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What is the HIPAA Security Rule? Understanding Its Impact and Upcoming Changes for ePHI

What is the HIPAA Security Rule?

The HIPAA Security Rule is a critical part of The Health Insurance Portability and Accountability Act (HIPAA): legislation specifically designed to establish national security standards to protect the electronic protected health information (ePHI) held by healthcare organizations. Compliance with the HIPAA Security Rule is essential for safeguarding sensitive patient data against security breaches, cyber threats and even physical damage. 

However, as cyber threats grow in both variety and, more alarmingly, sophistication and technological advancements, the Office for Civil Rights (OCR), which enforces the Security Rule, has proposed updates to further strengthen the data security and risk management postures of healthcare organizations. 

In light of these upcoming changes to the HIPAA Security Rule and their importance to healthcare organizations, this post details the existing HIPAA Security Rule and what it entails. From there, we’ll look at the proposed modifications to the HIPAA Security Rule, helping you to understand how it will affect your organization going forward and, subsequently, how to best prepare for potential changes coming later this year to remain compliant.

What is the HIPAA Security Rule?

Added to HIPAA in 2003, the Security Rule introduced a series of mandatory safeguards to protect the increasing amount of digital data, i.e., ePHI, and the increasing prevalence of electronic health record (EHR) systems, customer data platforms (CDPs) and revenue cycle management (RCM) platforms. 

The HIPAA Security Rule centers around three fundamental categories of safeguards:

  1. Administrative Safeguards
    • Risk modeling: frequent risk assessments to identify, categorize, and manage security risks.
    • Workforce security policies: including role-based access controls.
    • Contingency planning for emergency access to ePHI:  i.e., disaster recovery and business continuity planning.
  2. Technical Safeguards
    • Access controls: implementing controls to restrict access to ePHI, e.g., Zero Trust, user authentication, and automatic timeouts. 
    • Audit controls: to track access to sensitive patient data.
    • Encryption protocols: to protect ePHI end-to-end, in transit and at rest.
  3. Physical Safeguards
    • Onsite security measures: to prevent unauthorized physical access, e.g., locks, keycards, etc.
    • Surveillance equipment: cameras and alarms, for example, to signal unauthorized access. 
    • Secure disposal of redundant hardware: devices containing ePHI must be properly disposed of by companies that specialize in data destruction. 

The HIPAA Security Rule: The Dangers of Non-Compliance

Consequently, should a healthcare company fail to comply with the safeguards outlined in the HIPAA Security Rule, it can result in severe consequences, including:

  • Civil penalties: up to $2.1 million per violation; repeat offenses can result in multi-million dollar settlements.
  • State-Level HIPAA Fines: in addition to federal HIPAA penalties, states, such as California and New York, can impose fines for compliance violations under the Health Information Technology for Economic and Clinical Health (HITECH) Act
  • Criminal charges: for willful neglect, unauthorized collection of ePHI, and, the malicious use of patient data (including its sale). This can result in up to 10 years in prison. 
  • Reputational damage: demonstrating an inability to secure ePHI results in a loss of patient trust, making them less inclined to purchase your services or products. More alarmingly, cybercriminals will also become aware that your company’s IT infrastructure is vulnerable, which could invite more attempts to infiltrate your network and steal ePHI.  

Proposed Updates to the HIPAA Security Rule

Now that we’ve discussed the present HIPAA Security Rule, and the consequences for failing to implement its required threat mitigation measures, let’s turn our attention to the proposed changes to the Security Rule, which were announced by the U.S. Department of Health and Human Services (HHS) in December, 2024, and how they will affect healthcare organizations. 

Mandatory Encryption for All ePHI Transmission

The proposed updates require end-to-end encryption for emails, messages, and data transfers involving ePHI, making all implementation specifications required with specific, limited exceptions. This means that patient data must be encrypted in transit, i.e., from one place to another (when collected in a secure form, sent in an email, etc.), and in storage, i.e., where it will reside. 

To accommodate these changes, many healthcare organizations will need to upgrade to HIPAA-compliant email solutions, for their outreach requirements, as well as encrypted databases to store the ePHI in their care.

Expanded MFA Requirements

Healthcare providers must implement Multi-Factor Authentication (MFA) for all personnel with access to ePHI. MFA moves beyond usernames and passwords, requiring users to prove their identity in more than one way. 

This could include:

  • One-time passwords (OTPs) via email, an app, or a physical security dongle (e.g., an RSA token)
  • Access cards or Fobbs
  • Biometric identification, such as retina scans, fingerprints, or voice recognition. 

This proposed rule change addresses increasing risks from phishing and other credential-based attacks, in which malicious actors acquire employee login details to access ePHI.

Stronger Risk Management and Third-Party Security Controls

Healthcare organizations must conduct more frequent risk assessments to identify, categorize, and mitigate threats to ePHI. A considerable part of this is implementing stricter security controls for business associates who have access to the healthcare company’s ePHI. 

A business associate could be a software vendor with which an organization processes patient data, or it could be a supplier or partner that requires access to ePHI to fulfill its operational duties. In light of this, one of the proposed changes to the HIPAA security rule is that vendor security audits will become more mandatory rather than optional.

New Incident Response (IR) and Breach Reporting Rules

The new rule changes emphasize stricter breach notification timelines for healthcare entities and the business associates that handle ePHI on their behalf. This means that healthcare companies are obligated to inform affected parties of a data breach as soon as possible. 

For healthcare companies, this means devising, or strengthening, continuous monitoring protocols, so their security teams become aware of suspicious activity as as soon as possible and can accurately communicate their containment efforts and take the neccessary actions to mitigate damages. 

Preparing For The Changes to the HIPAA Security Rule: Next Steps for Healthcare Organizations 

As the proposed changes to the HIPAA Security Rule move forward, and are likely to go into effect by the end of this year, healthcare organizations can prepare by:

Conducting frequent risk assessments to pinpoint vulnerabilities to the ePHI in IT ecosystems. This should be done annually, at least – or when changes are made to IT infrastructure that may affect ePHI.

Evaluating existing email and communication platforms to ensure compliance with encryption and authentication requirements, especially under the newly proposed security rule and its requirements.

Hardening your organization’s cybersecurity posture by considering the implementation of network segmentation, zero-trust security principles, and data loss protection (DLP) protocols.

Strengthening vendor risk management to ensure third-party service providers meet HIPAA compliance standards and that you have a Business Associate Agreement in place. 

How the Proposed Changes to the HIPAA Security Rule Affect Healthcare Communications and Email Security

One of the most significant implications of the proposed changes to the Security Rule is the heightened focus on secure email communications involving ePHI. Key takeaways for secure healthcare email include:

  • Encryption is now essential: healthcare organizations relying on unencrypted email delivery platforms to communicate with patients will need to switch to secure, HIPAA-compliant email solutions with the appropriate encryption capabilities. 
  • Email providers must meet stronger compliance standards: if your current email service provider doesn’t support automatic encryption, for instance, it may be non-compliant under the new rule.
  • Stronger authentication for email access: healthcare professionals sending or receiving ePHI via email must implement MFA and similar, robust access control protocols.

With email communication being a key part of patient outreach and engagement, it’s vital for healthcare companies to identify and address security gaps in their IT infrastructure, and prepare for the coming changes to the HIPAA security rule.   

Changes to the HIPAA Security Rule: Final Thoughts

The HIPAA Security Rule remains the foundation for protecting ePHI within healthcare organizations. The proposed updates to the Security Rule reflect the growing need for stronger cybersecurity controls in healthcare. The stark reality is that patient data is, and always will be, sensitive and, as such, will always be a valuable target for cybercriminals. 

In light of the persistent and growing threat to ePHI, healthcare organizations that fail to proactively address the requirements brought forth by the proposed changes to the HIPAA Security Rule risk data breaches, financial penalties and other punitive action. 

If you have questions about HIPAA compliant secure email, encryption, or how the coming changes to the Security Rule will impact your healthcare communications, contact LuxSci today for expert guidance.

Picture of Pete Wermter

Pete Wermter

As a marketing leader with more than 20 years of experience in enterprise software marketing, Pete's career includes a mix of corporate and field marketing roles, stretching from Silicon Valley to the EMEA and APAC regions, with a focus on data protection and optimizing engagement for regulated industries, such as healthcare and financial services. Pete Wermter — LinkedIn

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Most Popular LuxSci Blog Posts of 2025

As we close out 2025, healthcare communicators, IT and compliance leaders, and digital marketers face an ever-changing landscape of security threats, regulatory updates, and technology innovations. At LuxSci, we’re committed to helping you with continuous updates and guidance on the future of secure healthcare communications.

In case you missed it, or need a refresh, below are some of our most popular blog posts from 2025. Enjoy!

1. Improve Email Engagement and Marketing Results with Automated Workflows

Automated workflows are transforming how healthcare organizations engage patients and customers — enabling dynamic, event-driven campaigns that easily scale your outreach and keep you HIPAA compliant. In this post, we introduce LuxSci’s Automated Workflows capability for our Secure Marketing healthcare solution. Learn how sequence-based journeys can personalize outreach and optimize engagement with behavior-based triggers that improve campaign performance — without sacrificing data security.

Read the full post: LuxSci Enhances Secure Marketing with Automated Workflows

2. Healthcare Email Threat Readiness Strategies

Email remains a frontline channel for healthcare communications, and a prime target for cyber threats and criminals. This deep-dive into email threat readiness strategies covers essential practices like continuous monitoring, business continuity planning, and workforce training to mitigate email-borne security risks. Whether you’re responsible for clinical systems, marketing, or enterprise IT, this post provides a strategic playbook to strengthen your defenses, while maximizing your results.

Read the full post: Healthcare Email Threat Readiness Strategies

3. HIPAA Compliant Email — 20 Tips in 20 Minutes

For practical guidance you can apply right now, this on-demand webinar distills 20 key tips for HIPAA-compliant email across technical, legal, and operational domains. Whether you’re refining your infrastructure, improving deliverability, or modernizing your data security posture in 2026, this resource is a time-efficient way to elevate your compliance and security.

Read the post and watch the webinar on demand: HIPAA Compliant Email: 20 Tips in 20 Minutes

4. Is SendGrid HIPAA-Compliant? What You Should Know

Choosing the right email provider matters, especially when Protected Health Information (PHI) is at stake. In this post, we examine SendGrid’s capabilities in the context of HIPAA compliance, outline what it takes to send PHI securely, and offer guidance on evaluating third-party services for secure healthcare email and communication needs.

Read the full post: Is SendGrid HIPAA-Compliant?

5. LuxSci Shines in G2 Winter 2026 Reports

Customer feedback matters to LuxSci. In this post, we share the most recent news about LuxSci’s performance in the G2 Winter 2026 Reports, where we earned 20 badges across categories like Email Security, Encryption, Gateway, and HIPAA-Compliant Messaging. These reviews reflect not just product excellence, but trust from real users, which we work hard to build every day!

Read the full post: LuxSci Shines in G2 Winter 2026 Reports

Looking Ahead to 2026

We look forward to providing more information and insights on secure healthcare communications in the coming year, including the latest on HIPAA compliant email, PHI security, healthcare marketing, threat readiness, and personalized engagement. In the meantime, if you’re not already, follow us on LinkedIn below, and we’ll see you here in 2026!

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HIPAA compliant email

LuxSci Welcomes Angel Mazariegos as Head of Finance

LuxSci, a leader in secure healthcare communications and HIPAA compliant email, is pleased to announce the appointment of Angel Marie Mazariegos as the company’s new Head of Finance. With over 25 years of experience in financial management, accounting, and human resources, Angel will play a central role in advancing LuxSci’s operational excellence and supporting the company’s rapid growth in 2026 and beyond.

Angel brings a wealth of expertise to LuxSci, having held senior leadership positions at organizations focused on financial services, language and access services for healthcare, and human resources. In these roles, Angel has led multi-department Finance and HR teams, spearheading critical initiatives, including ERP implementations, streamlined employee onboarding, and financial process optimization.

In her role at LuxSci, Angel will oversee all aspects of the company’s finance operations, including budgeting, forecasting and reporting. Additionally, Angel will manage the company’s HR function, ensuring that LuxSci continues to foster a strong, people-driven culture based on its Secure, Trust, Responsible and Smart company values.

“Angel’s blend of financial and HR leadership makes her an invaluable addition to the LuxSci executive team and a real asset for our people,” said Mark Leonard, CEO of LuxSci. “We look forward to working with Angel to build the high-performing teams that will be critical to our future growth and serving the evolving needs of our customers.”

Angel holds dual MBA degrees in Accounting and Human Resource Management from Cappella University, as well as dual BS degrees in Business Administration (Accounting and CIS Business Systems) from California State University, Los Angeles.

“I am honored to join the LuxSci team at such an exciting time for the company,” said Mazariegos. “I look forward to working with the team and helping build on LuxSci’s reputation for excellence and reliability in secure healthcare communications.”

HIPAA Compliant Email

LuxSci Shines in G2 Winter 2026 Reports, Underscoring Commitment to Product Leadership and Trusted Relationships

We’re pleased to announce that LuxSci has been recognized for excellence and leadership for HIPAA compliant email and messaging in the just-released G2 Winter 2026 Reports!

Based on verified customer reviews, LuxSci earned 20 G2 badges as part of the most recent G2 reports, including top honors such as Grid Leader, Highest User Adoption, Best Support, and Best Estimated ROI.

This recognition further validates what we’ve always believed: our customers don’t just choose a great product — they choose a great partner. At LuxSci, we build long-term, trusted relationships with our customers, anchored in product reliability, industry-leading email deliverability and performance, and the best customer support in the business.

Why G2 Matters

G2 is a globally trusted peer‑review platform that aggregates verified user feedback and real‑world usage data to rank software and service providers. G2’s seasonal reports like the Winter 2026 editions shine a spotlight on latest tools and vendors that deliver consistent value and satisfaction to real customers.

Earning 20 badges this quarter signals a strong vote of confidence from our customers and community, helping affirm that LuxSci is a leading, highly adopted secure email solutions provider.

What We Earned in Winter 2026

Among the 20 badges awarded to LuxSci across Email Security, Email Encryption, Email Gateway and HIPAA Compliant Messaging are:

  • Grid Leader
  • Highest User
  • Best Support
  • Best Estimated ROI

This broad range of accolades spanning leadership, adoption, support and return on investment underscores the reliability of our solutions and the trust our customers place in us.

Awards Reflect Our Commitment to Customer Success

Reliable. Winning Grid Leader and Highest User Adoption demonstrates that thousands of users are depending on LuxSci, securely delivering emails to today’s most popular platforms, including Gmail, Apple Mail, Yahoo Mail and AOL, to name a few.

Proven. With Best Estimated ROI, customers are saying that LuxSci delivers tangible results, whether in secure email delivery, regulatory compliance, or operational efficiency.

Long‑Term Trust. Best Support is perhaps the most telling because for us, success isn’t just about features, it’s about being there for our customers every step of the way.

Thank you to all of our customers. We remain committed to your success — today and in the future.

Want to learn more about LuxSci? Reach out and connect with us today!

HIPAA Compliant Email

Here’s What HIPAA Compliant Email Salespeople Don’t Tell You

With email security threats continuously increasing in number and sophistication, as well as healthcare companies requiring secure solutions to communicate with patients and customers, the need for HIPAA compliant email solutions has never been greater. 

However, when looking for the right secure email services provider (ESP), healthcare organizations run the risk of making inaccurate assumptions about HIPAA compliance via what they learn from prospective vendors. This is due to the tendency for sales materials for HIPAA compliant email services, such as web pages or promotional videos, to highlight the strengths of the platform, while downplaying a healthcare company’s own role and responsibilities in securing protected health information (PHI). 

With this firmly in mind, here are six key things that HIPAA compliant email salespeople don’t tell you about securing communications and achieving compliance. 

1. The Shared Responsibility Model

Firstly, HIPAA compliant email salespeople are unlikely to emphasize the idea of shared responsibility when it comes to data security. This is the idea that two entities that share access to data, e.g., a healthcare company and their ESP, have a shared responsibility to preserve the privacy of that data.

In reality, most sales pitches explain the benefits and features of the solution, as opposed to stressing that compliance truly depends on how it’s configured and used. Now, that’s not to say that a salesperson is trying to hide this fact, as they’ll probably allude to training and configuration requirements. But, they’ll be less likely to make light of this and, more broadly, how shared responsibility factors into compliance.

2. A BAA Doesn’t Automatically Make You HIPAA Compliant

A business associate agreement (BAA) is essential for HIPAA compliance, but signing one doesn’t automatically make you compliant. Your organization still has to use the email delivery solution in a way that aligns with HIPAA regulations, which involves proper configuration, training, oversight, and reporting.

The misconception among some healthcare companies that a BAA equals compliance may be perpetuated by the term “HIPAA compliant email services provider”.  This could give some the impression that the vendor is fully HIPAA compliant and, subsequently, in signing a BAA with them, the use of their services is fully compliant.

But, it’s not that simple.

Simply signing a BAA obscures the real effort involved in achieving compliance. There’s no official HIPAA seal of approval, and HIPAA compliant means that the solution is capable of being configured for compliant use, which is a shared responsibility. HIPAA compliant email salespeople are unlikely to volunteer this nuance, especially if their email solution requires considerable configuration or has a steep learning curve to use it securely.

3. Not All Solutions or Features Are HIPAA Compliant

Another key detail often underplayed by vendor sales materials of HIPAA compliant email solutions is that some of their features, or even entire services, aren’t covered by their BAAs, so they can’t be used to handle PHI. 

These tools are referred to as “out of scope” and may include tools capable of integration with the email service, such as analytics or AI capabilities, but they don’t possess the cyber risk mitigation measures that align with HIPAA regulations. Perhaps the main reason for this is that many mass-market email delivery solutions, such as Microsoft 365 or Google Workspace, are designed for companies across all sectors. Consequently, while they can be HIPAA compliant, they weren’t developed from the ground up with the stringent regulatory demands of the healthcare industry in mind.

4. Solutions Are Not HIPAA Compliant “Out of The Box”

HIPAA compliant email salespeople may suggest that compliance is built into their platform, and healthcare organizations can use it to transmit PHI straight away, but this isn’t the case. Healthcare companies must still configure the email platform accordingly, as per the security requirements determined by their risk assessment, e.g., applying the right level of encryption. 

Also, if the email service is difficult to configure for HIPAA compliance or if the vendor’s configuration documentation lacks detail, that presents another obstacle to its compliant use. 

In addition to configuration, healthcare companies also have to implement access management controls and policies, establishing the extent to which each employee can access PHI in respect to their roles and responsibilities. From there, they will have to train their workforce on how to use the HIPAA compliant email solution securely, which may include those tools that fall outside the scope of your BAA with the vendor, and must not be used for the disclosure of patient data.

5. Essential Security Features Cost Extra 

Another more egregious version of an ESP not being HIPAA compliant out of the box is having features required for compliance, such as encryption or audit logging, as premium add-ons and not included in the solution’s base pricing. 

A vendor’s sales materials for its email service might list the necessary safeguards, but underemphasize the fact that only some versions of their platform are truly HIPAA compliant. Consequently, healthcare companies must confirm that the features required for HIPAA compliant email communications are included in the plan they’re purchasing. 

6. The Importance of Staff Training on HIPAA

HIPAA compliant email salespeople are often remiss in stressing the need for additional workforce training alongside the deployment of their platform. A healthcare company’s employees must be trained on how to securely use the email client, how to ID potential threats, and best practices for including PHI in email communications, as well as the regulations tied to HIPAA and data security.

This includes educating users on the differences between regular and secure email, and what they must do to safeguard patient and customer data. Fortunately, secure email solutions from providers like LuxSci enable automated email encryption, and users do not need to take any additional actions to ensure encryption when sending emails.

Additionally, in some cases, employees will need to be trained on which tools or features do not align with HIPAA guidelines and must not be used to process PHI.

LuxSci: Fully HIPAA Compliant – No Hidden Surprises

LuxSci specializes in solutions that enable companies to carry out secure, personalized, and HIPAA compliant email communications and campaigns. With more than 20 years of experience and billions of emails sent for companies including Athenahealth, 1 800 Contacts, Lucerna Health and Rotech Healthcare, we’ve acquired invaluable experience in helping healthcare organizations enhance their engagement efforts, all while adhering to HIPAA regulations. In addition, LuxSci’s secure high-volume and marketing email solutions feature HIPAA-required security controls, including encryption, audit logging, and multi-factor authentication (MFA) by default, not as optional, hidden extras.

Contact us today to learn more about how LuxSci’s secure email solutions can help increase the ROI on your patient and customer outreach efforts, while safeguarding PHI in line with HIPAA requirements.

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HIPAA Emailing Medical Records

What Are The Requirements For HIPAA Emailing Medical Records?

HIPAA emailing medical records mandate that healthcare organizations implement encryption, access controls, and audit protections when transmitting protected health information electronically. Organizations must obtain patient authorization for medical record disclosures, ensure secure transmission methods, and maintain detailed logs of all email activities involving PHI to comply with Privacy and Security Rule obligations. Medical record transmission via email has become routine in healthcare operations, yet many organizations struggle with balancing convenience and compliance requirements. Understanding specific HIPAA obligations for email communications helps healthcare providers avoid costly violations while maintaining efficient patient care workflows.

Patient Authorization and Disclosure Requirements

Patient access rights under HIPAA allow individuals to request copies of their medical records in electronic format, including email delivery when requested. Healthcare organizations must honor these requests within 30 days and cannot require patients to provide justification for their preferred delivery method. Third-party disclosures require explicit patient authorization before medical records can be emailed to family members, attorneys, or other healthcare providers. These authorizations must specify what records will be shared, with whom, and for what purpose to ensure HIPAA compliance with privacy standards. Minimum necessary standards apply to HIPAA emailing medical records, requiring healthcare organizations to limit disclosures to only the information needed for the intended purpose. Complete medical records should only be shared when specifically authorized or when the entire record is necessary for the disclosed purpose.

Encryption Standards and Message Security

End-to-end encryption provides the strongest protection for medical records transmitted via email by ensuring that only authorized recipients can access patient information. This encryption method protects data throughout the entire transmission process, including temporary storage on email servers. Transport layer security protects medical records during transmission between email servers but may not encrypt messages while stored on recipient systems. Healthcare organizations should verify that this level of protection meets their risk tolerance and patient expectations for privacy. Secure portal delivery offers an alternative to direct email transmission by providing encrypted storage where patients or authorized recipients can access medical records through password-protected websites. This method maintains organization control over access and provides detailed audit trails.

Identity Verification and Recipient Authentication

Patient identity confirmation helps ensure that HIPAA emailing medical records reach intended recipients and prevents unauthorized disclosure to wrong email addresses. Healthcare organizations should implement verification procedures that confirm patient identity before emailing sensitive medical information. Recipient authentication systems verify that authorized individuals access emailed medical records rather than unintended recipients who might gain access through shared email accounts or compromised systems. Multi-factor authentication provides additional security layers for sensitive record access. Email address validation helps prevent medical record disclosure to incorrect recipients due to typographical errors or outdated contact information. Healthcare organizations should confirm email addresses with patients before transmitting medical records electronically.

Record Integrity and Transmission Controls

Digital signatures help ensure that medical records remain unchanged during email transmission and provide verification that documents originated from legitimate healthcare sources. These signatures help recipients confirm record authenticity and detect any unauthorized modifications. File format standards help ensure that emailed medical records can be accessed by recipients while maintaining security protections. PDF formats with password protection offer good compatibility while providing basic security controls for medical record transmission. Attachment size limitations may require healthcare organizations to split large medical records across multiple email messages or use alternative delivery methods. These constraints must be managed while maintaining record completeness and patient access rights.

Audit Trail and Documentation Obligations

Transmission logs must capture detailed information about medical record email activities including sender identity, recipient addresses, transmission timestamps, and record types shared. These logs support compliance monitoring and provide documentation for potential breach investigations. Access tracking helps healthcare organizations monitor who views emailed medical records and when access occurs. This information supports audit requirements and helps identify potential unauthorized access to patient information shared via email. Retention policies for email logs and transmitted medical records must align with state and federal requirements while supporting potential legal discovery and compliance audit needs. Healthcare organizations should establish clear schedules for maintaining and disposing of HIPAA emailing medical records transmission records.

Managing Failed Deliveries and Bounced Messages

Error handling procedures must protect medical record information when email transmissions fail or bounce back to senders. Healthcare organizations need policies for managing failed deliveries that prevent PHI exposure through error messages or automated responses. Alternative delivery methods should be available when email transmission fails to ensure that patients receive requested medical records within required timeframes. These backup procedures might include secure portals, encrypted file transfer, or physical mail delivery options. Notification protocols help healthcare organizations inform patients when medical record email deliveries fail while maintaining confidentiality about record contents. These communications should provide alternative access methods without revealing specific medical information in potentially unsecured messages.

Staff Training and Policy Implementation

Email usage policies must provide clear guidance for healthcare personnel about when and how to issue HIPAA emailing medical records while maintaining HIPAA compliance. These policies should address authorization requirements, encryption standards, and procedures for handling transmission errors. User training programs should cover both the mechanics of secure email transmission and the regulatory requirements for medical record disclosure. Staff need to understand patient rights, authorization procedures, and security measures required for different types of record sharing. Compliance monitoring helps healthcare organizations identify policy violations and training needs related to medical record email transmission.

Best HIPAA Compliant Email Software

Is ProtonMail HIPAA Compliant?

ProtonMail can be HIPAA compliant with proper implementation and a signed Business Associate Agreement (BAA). The platform offers end-to-end encryption, secure message storage, and multiple authentication factors that align with HIPAA security requirements. Healthcare organizations must obtain ProtonMail’s BAA, implement appropriate usage policies, and ensure staff understand proper email handling practices to maintain compliance when using the service for patient communications.

ProtonMail’s Security Architecture and HIPAA Compliant Status

ProtonMail provides several security features that support HIPAA compliance requirements. End-to-end encryption protects message content from interception during transmission and prevents ProtonMail itself from accessing message contents. Zero-access encryption ensures emails remain encrypted while stored on ProtonMail’s servers. Two-factor authentication adds protection beyond passwords when accessing accounts. Message expiration allows senders to set automatic deletion timeframes for sensitive communications. The platform’s Swiss location provides additional privacy protections under Swiss law. While these technical features are the foundation for becoming HIPAA complia, tentchnology alone doesn’t create compliance without proper organizational measures and agreements.

Business Associate Agreement Availability

Healthcare organizations must obtain a Business Associate Agreement before using any service for protected health information. ProtonMail offers BAAs for users of their Professional and Enterprise plans, but not for free or Plus accounts. The agreement establishes ProtonMail’s responsibilities for protecting healthcare data according to HIPAA regulations. Organizations should review the BAA terms carefully to understand which ProtonMail features and services it covers. The agreement outlines breach notification procedures and compliance responsibilities for both parties. Without this formal agreement in place, healthcare organizations cannot legally use ProtonMail for patient information regardless of the platform’s security capabilities or other protective measures implemented.

Limitations and Compliance Challenges

Despite strong security features, ProtonMail presents several challenges for healthcare organizations seeking HIPAA compliance. When sending emails to non-ProtonMail users, end-to-end encryption requires recipients to access messages through a separate portal using shared passwords, potentially creating friction in patient communications. Access controls may not provide the granularity needed for larger healthcare organizations with complex permission requirements. Audit logging capabilities could fall short of HIPAA’s detailed tracking requirements for some implementations. Integration with existing healthcare systems might require custom development work. Organizations must evaluate these limitations against their workflow needs and compliance requirements before selecting ProtonMail as their email solution.

Implementation Requirements for Healthcare Users

Healthcare organizations using ProtonMail must implement several measures beyond basic account setup. Administrative policies should clearly define what types of patient information may be communicated via email. Staff training needs to cover proper handling of protected health information, including when encryption is required and how to verify recipient addresses. Organizations must establish procedures for securely communicating passwords when sending encrypted messages to non-ProtonMail users. Account management processes should address staff departures and role changes to maintain appropriate access controls. Documentation practices need to demonstrate compliance measures during potential regulatory reviews or audits. The completeness of these organizational measures ultimately determines whether ProtonMail functions as a HIPAA compliant solution.

Comparison with Healthcare-Focused Email Solutions

ProtonMail differs from email services specifically designed for healthcare organizations. While ProtonMail emphasizes general security and privacy, healthcare-focused providers build their services around HIPAA compliance requirements. Specialized solutions often include features like automated patient data detection, healthcare-specific DLP rules, and integration with electronic health records. Their administrative tools typically provide more detailed compliance reporting tailored to healthcare requirements. Support staff understand healthcare workflows and compliance challenges. Healthcare-specific platforms may offer simpler HIPAA compliant documentation to streamline regulatory requirements. Organizations must weigh whether ProtonMail’s general security approach or a healthcare-specialized solution better addresses their individual requirements.

Practical Usage Guidelines for Healthcare Organizations

Healthcare organizations can maximize ProtonMail’s HIPAA compliant potential through thoughtful usage practices. Creating clear distinction between communications containing protected health information and general business emails helps maintain appropriate security boundaries. Implementing standardized subject line tags identifies messages containing patient information. Establishing approved contact lists ensures protected information goes only to verified recipients. Creating email templates for common patient communications helps maintain consistency and proper security practices. Developing escalation procedures addresses situations where email might not provide appropriate security for particularly sensitive information. Regular security reviews verify that ProtonMail usage continues to meet both regulatory requirements and organizational security standards as practices evolve.

patient engagement solutions

HIPAA And Explanation of Benefits Notifications

Explanation of benefits notifications are detailed summaries of healthcare claims processing that health plans send to members after receiving and adjudicating medical service claims from healthcare providers. These documents contain protected health information including patient names, dates of service, provider details, diagnostic codes, and payment information that falls under HIPAA privacy and security requirements. Healthcare providers, payers, and suppliers must understand how HIPAA regulations govern the creation, transmission, and storage of explanation of benefits communications to maintain compliance while serving their members effectively. Understanding the intersection of HIPAA requirements and explanation of benefits processes helps healthcare organizations avoid costly violations while maintaining transparent communication with patients about their healthcare coverage and claims.

Privacy Requirements for Explanation of Benefits Content

HIPAA privacy regulations establish specific requirements for how explanation of benefits documents can include, display, and protect patient information during all phases of the communication process. Health plans must ensure that explanation of benefits contain only the minimum necessary information required to inform patients about their claims processing while avoiding unnecessary disclosure of sensitive medical details. This requirement means that diagnosis codes, procedure descriptions, and provider notes should be limited to what patients need to understand their coverage and payment responsibilities.

The privacy rule permits health plans to include certain types of information in explanation of benefits without obtaining additional patient authorization, as these communications fall under permitted uses for payment and healthcare operations. Patient names, dates of service, provider names, and basic claim information can be included because they serve legitimate business purposes in helping patients understand their insurance coverage. Detailed clinical notes, mental health treatment specifics, or other sensitive medical information may require additional privacy protections or patient consent.

Explanation of benefits documents must include clear privacy notices that inform patients about how their protected health information is being used and their rights regarding this information. These notices should explain how patients can request restrictions on information use, file complaints about privacy practices, and access their complete medical records. Health plans must also provide contact information for privacy officers who can address patient concerns about their explanation of benefits communications.

The minimum necessary standard requires health plans to evaluate whether all information included in explanation of benefits serves a legitimate purpose for patient understanding or claims administration. This evaluation should consider whether patients truly need access to specific diagnostic codes, provider credentials, or detailed procedure descriptions to understand their coverage. Regular review of explanation of benefits content helps ensure compliance with privacy requirements while maintaining useful communication with plan members.

Security Safeguards for Electronic Explanation of Benefits

Electronic transmission and storage of explanation of benefits requires implementation of administrative, physical, and technical safeguards to protect the protected health information contained within these documents. Administrative safeguards include appointing security officers responsible for explanation of benefits systems, conducting regular workforce training on privacy requirements, and establishing procedures for granting and revoking access to explanation of benefits databases. These safeguards help ensure that only authorized personnel can access patient information during explanation of benefits processing.

Physical safeguards protect the computer systems, equipment, and facilities where explanation of benefits are created, stored, and transmitted from unauthorized access or environmental hazards. Health plans must implement access controls for data centers, secure workstation configurations for staff accessing explanation of benefits systems, and media disposal procedures for devices containing patient information. Protections help prevent unauthorized individuals from accessing explanation of benefits data through physical security breaches.

Technical safeguards focus on access controls, audit logging, data integrity measures, and transmission security for explanation of benefits systems. Health plans must implement user authentication systems that verify the identity of individuals accessing explanation of benefits data, maintain detailed audit logs of all system activities, and use encryption to protect explanation of benefits during transmission and storage. Technical controls help detect and prevent unauthorized access to patient information.

Regular security assessments of explanation of benefits systems help identify vulnerabilities that could lead to data breaches or unauthorized disclosures. Health plans should conduct penetration testing, vulnerability scanning, and security audits of their explanation of benefits platforms to ensure that technical safeguards remain effective against evolving cyber threats. Documentation of these assessments demonstrates ongoing commitment to protecting patient information in explanation of benefits communications.

Patient Rights and Access to Explanation of Benefits

Patients have specific rights under HIPAA regarding their explanation of benefits, including the right to receive copies in accessible formats, request amendments to incorrect information, and control how these documents are delivered to them. Health plans must accommodate reasonable requests for explanation of benefits in alternative formats, such as large print, electronic delivery, or translation into other languages when patients have communication barriers. Accommodations help ensure that all patients can understand their coverage and claims processing regardless of their individual circumstances.

The right to request amendments applies when patients identify errors in their explanation of benefits, such as incorrect dates of service, wrong provider information, or inaccurate claim amounts. Health plans must have established procedures for handling these amendment requests, including timeframes for responding to patients and processes for investigating and correcting errors. When amendments are approved, health plans must notify patients and update their records accordingly.

Patients can designate how they prefer to receive explanation of benefits notifications, including requesting that documents be sent to alternative addresses for safety reasons or medical necessity. Health plans must honor these requests when they are reasonable and help protect patient privacy or safety. This flexibility allows patients to maintain control over their personal information while ensuring they receive important coverage information.

Access rights extend to requesting accounting of disclosures related to explanation of benefits information, allowing patients to understand who has received their protected health information and for what purposes. Health plans must maintain records of explanation of benefits disclosures and provide this information to patients upon request. These accounting requirements help patients monitor how their information is being shared and identify any unauthorized uses.

Disclosure Rules for Explanation of Benefits Information

HIPAA establishes specific rules governing when and how health plans can disclose explanation of benefits information to third parties, including healthcare providers, family members, and business partners. Disclosure for treatment purposes allows health plans to share relevant explanation of benefits information with healthcare providers who need this data to coordinate patient care or understand coverage limitations. These disclosures must be limited to information necessary for the specific treatment purpose.

Payment-related disclosures permit health plans to share explanation of benefits information with healthcare providers for billing and claims processing purposes. Providers may need access to explanation of benefits data to understand payment amounts, coverage decisions, and patient responsibility amounts. These disclosures help facilitate efficient payment processing while maintaining patient privacy protections.

Healthcare operations disclosures allow health plans to share explanation of benefits information for quality improvement activities, care coordination, and administrative functions that support patient care. These uses must serve legitimate business purposes and comply with minimum necessary standards. Health plans must evaluate whether proposed disclosures serve appropriate healthcare operations purposes before sharing explanation of benefits information.

Disclosure to family members or personal representatives requires either patient authorization or demonstration that the person has legal authority to act on behalf of the patient. Health plans cannot automatically share explanation of benefits information with spouses, adult children, or other family members without proper authorization. Emergency situations may provide exceptions to this requirement when immediate disclosure is necessary for patient safety or care coordination.

Business Associate Requirements for Explanation of Benefits Processing

Third-party vendors involved in explanation of benefits processing must operate as business associates under HIPAA and comply with specific privacy and security requirements when handling protected health information. Business associate agreements must clearly define how vendors will protect explanation of benefits data, limit its use to authorized purposes, and implement appropriate safeguards during processing activities. Agreements of this nature help ensure that outsourced explanation of benefits functions maintain the same privacy protections required of health plans.

Common business associates in explanation of benefits processing include printing companies, mailing services, electronic delivery platforms, and customer service providers. Each of these relationships requires careful evaluation of privacy and security risks, along with appropriate contractual protections. Health plans must verify that business associates have adequate security measures in place before allowing them to handle explanation of benefits information.

Business associates must implement their own administrative, physical, and technical safeguards for explanation of benefits data and ensure that any subcontractors also comply with HIPAA requirements. This includes providing security training to their workforce, maintaining audit logs of information access, and reporting security incidents to the health plan. Business associates also must return or destroy explanation of benefits information when their contracts end, unless retention is required for legal purposes.

Regular monitoring and oversight of business associate performance helps ensure ongoing compliance with HIPAA requirements for explanation of benefits processing. Health plans should conduct periodic audits of business associate security practices, review incident reports, and verify that contractual obligations are being met. This oversight helps identify potential compliance issues before they result in privacy violations or security breaches.

Compliance Monitoring and Breach Response

Healthcare organizations must establish comprehensive monitoring programs to ensure that explanation of benefits processing remains compliant with HIPAA requirements and identify potential issues before they result in violations. Regular audits should examine explanation of benefits content for appropriate privacy protections, verify that security safeguards are functioning correctly, and assess whether disclosure practices comply with regulatory requirements. Audits help demonstrate ongoing commitment to protecting patient information.

Incident response procedures specifically address explanation of benefits-related security breaches or privacy violations, including notification requirements and remediation steps. Health plans must have clear procedures for investigating potential breaches, determining whether notification is required, and implementing corrective actions to prevent future incidents. Training on incident response helps ensure that staff can recognize and respond appropriately to explanation of benefits security issues.

Documentation requirements include maintaining records of explanation of benefits policies, training activities, security assessments, and compliance monitoring efforts. This documentation helps demonstrate compliance efforts during regulatory investigations and supports continuous improvement of explanation of benefits processes. Health plans should retain documentation for required periods and ensure that records are complete and accessible when needed.

Staff training programs must address HIPAA requirements specific to explanation of benefits processing, including privacy obligations, security procedures, and appropriate handling of patient information. Training should be provided to all personnel involved in explanation of benefits creation, transmission, and storage, with regular updates to address regulatory changes and emerging threats. Competency assessments help verify that staff understand their responsibilities for protecting patient information in explanation of benefits communications.

HIPAA Compliant Hosting Requirements

Integrating HIPAA Compliant Email with EHR Systems

With digital healthcare here to stay, today’s providers, payers and suppliers are making increasing use of Electronic Health Record (EHR) systems for more connected care – and better health outcomes.

However, while EHR systems help increase the speed and efficiency at which care can be delivered to patients, healthcare companies must still consider the security of electronic protected health information (ePHI) throughout the process, especially when it comes to communicating sensitive data with patients, customers, and other organizations. 

Fortunately, integrating an EHR system with a HIPAA compliant email service provider (ESP), like LuxSci, offers a secure way to engage with your patients, while leveraging – and protecting – the wealth of information within EHR systems to personalize communications.

In this post, we discuss the benefits of integrating EHR systems with a HIPAA compliant email platform, as well as several use cases made possible by bringing these two powerful solutions together.

What is an EHR System?

An EHR system is a platform used by healthcare companies to store and manage their patient’s digital data, including PHI. In providing a digital repository for a patient’s medical history, including diagnoses, prescribed medication, lab results, and other data related to their healthcare journey, EHR systems enable organizations to access, update, and share patient data more quickly and efficiently.

As EHR systems have steadily replaced paper-based records, namely, after the HITECH Act was enacted in 2009, which incentivized EHR adoption, healthcare companies are better able to access and share PHI across different environments, greatly enhancing the coordination and cooperation of providers, payers, and suppliers.

Why Should You Integrate EHR Systems with a HIPAA Compliant Email Platform?

Let’s discuss the key benefits of integrating your EHR Systems with a HIPAA compliant email platform:

Secure ePHI Transmission

When the sensitive data in EHR systems is sent out to patients and other healthcare providers and organizations, it must be encrypted, as per HIPAA regulations to safeguard it from exposure. That way, even in the event of a security breach, it will be unreadable to malicious actors, preserving the privacy of patients and customers. In light of this, HIPAA compliant email delivery platforms emphasize strong encryption capabilities to ensure sensitive patient data is always encrypted during transmission.

LuxSci’s SecureLine encryption technology employs automatic, flexible encryption, which applies the appropriate encryption standard depending on the recipient’s email security posture and infrastructure, making sure emails are always encrypted in transit. 

HIPAA Compliant Patient Engagement Campaigns

Healthcare organizations are often reluctant to include the patient data stored in their EHR systems for fear of accidental exposure – and violating HIPAA regulations as a result. In addition to encryption, LuxSci provides other HIPAA-mandated security features, such as access control capabilities, to maintain precise control over who can access patient data, and audit logging, to track access to ePHI. Perhaps most importantly, LuxSci provides you with a Business Associate Agreement (BAA): a legal document, and key pre-requisite for HIPAA compliance, that clearly establishes its responsibilities in safeguarding the ePHI that originates in your EHR systems. 

With these security capabilities in place, healthcare providers can confidently incorporate patient and customer data from their EHR systems into their outreach efforts, using ePHI to personalize emails accordingly to maximize engagement and improve communications.

Automated Secure EHR-Driven Communication

EHR systems facilitate automated healthcare workflows, including for clinical or administrative events that require effective communications, such as appointment scheduling, a patient diagnosis, or test results becoming available, automatically triggering follow-up actions, including updating patient care plans, generating invoices, sending outbound emails. In addition to facilitating consistency and coordination between the various companies involved in a patient’s healthcare journey, it reduces the amount of required manual work, lowering each organization’s administrative overhead. 

LuxSci’s suite of HIPAA compliant, secure communications tools aid in the enhanced efficiency and productivity of EHR systems by streamlining digital communication across multiple channels. LuxSci Secure High Volume Email can automatically send personalized, HIPAA-compliant messages triggered by EHR events. Similarly, LuxSci Secure Text allows companies to notify patients via SMS, as per the situation or patient preferences. LuxSci’s Secure Forms, meanwhile, simplifies onboarding and consent processes by pre-filling web forms with EHR data, eliminating the need for manual input paperwork and manual entry.

Common Email and EHR Integration Use Cases

Integrating your EHR system with a HIPAA compliant email solution, like LuxSci, opens the door for a wide variety of enhanced patient engagement opportunities. Let’s explore some of the most valuable use cases for EHR integration below.

  • Appointment Confirmations and Reminders: companies can create EHR-driven workflows that send out an email confirmation as soon as an appointment is scheduled. Similarly, automated email reminders and text messages can be scheduled to go out a set number of days before the patient’s appointment, lowering the chance of a no-show.
  • Pre-Visit Instructions: when appropriate, tailored preparation instructions can be scheduled to be sent out by email before the appointment, according to the nature of the appointment and other relevant patient data.
  • Follow-Up Care Guidance: by the same token, an EHR event can be set up to send out personalized after-care advice, sourced from care plans or notes stored in the EHR system.
  • Test Results: an email or text can be triggered as soon as a patient’s lab results become available; this could be in the form of an alert to contact their provider to collect the results or a summary alongside a secure link to a portal for full access.
  • Preventive Screening Reminders: EHR data can be used to identify patients due for screenings, immunizations, or chronic care follow-ups.
  • Preventative Care: sending patients advice and recommendations relevant to their condition, based on ePHI stored in their healthcare provider’s EHR.
  • Early Detection Self-Assessments: EHR-driven emails can be used to send patients personalized risk assessments designed to detect early warning signs of conditions such as diabetes or cancer, based on ePHI like age, lifestyle factors, or family history.
  • Feedback Collection: healthcare organizations can schedule feedback to be collected from patients, e.g., surveys, questionnaires, etc, to measure patient satisfaction and identify key areas of improvement.  

Discover the Power of EHR Integration with LuxSci

Integrating HIPAA compliant communications solutions like LuxSci with EHR systems empowers healthcare companies to craft more timely, efficient and consistent digital healthcare communications and workflows. This personalized approach to patient and customer engagement enables efficient, effective and above all, compliant communications strategies that improve individual engagement, providing better health outcomes and a higher quality of life.

Want to learn more? Contact us today!