Healthcare Cybersecurity → Medical Device Cybersecurity
The Devices Your Hospital Buys Could Put Patients at Risk
FDA enforcement started October 2023. Hospitals are rejecting devices that don't meet the new standards. Your procurement team needs to know what changed.
of hospitals have the riskiest IoMT devices on their networks—devices with known vulnerabilities tied to active ransomware campaigns
Connected medical devices create entry points attackers already exploit
What Happens When Medical Devices Get Hacked
These aren't abstract risks. They're documented outcomes from 2024:
A single ransomware attack in 2024 disrupted prescription processing nationwide for weeks. The financial cost was massive. The patient impact was worse.
One compromised device can cascade into system-wide outages
Imaging systems are particularly dangerous. 8% have exploitable vulnerabilities linked to ransomware, and they're present in 85% of hospitals.
What FDA Actually Requires Now
The Consolidated Appropriations Act of 2022 added Section 524B to the Federal Food, Drug, and Cosmetic Act. Here's what changed and when:
Section 524B Takes Effect
New cybersecurity requirements for medical devices become law. Manufacturers have six months to comply.
FDA Issues Updated Guidance
"Cybersecurity in Medical Devices" guidance provides specific requirements for premarket submissions.
Enforcement Begins
FDA starts refusing device submissions that lack required cybersecurity documentation, including SBOMs.
Final Guidance Published
FDA finalizes quality system considerations and premarket submission requirements.
The regulatory landscape shifted in 2023—hospitals buying devices need proof of compliance
Pre-Market Requirements
Before FDA approval, manufacturers must demonstrate:
- Threat modeling and risk analysis
- Secure development practices
- Software Bill of Materials (SBOM)
- Vulnerability management plan
- Security update procedures
Post-Market Obligations
After devices are deployed, manufacturers must:
- Monitor for vulnerabilities
- Provide timely security patches
- Update SBOMs when components change
- Coordinate vulnerability disclosure
- Report cybersecurity incidents to FDA
Why Hospitals Care About SBOMs
A Software Bill of Materials lists every software component in a device—like an ingredient label for code.
SBOMs let you track vulnerabilities across your entire device fleet
❌ Without an SBOM
Log4Shell vulnerability announced. Your hospital has 300 connected devices. You have no idea which ones contain the vulnerable component. You can't patch what you can't see.
✓ With an SBOM
Search your SBOM database for Log4j. Identify the 12 devices that contain it. Contact vendors for patches. Segment the vulnerable devices until patches arrive. The vulnerability is contained in hours, not weeks.
FDA requires SBOMs. Hospitals should demand them during procurement.
If a vendor won't provide one, that's a red flag. SBOMs must be machine-readable (SPDX or CycloneDX format), comprehensive, updated when software changes, and accessible to hospital security teams.
You Need Both Built-In Security and Runtime Protection
No single security layer is enough—defense requires depth
Built-In Security
For new devices
Manufacturers build security into the design:
- Encrypted data storage and transmission
- Secure boot and code signing
- Authentication and access controls
- Security testing during development
- Patch deployment mechanisms
FDA requires this for new device submissions. Refuse devices without it.
Add-On Protection
For legacy devices already deployed
You can't replace everything overnight. Compensating controls:
- Network segmentation (isolate medical devices)
- Traffic monitoring and anomaly detection
- Firewall rules limiting device communication
- Access control at the network layer
- Regular vulnerability scanning
These don't fix the device, but they reduce the risk while it's still in use.
What to Demand Before Buying Medical Devices
Give this checklist to your procurement team. If vendors can't answer these questions, don't buy the device:
Make cybersecurity part of every device purchase—not an afterthought
- FDA Cybersecurity Documentation: Proof that the device meets Section 524B requirements. Look for the premarket cybersecurity submission.
- Software Bill of Materials (SBOM): Machine-readable format (SPDX or CycloneDX). Updated when software changes. Accessible to your security team.
- Vulnerability Management Plan: How often they scan for vulnerabilities. How fast they patch critical issues. How they notify customers.
- Security Update Mechanism: Can the device receive patches remotely? How long does deployment take? Do updates require downtime?
- Incident Response Commitment: If a vulnerability is discovered, who do you call? What's the response time SLA?
- End-of-Life Security Support: How long will the device receive security updates? What happens after support ends?
- Liability Terms: If the device is compromised and patient data leaks, who's responsible? What does the contract actually say?
Who Pays When Insecure Devices Cause Harm?
Liability is shifting. It's no longer just the manufacturer's problem—hospitals are increasingly held responsible when they deploy devices without adequate cybersecurity safeguards.
Documented Consequences:
- HHS fined healthcare providers $12.84M in 2024 for HIPAA violations related to data breaches
- Surgery delays from ransomware at multiple hospitals resulted in patient transfers and emergency declarations
- Average breach cost: $10.93 million per incident according to IBM
- 31% of device cybersecurity incidents caused up to 12 hours without critical systems
Why Hospitals Are Liable:
- You chose to deploy the device
- You're responsible for protecting patient data
- You control the network environment
- You knew (or should have known) about the risks
- You had alternatives and chose the cheaper option
Related Healthcare Security Topics
Penetration Testing for Healthcare
HIPAA-aligned security assessments that identify vulnerabilities in EHRs, medical devices, and hospital networks—without disrupting patient care.
CTEM for Healthcare
Move beyond annual testing with continuous threat exposure management—ongoing assessment that finds vulnerabilities as they emerge, not months later.
HIPAA Cybersecurity & Data Security
Understand HIPAA Security Rule requirements, technical safeguards, and how to build a compliance program that protects patient data and avoids costly violations.
Ransomware in Hospitals
Learn how ransomware attacks unfold in healthcare settings, real breach costs, and proven strategies to reduce your hospital's ransomware risk.
Get Your Devices Ready for the Next Audit
FDA compliance is mandatory. Hospital liability is real. Insurance companies are asking hard questions about device security.
If you need help validating your current devices, reviewing procurement policies, or testing runtime protections, our team has tested medical device security for hospitals across the country.
30-minute assessment. We'll review your device inventory and identify the highest-risk systems.