Medical Device Risk Assessment

HICP Practice 9.2 requires you to conduct cybersecurity risk assessments for medical devices that explicitly account for patient safety, PHI confidentiality, and clinical/operational impact, not just traditional IT risk. Operationalize it by building a device inventory, defining safety-and-workflow risk criteria, assessing each device (including third-party dependencies), documenting decisions, and tracking remediation to closure. ¹

Key takeaways:

• Your medical device risk assessment must evaluate patient safety and care delivery impact alongside data confidentiality. ¹
• The “device” scope includes embedded software, network connectivity, integrations, and third-party remote access paths. ¹
• Auditors will look for repeatable criteria, documented sign-off across clinical/biomed/IT, and evidence that remediation is tracked and sustained. ¹

Medical device risk assessment is easy to under-scope because many organizations treat devices like standard endpoints. HICP Practice 9.2 sets a higher bar: assess cybersecurity risk in a way that reflects how devices affect patients, clinicians, and clinical operations, not only how they affect networks and data. ¹

For a CCO or GRC lead, the practical challenge is governance. You need a method that creates consistent, defensible risk decisions across departments that do not share the same language: clinical leadership (patient harm and workflow disruption), biomedical/clinical engineering (device lifecycle and maintenance constraints), IT/security (vulnerabilities, segmentation, monitoring), and procurement/vendor management (third-party obligations and service dependencies). Your assessment process must also work under real constraints: limited patching ability, FDA-regulated change control in some contexts, and “can’t take it down” operational realities.

This page translates the requirement into an implementable workflow: who owns what, the minimum fields your assessment must capture, step-by-step execution, evidence to retain, and the failure modes that trigger audit findings or operational risk.

Regulatory text

Requirement (HICP Practice 9.2): “Conduct cybersecurity risk assessments for medical devices considering patient safety, data confidentiality, and operational impact.” ¹

What the operator must do:
You must run a cybersecurity risk assessment process specifically for medical devices where the risk statement and scoring reflect:

• Patient safety impact (direct or indirect harm scenarios tied to device compromise or unavailability)
• Data confidentiality impact (especially PHI exposure through device storage, transmission, or integrations)
• Operational impact (clinical workflow disruption, downtime tolerance, care diversion, and recovery complexity)
  This is in addition to standard cybersecurity considerations like vulnerability exposure, threat likelihood, and existing controls. ¹

Plain-English interpretation (what “good” looks like)

A compliant medical device risk assessment is not a one-time spreadsheet. It is a repeatable method that:

1. Identifies which medical devices you have and how they connect
2. Determines how compromise could affect patients, PHI, and care delivery
3. Assigns an accountable risk owner and documents acceptance vs. remediation
4. Tracks mitigations to completion and re-assesses when conditions change ¹

If your current enterprise risk process can’t express patient harm and workflow downtime in a meaningful way, you need a medical-device-specific overlay (criteria, workflow, and clinical sign-off), even if you keep a common enterprise risk register.

Who it applies to (entity and operational context)

Applies to:

• Healthcare organizations operating, managing, or connecting medical devices to their environment (hospitals, clinics, imaging centers, ambulatory surgery centers, home-health operators with managed devices). ¹
• Health IT vendors where the product directly manages, monitors, connects to, or enables remote access to medical devices, or where the vendor provides device-adjacent platforms used in clinical environments. ¹

Operational contexts that typically fall in scope:

• Network-connected devices (imaging, infusion, patient monitoring, lab systems)
• Devices with embedded operating systems and software dependencies
• Devices with remote support channels or third-party connectivity
• Devices that integrate with EHR/clinical systems or store/transmit PHI ¹

What you actually need to do (step-by-step)

1) Set ownership and a decision forum

Define a standing group that can make risk decisions. Minimum representation:

• Security/IT (threat and control perspective)
• Clinical engineering/biomed (device lifecycle constraints)
• Clinical operations (workflow and patient impact)
• Privacy/compliance (PHI and documentation expectations)
• Procurement/vendor management when third-party access or service obligations exist ¹

Output: a RACI for device risk assessments and a defined approval path for risk acceptance.

2) Build or validate the medical device inventory (asset + connectivity)

A medical device risk assessment fails without a credible inventory. At minimum, capture:

• Device name, model, manufacturer, and unique identifier (asset tag/serial)
• Location (facility/unit) and clinical use
• Network attributes (IP/MAC where applicable, VLAN/segment, wireless use)
• Software/OS version where accessible
• Integrations (EHR interfaces, middleware, PACS/LIS)
• Third-party relationships (remote support method, who has access, when, and how it is controlled)
• Data handling (does it store PHI locally, transmit PHI, or display PHI only) ¹

Practical note: start with your CMMS/biomed inventory and reconcile with network discovery. Each source is incomplete in different ways.

3) Define your medical-device-specific risk criteria

You need criteria that force consideration of the three required dimensions. Use a simple rubric your stakeholders can apply consistently:

A. Patient safety impact (examples of prompts)

• Could compromise cause incorrect therapy/dose, delayed therapy, or false readings?
• Would unavailability create a time-critical care gap?
• Is there a safe manual workaround, and how reliable is it? ¹

B. Data confidentiality (PHI) impact

• Does the device store PHI at rest?
• Is PHI encrypted in transit to downstream systems?
• Are logs/screens/photos/exports a PHI leakage vector? ¹

C. Operational/clinical workflow impact

• Downtime tolerance for the device in its clinical context
• Dependency chain (if this device is down, what else stops working?)
• Recovery path (restore complexity, vendor dependency, lead times) ¹

Tip for faster adoption: define categories (High/Medium/Low) for each dimension, then create a rule for overall criticality (for example, any “High patient safety impact” forces senior clinical sign-off for risk acceptance).

4) Perform the assessment per device or device class (and document assumptions)

Assess at the right granularity:

• Per device class when devices are truly identical in model, configuration baseline, use case, and network placement.
• Per individual device when location/use differs materially (ICU vs. general ward), configurations diverge, or compensating controls vary. ¹

Include the following elements in each assessment record:

• Intended clinical function and care setting
• Threat exposure (internet-facing, remote access, lateral movement potential)
• Known constraints (patching limitations, vendor-controlled updates)
• Current controls (segmentation, access control, monitoring, backup/restore approach)
• Rated impacts (patient safety, confidentiality, operational)
• Risk decision: remediate, mitigate, accept, or replace
• Accountable owner and due dates for actions ¹

5) Identify and assign mitigations that fit device constraints

Medical device constraints often rule out “standard IT fixes.” Build a menu of realistic mitigations:

• Network segmentation and strict allow-listing
• Removal or hardening of remote access paths; require controlled jump hosts
• Strong authentication for administration and vendor access
• Compensating monitoring (alerts for anomalous traffic, device behavior)
• Maintenance windows and coordinated clinical downtime plans
• Device replacement plan when the residual risk is not acceptable and controls are limited ¹

Tie each mitigation to the risk dimension it reduces. Auditors and clinical stakeholders want to see that the mitigation maps to patient safety, PHI, or workflow impact, not only “security posture.”

6) Connect the assessment to procurement and third-party governance

Where third parties provide device software, connectivity, hosting, remote support, or maintenance:

• Require clear responsibility boundaries (who patches what, who monitors what)
• Document remote access controls and approval workflow
• Ensure incident reporting and coordination expectations are explicit for device-related events
• Keep the device risk assessment as an input to third-party risk decisions (onboarding, renewal, exceptions) ¹

If you use a platform like Daydream for third-party risk management, treat medical devices as a high-sensitivity service category: link each device class to the relevant third parties, attach assessment artifacts, and track remediation work items through renewal so risk does not reset each contract cycle.

7) Establish re-assessment triggers

You do not need to re-assess everything constantly, but you do need triggers that make sense operationally:

• New device introduction or major version change
• Network architecture changes affecting segmentation/exposure
• New integration that changes data flows
• Changes in third-party remote access methods
• Security incident, near miss, or safety event involving the device ¹

Required evidence and artifacts to retain

Keep artifacts that prove the assessment occurred and drove action:

• Medical device inventory extract with required fields (scope evidence)
• Risk assessment procedure (method, scoring, roles, approval path)
• Completed assessment records ¹, including assumptions and impact ratings
• Meeting notes or sign-offs showing clinical + biomed + security review for high-impact items
• Remediation plans and tickets (with owners, status, and closure evidence)
• Exceptions/risk acceptances with justification and time bounds
• Third-party access documentation (remote access diagrams, approvals, access logs where available)
• Change records tied to mitigations (segmentation changes, firewall rules, monitoring enablement) ¹

Common exam/audit questions and hangups

Auditors and internal reviewers typically press on:

• “Show me how patient safety was evaluated, not implied.”
• “Which devices store or transmit PHI, and how did you determine that?”
• “How do you control and monitor third-party remote access to devices?”
• “Where is the evidence that risks were remediated or formally accepted?”
• “How do you ensure the inventory is complete and current?”
• “What triggers a re-assessment?” ¹

Hangup to anticipate: teams often present a generic vulnerability scan report as the “risk assessment.” That rarely answers patient safety or workflow disruption questions.

Frequent implementation mistakes (and how to avoid them)

1. Treating the device like a normal workstation.
   Avoidance: require patient safety and clinical operations ratings in the template. No rating, no approval. ¹

2. Inventory gaps (especially “shadow” clinical devices).
   Avoidance: reconcile biomed CMMS, procurement records, and network discovery. Assign someone accountable for discrepancies. ¹

3. No documented decision trail.
   Avoidance: record who accepted risk, what mitigations were considered, and what constraints prevented standard fixes. ¹

4. Third-party remote access left out of scope.
   Avoidance: treat remote support as part of the device boundary. If a third party can reach the device, it belongs in the assessment record. ¹

5. Mitigations assigned without clinical downtime planning.
   Avoidance: require a clinical operations plan for any change that could affect device availability. ¹

Enforcement context and risk implications

No public enforcement cases were provided in the source catalog for this requirement, so you should treat HICP Practice 9.2 as an industry-recognized practice that strengthens defensibility and reduces the chance that a device-related incident becomes a broader compliance failure. ¹

From a risk perspective, medical devices concentrate multiple exposures in one place: patient safety outcomes, PHI handling, and operational continuity. A weak assessment process increases the odds that you accept residual risk without understanding clinical consequences, or that you miss third-party access paths that become the real attack surface. ¹

Practical 30/60/90-day execution plan

First 30 days (Immediate stabilization)

• Stand up the cross-functional decision forum and publish the RACI. ¹
• Define the assessment template with explicit patient safety, confidentiality, and operational impact sections. ¹
• Produce a baseline inventory by reconciling biomed and IT sources; flag unknowns and third-party remote access entries for investigation. ¹
• Pick a small set of high-exposure device classes (for example, those with remote access or broad deployment) and complete pilot assessments end-to-end, including sign-off and remediation tickets. ¹

Days 31–60 (Scale with governance)

• Expand assessments to remaining priority device classes based on patient safety criticality and connectivity exposure. ¹
• Standardize mitigations: segmentation patterns, remote access control patterns, monitoring requirements, and exception criteria. ¹
• Integrate third-party governance: ensure device-support third parties are mapped to device classes and that access methods and obligations are documented. ¹

Days 61–90 (Operationalize and sustain)

• Establish re-assessment triggers in change management and procurement intake so new devices and new integrations automatically route to the assessment workflow. ¹
• Implement reporting: an executive view of high patient-safety-impact devices, open remediation items, and accepted risks with owners. ¹
• Run a tabletop scenario for a device compromise or outage to validate downtime procedures, escalation paths, and third-party coordination. ¹

Frequently Asked Questions

Do I have to assess every single medical device individually?

Assess at the device-class level only when the model, configuration, use case, and network placement are materially the same. If patient safety impact or exposure differs by location or configuration, assess individually. ¹

What’s the minimum proof an auditor will accept as a “medical device risk assessment”?

A completed record that explicitly documents patient safety, PHI confidentiality, and operational impact, plus a clear decision (mitigate/accept/replace) and tracked actions to closure. A vulnerability scan alone usually does not meet the intent. ¹

How should we treat third-party remote support access in the assessment?

Treat remote access as part of the device’s attack surface and document the method, approvals, authentication, and monitoring. If you can’t describe how access is controlled, the risk assessment is incomplete. ¹

Who should sign off on high patient-safety-impact risks?

Require both a clinical leader (who understands care impact) and a technical owner (biomed or security) to approve acceptance. Document the rationale and any compensating controls. ¹

What if the manufacturer won’t allow patching or EDR on the device?

Document the constraint, then focus on compensating controls such as segmentation, strict allow-lists, controlled administration paths, and monitoring. If residual risk remains high, escalate to replacement planning with clinical leadership. ¹

How do we keep this from becoming a one-time project?

Put re-assessment triggers into procurement intake, change management, and third-party access changes. Track device risks and remediation items in your GRC workflow so renewals and changes reuse prior evidence instead of restarting. ¹

Footnotes

1. HICP 2023 - 405(d) Health Industry Cybersecurity Practices