Medical device and legacy system risk management

The medical device and legacy system risk management requirement means you must identify clinical devices and older technologies that cannot be hardened through normal patching or configuration, then reduce risk through compensating controls and documented risk acceptance decisions. Your goal is audit-ready proof that constrained assets are governed, segmented, monitored, and owned end-to-end ¹.

Key takeaways:

• Build and maintain an inventory of “constrained assets” (medical devices and legacy systems) with owners, network location, and support status ¹.
• Apply compensating controls (segmentation, access controls, monitoring, backups) when patching or hardening is not feasible, and document the rationale ¹.
• Formalize risk acceptance with time bounds, approvals, and a retirement/mitigation plan so exceptions do not become permanent ¹.

Medical devices and legacy systems create a predictable problem for healthcare security and compliance teams: you are accountable for risk, but the technology may be constrained by patient safety concerns, manufacturer limitations, outdated operating systems, or clinical workflow dependencies. The HICP requirement is short, but operationally it demands a repeatable governance process that turns those constraints into managed risk rather than unmanaged exposure ¹.

For a Compliance Officer, CCO, or GRC lead, the fastest path is to treat “medical device and legacy system risk management” as an exceptions-and-compensating-controls program. You need a defensible way to (1) identify constrained assets, (2) decide which security controls are not feasible, (3) implement compensating controls you can enforce, and (4) document decisions so leadership understands the residual risk and timelines.

This page provides requirement-level implementation guidance you can hand to IT, Security, Biomedical/HTM, and clinical operations with clear steps, evidence expectations, and the questions auditors actually ask.

Regulatory text

HICP requirement (excerpt): “Address risks from clinical devices and legacy technology constraints.” ¹

What the operator must do:
You must run a documented process that identifies clinical devices and legacy technologies that cannot meet standard security baselines (often due to patching limits, compatibility, or manufacturer restrictions), and then actively manages the risk through compensating controls and explicit risk acceptance decisions ¹.

This is not a one-time remediation project. It is governance: inventory, ownership, decisioning, control implementation, evidence retention, and periodic review tied to patient safety and operational continuity ¹.

Plain-English interpretation of the requirement

“Medical device and legacy system risk management requirement” means:

• You know which assets are constrained and why.
• You do not pretend they meet modern security expectations if they cannot.
• You reduce exposure using controls you can enforce around the asset (network, identity, monitoring, backups, physical safeguards).
• You document residual risk and get approvals for continued operation, with a plan to mitigate or retire.

A practical test: If leadership asked, “Which unpatchable devices do we have, where are they, what risk do they create, and what are we doing about it?” you can answer with evidence, not anecdotes ¹.

Who it applies to (entity and operational context)

Applies to: Healthcare organizations implementing HICP practices ¹.

Operational areas involved:

• Clinical engineering / HTM / Biomed: device lifecycle, manufacturer coordination, maintenance windows.
• IT infrastructure / network: segmentation, NAC, firewall rules, VLANs, routing, remote access.
• Information security / SOC: vulnerability intake, monitoring, alerting, incident response playbooks.
• Clinical operations: workflow impact, downtime procedures, patient safety alignment.
• Third parties: medical device manufacturers, managed service providers, remote service tools, cloud device management platforms. Treat them as third parties within your due diligence and access control model.

Asset scope (typical constrained assets):

• Imaging systems, infusion pumps, patient monitors, lab analyzers, nurse call systems.
• Legacy servers supporting EHR adjunct systems, interface engines, radiology/PACS components.
• Older OS endpoints in clinical areas that cannot be upgraded without replacing the device.

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

Step 1: Define “constrained asset” and set the decision rules

Create a short policy/standard that defines constrained assets, such as:

• Cannot be patched on your required cadence due to manufacturer restrictions or certification concerns.
• Runs an OS or application version that cannot be upgraded without hardware replacement.
• Cannot run endpoint protection or security agents due to performance, safety, or compatibility.
• Requires remote vendor access that you cannot fully control without compensating controls.

Add a rule: constrained assets must have documented compensating controls and, if risk remains, a documented risk acceptance decision ¹.

Step 2: Build an inventory you can govern (not just a CMDB dump)

Minimum fields that make the inventory operational:

• Asset name, type (medical device vs legacy IT), model, OS/firmware, serial/ID.
• Location (facility, unit), network segment/VLAN, IP/MAC if applicable.
• Business/clinical owner and technical owner (named roles, not a team alias).
• Manufacturer and support status (supported, end-of-support, unknown).
• Known constraints (patching blocked, agent not supported, protocol limitations).
• Patient safety / criticality classification (your internal scale).
• Current compensating controls in place and last review date.

Most teams fail here by tracking “legacy” informally. Your goal is a list that drives action and exception governance.

Step 3: Perform a focused risk assessment per constrained asset class

You do not need a thesis per device. You need consistent decisioning:

• Threat exposure: internet-facing, vendor remote access, lateral movement paths, removable media use.
• Impact: patient safety disruption, care delays, data confidentiality (including PHI), downtime.
• Control gaps: patching, authentication, logging, EDR, encryption, secure configuration.

Group devices into classes where appropriate (example: “Infusion pumps model X across all campuses”) if controls and constraints are the same. Document why grouping is valid.

Step 4: Implement compensating controls (the core of the requirement)

Prioritize controls you can enforce without touching the device:

Network controls

• Segment clinical devices from corporate user networks.
• Restrict east-west traffic; only allow required ports to required destinations.
• Put vendor remote access behind a controlled entry point (jump host, VPN with MFA, time-bound access).

Identity and access controls

• Remove shared local accounts where feasible; control administrative access centrally.
• Implement time-limited access for third-party support sessions with approval and logging.

Monitoring and detection

• Centralize logs you can collect (network telemetry, firewall events, authentication logs, remote access logs).
• Create alert rules for abnormal communications (new destinations, high-volume traffic, repeated failed logins).

Resilience

• Backups for connected systems that can be backed up (configs, supporting servers).
• Document downtime and manual fallback procedures for patient care where applicable.

Physical and procedural controls

• Lockdown ports, control removable media, restrict device movement between units without authorization.

HICP’s practical control direction is explicit: maintain compensating controls and risk acceptance decisions for constrained assets ¹.

Step 5: Document risk acceptance decisions (and make them expire)

Risk acceptance is required when residual risk remains after compensating controls ¹. Your acceptance record should include:

• What requirement/control cannot be met (example: “No vendor-supported patch path”).
• Why (manufacturer limitation, safety certification concerns, operational dependency).
• Compensating controls implemented and their owner.
• Residual risk statement in plain language.
• Approver(s): security leadership plus clinical/operational leadership for patient-impacting assets.
• Review trigger: patch availability, manufacturer advisory, renewal date, device replacement project milestone.
• Exit plan: retire, replace, isolate further, or migrate workflow.

Make “no end date” an explicit exception that needs higher approval. Unbounded exceptions become audit findings.

Step 6: Tie the program to lifecycle management and procurement

If you only manage risk after deployment, the inventory grows forever. Add gates:

• Procurement security review for connected medical devices and supporting systems.
• Contract requirements for patch guidance, vulnerability disclosure, and remote access controls for third parties (where your contracting model allows).
• End-of-support tracking with replacement planning.

Step 7: Operational cadence and reporting

Run a recurring review with Security + IT + HTM:

• Newly discovered constrained assets
• Expiring acceptances
• Network segmentation drift (new ports/destinations)
• Major incidents or near misses tied to constrained assets

Where Daydream fits naturally: Many teams struggle to keep constrained-asset exceptions, compensating controls, and approvals consistent across sites. Daydream can act as the system of record for exception workflows, control mapping, and evidence collection so audits do not become a scavenger hunt.

Required evidence and artifacts to retain

Auditors and internal reviewers will look for proof that the requirement is operating, not just written down ¹. Retain:

1. Constrained asset inventory

• Exportable list with the minimum fields above
• Ownership assignments and last review dates

2. Risk assessment records

• Device class risk assessments and/or asset-specific assessments
• Notes on constraints and impacted controls

3. Compensating control documentation

• Network diagrams or segmentation policy excerpts
• Firewall/NAC rule change tickets and approvals
• Remote access design (jump host/VPN) and access procedures
• Monitoring coverage documentation (log sources, alert rules)

4. Risk acceptance packages

• Approved exception forms with rationale, scope, residual risk, review date, and exit plan

5. Operational proof

• Meeting minutes or agenda showing recurring review
• Samples of access logs for vendor sessions
• Evidence of periodic validation (spot checks, configuration reviews)

Common exam/audit questions and hangups

Expect these questions in assessments aligned to HICP practices ¹:

• “Show me your inventory of medical devices and legacy systems that cannot be patched.”
• “Who owns each device: HTM, IT, or the clinical department?”
• “How do you decide segmentation requirements for a new clinical device?”
• “Which constrained assets have accepted risk, and who approved it?”
• “How do you control third-party remote access to clinical devices?”
• “How do you detect abnormal behavior from devices that cannot run EDR?”

Hangup to anticipate: teams can describe compensating controls verbally but cannot produce consistent evidence (tickets, diagrams, acceptance records) across facilities.

Frequent implementation mistakes and how to avoid them

Mistake	Why it fails	Avoid it by doing this
Treating medical devices as “biomed’s problem”	Security controls live in the network and identity stack	Create shared ownership: HTM for lifecycle, IT/Sec for controls, clinical ops for impact
Inventory without constraints	You cannot prove you addressed “legacy constraints”	Add explicit constraint fields and required compensating controls per constraint type
Exceptions that never expire	Risk acceptance turns into permanent risk	Require review dates and an exit plan for every acceptance
Vendor remote access with weak controls	Third-party pathways are common attack paths	Put all remote access behind MFA, approvals, and logging you control
Segmentation that exists only on paper	Network drift happens fast	Validate segments and rules periodically; keep rule tickets as evidence

Enforcement context and risk implications

No public enforcement cases were provided in the source catalog for this requirement. Treat the risk as operational and patient-safety adjacent: constrained assets often have high availability requirements, limited patch paths, and third-party service dependencies. Your compliance exposure rises when you cannot show governance decisions and compensating controls with retained evidence ¹.

A practical 30/60/90-day execution plan

Days 0–30: Establish control and visibility

• Publish the constrained asset definition and the required workflow for compensating controls and risk acceptance ¹.
• Stand up a minimum viable inventory for one facility or one device domain (example: imaging + supporting servers).
• Identify existing vendor remote access paths and document current state.
• Pick an evidence repository and naming convention for tickets, diagrams, and acceptance forms.

Days 31–60: Implement compensating controls where they matter most

• Segment the highest-risk device networks (based on exposure and clinical criticality).
• Implement controlled third-party access (MFA, approvals, logging) for top manufacturers.
• Create standard compensating control patterns (templates) by device class.
• Run your first formal risk acceptance cycle for assets that cannot meet baselines ¹.

Days 61–90: Make it repeatable and audit-ready

• Expand inventory coverage across additional facilities and device types.
• Operationalize recurring reviews: expiring acceptances, segmentation drift, new device onboarding.
• Validate monitoring: confirm you can see remote access events and key network telemetry for device segments.
• Build an executive report: constrained asset count by category, top risks, acceptances nearing renewal, replacement roadmap themes.

Frequently Asked Questions

What counts as a “legacy system” for this requirement?

Any technology you operate that cannot meet your normal security baseline due to technical or support constraints, especially end-of-support OS or applications. Define it formally in your policy so teams classify assets consistently ¹.

Do we need a full risk assessment for every single medical device?

No. You need defensible decisioning. Many organizations assess by device class when constraints and controls are the same, then document exceptions for outliers ¹.

What’s the minimum compensating control set auditors expect to see?

Controls you can enforce around the device: segmentation, restricted remote access, monitoring, and documented risk acceptance when gaps remain. The key is evidence that these controls exist and are maintained ¹.

How do we handle a manufacturer that refuses to support security changes?

Record the constraint, implement network and access compensating controls you control, and document risk acceptance with an exit strategy (replacement planning, additional isolation, or workflow change). Keep manufacturer correspondence as evidence ¹.

Who should sign risk acceptance for patient-impacting devices?

Security leadership should approve the cybersecurity posture, and clinical/operational leadership should approve patient care and workflow risk. Document roles and approval authority in your exception process ¹.

Can we “accept risk” without a remediation plan if the device is still under warranty?

You can accept risk, but approvals should state what would change the decision (patch availability, supported upgrade, replacement cycle) and who is accountable for tracking it. Avoid indefinite acceptance with no trigger for re-evaluation ¹.

Related compliance topics

• 2025 SEC Marketing Rule Examination Focus Areas
• Access and identity controls
• Access Control (AC)
• Access control and identity discipline
• Access control lifecycle management

Footnotes

1. HHS 405(d) HICP