation. However, this requires close collaboration with HDOs, which doesn’t always happen smoothly. Compounding this issue, assessments now frequently demand SLSA (Supply-chain Levels for Software Artifacts) Level 2 attestations or higher, raising the bar for vendors still working on basic documentation practices [1].
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HDO Perspective: How HDOs Approach Security Requirements Collaboration
For Healthcare Delivery Organizations (HDOs), patient care and safety always take precedence in security decisions. Every choice revolves around one key question: Could this impact patient care or safety?
Key HDO Priorities
Protecting patient care and safeguarding Protected Health Information (PHI) are at the heart of HDO operations. With medical records being prime targets for identity theft and fraud, ensuring robust data security is non-negotiable.
HDOs don’t view security assessments as mere formalities. Instead, they use these evaluations to diagnose the risks a vendor might introduce. The goal isn’t just about passing or failing - it’s about understanding the vendor’s impact on the overall risk landscape.
"Assessment does not mean 'collect a questionnaire and file it.' It means you gather evidence, assign and defend a risk rating, require fixes where needed, and document why access to PHI is allowed (or not allowed)." - Daydream Implementation Guide [2]
How HDOs Derive Security Requirements
HDO security requirements are shaped by the vendor’s interaction with PHI. The more sensitive the data or the greater its volume, the stricter the scrutiny. For instance, vendors handling clinical notes face more rigorous evaluations than those dealing with imaging files. Similarly, systems critical to patient care operations undergo heightened review.
HDOs assess vendor security by examining their security posture, incident history, and compliance certifications. These requirements are formalized in agreements like Security Requirements Exhibits and Business Associate Agreements (BAAs). These agreements often include clauses for audits and specific timelines for breach notifications. Vendors typically don’t gain access to production credentials, VPN, or Single Sign-On (SSO) integration until a formal risk assessment has been completed. This process underscores the importance of ongoing collaboration between HDOs and vendors.
"Conduct cybersecurity risk assessments of third-party vendors and business partners who access, process, or store PHI." - Health Industry Cybersecurity Practices (HICP) [2]
While this structured approach is effective, real-world challenges can complicate implementation.
Challenges HDOs Face
Despite having well-defined frameworks, HDOs often face operational hurdles. One of the most pressing issues is staffing. With 90% of U.S. healthcare organizations classified as small businesses [3], many lack the internal expertise to thoroughly validate vendor evidence. Even larger organizations struggle to maintain consistent oversight after a vendor has been approved.
"The biggest theme is that healthcare organizations have gotten better at front-end vendor intake and approval, but ongoing oversight is still hard." - Jaren Day, Group Director, KLAS [3]
This lack of ongoing monitoring can lead to control drift, where a vendor’s security posture deteriorates over time without detection. The stakes are high - 75% of healthcare organizations experienced a vendor-related breach in the 24 months leading up to November 2025 [3]. This is why tools like Censinet RiskOps™ are crucial. They provide continuous, automated vendor risk monitoring, flagging issues well before annual reviews would catch them.
Another challenge is the placement of Third-Party Risk Management (TPRM) programs within organizations. Often buried within IT, compliance, or operations, these programs lack the visibility and funding needed to enforce requirements effectively - especially when negotiating with large vendors.
"In many companies, TPRM is three or four layers down buried within IT, compliance or operations and doesn't receive the right sponsorship and funding by leadership." - Steven Adler, Partner, The Edmund Group [3]
Without proper executive support, these programs struggle to hold ground, particularly when dealing with vendors that have more leverage than smaller regional hospitals.
Vendor vs. HDO Collaboration: Key Differences and Gaps
Vendor vs. HDO Security Collaboration: Key Differences & Gaps
Comparison of Collaboration Models
Vendors and healthcare delivery organizations (HDOs) aim to build secure and compliant partnerships, but their approaches often differ significantly. These differences can create friction and misunderstanding. Here's a quick look at how their collaboration models compare:
| Dimension | HDO Perspective | Vendor Perspective |
|---|---|---|
| Primary Objective | Focused on diagnosing and mitigating risks | Centered on completing procurement and closing sales |
| View of Questionnaires | Seen as a diagnostic tool to ensure alignment | Viewed as a pass-fail checkpoint or obstacle |
| Documentation Style | Emphasizes verifiable, evidence-based proof | Relies on self-reported information, often less rigorous |
| Communication Tone | May come across as authoritative or evaluative | Can feel defensive or guarded |
| Risk Tolerance | Varies depending on the HDO's experience and risk posture | Assumes a one-size-fits-all compliance standard |
| Lifecycle Focus | Ideally continuous, though often constrained by resources | Primarily concentrated during onboarding phases |
These contrasting approaches often lead to misalignments, especially when expectations around risk management and compliance diverge.
Common Misalignments
Even with these structured approaches, gaps in collaboration frequently emerge. Initial compliance efforts, while critical, don’t always translate into long-term security.
One major issue arises after approval. While HDOs have improved their healthcare TPRM solution vetting processes, maintaining oversight over time remains a significant challenge. On the vendor side, compliance is sometimes treated as a one-and-done milestone rather than an ongoing responsibility.
"While a vendor may appear acceptable during initial evaluation and onboarding, risk can emerge later due to control drift, product changes, poor follow-through or business disruption." - KLAS Report [3]
Another area of disconnect involves evidence verification. HDOs often require detailed, comprehensive proof - such as penetration test results, audit logs, and incident response plans. Vendors, however, may only provide high-level summaries, leaving HDOs with incomplete information. This challenge is compounded by the fact that around 33% of healthcare organizations still manage third-party risk largely on their own [3]. This lack of robust, ongoing verification creates significant vulnerabilities. Utilizing a collaborative risk exchange can help automate this verification and close the gap between vendors and HDOs.
Bridging these gaps demands consistent effort, clear communication, and strong executive backing from both sides.
Closing the Gap: Practical Solutions for Better Vendor–HDO Collaboration
Best Practices for Alignment
To align practices between healthcare delivery organizations (HDOs) and vendors, adopting a shared security playbook is key. HDOs should implement layered security requirements based on established frameworks like NIST CSF, HIPAA, and HICP. These requirements should be categorized by solution type - such as cloud SaaS, networked medical devices, or EHR integrations - allowing vendors to map their controls and certifications directly to these profiles. This approach minimizes unnecessary back-and-forth discussions before contracts are finalized.
Joint threat modeling workshops can also be highly effective. These sessions, held during procurement or pre-contract phases, focus on clinical workflows like radiology image sharing or medication administration. Together, HDOs and vendors can map data flows, integration points, and potential threats (e.g., ransomware or API abuse). The result? A prioritized risk register that outlines agreed-upon controls, residual risks, and clearly defined responsibilities. This step ensures security requirements move from being static documents to actionable commitments.
Lifecycle management is another critical piece. Both parties should establish a review schedule, ideally on an annual basis or triggered by significant events like product updates or major vulnerability disclosures. Vendors can support this process by including formal security impact statements with major release notes. Meanwhile, HDOs should incorporate vendor solutions into their change management workflows.
By combining these practices, structured governance can further reinforce accountability and collaboration.
Role of Governance and Tools
A solid governance framework ensures that these collaborative efforts are sustainable. Addressing misalignments requires governance structures that promote ongoing communication and accountability. For example, HDOs can create a cross-functional vendor risk committee. This committee - composed of representatives from security, privacy, legal, compliance, and clinical teams - should be empowered to approve or reject vendor solutions based on their risk posture. Vendors, on their end, can establish an internal product security council to ensure that customer commitments are realistic and consistently upheld.
Strengthening BAAs (Business Associate Agreements) and service agreements with specific security expectations is another step forward. These agreements should include clear requirements for multi-factor authentication, encryption standards, logging, and incident notification timelines (e.g., within 24–72 hours). Incorporating RACI matrices for areas like patching timelines, incident response, and business continuity can help eliminate confusion about responsibilities. Tools like Censinet RiskOps™ enhance this governance layer by centralizing questionnaires, evidence, and approval workflows. They also offer pre-built healthcare-specific control libraries and automated reminders to keep assessments on track.
Benefits of Shared Platforms
Technology-driven platforms complement governance efforts by streamlining risk management processes. Transitioning from spreadsheets and emails to a shared platform can significantly improve efficiency. Vendors can maintain a single, updated evidence repository - containing documents like SOC 2 reports, penetration test summaries, SBOMs, and incident response plans - that multiple HDOs can access. For HDOs, this means receiving structured and comparable data that can be filtered by factors like severity, clinical impact, or data sensitivity, and quickly routed to the right experts.
Shared platforms also support ongoing oversight. Instead of treating assessments as one-time tasks, platforms like Censinet RiskOps™ monitor remediation progress, flag expiring certifications, and highlight shifts in vendor risk posture over time. Tools like Censinet AI™ further streamline these processes, offering up to a 66% time reduction for critical assessment tasks such as evidence review, risk scoring, and summary report generation [4]. This ensures that risk management programs stay aligned with evolving threats, rather than becoming outdated by the time contracts are signed.
| Feature | Benefit for HDOs | Benefit for Vendors |
|---|---|---|
| Standardized questionnaires | Consistent data for audits | Reduced effort from varying requests |
| Automated corrective action plans (CAPs) | Clear tracking of fixes | Transparent expectations for remediation |
| Reusable evidence repository | Faster reviews, fewer follow-ups | One-time effort, reusable across clients |
| AI-powered risk agents | Up to 66% faster assessments [4] | Shorter sales cycles, quicker onboarding |
| Continuous monitoring | Real-time risk visibility | Proactive demonstration of improvements |
Conclusion: Building Stronger Vendor–HDO Security Partnerships
At the heart of vendor–HDO security collaboration lies a fundamental tension: vendors aim for scalability and reusability to serve multiple clients, while HDOs prioritize patient safety, regulatory compliance, and seamless clinical workflows [5]. When these differing goals aren't aligned, security requirements can stall, leaving sensitive PHI exposed and trust eroded. The ripple effects of this misalignment extend across the entire vendor ecosystem.
According to HHS, 59% of healthcare data breaches in 2023 involved a business associate or third-party vendor [6]. For large integrated delivery networks, managing relationships with numerous vendors that access ePHI or critical clinical systems is a daunting task [6][7]. Outdated, manual processes like spreadsheets simply can't keep up with the volume of vendors or the rapidly evolving threat landscape. This highlights the urgent need for continuous, systematic oversight.
The key to closing this gap is treating security as a shared, ongoing responsibility. This involves conducting joint risk reviews, clearly defining roles and responsibilities using RACI matrices, and tying remediation plans directly to clinical impact with firm deadlines. Both sides must agree on what "done" looks like - not just at the start of the relationship, but throughout its duration. Leveraging structured, technology-driven approaches can make this collaboration more manageable and effective.
Censinet RiskOps™ offers a way to streamline this process by giving HDOs and vendors a unified platform. It enables standardized assessments, efficient evidence exchange, remediation tracking, and vendor risk benchmarking - all within a healthcare-specific framework that addresses PHI, clinical applications, medical devices, and healthcare supply chain security challenges. Instead of relying on scattered email chains, both parties work with the same up-to-date risk data, making it easier to prove due diligence to regulators and auditors.
Ultimately, stronger vendor–HDO partnerships rest on mutual accountability, transparent processes, and a shared commitment to protecting patients. Organizations that embrace this approach see security not as a barrier, but as an integral, measurable part of their collaboration.
FAQs
Who owns which security responsibilities - vendor or HDO?
In the shared responsibility model, vendors are in charge of the security of the cloud. This includes managing infrastructure, data centers, hardware, networking, and ensuring compliance with standards like SOC 2 and ISO 27001. On the other hand, healthcare delivery organizations (HDOs) are responsible for security in the cloud, which focuses on safeguarding data, applications, access controls, and configurations. HDOs must also ensure HIPAA compliance and address any misconfigurations.
To simplify this process, Censinet RiskOps™ offers tools to streamline risk assessments and improve visibility into vendor security and configurations.
What evidence should vendors provide beyond questionnaires?
When it comes to backing up security claims, relying solely on questionnaires isn't enough. Vendors need to present audit-ready documentation to offer a clearer picture of their security posture. This includes key pieces of evidence like:
- Recent third-party audit reports: Examples include SOC 2, ISO 27001, or ISO 27017 certifications.
- Signed Business Associate Agreements (BAAs): Essential for ensuring compliance in healthcare-related partnerships.
- Penetration test results: These demonstrate proactive efforts to identify and address vulnerabilities.
- Incident response plans: A clear strategy for handling potential security breaches.
For medical devices or software, providing a machine-readable Software Bill of Materials (SBOM) is critical. An SBOM offers transparency into the supply chain, helping to identify and manage risks. Together, these documents underline adherence to industry standards like NIST or HITRUST, proving a commitment to robust security practices.
How can HDOs prevent vendor risk from drifting over time?
Healthcare organizations can stay ahead of vendor risks by shifting to continuous monitoring rather than depending on static, once-a-year assessments. Real-time tracking is key to spotting unauthorized changes or vulnerabilities as they arise, keeping potential threats in check.
It's also important to keep an up-to-date vendor inventory and perform thorough reviews during contract renewals or after major changes. Tools like Censinet RiskOps™ can simplify this process by automating assessments and monitoring, helping compliance programs stay aligned with emerging risks.
