Best Practices for Medical IoT Device Security in Modern Clinical Environments

A security update might take only a few minutes on an office computer, but to update medical device it needs more planning. Hospitals cannot simply disconnect essential equipment whenever a vulnerability appears. Patient appointments, treatment schedules, and manufacturer restrictions all influence what security teams can do.

This makes medical IoT device security a challenge beyond conventional IT protection. An overlooked connection or unauthorised access could put clinical systems at risk, while poorly planned security changes could interfere with equipment that patients depend on.

Healthcare organisations need security practices that work within these clinical limitations. This guide explains how to reduce device vulnerabilities, manage access and strengthen protection without compromising essential medical operations.

What Is Medical IoT Device Security?

Medical IoT device security refers to protecting connected medical equipment, its software, communication networks and supporting systems from unauthorised access, data theft, operational disruptions and malicious changes. It aims to preserve the confidentiality of patient information, the accuracy of medical data and the reliable functioning of devices used in patient care.

These devices form part of the Internet of Medical Things (IoMT), a network of medical technologies that collect, process and exchange healthcare information. IoMT cybersecurity focuses on securing these medical devices and their associated technologies. Unlike broader healthcare IoT, which also includes building sensors, environmental monitoring and access control systems, IoMT focuses specifically on medical equipment and its associated technologies.

Different medical devices have different security priorities:

Common Security Threats to Medical IoT Devices

Connected medical equipment faces threats from vulnerabilities in device software, access controls, communication channels and supporting infrastructure. Understanding these risks helps healthcare organisations identify where security failures could affect clinical operations.

1. Ransomware and Malware

Malicious software can infect hospital networks, medical device management servers and connected workstations. Ransomware can lock access to essential applications or clinical data, leaving healthcare teams unable to use affected systems. This can delay diagnostic imaging, interrupt monitoring services and interfere with scheduled treatments.

2. Weak Authentication and Unauthorised Access

Default passwords, shared administrator accounts and exposed management interfaces create opportunities for unauthorised access. Attackers who obtain sufficient privileges could change device configurations, access medical information or interfere with equipment functions. Such activity can also make it difficult to identify who performed a particular action.

3. Outdated Software and Firmware

Medical equipment often remains operational for many years, even after its underlying software becomes outdated. Older operating systems, unsupported firmware and delayed manufacturer updates can leave known security weaknesses unresolved. Attackers could exploit these vulnerabilities to compromise devices or the systems connected to them.

4. Insecure Communication Protocols

Medical devices exchange information through wired networks, wireless connections and software interfaces. When these communications lack adequate protection, attackers could intercept sensitive information or interfere with transmitted data. Weak wireless security and exposed interfaces also increase the risk of unauthorised connections.

5. Third Party and Supply Chain Vulnerabilities

Medical equipment frequently depends on external software libraries, manufacturer applications and remote maintenance services. Security weaknesses in these components can expose devices even when their primary functions operate normally. A compromised supplier connection could also provide attackers with access to hospital systems.

6. Poor Network Isolation

When medical equipment communicates unnecessarily with unrelated hospital systems, a security incident elsewhere on the network can threaten connected clinical devices. Attackers who compromise one system could use existing network connections to reach other equipment, potentially affecting multiple departments and disrupting healthcare services.

12 Best Practices for Medical IoT Device Security

Antivirus software and vulnerability scans alone cannot protect medical equipment. Hospitals must consider device limitations, manufacturer support, clinical requirements, and cybersecurity.

1. Maintain a Complete Inventory of Connected Medical Devices

First, check whether every medical device connected to your hospital network appears in your asset records. Equipment transferred between departments, installed by vendors or temporarily disconnected can easily be missed.

Compare procurement records with biomedical engineering maintenance logs, device management platforms and network discovery results. This will help you identify missing entries and bring device information into one inventory.

For effective IoT medical device security, record the following details for each device:

Identification:

• Manufacturer
• Model
• Serial number
• Unique device identifier (UDI), if assigned

Clinical information:

• Device type and clinical purpose
• Department
• Physical location

Software details:

• Operating system and version
• Installed software versions
• Firmware version

Network information:

• IP address
• Network segment
• Communication protocols
• Connected applications and systems

Security information:

• Manufacturer support status
• Known vulnerabilities

Assigned responsibilities:

• Biomedical engineer
• IT contact
• Clinical owner

Use passive network discovery to identify equipment through observed network traffic without sending active scans to sensitive devices. You will still need to check maintenance records and physical equipment because offline devices and those that rarely transmit data can go unnoticed.

2. Conduct Security Risk Assessments Based on Clinical Criticality

A vulnerability in an intensive care unit patient monitor carries different consequences from one affecting an administrative computer. Even if the computer has a higher technical severity score, the monitoring system could require more urgent attention because clinicians depend on it for patient observations. 

To prioritise vulnerabilities in medical device IoT security, assess the following factors:

• Vulnerability severity: Review Common Vulnerability Scoring System (CVSS) scores and relevant Common Vulnerabilities and Exposures (CVE) records.
• Exploitation evidence: Check CISA's Known Exploited Vulnerabilities (KEV) catalogue to identify vulnerabilities already exploited in real attacks.
• Network exposure: Examine wireless connectivity, remote access permissions and accessible network interfaces.
• Clinical dependency: Determine whether the affected equipment supports essential treatment, monitoring or diagnosis.
• Scale and existing safeguards: Identify how many devices are affected and what protections already limit exposure.
• Manufacturer support: Confirm whether approved security updates, fixes or alternative measures are available.

Risk assessments should also consider what an attack could do to patient information, the accuracy of clinical data and equipment availability. For medical devices, these concerns must be evaluated alongside the possibility of patient injury or delayed treatment.

Record the findings, assign responsibility for each risk and document why it has been accepted or requires further action. Review these decisions whenever new exploitation evidence appears, device usage changes or existing safeguards no longer provide sufficient protection.

3. Implement Network Segmentation for Medical IoT Devices

Hospital networks often carry traffic from medical equipment, administrative computers, and external service providers. These systems should not have unrestricted access to one another. Network segmentation creates boundaries that limit which systems can communicate, reducing the potential spread of an attack.

To strengthen network isolation, focus on the following measures:

1. Group medical equipment: Organise devices into appropriate network segments based on their clinical functions, connectivity needs and security requirements.
2. Define permitted connections: Specify approved destinations, IP addresses, ports and protocols. Include any external connections required for manufacturer maintenance.
3. Apply traffic restrictions: Configure VLANs, internal firewalls, access control lists (ACLs) and suitable microsegmentation controls to manage communication between systems.
4. Verify network isolation: Check whether traffic can still pass between VLANs through existing routing configurations. Use appropriate firewall policies or ACLs to restrict unauthorised communication.
5. Test configurations: Evaluate proposed restrictions in a controlled setting and obtain clinical engineering approval before applying them to operational equipment.
6. Prepare a rollback plan: Keep the previous network configuration available so essential communication can be restored if a change affects device functionality.

For iot medical device security, segmentation policies should reflect actual clinical communication needs rather than applying identical restrictions across all equipment. Review the rules after significant network or device changes to ensure necessary connections remain available.

4. Strengthen Device Authentication and Access Controls

Restrict access to medical device functions and management interfaces according to staff responsibilities. Clinical operators, biomedical engineers and IT administrators should only have the permissions necessary for their work.

Apply the following access controls:

• Change default passwords: Replace factory credentials where supported and approved by the manufacturer. Disable unused accounts.
• Assign individual accounts: Give authorised users separate login credentials instead of sharing administrator accounts.
• Limit administrative privileges: Allow only designated personnel to change device configurations or access sensitive management functions.
• Use role-based access control (RBAC): Set permissions according to clinical, maintenance and IT responsibilities.
• Enable multifactor authentication (MFA): Require additional verification for management servers, administrative portals and remote access gateways where supported.
• Protect older devices: Use restricted management connections, controlled access systems and session monitoring when equipment cannot support modern authentication.
• Maintain emergency access: Establish procedures that allow authorised clinical staff to access essential device functions during urgent treatment without unnecessary delays.

Remove access when employees leave or change responsibilities. Review external service provider permissions regularly and revoke them when maintenance work is complete.

5. Establish Safe Patch and Vulnerability Management Procedures

In July 2025, the FDA announced a software patch for certain Contec and Epsimed patient monitors affected by cybersecurity vulnerabilities. However, the update removed their networking capabilities, leaving the equipment suitable for local monitoring only. The FDA also advised healthcare facilities to contact the manufacturer because installation required specialised expertise.

This case shows why medical device patches need clinical review before installation. An update can address a security flaw while changing how equipment functions or communicates with other systems.

Healthcare facilities should follow a controlled patching process:

1. Find affected equipment: Match manufacturer security notices and vulnerability advisories against installed device models and software versions.

2. Verify the vulnerability: Confirm that the reported issue applies to the equipment's current configuration.

3. Check manufacturer instructions:

• Identify approved patches
• Installation requirements
• Temporary workarounds.

4. Review operational effects: Determine whether the update changes device functions, compatibility or availability during treatment.

5. Test before installation: Use representative equipment to check update behaviour where testing is feasible.

6. Obtain approval: Have biomedical engineering, IT and the relevant clinical department review the proposed change.

7. Arrange a maintenance window: Schedule installation when the affected equipment can be safely taken out of service.

8. Check device performance: Verify essential functions and connections to clinical systems before returning the equipment to use.

Keep a record of unresolved vulnerabilities, approved exceptions, assigned owners and reassessment dates. Patch deadlines should reflect the security risk, manufacturer instructions and clinical circumstances rather than applying one fixed schedule to every device.

6. Continuously Monitor Medical Device Network Activity

Some medical devices cannot support conventional endpoint security software due to technical limitations or manufacturer restrictions. Passive network monitoring offers another way to observe communications without sending direct requests to equipment during clinical use.

The first task is to establish normal communication patterns. Record which systems each device routinely contacts, its usual traffic volume and expected communication frequency. These baselines help security teams recognise activity that requires investigation.

Look for signs such as:

• Connections to unfamiliar external IP addresses or unapproved services.
• Attempts to access device management interfaces without authorisation.
• Unexpected communication between separate clinical networks.
• Sudden changes in network traffic volume, destinations or frequency.
• Interruptions in device telemetry without a known operational cause.

Unusual activity does not always indicate a cyberattack. Manufacturer maintenance, equipment faults and legitimate configuration changes can produce similar behaviour.

7. Protect Patient Data and Medical Device Communications

Medical equipment exchanges sensitive information with electronic health records (EHRs), Picture Archiving and Communication Systems (PACS), clinical applications and cloud platforms.

Protect this information through the following measures:

• Encrypt stored data and network transmissions where supported.
• Authenticate communicating systems and safeguard encryption keys, certificates and management credentials.
• Restrict patient information access according to staff duties and privacy requirements.
• Secure data exports, backups, cloud interfaces and third party applications.
• Use approved gateway protections for legacy devices lacking encryption capabilities. Avoid changing clinical protocols without manufacturer approval.

Encryption protects confidentiality, but reliable clinical data also requires integrity checks, including verification of readings and patient identity.

8. Secure Manufacturer and Third Party Remote Access

Manufacturers sometimes need remote access to diagnose equipment faults, perform maintenance or install software updates. Hospitals should establish clear rules for how these connections are requested, authorised and closed. Manufacturers can follow FDA medical device cybersecurity guidance to help protect devices from unauthorised access. 

Before granting access:

• Ask the manufacturer which systems, protocols and service accounts are required.
• Confirm whether continuous connectivity is necessary or access can be enabled only during maintenance.
• Route remote sessions through an approved management gateway instead of exposing devices directly to the internet.
• Approve maintenance sessions for a defined period and record the work performed.
• Disable temporary connections and revoke unnecessary permissions once maintenance is complete.

Obtain written details of the manufacturer's vulnerability disclosure process, security update commitments and incident escalation contacts.

Before changing existing vendor connections, check the service agreement and confirm that restrictions will not interfere with essential equipment support.

9. Include Cybersecurity Requirements in Medical Device Procurement

Security requirements should be part of medical equipment purchase specifications. Checking these details before placing an order helps hospitals identify unsupported features, hidden dependencies and potential maintenance costs.

Request the following documentation from manufacturers:

• Device security architecture and supported authentication controls.
• Software Bill of Materials (SBOM), where applicable.
• Manufacturer Disclosure Statement for Medical Device Security (MDS2).
• Vulnerability reporting and remediation procedures.
• Software update methods and security support duration.
• Encryption capabilities and required communication protocols.
• Network connectivity and remote servicing requirements.
• Backup, restoration and device recovery instructions.
• End of support policies and expected replacement requirements.

The Manufacturer Disclosure Statement for Medical Device Security (MDS2) provides standardised information about a device's security capabilities and limitations. Hospitals can use it to evaluate products, although the document itself does not certify that equipment is secure.

Before finalising a purchase, confirm how long the manufacturer will provide security updates and technical support.

10. Develop a Medical IoT Incident Response Plan

Disconnecting a compromised office computer is usually a routine security decision. Doing the same to a ventilator or patient monitoring system requires clinical approval because an abrupt disconnection could interrupt essential care.

Prepare a device-specific incident response plan with the following stages:

1. Detection: Identify affected equipment, supporting applications and the extent of suspicious activity.
2. Clinical assessment: Confirm whether patients currently depend on the affected equipment and identify immediate safety concerns.
3. Containment: Select suitable restrictions or isolation measures after evaluating their effects on clinical operations.
4. Remediation: Work with biomedical engineers and manufacturers to investigate the compromise and carry out approved corrective actions.
5. Recovery: Check equipment functionality, clinical data accuracy and required system connections before resuming normal operation.
6. Review: Record the incident, decisions made and improvements needed in response procedures.

Define who can authorise clinically disruptive actions and how urgent decisions should be escalated.

Prepare alternative equipment, approved manual procedures and failover arrangements for situations where medical systems become unavailable.

11. Define Cybersecurity Responsibilities Across Clinical and IT Teams

Unclear ownership can leave a reported vulnerability unresolved simply because no department has accepted responsibility for it. Each team should have a defined role based on its expertise and authority.

Record these responsibilities in a formal accountability document. Specify who receives vulnerability reports, who owns unresolved issues and who approves maintenance activities.

12. Regularly Validate and Improve Medical IoT Security Controls

Regular assessments help hospitals identify such gaps before they affect clinical operations.

Review device configurations, access settings, network policies and exposed interfaces through approved security assessments. Penetration testing and active vulnerability scans require particular care. Obtain authorisation, consider manufacturer instructions and agree on safe testing methods with clinical personnel before testing operational equipment.

Track these indicators to measure progress:

• Percentage of connected devices with verified inventory records.
• Number of unsupported devices still in operation.
• Percentage of devices with assigned clinical and security owners.
• Average time taken to assess relevant vulnerability advisories.
• Percentage of critical device groups with validated segmentation rules.
• Network monitoring coverage for clinically important equipment.
• Completion rates for approved remediation activities and incident response exercises.

Medical IoT Security Standards and Regulatory Requirements

Medical device manufacturers and healthcare providers have different cybersecurity responsibilities. Regulatory requirements govern certain aspects of device development and approval, while security standards guide how organisations manage risks.

FDA Cybersecurity Guidance and Section 524B

Section 524B of the Federal Food, Drug, and Cosmetic Act requires sponsors of qualifying cyber devices to include specific cybersecurity information in applicable FDA premarket submissions. This includes plans for addressing vulnerabilities after devices reach the market, procedures for providing security updates and a Software Bill of Materials (SBOM) identifying software components.

The FDA's February 2026 cybersecurity guidance, which replaced the June 2025 version, provides recommendations for secure device design, cybersecurity risk management and premarket documentation.

These premarket requirements primarily apply to manufacturers and submission sponsors. Hospitals are not required under Section 524B to submit cybersecurity documentation for every medical device they operate.

HIPAA Security Rule

The HIPAA Security Rule requires healthcare organisations covered by HIPAA and their business associates to protect electronic protected health information (ePHI). This includes patient information stored or shared through connected medical equipment and related systems.

The rule requires administrative, physical and technical safeguards to prevent unauthorised access, protect information from improper changes and keep it available when needed. However, HIPAA does not automatically apply to every medical device manufacturer. It depends on whether the organisation qualifies as a covered entity or business associate.

NIST, IEC, and Healthcare Cybersecurity Frameworks

• NIST Cybersecurity Framework (CSF) 2.0: Organises cybersecurity activities into six functions: Govern, Identify, Protect, Detect, Respond and Recover. It helps organisations manage security responsibilities and assess their overall cybersecurity programme.
• NIST SP 1800- 8: Provides a practical example of securing wireless infusion pumps and the clinical systems connected to them. Hospitals can use the reference architecture to understand how security technologies work together.
• IEC 81001 Part 5 1: Specifies security activities for developing and maintaining healthcare software. It is particularly relevant to manufacturers building software into medical devices or associated health IT systems.
• ISO 14971: Establishes a medical device risk management process. Manufacturers use it to assess potential hazards, including security-related problems that could affect patient safety. The 2019 edition remains current following its review in 2025.
• HHS Healthcare Cybersecurity Performance Goals: Sets out voluntary essential and enhanced security goals to help healthcare organisations prioritise cybersecurity improvements.

These frameworks are not interchangeable, and none should be treated as automatically mandatory for every medical device or healthcare organisation. Their regulatory relevance depends on the applicable laws, device classification and jurisdiction.

Strengthen Medical Device Cybersecurity With Medysec

Security weaknesses found late in medical device development can lead to additional testing, design changes and regulatory documentation work. Medysec helps manufacturers identify these issues and prepare cybersecurity evidence for connected medical devices, healthcare software and Software as a Medical Device (SaMD) products.

Medysec provides the following services:

• Medical device penetration testing: Examines firmware, hardware interfaces, applications and device communications for exploitable security weaknesses.
• Cybersecurity risk assessment and threat modelling: Identifies potential attack paths, evaluates product security risks and helps determine suitable protective measures.
• FDA cybersecurity support: Assists with SBOM preparation, security testing reports, risk assessments and documentation for applicable FDA submissions.
• EU MDR cybersecurity support: Helps manufacturers prepare cybersecurity risk management records, testing evidence and technical documentation relevant to EU MDR requirements.

By combining security testing with supporting documentation, Medysec helps manufacturers address identified vulnerabilities and prepare evidence for regulatory review.

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Conclusion

Medical devices remain in use for years, but the security risks surrounding them continue to change. Hospitals need accurate equipment records, regular risk assessments and effective security controls to identify weaknesses before they affect clinical services. Medical IoT device security helps address these risks by protecting connected equipment throughout its lifecycle.

Patient safety must guide decisions about software updates, network restrictions and incident response. Manufacturers, biomedical engineers and cybersecurity teams also need clear responsibilities to prevent security gaps from going unresolved.

Regular testing, timely corrective action and ongoing review help healthcare organisations maintain secure medical equipment without compromising the care patients depend on.

Developing a connected medical device or healthcare software product? Connect with Medysec's medical device cybersecurity specialists to discuss your product architecture, testing requirements and the cybersecurity documentation needed for your regulatory pathway.

FAQs

1. What is the biggest security risk for medical IoT devices?

Unsupported software, insecure connections and limited security features are major concerns. However, the greatest risk depends on how exposed a device is and what could happen to patients if it becomes compromised.

2. How can hospitals secure medical devices that cannot be patched?

Hospitals can apply manufacturer-approved safeguards, restrict unnecessary network access and monitor suspicious activity. They should also document remaining risks, review them regularly and plan replacements when equipment can no longer be adequately protected.

3. What is the difference between medical IoT security and traditional IT security?

Medical IoT security must account for patient safety, specialised equipment and uninterrupted clinical services. Unlike ordinary IT systems, medical devices often require manufacturer approval, clinical coordination and additional testing before software changes.

4. How often should hospitals assess medical IoT device security?

Assessments should follow a documented schedule based on device risk and clinical importance. Additional reviews are appropriate after significant system changes, newly disclosed vulnerabilities, security incidents or changes in manufacturer support.