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.

So – you’ve just been told that your email marketing program is putting your company at risk of violating HIPAA.

Ok. What now?

If you want to continue your email-based patient engagement efforts – without the risk of the financial, operational, and reputational risk that accompanies the exposure of sensitive patient data, you must implement HIPAA compliant email marketing practices.

This is comprised of two components: becoming HIPAA-compliant, setting up the required systems and procedures to ensure your PHI (PHI) and EPHI (EPHI) are protected, and your marketing objectives, who you want to reach and what to communicate.

However, you don’t have to let your marketing objectives suffer for the sake of security.

Implementing a HIPAA-compliant marketing program can actually help you achieve better marketing results.

Asking yourself these 12 questions ensures your email marketing campaigns align with your business goals and are HIPAA-compliant.

———

HIPAA-Compliant Marketing Emails

1. Do you have security controls to protect access to your email marketing system?

2. Do you have a documented procedure to guide you HIPAA-compliant email marketing?

3. Can you send encrypted emails?

4. Do you have a complete understanding of your organization’s PHI and ePHI?

5. Do you have a required training process for anyone sending HIPAA-compliant marketing emails?

6. Do you have effective protection against malware?

7. Do you have valid Business Associate Agreements (BAA) in place?

8. Why am I sending this email?

9. Is my email’s subject line standing out?

10. What is the recipient’s brand and product awareness level?

11. Have I tested my message for readability?

12. Have I sent my message to a test email account?

HIPAA-Compliant Marketing Emails

If your organization requires HIPAA-compliant email, start by using these questions to inspect your email marketing for compliance. Note that while we can’t provide legal advice, the below questions will help you identify some of the most common points of vulnerability and non-compliance.

1. Do you have security controls to protect access to your email marketing system?

Email security is an essential component of being HIPAA-compliant. As a starting point, check your internal security processes for access restrictions. This includes:

• A robust password policy, i.e., changed frequently (e.g., 30 days), has to contain a mixture of characters, etc.
• Multi-factor authentication (MFA), i.e., users verifying their identity in multiple ways, e.g., username/password and sent number codes (text, email, key fob, etc.), biometrics, etc.
• Role-based access controls, i.e., granting access to individuals based on the responsibilities of their job role.
• Zero Trust Architecture (ZTA), i.e., “never trust, always verify” – where users are required to reconfirm their identity on a case-by-case basis, as opposed to once when logging on, which mitigates session hijacking and similar threats.

2. Do you have a documented procedure to guide you HIPAA-compliant email marketing?

“Winging it” simply doesn’t cut it when it comes to HIPAA-compliant email marketing; you must develop a comprehensive documented process detailing how you intend to safeguard PHI throughout your email marketing campaigns.

This should include:

• Specifying the HIPAA-compliant email delivery service you’ll use to execute your marketing campaigns

• The processes and controls you’ll use to encrypt data  for ePHI at rest and in transit

• The access and authentication controls you have in place

• How you’ll implement data minimization: only using the minimum necessary PHI in communications – and not including sensitive PHI unless it’s essential.
• How you’ll securely dispose of data: Implement a process for securely deleting emails containing ePHI once they’re no longer needed, to comply with retention policies.
• Staff training: educating employees involved in email marketing on how to securely handle PHI and other HIPAA requirements.
• Incident response plan, i.e., an additional documented plan for how you’ll respond to data breaches and other cyber attacks; this also includes notifying any affected parties as mandated by HIPAA.

If you’re starting from scratch, the information contained in the answers to the questions in this article provides a useful starting point for creating your first procedure.

3. Can you send encrypted emails?

If you are sending highly sensitive data or PHI in your emails, be aware that HIPAA requires the data to be encrypted a rest, i.e., the storage medium where it resides, and in transit, when being sent to recipients.

To the surprise of many healthcare organizations, most major email marketing providers, such as Mailchimp and Constant Contact are unable to provide encryption for data in transit and only protect data in their systems. To avoid falling foul of HIPAA regulations, ensure that the email delivery platform you use to transmit messages containing PHI offers end-to-end encryption.

4. Do you have a complete understanding of your organization’s PHI and ePHI?

Much of the time, when we, as well as healthcare providers, talk about PHI, we’re actually referring to electronic protected health information (EPHI). While PHI is a catch-all term to account for all sensitive health information, in truth, in the digital age, the vast majority is stored electronically in data centers – and the patient data handled is EPHI.

You can discover “PHI” and “ePHI” within the context of your organization’s context by identifying and categorizing the PHI and ePHI typically handled in your business. It’s an absolutely crucial tenet of data protection that you simply can’t protect what you’re not aware of.

Comprehensive PHI categorization will help your staff navigate HIPAA-compliant email requirements.

5. Do you have a required training process in place for anyone sending HIPAA-compliant marketing emails?

Your HIPAA compliance program, as with your company’s overall cybersecurity posture, is only as strong as your weakest link. In light of this, it’s essential to educate the staff within your company who are involved in your healthcare engagement campaigns on the secure use of ePHI and HIPAA-compliant marketing practices.

Additionally, this needs to be reflected in your onboarding process, so new hires are made familiar with HIPAA regulations, should their role require it.

6. Do you have effective protection against malware?

In the unlikely event you need any further encouragement to revisit your company’s anti-malware (viruses, ransomware, Trojans, etc.) measures, there are always HIPAA compliance requirements! 

To better protect your sensitive customer data against a slew of increasingly sophisticated cyber threats, start with these three key considerations:

1. Do you have anti-malware protection running on all of your organization’s devices? Additionally, does this extend to your employee’s personal devices on which they handle PHI?
2. How frequently do you update your anti-malware solution?
3. Does your email marketing provider have sufficient protection malware mitigation measures in place, as per HIPAA requirements?

7. Do you have valid Business Associate Agreements (BAA) in place?

It’s normal to outsource activities like email marketing to a third party, but for the service they provide to be HIPAA-compliant, you must have a business associate agreement (BAA) in place.

A BAA documents how two organizations will share PHI and under what circumstances. A BAA also details the legal responsibilities of each party in the event of a serious issue. With a BAA being a core component of HIPAA compliance, failure to have one in place with your email service provider is an immediate HIPAA violation – and one that can result in serious consequences for a healthcare company.

Getting Better Results from HIPAA-Compliant Email Marketing

Now that you’ve confirmed your systems are HIPAA-compliant, let’s move on to making sure your email marketing strategy aligns with your overall business objectives.

In pursuit of this, the following questions serve as a handy “monthly review” for refining the effectiveness of your email-based patient outreach efforts .

8. Why am I sending this email?

First and foremost, for the best results, each email you send should have a single, clearly defined purpose.

I know what you’re thinking – “my customers and patients are smart, they can handle multiple points in a single message.”  And while that’s true, at whatever point your email reaches a recipient, they’re already juggling several different priorities at once. While they’re capable of juggling multiple points in a message – they’re unlikely to want to; when it comes to email marketing, a single goal is the best way to go.

Similarly, it’s important to remember that your email is one of dozens –  or hundreds – received by your patient that day. So, if your message is long and overly complicated, the reader will likely skip over or delete it.

9. Is my email’s subject line standing out?

Following on the above point, is your email subject line impactful enough to stand out amidst the pile of messages that will land in the patient’s inbox that day? The email subject line is the most important part of your email because it’s responsible for persuading the reader to open your message.

Despite this, many marketers still use terrible, ineffective subject lines and wonder why their emails are failing to produce results!

For the best results, write up three to ten subject lines for your next email, step away for 5-10 minutes, and then choose the headline you determine as best.

Consider these examples to check your understanding:

Ineffective Email Subject Lines

1. Blank (no subject): writing nothing in the subject line
2. Clinic Newsletter (tell them more, e.g., the subject or theme for the month)
3. Overusing exclamation marks!!!

Effective Email Subject Lines (examples based on a dental practice)

1. BRAND-NEW Dental Product Released Today
2. How to Cut Down on Your Health Insurance Paperwork
3. [Case Study] How We Helped 3 Ex-Smokers Get White Teeth

10. What is the recipient’s brand and product awareness level?

Whether promoting medical devices, new digital solutions technology, or any healthcare product or service, understanding the prospect’s awareness level is essential.

If your email is designed to introduce a brand-new product, stick to high-level features and benefits while avoiding technical jargon and granular product details. Conversely, if you’re writing an email to experienced, highly knowledgeable readers, going into greater depth makes sense.

Advanced list management and segmentation tools, as offered by Luxsci Secure Marketing, are key for ensuring the communications you send match the reader’s awareness level.

11. Have I tested my message for readability?

Do you know one of the reasons that Hemingway was popular? He   was skilled at writing short phrases and phrases. Consequently, his writing was easy to understand and appealed to a wide variety of people. When in doubt, keep your writing short and free of jargon, abbreviations and “insider” terms.

When you’re deeply involved in the details of your business, it’s so easy to overlook just how much specialized jargon and language you frequently use. However, if you want your communications to engage with patients and customers, they need to be as accessible as possible.

Fortunately, there are simple solutions to this, with tools like the Text Readability Calculator that are designed to quickly enhance the readability of your emails.

12. Have I sent my message to a test email account?

Finally, if you’ve followed all of the above advice, you’re almost ready to hit SEND…there’s just one more thing you need to check.

Determine how your email will look to recipients, including its clarity, and readability by simply sending a test email to one of your own email accounts once it is received.

In particular, pay attention to how the subject line looks and test all the links in the email to ensure they take the reader through to the intended destination, such as a product or service page. A broken link will only frustrate the recipient – who was interested enough to click through, no less – and lower your conversion rate.

Better still, send the test email to a colleague somebody and ask for their opinion about the quality of the message and whether it creates the desired impression.

Demystifying HIPAA-Compliant Email Marketing

As the most experienced HIPAA-compliant email provider, LuxSci specializes in providing secure and HIPAA-compliant solutions for companies aiming to send hundreds of thousands – or millions – of emails. Our hypersegmentation tools allow you to precisely target an unlimited number of patient sub-populations to maximize the efficacy of your messaging.

Are you interested in discovering how LuxSci’s secure email marketing platform will streamline your healthcare engagement efforts?

Contact us to learn more about our products and pricing.