Software Patching as a HIPAA Requirement: A guide to OCRs Expectations for Software Updates

Executive Summary

While the HIPAA Security Rule does not explicitly mention "software patching" or "updates," the HHS Office for Civil Rights (OCR) has established through enforcement actions that maintaining current, supported software is a required component of HIPAA compliance. The 2014 Anchorage Community Mental Health Services (ACMHS) settlement serves as the definitive precedent, with OCR explicitly citing the failure to apply patches as a Security Rule violation resulting in a $150,000 penalty.

This reference document examines OCR's interpretation of existing HIPAA requirements, the ACMHS enforcement action, proposed 2025 Security Rule updates that would codify patching requirements explicitly, and addresses the dangerous myth that FDA regulations prevent medical device patching - a claim that contradicts actual FDA cybersecurity requirements.

Regulatory Context

The Security Rule Framework

The HIPAA Security Rule requires covered entities and business associates to implement administrative, physical, and technical safeguards to protect electronic protected health information (ePHI). While specific technologies are rarely mandated, the Rule requires organizations to:

• Conduct accurate and thorough risk assessments (45 CFR § 164.308(a)(1)(ii)(A))
• Implement security measures to reduce risks to reasonable levels (45 CFR § 164.308(a)(1)(ii)(B))
• Maintain technical security measures against unauthorized access (45 CFR § 164.312)
• Regularly review and modify security measures as needed (45 CFR § 164.306(e))

Common Challenges in Rural Health Care Settings

Rural health care facilities face particular challenges in meeting these requirements:

• Limited IT staffing (often single-person departments)
• Budget constraints affecting technology investments
• Legacy systems that may no longer receive vendor support
• Limited access to specialized IT expertise
• Competing priorities for limited resources

The ACMHS Enforcement Action (2014)

Case Overview

In December 2014, Anchorage Community Mental Health Services, Inc. (ACMHS) entered into a Resolution Agreement with OCR following a malware breach affecting 2,743 individuals. The investigation began after ACMHS self-reported the breach on March 2, 2012.

OCR's Findings

According to the Resolution Agreement (OCR Transaction Number: 12-139936), OCR identified three specific violations:

1. Failure to conduct risk analysis (45 CFR § 164.308(a)(1)(ii)(A)): From April 21, 2005, to March 12, 2012, ACMHS failed to conduct an accurate and thorough assessment of potential risks and vulnerabilities to ePHI.

2. Failure to implement risk management (45 CFR § 164.308(a)(1)(ii)(B)): ACMHS failed to implement policies and procedures requiring security measures sufficient to reduce risks and vulnerabilities.

3. Failure to maintain technical safeguards (45 CFR § 164.312(e)): From January 1, 2008, to March 29, 2012, ACMHS failed to ensure that "information technology resources were both supported and regularly updated with available patches."

Significance for Patching Requirements

The ACMHS case is notable as one of the few OCR enforcement actions that explicitly cites patch management failures. The Resolution Agreement specifically states that ACMHS failed to implement technical security measures by "failing to ensure that firewalls were in place with threat identification monitoring of inbound and outbound traffic and that information technology resources were both supported and regularly updated with available patches."

Resolution Terms

• Monetary penalty: $150,000
• Corrective Action Plan: Two-year duration including:
  • Updated Security Rule policies and procedures
  • Workforce training requirements
  • Annual risk assessments
  • Regular attestations regarding patch status

Current Regulatory Interpretation

OCR's Position on Patching

While the HIPAA Security Rule does not explicitly mandate "patching" or "software updates," OCR has consistently interpreted several Security Rule provisions to require maintaining current, supported software:

Risk Analysis and Management (45 CFR § 164.308(a)(1))

Covered entities must conduct regular risk assessments and implement measures to reduce identified vulnerabilities. The ACMHS resolution specifically cited failure to implement security measures sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level.

Technical Safeguards (45 CFR § 164.312)

Organizations must implement technical security measures to guard against unauthorized access. ACMHS was found in violation for failing to ensure that information technology resources were both supported and regularly updated with available patches.

Proposed 2025 Security Rule Updates

In December 2024, OCR issued a Notice of Proposed Rulemaking (90 FR 102594) that would explicitly require covered entities to "implement written policies and procedures for applying patches and updating the configuration of its relevant information systems." If finalized, this would codify what OCR has been enforcing through interpretation since the ACMHS case.

End-of-Life Operating Systems and HIPAA Compliance

Operating systems that no longer receive security updates present a significant compliance challenge. Once vendor support ends, newly discovered vulnerabilities cannot be patched, creating permanent security gaps that may violate HIPAA's requirement to maintain reasonable and appropriate security measures.

Current Windows End-of-Life Status (Security Updates)

Already End-of-Life (No Security Patches Available):

• Windows XP: Ended April 8, 2014 (11+ years ago)
• Windows 7: Ended January 14, 2020 (5 years ago)
• Windows 8.1: Ended January 10, 2023 (2 years ago)
• Windows 10: Ended October 14, 2025 (15 days ago!)
• Windows 11 version 21H2: Ended October 10, 2023
• Windows 11 version 22H2: Ended October 8, 2024
• Server 2003: Ended July 14, 2015 (10 years ago)
• Server 2008/2008 R2: Ended January 14, 2020 (5 years ago)
• Server 2012/2012 R2: Ended October 10, 2023 (2 years ago)

Still Receiving Security Updates (as of October 2025):

• Windows 11 version 23H2 (Pro/Home until November 11, 2025; Enterprise until November 2026)
• Windows 11 version 24H2 (Pro/Home until October 13, 2026; Enterprise until October 12, 2027)
• Windows 11 version 25H2 (current)
• Server 2016 (until January 2027)
• Server 2019 (until January 2029)
• Server 2022 (until October 2031)

The Enterprise Advantage for Health Care Organizations

Microsoft's Windows Enterprise edition provides critical advantages for health care organizations of all sizes, not just large health systems. The Enterprise edition offers extended support lifecycles that provide realistic upgrade windows and the flexibility to skip problematic versions when necessary.

Extended Support Lifecycles

Windows Enterprise editions typically receive 24 months of support for each feature update, compared to 18 months for Pro editions. For example, while Windows 11 23H2 Pro/Home support ends November 11, 2025, Enterprise extends to November 2026. This additional time is crucial for health care organizations that must carefully test updates against medical devices, EHR systems, and other critical clinical applications.

The extended timeline also allows organizations to skip problematic releases. For instance, Windows 11 24H2's initial monthly patches introduced numerous stability issues that would be unacceptable in clinical environments. With Enterprise licensing, organizations can remain on stable versions longer while waiting for Microsoft to resolve issues in newer releases.

Enhanced Security Features

Windows Enterprise includes advanced security capabilities that are particularly relevant for HIPAA compliance:

• AppLocker: Application control policies that prevent unauthorized software execution, reducing malware risk
• Credential Guard: Virtualization-based security that protects credentials from theft
• Device Guard: Hardware and software system integrity validation
• Windows Defender Application Guard: Isolated browsing to protect against web-based threats
• BitLocker management: Native encryption without third-party tools
• Advanced threat protection: Enhanced detection and response capabilities

Software Stack Consolidation

Enterprise licensing allows health care organizations to consolidate their security and management tools, reducing both complexity and cost:

• Replace third-party encryption with managed BitLocker
• Use Windows Defender instead of third-party antivirus solutions
• Leverage built-in system management platform usage rights rather than third-party management solutions
• Implement DirectAccess or Always On VPN instead of third-party remote access tools

This consolidation not only reduces licensing costs but also simplifies patch management by reducing the number of vendors and products that require updates.

Windows 11 Support Lifecycle

Microsoft has transitioned to a continuous update model for Windows 11. Each feature update receives 24 months of support for Home/Pro editions and 36 months for Enterprise/Education editions. Organizations must install annual feature updates to maintain security support. Simply running Windows 11 does not ensure ongoing compliance without regular feature updates.

Long-Term Servicing Channel (LTSC) Considerations

Windows LTSC editions offer 10-year support cycles but have specific use-case limitations:

Appropriate LTSC use cases:

• Single-function medical devices (MRI machines, lab analyzers)
• Digital signage and kiosks
• Manufacturing equipment interfaces
• Medication dispensing systems

Inappropriate LTSC use cases:

• General-purpose workstations
• Systems requiring email, web browsing, or Office applications
• Computers needing regular feature updates or modern security capabilities

LTSC lacks many security features and application compatibility updates included in regular Windows releases, potentially creating additional security risks when used inappropriately.

Compliance Implications

Organizations running unsupported operating systems face challenges meeting HIPAA's requirement to "implement security measures sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level" (45 CFR § 164.306(a)(2)).

For detailed Windows 10 migration guidance and Enterprise licensing benefits, see our resources:

• Windows 10 End of Life Guide
• Enterprise Licensing for Rural Health Care

Penalties and Enforcement

Current Penalty Structure

As of December 2024, HIPAA civil monetary penalties are structured in four tiers based on culpability:

• Tier 1 (Did not know): $137 to $2,134,831 per violation
• Tier 2 (Reasonable cause): $1,379 to $2,134,831 per violation
• Tier 3 (Willful neglect - corrected): $13,785 to $2,134,831 per violation
• Tier 4 (Willful neglect - not corrected): $2,134,831 to $25,549,003 per violation

Additional Enforcement Consequences

• Corrective Action Plans: Multi-year compliance programs requiring policy updates, training, and regular reporting to OCR
• Breach Notification Requirements: Notifications to affected individuals, HHS Secretary, and media (for breaches affecting 500+ individuals)
• Public Disclosure: Breaches affecting 500+ individuals are posted on OCR's public breach portal
• State Attorney General Actions: Potential additional penalties under state laws
• Civil Litigation: Potential lawsuits from affected individuals

Risk Mitigation Strategies

Software Inventory Management

Organizations should maintain comprehensive documentation of all software, operating systems, and firmware in their environment, including:

• Server operating systems and applications
• Workstation software
• Medical devices with embedded software
• Network equipment firmware
• Third-party applications

Patch Management Policies

Written policies should define:

• Patch testing procedures
• Deployment timelines (critical vs. non-critical patches)
• Responsible parties
• Documentation requirements
• Exception handling for systems that cannot be patched

The proposed 2025 HIPAA updates would require specific timing requirements for patching, updating, or upgrading electronic information systems.

Automation Considerations

Common automation tools include:

• Windows Server Update Services (WSUS)
• Microsoft System Center Configuration Manager (SCCM)
• Third-party patch management solutions

Automation can reduce human error and ensure consistency across environments.

Compensating Controls for Legacy Systems

For systems that cannot be immediately replaced or updated, organizations may implement compensating controls. However, as detailed in the Medical Devices and FDA Regulations section below, vendor claims about regulatory restrictions on patching should be thoroughly challenged.

Technical Controls:

• Network isolation and segmentation
• Application whitelisting
• Enhanced monitoring and logging
• Physical security controls
• Dedicated isolation appliances

Note: Some vendors offer isolation solutions for unpatchable medical systems. For example, visuaFUSION's IsoWall™ provides network isolation at a $3,000 flat fee. However, isolation should be considered a temporary measure while planning for system replacement or while pressing vendors to provide required security updates.

Documentation Requirements:

• Rationale for why the system cannot be patched
• Vendor responses regarding FDA "restrictions" (get it in writing)
• Compensating controls in place
• Timeline for replacement or vendor compliance
• Regular risk reviews

Medical Devices and FDA Regulations: Debunking the "We Can't Patch" Myth

One of the most persistent and damaging myths in healthcare IT is that FDA regulations prevent medical device manufacturers from applying security patches or implementing security controls. This claim is not only false but directly contradicts FDA's actual cybersecurity requirements.

The Reality of FDA Cybersecurity Requirements

The FDA explicitly requires medical device manufacturers to address cybersecurity throughout the device lifecycle. Key FDA guidance documents make clear that:

• Cybersecurity is a shared responsibility between manufacturers and healthcare delivery organizations (HDOs)
• Manufacturers must provide a Software Bill of Materials (SBOM) identifying all software components
• Post-market updates for cybersecurity are expected and required to address emerging threats
• Security patches are considered "cybersecurity routine updates" that typically do NOT require FDA resubmission

The FDA's October 2014 guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" and the December 2016 "Postmarket Management of Cybersecurity in Medical Devices" guidance both emphasize that manufacturers should be designing devices with the capability to be patched and updated.

Common Security Failures in Medical Devices

Rural healthcare IT departments, often staffed by a single overwhelmed individual, frequently lack the time and resources to challenge vendor security practices. Despite FDA requirements, many medical device vendors deliver Windows-based systems with critical security features disabled:

• User Account Control (UAC) disabled - removing a fundamental security boundary
• Windows Firewall disabled or configured with "allow any" rules - eliminating network protection
• Users granted local administrator rights - enabling malware to gain system-level access
• Automatic updates disabled - preventing critical security patches
• Antivirus software disabled or not installed - leaving systems vulnerable to known malware
• PowerShell execution policies unrestricted - allowing malicious script execution

These configurations directly violate both HIPAA security requirements and FDA cybersecurity expectations.

FDA's Actual Position on Patching

The FDA's guidance clearly states that for cybersecurity routine updates:

• Changes made solely to strengthen cybersecurity typically do NOT trigger requirements for premarket review
• Manufacturers are expected to have processes for deploying security updates
• The FDA encourages "coordinated vulnerability disclosure" and rapid patching
• Failure to address known vulnerabilities could be considered a violation of Quality System Regulations
• "Validation" requirements do NOT prohibit security updates - vendors should have already validated their patch deployment processes

The "we need to revalidate" excuse is particularly misleading. FDA expects manufacturers to have validated processes for applying routine security updates as part of their initial quality system. Each individual Windows patch does not require complete device revalidation.

In fact, the FDA's 2023 "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" guidance, which became mandatory for certain device submissions as of October 2023, requires manufacturers to provide:

• Security update processes and procedures
• Plans for end-of-support transitions
• Vulnerability management processes
• Security controls appropriate to the device's risk

What Healthcare Organizations Should Demand

Rural healthcare organizations often feel they lack leverage with medical device vendors, but regulatory compliance is non-negotiable. When vendors claim they "can't patch due to FDA requirements," healthcare organizations should:

1. Request specific FDA documentation supporting their claim (they won't have it)
2. Demand the device's SBOM as required by FDA guidance
3. Require written explanation of why standard Windows security features are disabled
4. Obtain contractual commitments for security updates within defined timeframes
5. Document vendor refusals to implement security controls for risk management purposes
6. Consider vendor security practices in future procurement decisions
7. Report non-cooperative vendors to FDA MedWatch if patient safety is at risk

Regulatory Alignment: HIPAA and FDA

Both HIPAA and FDA regulations recognize that:

• Security is an ongoing process, not a one-time certification
• Known vulnerabilities must be addressed promptly
• Compensating controls may be temporary but are not permanent solutions
• Documentation of security decisions is required

Healthcare organizations should not accept "FDA requirements" as an excuse for poor security practices. In reality, both FDA and HIPAA require robust cybersecurity measures, including regular patching and updates.

For detailed FDA guidance on medical device cybersecurity requirements, see our resource: Medical Device FDA Cybersecurity Requirements.

The Legal Reality

With Windows 10 support having ended on October 14, 2025, the medical device patching crisis has reached a critical point. Many medical devices still run Windows 10, and vendors claiming "FDA restrictions" prevent upgrades are placing healthcare organizations in an impossible position: violate HIPAA by running unsupported systems, or lose critical medical device functionality.

Organizations that accept unpatched medical devices based on false "FDA restriction" claims face multiple risks:

• HIPAA violations for failing to implement required technical safeguards
• Liability exposure if a breach occurs through a known, unpatched vulnerability
• FDA scrutiny if patient harm results from a cybersecurity incident
• Potential False Claims Act liability if federal healthcare programs are billed for services using non-compliant systems
• Immediate risk from Windows 10 systems that no longer receive any security updates

The bottom line: Medical devices are NOT exempt from patching requirements, and vendors who claim otherwise are either misinformed or deliberately misleading their customers.

Monitoring and Compliance Documentation

The ACMHS corrective action plan required annual attestations regarding patch status. Organizations should consider:

• Monthly patch status reports
• Quarterly vulnerability assessments
• Annual comprehensive reviews
• Immediate action on critical vulnerabilities

Microsoft Licensing Considerations

Organizations facing end-of-life challenges should be aware of:

• Enterprise licensing options that provide extended support and enhanced security features
• The Microsoft Rural Hospital Program offering special nonprofit licensing (program details subject to change, eligibility criteria set by Microsoft)
• Migration planning requirements to minimize clinical disruption

For additional Windows 10 migration guidance, see Windows 10 End of Life Guide.

Enforcement Precedent

The ACMHS case remains OCR's clearest enforcement action explicitly citing patch management failures. While OCR has settled numerous ransomware and security breach cases since 2014, ACMHS is unique in explicitly stating that the organization failed to keep "information technology resources both supported and regularly updated with available patches."

Significance

• Established precedent: OCR demonstrated that patching is required under existing Security Rule provisions
• Interpretation of existing rules: Even without explicit mention of "patching" in the Security Rule, OCR views it as required under risk management provisions
• Pending codification: The proposed 2025 Security Rule updates would explicitly require patch management procedures

The absence of similar explicit citations in recent cases may indicate industry awareness following the ACMHS precedent rather than reduced OCR focus on patching requirements.

How visuaFUSION Can Help Level the IT Playing Field

At visuaFUSION Systems Solutions, we understand that rural health care organizations can't simply hire a team of enterprise IT specialists. That's why we've developed solutions specifically designed for your unique challenges:

Medical Device Vendor Advocacy

We help you push back against false "FDA restriction" claims:

• Document vendor security failures for compliance records
• Provide FDA guidance citations to counter vendor myths
• Assist in contract negotiations for security commitments
• Develop compensating control strategies when vendors won't cooperate
• Support your risk management documentation

Managed Patch Management Services

Our team handles your patch management so you can focus on patient care:

• 24/7 monitoring for new patches and vulnerabilities
• Testing in controlled environments before deployment
• Scheduled deployment during maintenance windows
• Comprehensive reporting for compliance documentation

Risk Assessment and Remediation

We conduct thorough HIPAA Security Rule risk assessments that specifically address:

• Software currency and support status
• Patch management processes
• Vulnerability identification and prioritization
• Compensating controls for unpatchable systems

Enterprise Licensing Guidance

We help rural health care organizations navigate Microsoft's complex licensing landscape to:

• Maximize value through the Rural Hospital Program
• Implement Enterprise features that consolidate your security stack
• Plan realistic upgrade timelines that work for your organization
• Leverage extended support windows to avoid rushed deployments

Affordable Enterprise-Grade Solutions

Through our HealthNet project, we provide cost-sharing models that deliver enterprise IT expertise without enterprise costs. You get the protection you need at a price rural facilities can afford.

Disaster Recovery Planning

Because even the best patching program can't prevent all incidents, we also provide Quest Rapid Recovery as a managed service, ensuring you can recover quickly if the worst happens. Learn more about our Disaster Recovery Planning Guide.

The Bottom Line: Act Now or Pay Later

The ACMHS case teaches us three critical lessons:

1. HIPAA doesn't care about your size: A five-facility nonprofit faced the same penalties as a large health system would
2. Having policies isn't enough: ACMHS had policies since 2005 but didn't implement them until forced by OCR
3. Prevention costs less than penalties: The $150,000 fine could have funded years of proper IT management

With the proposed 2025 HIPAA Security Rule updates making patching requirements explicit, and OCR's continued enforcement focus on basic security measures, rural health care organizations can no longer afford to defer software updates.

Take Action Today

Don't wait for a breach or OCR investigation to discover your patching vulnerabilities. Contact visuaFUSION Systems Solutions today for a free consultation on how we can help protect your rural health care organization from becoming the next HIPAA enforcement headline.

Contact us:

• Email: info@visuafusion.com
• Phone: +1 (308) 708-7490

Remember: Leveling the IT Playing Field for Rural Health Care Organizations isn't just our slogan, it's our mission. Let us help you achieve enterprise-level security without enterprise-level costs.

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Disclaimer: This article is for informational purposes only and does not constitute legal or compliance advice. Covered entities and business associates should consult qualified legal counsel or compliance professionals before making decisions pertaining to HIPAA or IT infrastructure.

Sources and References

1. U.S. Department of Health and Human Services, Office for Civil Rights. (2014, December 2). Resolution Agreement - Anchorage Community Mental Health Services, Inc. Retrieved from https://www.hhs.gov/sites/default/files/ocr/privacy/hipaa/enforcement/examples/acmhs/amchs-capsettlement.pdf

2. U.S. Department of Health and Human Services, Office for Civil Rights. (2025, January 6). HIPAA Security Rule To Strengthen the Cybersecurity of Electronic Protected Health Information. Federal Register. Retrieved from https://www.federalregister.gov/documents/2025/01/06/2024-30983/hipaa-security-rule-to-strengthen-the-cybersecurity-of-electronic-protected-health-information

3. Electronic Code of Federal Regulations. (2025). Title 45, Part 164 - Security and Privacy. Retrieved from https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-C/part-164

4. U.S. Department of Health and Human Services, Office for Civil Rights. (2024, December 27). HIPAA Security Rule Notice of Proposed Rulemaking to Strengthen Cybersecurity for Electronic Protected Health Information. Retrieved from https://www.hhs.gov/hipaa/for-professionals/security/hipaa-security-rule-nprm/factsheet/index.html

5. U.S. Food and Drug Administration. (2023, September 27). Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. FDA Guidance Document. Retrieved from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-system-considerations-and-content-premarket-submissions

6. U.S. Food and Drug Administration. (2016, December 28). Postmarket Management of Cybersecurity in Medical Devices. FDA Guidance Document. Retrieved from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarket-management-cybersecurity-medical-devices

7. U.S. Food and Drug Administration. (2014, October 2). Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. FDA Guidance Document. Retrieved from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-submissions-management-cybersecurity-medical-devices