The healthcare industry is at a turning point. The proposed updates to the HIPAA Security Rule introduce stringent requirements designed to meet the evolving cybersecurity landscape. For smaller healthcare organizations, these changes can feel overwhelming, especially when resources are limited, and risks are growing.

This guide simplifies the complexities of the proposed HIPAA updates, breaking down what’s changing, why it matters, and how to prepare. You’ll find practical strategies and actionable insights tailored to decision-makers like you.  

We've also prepared a self-assessment checklist you can use to evaluate your organization’s preparedness for the proposed HIPAA Security Rule updates. 

What's Covered in This Guide  

  • Challenges and Risks of Non-Compliance. The unique obstacles smaller healthcare organizations face and the financial, reputational, and operational consequences of failing to meet the updated requirements. 
  • Steps to Prepare for Compliance. Get a step-by-step roadmap to address compliance gaps, from risk analysis to technical controls and workforce training. 
  • Self-Assessment Checklist. Use our self-assessment checklist to quickly evaluate your organization’s readiness with this concise checklist covering key compliance areas. For additional help, reach out to our GRC and Compliance experts for a free consultation.

Challenges for Small to Mid-Sized Organizations 

Limited resources, increasing regulations, and a relentless wave of cyber threats can make compliance seem out of reach. But the challenges you face don’t have to hold you back. Let’s break down the biggest obstacles and how they impact your path to readiness.

Limited Resources 

Many smaller healthcare organizations operate with lean IT teams—or none at all. Balancing day-to-day operations with compliance demands stretches resources thin, leaving security gaps. 

Regulatory Complexity 

Navigating evolving rules can feel overwhelming, especially without dedicated compliance expertise. Overlapping requirements often lead to confusion and missed deadlines. 

Rising Cyber Threats 

Cyberattacks targeting healthcare are increasing, and smaller organizations are at greater risk. Threat actors know these organizations often lack advanced protections, making them attractive targets. 

Third-Party Risks 

Outsourced IT functions and business associates can inadvertently expose organizations to breaches. Without proper monitoring and safeguards, these partnerships become vulnerabilities. 

For small to mid-sized healthcare providers, these challenges make compliance a moving target. But with the right plan, you can overcome them—and turn cybersecurity into a strategic advantage. 

The Risks of Noncompliance 

Noncompliance with the updated HIPAA Security Rule isn’t just a regulatory issue—it’s a business risk with far-reaching consequences. Small to mid-sized healthcare organizations are particularly vulnerable, often facing the same penalties and reputational fallout as larger systems, but with fewer resources to recover. 

Financial Penalties 

Fines for HIPAA violations can be staggering, reaching into the millions. Whether it’s a result of a data breach, inadequate safeguards, or failure to address known vulnerabilities, the financial impact can cripple smaller organizations. 

Reputational Damage 

Patients trust you to protect their sensitive information. A breach can erode that trust overnight, driving patients and partners away while inviting public scrutiny. Rebuilding your reputation takes years—and significant effort. 

Operational Disruptions 

A ransomware attack or data breach doesn’t just impact finances. It can halt operations, disrupt patient care, and force your team into crisis mode. Recovering from these incidents often costs more time and money than proactive compliance. 

Heightened Risk for Cyberattacks 

Noncompliance signals weak defenses to cybercriminals. Outdated systems and poor controls make you a prime target for increasingly sophisticated attacks. 

Missed Growth Opportunities 

Compliance isn’t just about avoiding risks—it’s a prerequisite for growth. Organizations struggling with security and compliance often face barriers to attracting new customers, entering partnerships, or securing investment. 

Noncompliance leaves your organization exposed. The risks are clear, and the costs of inaction far outweigh the effort to prepare. The good news? Proactive steps today can shield your business tomorrow. Up next, we’ll dive into the key changes shaping the HIPAA Security Rule. 

What’s Changing in the HIPAA Security Rule? 

The proposed updates to the HIPAA Security Rule introduce significant changes aimed at strengthening cybersecurity practices across the healthcare industry. These updates eliminate ambiguity and establish clear, mandatory standards for all organizations handling electronic protected health information (ePHI). 

Mandatory Compliance for All Specifications 

The distinction between “required” and “addressable” specifications will be removed. Every organization must implement the outlined safeguards, leaving little room for flexibility or delay. 

Enhanced Risk Analysis Requirements 

Organizations must conduct detailed risk analyses that include: 

  • Comprehensive reviews of technology asset inventories and network maps. 
  • Assessments of threats and vulnerabilities to ePHI. 
  • Determination of risk levels based on likelihood of potential exploitation. 

Expanded Incident Response and Contingency Planning 

New requirements emphasize resilience, including: 

  • Restoring ePHI and critical systems within 72 hours of an incident. 
  • Regularly testing and updating incident response plans to ensure effectiveness. 

Stronger Technical Controls 

The updates demand robust technical safeguards, such as: 

  • Mandatory multi-factor authentication (MFA) for all relevant systems. 
  • Encryption of ePHI both in transit and at rest. 
  • Biannual vulnerability scans and annual penetration testing. 

Vendor Risk Management 

Third-party business associates must now: 

  • Verify annually that they’ve implemented required technical safeguards. 
  • Notify covered entities within 24 hours of activating contingency plans. 

Annual Compliance Audits 

All organizations must conduct yearly compliance audits to ensure ongoing adherence to the updated rules. 

These changes reflect the healthcare sector’s heightened focus on preventing breaches, improving accountability, and safeguarding patient data. Up next, we’ll explore how these updates align with the HPH Cybersecurity Performance Goals to create a comprehensive framework for security and compliance. 

Aligning with the HPH Cybersecurity Performance Goals 

The proposed HIPAA Security Rule updates align closely with the Healthcare and Public Health Sector Cybersecurity Performance Goals (HPH CPGs), creating a robust framework for protecting sensitive healthcare data. These goals, developed by the Department of Health and Human Services (HHS), help healthcare organizations prioritize high-impact cybersecurity practices. 

Essential Goals for Foundational Protection 

The HPH CPGs outline foundational steps to address common vulnerabilities and improve baseline defenses, including: 

  • Mitigating Known Vulnerabilities: Regular updates and patches to reduce exploitation risks. 
  • Email Security: Preventing phishing and spoofing through email protection measures. 
  • Basic Incident Planning: Ensuring your organization can respond effectively to cybersecurity incidents and restore operations quickly. 
  • Asset Inventory and Network Segmentation: Mapping critical assets and isolating mission-critical systems to minimize lateral movement by attackers. 
  • Centralized Logging and Incident Response: Establishing robust logging systems to maximize visibility and streamline response efforts. 
  • Third-Party Risk Management: Implementing processes to monitor and secure vendor relationships. 

How the Proposed Rule Aligns 

The HIPAA Security Rule changes reflect many HPH CPG priorities, such as: 

  • Enforcing multi-factor authentication and strong encryption. 
  • Requiring updated asset inventories and network mapping. 
  • Strengthening incident response plans and testing protocols. 

By aligning your compliance efforts with both HIPAA requirements and HPH CPGs, you can establish a layered, resilient approach to cybersecurity. This dual focus reduces the risk of noncompliance and helps you build a proactive defense against emerging threats. 

Steps to Prepare for Compliance 

Navigating the proposed HIPAA Security Rule updates may seem daunting, but with a strategic plan, small to mid-sized healthcare organizations can confidently meet these requirements. These steps will help you close compliance gaps and build a resilient cybersecurity foundation. 

1. Conduct a Gap Analysis 

Evaluate your current compliance status to identify weaknesses. 

Review existing policies, procedures, and technical controls. 

Compare your practices against the new requirements, such as asset inventories, encryption standards, and vendor monitoring. 

2. Develop a Security Roadmap 

Create a prioritized action plan to address identified gaps. 

Focus on high-risk areas first, such as unprotected ePHI or weak access controls. 

Set achievable timelines to implement mandatory changes, like multi-factor authentication and performing a risk analysis. 

3. Strengthen Technical Controls 

Implement key safeguards to meet new compliance standards. 

Encryption: Ensure ePHI is encrypted both in transit and at rest. 

Multi-Factor Authentication: Deploy MFA across all relevant systems to secure user access. 

Vulnerability Scanning: Schedule biannual scans and annual penetration tests to detect and address weaknesses. 

4. Formalize Incident Response Plans 

Enhance your organization’s ability to respond to and recover from cybersecurity incidents. 

Develop detailed contingency plans for restoring relevant electronic information systems and data within 72 hours. 

Regularly test and update incident response protocols to ensure they’re effective. 

5. Manage Vendor and Business Associate Risks 

Address the threats and vulnerabilities introduced by third-party relationships and cloud service providers. 

Require Annual Verification: Business associates must annually verify their implementation of HIPAA-compliant technical safeguards, such as encryption and access controls. 

Monitor Vendor Risk: Conduct regular assessments of vendors to evaluate their security practices and ensure adherence to incident reporting timelines, such as notifying you within 24 hours of contingency plan activation. 

Leverage Contracts: Use contracts to clearly outline cybersecurity expectations, responsibilities, and accountability for data protection. 

Address Cloud Security Challenges: When handling PHI in the cloud or allowing Cloud Service Providers (CSP) to host, store, or process your customer’s PHI, adopt the shared responsibility model to clearly delineate security roles between your organization and cloud providers. Risk assess your providers’ compliance with HIPAA safeguards, including encryption, access control, and breach response. Regularly review contracts and agreements to confirm they align with current compliance requirements. 

6. Conduct Workforce Training 

Educate your team on updated compliance requirements and best practices. 

Provide training on secure behaviors, such as recognizing phishing attempts and safeguarding ePHI. 

Empower staff to play an active role in maintaining security and instruct them to communicate any unusual behavior or noncompliance to the appropriate team. 

7. Engage Experts 

Partner with compliance specialists who understand the unique challenges of healthcare organizations. 

Experts can guide your organization through complex regulatory changes and identify blind spots in your cybersecurity program. 

They bring proven strategies to simplify compliance while ensuring your organization meets both HIPAA requirements and broader cybersecurity goals. 

By taking these steps now, you can improve your organization’s readiness to meet the updated HIPAA Security Rule while strengthening your overall cybersecurity posture. 

Self-Assessment Checklist: Check Your Readiness 

Evaluate your organization’s preparedness for the proposed HIPAA Security Rule updates. Each item addresses a critical component of compliance, helping you identify areas that need improvement. 

Download the Checklist

Take the Next Step: Simplify Compliance with Expert Support 

Navigating the complexities of the updated HIPAA Security Rule can feel overwhelming, but you don’t have to do it alone. Seiso specializes in helping small to mid-sized healthcare organizations turn compliance challenges into opportunities for stronger cybersecurity and business resilience. 

Seiso offers a full suite of services and deliverables designed to simplify compliance with the updated HIPAA Security Rule. Our solutions are tailored to address the key requirements and challenges outlined in this guide, ensuring your organization is both compliant and resilient. 

Compliance Readiness 

  • Mandatory Compliance Alignment: Transition your organization to meet mandatory implementation specifications, eliminating outdated "addressable" distinctions. 
  • Written Documentation: Maintain comprehensive, up-to-date documentation of security policies, procedures, and risk analyses. 
  • Compliance Audits: Conduct annual compliance audits to verify adherence to HIPAA Security Rule requirements.  
  • Encryption and MFA: Implement encryption for ePHI at rest and in transit, along with multi-factor authentication for secure system access. 
  • Vulnerability Management: Perform biannual vulnerability scans and annual penetration testing to identify and remediate vulnerabilities and system weaknesses. 
  • Network Segmentation: Isolate mission-critical systems to prevent lateral movement during a breach. 
  • Backup and Recovery: Deploy technical controls to ensure rapid restoration of ePHI and critical systems within 72 hours. 

Risk and Asset Management 

  • Risk Analysis: Conduct detailed assessments, including asset inventory reviews, threat identification, and risk level evaluations. 
  • Asset Inventory and Mapping: Develop and maintain a technology asset inventory and network map to track the flow of ePHI. 

Incident Response 

  • Contingency Planning: Establish and document plans to prioritize and restore systems based on criticality. 
  • Incident Response Testing: Regularly test and update response plans to ensure your organization is ready for any security event. 

Vendor and Business Associate Oversight 

  • Monitoring and Certification: Ensure annual verification from business associates of their compliance with technical safeguards for ePHI. 
  • Business Associate Notification: Require timely (24-hour) notifications of access changes or contingency plan activations. 

Customized Security Programs 

  • Technical Controls Implementation: Enforce strong system configurations, including anti-malware protections, port security, and removal of unnecessary software. 
  • Effectiveness Reviews: Test and refine the effectiveness of security measures annually to stay ahead of emerging threats. 
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