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Healthcare Industry Pushes Back on HIPAA Security Rule Overhaul: Impact on Electronic Protected Health Information (ePHI) Systems
- Rescana
- Dec 25, 2025
- 5 min read
Executive Summary
Publication Date: December 24, 2025
The US healthcare sector is facing a pivotal moment as the Department of Health and Human Services (HHS) advances a sweeping overhaul of the HIPAA Security Rule. This regulatory update, proposed in early 2025, is designed to address the escalating threat landscape targeting electronic protected health information (ePHI). However, the industry response has been marked by significant resistance, with leading healthcare organizations, advocacy groups, and technology vendors voicing concerns over the feasibility, cost, and operational impact of the proposed changes. This advisory report provides a comprehensive technical analysis of the proposed rule, the nature of industry pushback, and the broader cybersecurity context driving regulatory reform. It is intended to inform Rescana customers of the evolving compliance landscape and the technical realities shaping healthcare cybersecurity in 2025.
Technical Information
The proposed HIPAA Security Rule overhaul represents the most significant regulatory update to healthcare cybersecurity in over a decade. The new rule introduces prescriptive requirements for risk management, technical controls, and third-party oversight, reflecting the urgency of recent high-profile breaches and ransomware attacks.
Scope and Applicability
The revised rule applies to all covered entities (including hospitals, clinics, health plans, and healthcare clearinghouses) and business associates (vendors and service providers handling ePHI). Unlike previous iterations, the new rule is technology-agnostic, meaning it does not enumerate specific product versions but instead mandates security outcomes across all systems, devices, and software that process, store, or transmit ePHI. This includes Electronic Health Record (EHR) platforms such as Epic, Cerner, Meditech, Allscripts, athenahealth, and NextGen, as well as medical IoT devices, network infrastructure, and cloud-based services.
Key Technical Requirements
The proposed rule introduces several new and enhanced technical requirements:
Mandatory encryption for ePHI both at rest and in transit, with minimum standards aligned to NIST SP 800-53 and FIPS 140-2 validated cryptographic modules.
Universal deployment of multi-factor authentication (MFA) for all remote access to ePHI systems, including administrative interfaces, VPNs, and cloud portals.
Comprehensive asset inventory and continuous monitoring, extending to all endpoints, IoT devices, and shadow IT assets. Organizations must maintain real-time visibility into their digital environment and document all systems with ePHI exposure.
Rigorous patch management and vulnerability remediation processes, with defined service-level objectives for critical and high-severity vulnerabilities. The rule requires organizations to demonstrate timely application of security updates across all in-scope assets.
Documented third-party/vendor risk assessments, including independent security certifications (such as SOC 2 Type II, ISO 27001, or HITRUST CSF) for all business associates. Covered entities must maintain evidence of vendor due diligence and ongoing monitoring.
Explicit incident response and breach notification procedures, with requirements for tabletop exercises, forensic readiness, and post-incident reviews.
Short compliance window: The rule proposes a 180–240 day implementation period following final publication, with no phased or tiered approach for smaller organizations.
Industry Pushback: Technical and Operational Concerns
The healthcare industry’s response has been swift and coordinated. Over 100 organizations, including the College of Healthcare Information Management Executives (CHIME), the American Hospital Association (AHA), and numerous regional health systems, submitted formal comments urging HHS to reconsider or withdraw the rule. The primary technical and operational objections include:
Financial burden: Smaller providers and rural hospitals argue that the cost of implementing real-time asset inventory, continuous monitoring, and advanced encryption is prohibitive. Many lack the in-house expertise or budget to deploy enterprise-grade security solutions.
Unrealistic timelines: The proposed 180–240 day compliance window is viewed as unattainable, especially for organizations with legacy systems, complex vendor ecosystems, and limited IT staff. Industry groups advocate for phased implementation and technical assistance.
Uniform compliance expectations: The rule does not differentiate by organization size, complexity, or risk profile. This “one-size-fits-all” approach risks widespread noncompliance and could force some providers to reduce services or exit the market.
Vendor management complexity: The requirement for documented, independent security certifications for all business associates is seen as a major operational lift. Many vendors, especially smaller SaaS providers and medical device manufacturers, may not have the resources to achieve certifications such as SOC 2 or HITRUST within the compliance window.
Regulatory overlap: Healthcare organizations are already subject to a patchwork of federal and state cybersecurity mandates, including HITECH, 21st Century Cures Act, and state privacy laws. The new rule’s requirements may duplicate or conflict with existing obligations, increasing compliance complexity.
Threat Landscape: Exploitation in the Wild
The urgency behind the HIPAA Security Rule overhaul is underscored by a dramatic increase in cyberattacks targeting healthcare. According to the Compliancy Group (2024), the sector experienced 444 reported cybersecurity incidents, including 238 ransomware attacks and 206 data breaches in the past year alone. Notable incidents include the Singing River Health System breach, which forced a temporary shutdown of patient medical records, and the Baker University breach disclosed in December 2024.
Attackers are leveraging a range of sophisticated tactics, techniques, and procedures (TTPs) as cataloged in the MITRE ATT&CK framework. Common vectors include:
Phishing (T1566): Credential harvesting and initial access via malicious emails targeting healthcare staff.
Exploit Public-Facing Application (T1190): Attacks on unpatched web portals, VPNs, and remote access gateways.
Remote Services (T1021): Lateral movement using compromised RDP, SSH, or VPN credentials.
Credential Dumping (T1003): Extraction of cached or stored credentials from domain controllers and endpoints.
Data Encrypted for Impact (T1486): Ransomware deployment, often using FIN12, Conti, LockBit, or BlackCat/ALPHV payloads.
Data Destruction (T1485): Wiper malware and destructive attacks targeting backup systems and critical infrastructure.
Healthcare organizations are also grappling with the proliferation of medical IoT devices, many of which lack robust security controls and are difficult to patch or monitor. Attackers exploit these devices as entry points or pivot nodes within hospital networks.
Indicators of Compromise (IOCs) and Defensive Recommendations
Common IOCs observed in recent healthcare breaches include suspicious login attempts from foreign IP addresses, anomalous outbound data transfers, the presence of ransomware note files (such as README.txt or HOW_TO_DECRYPT.txt), and known ransomware hashes cataloged in threat intelligence repositories like VirusTotal.
To mitigate risk, organizations should prioritize the following technical controls:
Enforce MFA for all remote and privileged access.
Implement network segmentation to isolate critical ePHI systems from general-purpose IT infrastructure.
Deploy endpoint detection and response (EDR) solutions with behavioral analytics.
Maintain a comprehensive asset inventory, including unmanaged IoT and shadow IT devices.
Conduct regular vulnerability assessments and patch management cycles.
Establish robust incident response playbooks and conduct periodic tabletop exercises.
Regulatory and Industry References
The following sources provide in-depth analysis and primary documentation on the HIPAA Security Rule overhaul and industry response:
References
DataBreaches.net: Industry Continues to Push Back on HIPAA Security Rule Overhaul (December 24, 2025): https://databreaches.net/2025/12/24/industry-continues-to-push-back-on-hipaa-security-rule-overhaul/
Compliancy Group: Hospitals Pushback on Proposed HIPAA Security Rule Updates (2024): https://compliancy-group.com/pushback-on-proposed-hipaa-security-rule-updates/
DarkReading: Industry Continues to Push Back on HIPAA Security Rule Overhaul (2025): https://www.darkreading.com/cyber-risk/industry-oppose-hipaa-security-rule-overhaul
Alston & Bird: HIPAA Security Rule Overhaul (November 2025): https://www.alston.com/en/insights/publications/2025/11/hipaa-security-rule-overhaul
PYA: Industry Perspectives on HIPAA Security Rule Updates (2025): https://www.pyapc.com/insights/industry-perspectives-proposed-hipaa-security-rule-updates/
MITRE ATT&CK Framework: https://attack.mitre.org/
HHS HIPAA Security Rule NPRM: https://www.hhs.gov/hipaa/for-professionals/security/hipaa-security-rule-nprm/index.html
For The Record Magazine, Autumn 2025 Issue: https://www.fortherecordmag.com/archives/Spring25p10.shtml
Rescana is here for you
Rescana empowers organizations to proactively manage third-party risk and strengthen their cybersecurity posture through our advanced TPRM platform. Our technology provides continuous monitoring, automated risk assessments, and actionable intelligence to help you navigate complex regulatory environments and evolving threat landscapes. We are committed to supporting your organization as you adapt to new compliance requirements and defend against emerging cyber threats. For any questions or to discuss how these changes may impact your organization, please contact us at ops@rescana.com.
