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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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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.

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“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.

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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:

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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!

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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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What Does b2b Medical Marketing Help Healthcare Vendors Accomplish?

B2b medical marketing helps healthcare vendors to explain the practical value of a product to clinical and administrative buyers by presenting clear information that supports decision making across operational and regulatory domains. Buyers respond to communication that describes how a tool fits into routine workflows and how it handles information, and the process depends on steady explanations rather than promotional language.

Early Movement in the Buyer Relationship

The first stage of communication gives prospective buyers a clear sense of what the service does and why it belongs in their setting. Healthcare groups rely on predictable routines and they look for products that support those routines without creating unnecessary strain on staff. When an introduction explains how a tool fits into patient movement, documentation demands, or coordination between departments, readers can place the service into a familiar context. This lowers the cognitive effort required to evaluate whether further consideration is worthwhile and creates a smoother path for later discussions, which is why many vendors treat early stage explanations as the base of effective b2b medical marketing in this environment.

The Influence of Operational Structure

Clinical and administrative environments are shaped by long standing systems, varied software tools, and staff roles that have developed around known constraints. Vendors using b2b medical marketing describe how a product enters this environment so that the buyer can picture the transition from interest to adoption. Extended explanations of onboarding steps, data migration choices, and staff training routines help readers understand how daily operations shift when a new tool is introduced. These explanations allow decision makers to forecast workload changes rather than relying on assumptions, and they reflect the broader goal of b2b medical marketing which is to reduce uncertainty.

Regulatory Considerations in Vendor Communication

Healthcare buyers place great weight on regulatory matters, which is why clear descriptions of data handling are central to this type of communication. Readers look for information about access management, retention practices, audit preparation, and the path information takes through each component of a system. When vendors describe these areas in detail, compliance teams can perform early assessments and avoid long chains of clarification requests. This approach supports efficient internal review because the buyer gains confidence that the vendor maintains structured processes rather than improvised arrangements, and this clarity strengthens the overall impact of b2b medical marketing.

Reliability Expectations Within Clinical Settings

Healthcare settings cannot tolerate uncertainty in the systems that support patient care. B2b medical marketing provides insight into how a vendor manages service interruptions, planned updates, backup routines, and recovery efforts. A description of past events or internal procedures gives readers a sense of how the vendor behaves when conditions are difficult. Buyers place great value on this type of detail because it helps them differentiate between systems that hold up under stress and systems that falter when routine performance is disrupted, and these reliability discussions form a core thread in b2b medical marketing for clinical tools.

Perspectives That Influence Internal Decision Making

Each participant in the purchasing process evaluates a product through a different lens. Financial leaders consider long term spending patterns, clinical managers look for ease of use and effects on staff time, and compliance teams examine information practices. Communication that attends to these perspectives without shifting tone allows the reader to share information across departments with minimal friction. This prevents internal delays because each group can assess the service using information that relates to its role in the organisation, and thoughtful navigation of these viewpoints reinforces the strength of b2b medical marketing across healthcare markets.

The Role of Educational Content in Vendor Outreach

Healthcare groups respond well to educational material that speaks to challenges in clinical settings. Articles and guides that explain regulatory shifts, workflow bottlenecks, or mistakes observed in comparable organisations allow readers to examine their own processes. This form of communication helps buyers understand the vendor’s approach to problem solving and creates familiarity before any formal evaluation begins. Educational content performs well in this field because it demonstrates practical awareness rather than relying on abstract claims, making it a central component of many b2b medical marketing programs.

Use After Adoption

Decision makers frequently look beyond the moment of purchase and seek a clear view of the daily relationship that follows implementation. Communication describing staff support, update patterns, training formats, and communication channels helps buyers picture how the tool will fit into routine operations. Long paragraphs that describe the lived experience of using the service allow internal champions to advocate for the product with fewer unknowns, which supports faster movement through approval stages. This expectation of clarity after adoption aligns with the wider goals of b2b medical marketing which encourage predictable cooperation between vendor and buyer.

Documentation Supporting Review Processes

Healthcare organisations rely heavily on documentation during evaluation. Guides, records, administrative instructions, and explanations of data controls enable teams to examine the product without repeated requests for further detail. B2b medical marketing that introduces these documents early in the conversation reduces internal delays because reviewers can move through their procedures with all necessary information available at the outset. This transparent approach helps build trust between the vendor and the buyer and underscores the value of documentation as a recurring theme within b2b medical marketing.

B2b medical marketing works most effectively when vendors show an accurate grasp of clinical pressures and administrative realities. When communication reflects these conditions and acknowledges the challenges that healthcare groups experience during busy periods, readers gain confidence that the vendor understands the world they operate in. This supports deeper conversations about integration, performance, and long term cooperation across the organisation.

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Understanding Business Associate Agreements (BAAs) and Shared Responsibility

Modern-day healthcare organizations rely on a growing array of partners and vendors to provide them with the tools they need to effectively serve patients and customers. 

 

However, while new digital solutions and healthcare ecosystems often result in greater productivity and efficiency, they also increase the number of third parties a company must communicate with and share protected health information (PHI), requiring a business associate agreement (BAA). Unfortunately, this increases the risk of PHI being exposed, as it increases a healthcare organization’s supply chain network and the number of external organizations with access to their data, significantly raising the risk of a security breach. 

 

This is where the concept of shared responsibility comes in. 

 

In this article, we explore the shared responsibility model for data security, explaining the concept, the role of a BAA in shared responsibility, and why healthcare companies need to know how it works and where it factors into their HIPAA compliance efforts. 

What Is The Shared Responsibility Model? 

Shared responsibility is a core data security principle that divides the responsibility for protecting data between a company that collects the data and a vendor that supplies the infrastructure or systems used to process said data.

 

The shared responsibility model grew in prominence as more companies moved to cloud-based environments and applications. In the past, when companies kept their systems and data onsite, they had more control over who could access their data and, subsequently, a better ability to mitigate data security risks.

 

However, in adopting cloud-based infrastructure and applications, companies have to process and store their data in the cloud – often in shared infrastructure with other vendors using the same cloud – which consequently shifts some of the responsibility of information security to the cloud service provider (CSP) itself. This marked a profound shift in the way data was handled, transmitted, and stored – necessitating an evolved approach to data security. 

 

This fundamental shift in the way companies consume infrastructure and use apps ushered in the shared responsibility model: Where the cloud vendor provides the infrastructure or application, including HIPAA compliant and high secure environments, but it’s still the responsibility of the client to configure and use it securely. 

Business Associate Agreements (BAAs) and Shared Responsibility

By detailing the respective responsibilities of healthcare companies or Covered Entities (CEs) and their vendors or Business Associates (BAs) in securing PHI, a Business Associate Agreement is a prime example of shared responsibility. 

 

For example, the Business Associate shoulders the responsibility of providing the data safeguards required by HIPAA to secure patient data, such as infrastructure, encryption, audit logging, and even physical onsite security.

 

The Covered Entity, meanwhile, is responsible for conducting risk assessments, defining access control policies and processes, configuring services accordingly, workforce training, and continuous monitoring.

Additionally, both parties have the obligation to report security incidents to each other, as well as being independently accountable to the U.S. Department of Health and Human Services (HHS).

Why Shared Responsibility Is Essential for HIPAA Compliance

For healthcare companies, having a firm grasp of the shared responsibility model for safeguarding and securing PHI, and how they fit within your overall security posture is essential (for two key reasons).  

Security Gaps

Firstly, clearly understanding the shared responsibility decreases the likelihood of security gaps. If CEs are under the impression that the vendor handles all aspects of data security, they won’t be as vigilant. They’ll be less inclined to configure services, educate their staff accordingly, pay appropriate attention to vendor security alerts, etc. 

 

But the same is also true for BAs: If they assume their client does most of the heavy lifting in securing the data disclosed to them, they could be remiss in their duties to protect it. Without shared responsibility, each side simply assumes the other is covering a safeguard, opening the door for security gaps that malicious actors can exploit.

 

Fortunately, by detailing both parties’ (CEs and BAs) responsibilities and liabilities regarding data protection, a BAA removes this ambiguity and, more importantly, reduces the risk of security gaps. It’s critical to know the details and work with vendors building products for compliance versus implementing a tick-box approach to compliance that places too much burden on the CE.

Covered Entities (CEs) Are Ultimately Accountable

Subsequently, the second reason why it’s essential for CEs to understand the shared responsibility model, and increase their cybersecurity readiness accordingly, is that it’s the CE that’s ultimately held accountable for data breaches. 

 

Mistakenly thinking that a BAA automatically makes them compliant may result in healthcare companies underinvesting in training, monitoring, and incident response. Conversely, understanding that even with a BAA in place, they’re the ones primarily accountable for protecting PHI gives them a greater sense of urgency to properly implement HIPAA compliant security measures. 

The Covered Entity’s Role Within Shared Responsibility

Let’s look at the ways that healthcare companies have to hold up their end in the shared responsibility model. 

Choose Compliance-Conscious Vendors 

First and foremost, companies have to choose the right vendors to supply them with HIPAA compliant services and solutions.

 

Look for companies that market themselves as HIPAA compliant and display a detailed understanding of HIPAA requirements, particularly the HIPAA Security Rule. Do your due diligence and perform deeper dives on potential vendors, researching their stated security features, reviews from existing clients, whether they have certifications like HITRUST – and if they’ve been involved in any data breaches. 

 

Naturally, a core prerequisite of being a HIPAA compliant vendor is being willing to sign a BAA, so you can immediately rule out any vendors not willing to do so. For instance, some healthcare companies may assume they can use widely adopted solutions such as SendGrid, Mailchimp, but they don’t offer a BAA. 

 

Once you’ve confirmed a vendor offers a BAA, look through it to establish its terms and determine if it covers the services you’re interested in. 

Configuration 

Another core component of shared responsibility is comprehensive configuration management. While the BA’s responsibility is to provide a secure solution that satisfies HIPAA requirements, it’s the CE’s responsibility to configure it securely to fit within their IT ecosystem. 

Features that often require configuration include: 

 

  • Access control: Role-based access, Zero Trust, Multi-Factor Authentication (MFA).
  • Encryption settings: Enabling encryption, choosing encryption type, enforcing forced TLS, enabling storage encryption.
  • Feature restrictions: Disabling default configurations that enable integration with non-compliant tools. 
  • Audit logging: Enabling audit logging and configuring log formats.
  • Retention settings: How long to retain audit logs and who is permitted to review them.

Finally, establishing a patch management strategy, i.e., when and how your organization applies software updates, is an important element of configuration.  While the vendor must release updates to fix security vulnerabilities discovered in their solutions, it’s up to healthcare companies to deploy the patches. 

Training

Regardless of how many security features a vendor bakes into their solutions, once deployed by a healthcare company, the tool is only as secure as the practices of their least security-conscious employee. Consequently, companies must train their staff on how to properly use a solution to process protected health information and sensitive data. The more an employee is required to handle PHI, the more thorough and frequent their training should be. 

 

Key aspects of comprehensive cybersecurity training include:

 

  • Common cyber threats: what the most prevalent cyber threats are and how to recognize them.
  • Incident response: how to report a suspected security incident, i.e., who to contact and when. 
  • Specific solution training: how to securely use systems that process PHI
  • Scope awareness: knowing which services within your organization’s IT ecosystem are HIPAA-compliant and which are not

Reporting 

Although both healthcare companies and BAs have notification obligations to the HHS in the event of a data breach involving PHI, it’s the CE that bears most of the investigative burden. 

 

Firstly, while a BA may report a security incident, it’s the CE’s responsibility to conduct a risk assessment to determine the probability of compromise of PHI, assess risk, and determine whether an official notification of a breach to HHS is necessary.

 

Secondly, BAs must notify the CE without unreasonable delay and no later than 60 days after discovery. Although BAs often wait to complete internal investigations before notifying the CE, the CE’s 60-day clock starts upon the BA’s discovery, not upon the BA’s report. Therefore, BA delays can create compliance risks for the CE.

 

To prevent this, where possible, you can include stricter contractual reporting timelines in the BAAs. This constantly keeps your company in the loop, ensuring you have sufficient lead time to complete your own investigations and your HIPAA-regulated deadlines.

LuxSci – Secure Healthcare Communications

Developed specifically to fulfil the stringent regulatory and ever-evolving data security needs of the healthcare sector, LuxSci’s secure email, text, marketing and forms solutions help companies protect PHI and personalize communications.  

 

Equally as importantly, instead of leaving you to “figure it out” – pushing additional responsibility back onto your company – LuxSci has a reputation for the best customer support in the business, offering onboarding, detailed documentation, secure default configurations, and ongoing support to help navigate the murky waters of HIPAA compliance, while getting best-in-class performance out of your solution.

 

Contact LuxSci today to learn more or get a demo.

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HIPAA Compliant Email

Signing a BAA Does Not Automatically Make You HIPAA Compliant

For healthcare organizations, choosing the right product and service vendors is essential for achieving HIPAA compliance. One of the key prerequisites of a HIPAA-compliant vendor is the willingness to sign a Business Associate’s Agreement (BAA): a legal agreement that outlines both parties’ responsibilities and liabilities in securing protected health information (PHI). 

However, despite what some healthcare organizations have been led to believe, simply signing a BAA with a vendor doesn’t guarantee your use of their product or service will be HIPAA-compliant. In reality, a BAA is just the beginning, and there are several subsequent actions both healthcare organizations and their supply chain partners must take to ensure the compliant use of PHI, especially over communications channels like email. 

With this in mind, this post explores some of the reasons why signing a BAA on its own doesn’t ensure the security of PHI and protect your organization from HIPAA violations.

Business Associate Agreements (BAAs) Explained 

As touched upon above, a BAA is a legally-binding document established between a covered entity (CE), i.e., healthcare organizations, and a business associate (BA), i.e, any company that handles PHI in providing a CE with products or services. For a BA to handle patient or customer data on behalf of a CE, following HIPAA regulations, there must be a BAA in place. 

A BAA details:

  • Each party’s roles, responsibilities, and liabilities in securing PHI.
  • The permitted uses of PHI by the BA and, conversely, restrictions on any other use.
  • The BA’s responsibilities in implementing appropriate administrative, technical, and physical security measures to best protect PHI.
  • The BA’s obligations to report any unauthorized use, disclosure, or breach of PHI.
  • That the BA is required to assist with patient rights support, i.e., data access, amendments, and accounting of disclosures, when appropriate.
  • The BA’s obligations in making records available for audits or investigations.  
  • The CE’s right to terminate the contract if the BA fails to fulfil their obligations in safeguarding PHI.

Additionally, if a BA employs a third-party company, i.e., a subcontractor, that will have access to a CE’s PHI, they are required to establish a BAA with that company. This then makes the subcontractor a “downstream BA” of the CE, and subject to the same obligations and restrictions placed on the original BA. This ensures the security protections mandated by HIPAA flow down the entire chain of custody for sensitive patient and customer data.

Compliance Considerations After Signing a Business Associate Agreement (BAA)

Now that we’ve covered what a BAA is and the role it plays in ensuring data privacy, let’s move on to exploring some of the key things you have to do following the singing of a BAA to ensure HIPAA compliance.  

1. Both Parties Must Implement HIPAA-Required Data Risk Mitigation Measures 

    First and foremost, while a BAA details each party’s respective responsibilities in implementing measures to protect PHI, both still actually need to implement those required security features to achieve HIPAA compliance. 

    The measures required under HIPAA’s Security Rule, including encryption and access control, are designed to mitigate and minimize the impact of data breaches. So, if a company suffers a security breach and later audits show the required security policies and controls were not in place, they would be subject to the consequences of HIPAA violations, including fines and reputation damage.   

    Also, while a BAA stipulates that the BA is responsible for implementing the HIPAA-required safeguards for the PHI under their care, it doesn’t specify exactly which security measures they must implement. Subsequently, that’s left to the BA to interpret based on their understanding of HIPAA requirements, and how they conduct their required risk assessments.

    For example, if you have a BAA with your email services provider, that alone may not be enough to keep your company or organization HIPAA compliant. That’s because the provider may not have the security measures your organization needs, and instead have a carefully worded BAA that will leave you vulnerable.

    Let’s say your email marketing service provider is a “semi-HIPAA compliant” provider. In these cases, they may not offer email encryption, or the necessary access control measures your organization needs to send PHI and other sensitive information safely. The so-called HIPAA compliance may be limited only to data stored at rest on their servers only.

    In short, although a BAA outlines each party’s commitment to securing data, both parties still have to follow through on implementing risk mitigation measures. Additionally, though a healthcare company has its BA’s assurances that they’ll have the appropriate safeguards in place, CEs often only have limited visibility into its ongoing security posture. As a result, asking the right questions and working with a proven HIPAA compliant provider are critical steps healthcare organizations must take to ensure full compliance.

    2. CEs Must Stick to “In-Scope” Services

      While a BA may provide a CE with a range of services, many limit the coverage of their BAAs to particular “in-scope” services. As a result, if a healthcare organization were to use a service outside the coverage of the BAA, i.e., an “out-of-scope” service, they’d risk exposing patient data and incurring HIPAA violations.

      And, even when a service is in-scope, the BA is still required to configure it properly for it to be compliant. These configurations could include:

      • Enabling encryption
      • Establishing access control
      • Activating multi-factor authentication (MFA)
      • Turning on audit logging 

      With this in mind, it’s crucial to ensure that the “complete” service or tool – not just a part of it – is covered by a BAA before using it to process PHI. Similarly, check the terms of your BAA for configuration or security best practices that offer guidance on fully HIPAA compliant use, and make sure your responsibilities as a CE are 100% clear.

      3. Staff Must Be Trained to Securely Handle PHI 

        Another key reason that signing a BAA doesn’t automatically result in HIPAA compliance is the likely need for both parties to educate their staff on how to securely handle sensitive data, such as PHI.

        Firstly, as discussed above, only some of the services offered by a BA may be covered by its agreement. Subsequently, a healthcare organization’s employees need to be sufficiently trained on the use and disclosure of PHI, namely, the services in which they’re permitted to process PHI and which, in contrast, services are non-compliant.

        By the same token, as well as implementing the stipulated safeguards, BAs are responsible for training their workforce on how to use and, where appropriate, configure them. This will help ensure the limited, correct use and disclosure of PHI as allowed by the BAA. 

        4. Reporting Requirements

          A BAA stipulates that a BA must notify the CE in the event of improper or unauthorized use of PHI. More specifically, this includes: 

          • Reporting immediately any use or disclosure not permitted by the terms of the BAA.
          • Notifying the CE of security incidents resulting in the potential exposure of  PHI.

          However, the commitment to reporting in the BAA and the ability to deliver on that commitment are two different things entirely. Firstly, the BA must implement the policies and infrastructure that allow for timely incident reporting. This includes conducting risk analysis, implemeting continuous monitoring, and developing a robust incident response plan. 

          Additionally, a key aspect of prompt, comprehensive reporting includes the BA ensuring that their staff are sufficiently trained to detect and report security events. As part of their training on the secure handling of PHI, a BA’s employees must be able to recognize common security issues and threats, such as improper email configurations and phishing attempts, and how to report them.

          5. Subcontractor BAAs

            While CEs must sign BAAs with their BAs for the compliant use and disclosure of PHI, they don’t have to sign such agreements with any subcontractors the BA may employ. Instead, it’s the responsibility of the BA to enter into their own business associate agreements with their subcontractors. As a result, the original security obligations are passed all the way down the data’s chain of custody. 

            While a CE can take certain measures to enforce this, such as requesting proof of subcontractor BAAs – or even the ability to review subcontractors before beginning engagement – ultimately, they have little control over their security postures. Ultimately, this means that they have to trust that the original service BA does their due diligence in selecting security-minded subcontractors, with the right PHI safeguards in place.  

            HIPAA Compliance Beyond a BAA with LuxSci

            LuxSci’s secure healthcare communications solutions – including HIPAA compliant email, text, marketing and forms – are designed specifically with the stringent compliance requirements of the healthcare industry in mind. 

            LuxSci also provides onboarding, comprehensive documentation, and support to ensure your infrastructure configurations align with HIPAA requirements, so you can confidently include PHI in your healthcare engagement communications campaigns.

            Contact LuxSci today to discover more about achieving compliance beyond obtaining a BAA.

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            How to Make Google Workspace HIPAA Compliant

            How to Make Google Workspace HIPAA Compliant

            Healthcare organizations can make Google Workspace HIPAA compliant by completing a Business Associate Agreement with Google, configuring advanced security settings, and training staff on proper data handling. Knowing how to make google workspace HIPAA compliant means understanding that compliance depends on both technology and human oversight. When these elements are managed carefully, Google Workspace can be used to handle Protected Health Information securely while maintaining efficiency and accessibility for healthcare teams.

            The compliance framework

            The process of learning how to make Google workspace HIPAA compliant begins with recognizing that Google provides the infrastructure, but the healthcare organization is responsible for compliance. The HIPAA Privacy and Security Rules require administrative, physical, and technical safeguards that must be applied through policy and configuration. Google Workspace, when managed under the right plan, offers encryption, access management, and detailed audit logs. To make google workspace HIPAA compliant, administrators must use the business version, not free Gmail accounts, because only paid Workspace plans allow for proper control and a Business Associate Agreement. Documented internal policies should define how messages, files, and calendars containing patient data are stored and monitored. Establishing this structure early makes every later compliance step easier to maintain.

            The importance of the Business Associate Agreement

            A Business Associate Agreement (BAA) is an unskippable step in how to make google workspace HIPAA compliant. Without it, compliance cannot be achieved regardless of system configuration. This legal contract specifies how Google protects healthcare data, reports incidents, and assists with investigations. The BAA covers key Workspace tools such as Gmail, Drive, Calendar, and Docs but excludes consumer products like YouTube and certain AI-based features. Administrators should disable any unsupported tools to prevent accidental data exposure. Reviewing and maintaining this agreement is essential to keeping google workspace HIPAA compliant as Google updates or expands its services. Many healthcare organizations include the BAA in their annual compliance review to confirm it still reflects current practices and security requirements.

            Configuring strong security and access controls

            Knowing how to make google workspace HIPAA compliant requires more than signing documents. It demands careful configuration of security controls that align with HIPAA’s technical safeguard requirements. Encryption should be enforced for all email traffic, and administrators should ensure that every account uses two-step verification. Device management policies can prevent unapproved computers or phones from connecting to accounts that contain Protected Health Information. Access privileges should be based on job roles so that staff only view the data they need to perform their duties. Audit logs can record sign-ins, file access, and configuration changes, giving compliance officers a clear view of user activity. Each of these steps contributes to a google workspace HIPAA compliant environment that protects against both external threats and internal misuse.

            Maintaining compliance through user awareness and training

            Even the most secure configuration cannot replace good judgment. A key part of how to make google workspace HIPAA compliant is ensuring that every staff member understands their responsibility when handling patient information. Training should explain how to identify Protected Health Information, when encryption is necessary, and how to report security incidents. Consistent reminders help prevent accidental sharing or unauthorized forwarding of sensitive messages. Regular audits of user activity can identify risks such as unused accounts, weak passwords, or improper storage of files. By reinforcing awareness and accountability, organizations maintain their google workspace HIPAA compliant status while reducing the risk of human error that can lead to violations.

            Compliance is not a static condition but a continuous process. Administrators who understand how to make google workspace HIPAA compliant know that monitoring and documentation are required to sustain it. Google Workspace offers audit reports, security dashboards, and alerts that track sign-ins and encryption status. Reviewing these reports ensures that no settings are altered without authorization and that user activity remains within policy limits. Keeping written records of policy updates, staff training, and audit results helps demonstrate compliance during inspections. These records also create accountability and give leadership confidence that the system continues to operate within HIPAA standards. With diligent monitoring, a google workspace HIPAA compliant setup can stay reliable even as teams and technologies evolve.

            A lasting culture of compliance

            Organizations that learn how to make google workspace HIPAA compliant build more than a secure system—they create a sustainable culture of responsibility. Google Workspace allows healthcare professionals to collaborate, communicate, and share resources efficiently while safeguarding patient data. Maintaining this balance requires consistent review of settings, updates, and employee practices. As new regulations appear and technology develops, compliance officers should revisit each requirement to ensure ongoing protection. A well-managed, google workspace HIPAA compliant configuration supports both privacy and productivity, proving that regulatory compliance and convenience can coexist when oversight and education remain priorities.

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            Best HIPAA Compliant Email Providers

            What Makes HIPAA Compliant Secure Email Important for Healthcare?

            HIPAA compliant secure email is a specialized communication platform that combines encryption technology, access controls, and regulatory compliance features to protect patient health information during electronic transmission. Healthcare organizations require these secure email solutions to meet federal privacy requirements while maintaining efficient communication workflows with patients, colleagues, and business partners. Standard email platforms lack the security infrastructure necessary to protect protected health information, making dedicated secure email services essential for any healthcare entity handling patient data electronically.

            Security Architecture Behind Protected Healthcare Communications

            Encryption protocols are imperative in any effective secure email system designed for healthcare use. Advanced Encryption Standard (AES) 256-bit encryption transforms patient information into unreadable code before transmission, ensuring that intercepted messages cannot reveal sensitive health data to unauthorized parties. Transport Layer Security protocols create secure tunnels between email servers, preventing message interception during transmission across public internet infrastructure.

            Digital signatures verify message authenticity and detect any unauthorized modifications during transmission, providing healthcare organizations with confidence that received communications have not been tampered with by malicious actors. Certificate-based authentication ensures that only verified recipients can access encrypted patient communications, preventing misdirected emails from exposing protected health information to unintended parties. These security layers work together to create comprehensive protection for healthcare communications that extends beyond simple password protection.

            Message integrity controls detect attempts to modify email content during transmission, alerting recipients when communications may have been compromised. Secure key management systems protect the encryption keys that safeguard patient information while ensuring that legitimate users can access necessary healthcare communications without unnecessary delays. Automatic security updates maintain current protection against emerging cyber threats without requiring manual intervention from busy healthcare staff.

            Redundant security measures provide multiple layers of protection, ensuring that if one security control fails, additional safeguards continue protecting patient information. These overlapping protections create robust defense systems that can withstand various types of cyber attacks while maintaining email availability for patient care activities. Healthcare organizations benefit from HIPAA compliant secure email systems that continue operating effectively even when individual security components require maintenance or updates.

            Regulatory Compliance Framework

            Business associate agreements establish the legal foundation for healthcare organizations using third-party email services to transmit protected health information. These comprehensive contracts specify exactly how email providers will protect patient data, what security measures they will maintain, and how they will report potential security incidents to healthcare organizations. Compliance documentation requirements include maintaining detailed records of security configurations, staff training activities, and audit results that demonstrate adherence to HIPAA regulations.

            Risk assessment procedures identify potential vulnerabilities in email security systems and guide healthcare organizations in implementing appropriate safeguards. These assessments evaluate encryption strength, access control effectiveness, and audit logging capabilities to ensure comprehensive protection of patient communications. Documentation of risk assessments provides evidence of due diligence during regulatory audits and helps healthcare organizations prioritize security improvements.

            Audit trail requirements mandate detailed logging of all email activities, including message transmission times, user access events, and administrative actions within the email system. Healthcare organizations using HIPAA compliant secure email must maintain these audit records for specified retention periods while ensuring that log storage systems have the same security protections as the primary email platform. Audit review procedures help identify unusual activity patterns that might indicate security incidents or unauthorized access attempts.

            Breach notification protocols specify how healthcare organizations must respond when security incidents occur involving patient information transmitted through email systems. Response procedures include immediate containment measures, assessment of potential patient impact, and notification requirements for affected individuals and regulatory authorities. Compliance monitoring ensures that email security measures continue meeting regulatory requirements as technology evolves and new threats emerge.

            Implementation Strategies for Healthcare Organizations

            Staff training programs prepare healthcare workers to use secure email systems effectively while maintaining patient privacy throughout all electronic communications. Training modules should cover platform navigation, recipient verification procedures, and decision-making guidelines for determining when email communication is appropriate versus when more secure alternatives are necessary. Healthcare organizations implementing HIPAA compliant secure email benefit from comprehensive training programs that address both security requirements and practical workflow considerations.

            Workflow integration planning ensures that secure email systems connect seamlessly with existing healthcare information systems without creating operational bottlenecks. Integration considerations include single sign-on capabilities, electronic health record connectivity, and mobile device accessibility that supports healthcare staff working from various locations. Change management strategies help overcome resistance to new communication technologies while ensuring consistent adoption across all departments.

            Pilot programs allow healthcare organizations to test secure email functionality with limited user groups before organization-wide implementation. Testing phases should verify encryption performance, user authentication processes, and audit logging capabilities under realistic usage conditions. Feedback collection during pilot programs helps identify potential usability issues that could interfere with patient care workflows or discourage staff adoption of secure communication practices.

            Phased rollout schedules minimize workflow disruptions while providing adequate support resources during the transition to secure email systems. Implementation timelines should account for varying technology comfort levels among healthcare staff while ensuring that all users receive necessary training before accessing patient information through email platforms. Support procedures must provide readily available assistance during the initial adoption period when questions about secure email usage are most frequent.

            Patient Communication Enhancement

            Direct patient communication through secure email platforms enables convenient access to healthcare information while maintaining appropriate privacy protections. Patients can receive lab results, appointment confirmations, and health education materials through encrypted channels that protect their personal health information from unauthorized access. Healthcare organizations using HIPAA compliant secure email can offer patients flexible communication options that accommodate different preferences and schedules.

            Appointment scheduling integration allows patients to request appointments, receive confirmations, and make changes through secure email channels rather than relying solely on telephone communications during business hours. Automated reminders sent through encrypted email reduce no-show rates while providing patients with convenient options to reschedule when necessary. Prescription refill requests can be processed efficiently through secure email channels that maintain detailed records for clinical and billing purposes.

            Health education delivery through secure email platforms ensures that patients receive personalized information about their conditions, treatment options, and prevention strategies. Educational materials can be tailored to specific patient diagnoses and sent through encrypted channels that protect patient privacy while providing valuable health information. Follow-up communication after appointments helps reinforce treatment instructions and provides opportunities for patients to ask questions about their care plans.

            Patient portal integration with secure email systems creates unified communication platforms that give patients convenient access to their complete health information. These integrated systems allow patients to review test results, communicate with their care teams, and access educational resources through single platforms that maintain consistent security standards. Healthcare organizations benefit from integrated communication systems that reduce administrative overhead while improving patient satisfaction with their healthcare experience.

            Cost-Effectiveness and Return on Investment

            Administrative efficiency improvements result from reduced phone call volumes when patients can communicate non-urgent questions and requests through secure email channels. Healthcare staff can respond to multiple patient inquiries more efficiently through written communication compared to individual telephone conversations. Appointment scheduling becomes more streamlined when patients can request and confirm appointments through secure email rather than requiring staff time for telephone coordination.

            Documentation benefits arise when patient communications are automatically preserved in searchable formats that integrate with electronic health record systems. Secure email systems maintain comprehensive records of patient interactions that support clinical decision-making and provide evidence of communication for billing and legal purposes. These automated documentation capabilities reduce staff time spent on manual record-keeping while improving the completeness of patient communication records.

            Competitive advantages accrue to healthcare organizations that offer patients convenient, secure communication options that meet modern expectations for digital interaction. Patient satisfaction scores increase when healthcare providers offer flexible communication channels that respect patient privacy while providing timely responses to questions and concerns. Healthcare organizations implementing HIPAA compliant secure email often experience improved patient retention rates and positive word-of-mouth referrals.

            Scalability benefits allow healthcare organizations to accommodate growing patient populations and increasing communication volumes without proportional increases in administrative staff. Secure email systems can handle larger message volumes more efficiently than telephone-based communication systems while maintaining consistent security standards. These scalability advantages become increasingly valuable as healthcare organizations expand their services or patient populations over time.

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