Today, we’re excited to announce two new reporting features designed to help healthcare organizations improve reporting accuracy and the overall effectiveness of their email campaigns. The new features offer deeper insights into Apple Mail and Google email performance by distinguishing between opens and clicks performed by human actions and automated events — and by giving users control over how these events are reflected in LuxSci email campaign reporting.
Let’s dive into what these features are and how they can help you get more precise data from your healthcare email marketing and communications efforts.
Feature 1: Enhanced Open and Click Tracking – Human vs. Automated
One of the biggest challenges in email tracking today is the rise of automated systems that pre-load images and scan links in emails. Automated systems can trigger open or click events without the recipient actually interacting with the email, leading to inflated and misleading open/click rates.
With LuxSci’s new enhanced open and click tracking, you can now tell whether Apple Mail and Google emails (Gmail and Google Workspace) were opened or a link was clicked by a human or by an automated system. This crucial distinction allows you to have a much clearer picture of actual user engagement.
Here’s how it works:
When emails are sent with open tracking enabled, a small tracking image (also known as a pixel) is embedded in the email. When that image is loaded, the system tracks the email as “opened.”
Similarly, links in the email are encoded to track clicks. If a recipient clicks a link, it triggers a “clicked” event, but these events can also be triggered by automated systems.
LuxSci’s enhanced open and click tracking feature analyzes these events and reports whether the actions were performed by a human or an automated system, helping you sift through false positives.
Feature 2: Suppressing Automated Events in Your Reporting
In addition to tracking the source of open and click events, LuxSci’s second new feature gives you the option to exclude automated events from Apple Mail and Google email from your email engagement statistics altogether. This setting, available in account-wide outbound email settings, is a powerful tool for ensuring the accuracy of your reports and understanding true user engagement.
Here’s how it works:
Automated opens and clicks can be removed from email reporting for better accuracy. For example, if a security bot clicks a link, that event will be logged, but it won’t mark the email as “clicked” in your statistics.
Your open, click, and click-through rates can be set to only reflect real human actions, making these metrics much more reliable for evaluating campaign performance and actual patient engagement.
Why These Features Matter for Healthcare Email Marketing
For healthcare organizations, reliable metrics are essential. Emails often carry critical information related to patient care, transactions, or marketing, and understanding who is engaging with your content is critical to ongoing improvement and long-term success. At the same time, automated actions can inflate your open and click rates, leading to inaccurate conclusions about your email performance.
LuxSci’s new features give you the power to:
Track email engagement with precision: Know the difference between human engagement and automated actions, so your metrics reflect reality.
Customize your reporting: Decide whether you want to include or suppress automated events in your reports.
Improve deliverability strategies: By analyzing which emails are genuinely opened or clicked by real people, you can fine-tune your email campaigns to maximize their effectiveness.
Ready to Enhance Your Email Tracking?
Take control of your email deliverability insights with LuxSci’s newest email tracking tools. Whether you want to gain deeper insights into recipient behavior or eliminate noise from automated systems, these features are designed to help you improve your email reporting, performance and engagement.
For current LuxSci customers, you can learn more about these features in the Support Library, under Support, when you are logged into your account.
If you’re new to LuxSci, reach out today and we’d be happy show you the power of our secure, HIPAA-complaint healthcare communications solutions, including high volume email, text, forms and marketing solutions. Contact us here.
Most conversations about HIPAA compliant email eventually land on the same acronym: TLS. It’s the most common encryption method in use, and for good reason — it’s widely supported and relatively simple to enforce. But TLS isn’t the only encryption standard healthcare organizations should understand, and it isn’t always the right tool for securing your email address and message content.
S/MIME is the other name that comes up frequently, especially in healthcare, and usually in the same breath as PGP, along with some confusion about what it actually does differently. This guide breaks down what S/MIME is, how MIME works underneath it, how to configure it, and — just as importantly — when it’s genuinely worth the effort versus when it isn’t, based on both the technical standard and real feedback from the people who’ve actually had to manage it.
If you haven’t yet worked through the basics of what makes email HIPAA compliant in the first place, our HIPAA Compliant Email guide is a useful starting point before diving into a specific encryption standard like this one.
What Is S/MIME?
S/MIME stands for Secure Multipurpose Internet Mail Extensions (also written Secure/Multipurpose Internet Mail Extensions). It’s a security extension of MIME, the original standard introduced in 1992 that first allowed email to carry more than plain text — attachments, formatting, and different character sets. Understanding how MIME works helps explain what S/MIME adds on top: where MIME made richer content possible, S/MIME made that content secure by encrypting it and digitally signing it.
S/MIME’s roots as a security standard go back to the early 2000s, largely through work done by RSA Security, one of the earliest companies focused on computer and network security. Because it’s been around for so long, S/MIME is supported natively by most major email clients, including Outlook and Apple Mail, without requiring third-party software or plugins.
At its core, S/MIME provides three distinct protections for email security:
Encryption — ensures that only the intended recipient, using their private key, can read the email messages sent to them
Sender authentication — verifies the identity of the sender, so the recipient can trust the email actually came from who it claims to be from
Digital signing — confirms the message wasn’t altered in transit, effectively letting you digitally sign each message you send
This combination is what distinguishes S/MIME from encryption methods that only protect the connection a message travels over. S/MIME protects the message itself — a meaningful distinction for any organization handling sensitive data security requirements.
How Does S/MIME Work?
S/MIME is built on Public Key Infrastructure (PKI) and asymmetric encryption — a system that uses two mathematically linked digital certificates instead of one shared password.
Public key — shared openly, used by others to encrypt messages sent to you and to verify your digital signature
Private key — kept secret and secure, used by you to decrypt received messages and sign outgoing ones
When someone sends you an S/MIME-encrypted email, they encrypt it using your public key. Only your corresponding private key can decrypt it, meaning that even if the message is intercepted somewhere along its path, it remains unreadable without that specific private key. This is what people mean when they describe S/MIME as end-to-end encryption: the protection travels with the message itself, not just the connection carrying it.
To configure S/MIME, both the sender and recipient need:
A digital certificate, issued by a trusted certificate authority (CA), tied to their specific email address
That certificate properly installed and configured in their email client
Each other’s public key, exchanged in advance, so encryption and decryption can actually happen
If any one of these pieces is missing on either side, S/MIME simply doesn’t work for that exchange — a limitation that comes up constantly in practitioner discussions, and one worth understanding before you invest time configuring it.
What IT Practitioners Actually Say About This
One useful, if slightly humbling, reality check comes up repeatedly in IT forums when people ask whether they should bother configuring S/MIME: as one systems administrator put it plainly, most people you correspond with have no idea how to verify a digital signature and won’t even notice if one is missing. Emails from your bank or a government tax agency, they pointed out, typically aren’t S/MIME signed at all — a sign of just how limited real-world verification behavior actually is outside of specific technical or regulatory contexts.
Another common thread: several IT professionals candidly noted that email clients like Outlook can create friction by automatically trying to reply with an S/MIME signed message, which can be genuinely annoying for a recipient who has no certificate configured and no way to make sense of the added complexity. Their advice, consistently, boiled down to one clarifying question: it isn’t a question of whether you should configure S/MIME, but whether you actually need it — if none of the people you communicate with require signed email, the added configuration probably isn’t buying you anything meaningful.
That distinction — need versus want — is exactly the lens healthcare organizations should apply too, and it’s the framing this guide uses throughout.
S/MIME vs. TLS vs. PGP: How They’re Different
It’s easy to lump every encryption acronym together, but each one solves a slightly different problem.
Method
What It Protects
Identity Verified Via
Complexity
TLS
The connection between mail servers
Server-level certificates, not individual senders
Low — largely automatic, minimal user setup
S/MIME
The message content itself, end-to-end
Trusted certification authorities issue and vouch for individual certificates
High — requires certificates and key exchange for every sender/recipient pair
PGP
The message content itself, end-to-end
A decentralized “web of trust” — users vouch for each other directly
High — similar certificate/key management burden as S/MIME
TLS encryption – most people interact without realizing it — it’s what protects the connection when your email travels from your server to the recipient’s server. The tradeoff is that TLS only protects the message in transit; once it lands on a mail server, TLS’s job is done.
S/MIME and PGP both aim to close that gap by encrypting email messages themselves, so they remain protected even after delivery. The key difference, as one privacy-focused forum discussion put it well, comes down to how identity is managed: S/MIME farms identity verification out to a trusted certification authority, while PGP requires you to manage that trust relationship yourself. For most healthcare organizations, S/MIME’s centralized CA model is the more practical fit, since it aligns better with how enterprise IT departments already manage digital certificates and existing vendor relationships.
Key Benefits of S/MIME
Genuine end-to-end protection. Because the message itself is encrypted, S/MIME protects data security even if it passes through servers that don’t support encryption.
Built-in sender authentication and message integrity. Digital signatures verify both the identity of the sender and that the message hasn’t been tampered with — a layer TLS alone doesn’t provide.
Broad native support across email clients. Most major email clients support S/MIME out of the box, without requiring a separate plugin.
Flexibility to sign without encrypting. As one practitioner pointed out, you can digitally sign an outgoing message without encrypting it — useful for something like a mailing list, where you want recipients to trust the message came from you, but full encryption isn’t necessary or practical for a broad distribution list.
The Real Tradeoffs of S/MIME
Certificate management is ongoing, not one-time. Every sender and recipient needs a certificate tied to their email address, renewed and reissued as staff change roles or leave. Manageable for a small group; significant admin overhead for a whole organization.
Both parties must be configured correctly. If a recipient lacks a certificate or the sender’s public key, the message bounces or fails to send encrypted — some systems fall back to TLS, but only if configured to do so.
Most recipients can’t verify it anyway. IT practitioners consistently note that outside specific business or regulatory contexts, recipients have no practical way to check a digital signature — and default behaviors like auto-signed replies can just create friction.
It doesn’t scale to high-volume email. S/MIME suits direct correspondence between known parties, not appointment reminders, billing notices, or large mailing lists.
It can conflict with malware scanning. End-to-end encryption blocks gateway-level inspection, so scanning has to happen at the endpoint instead.
How to Configure S/MIME?
For Individuals
Obtain an S/MIME certificate from a trusted certificate authority. Certificates come in different validation levels — Basic (validates only the email address), Individual Validation (confirms personal identity), Organization Validation (confirms the business’s legitimacy), or Sponsor validation (combining both).
Install the certificate in your email client — most major email clients, including Outlook and Apple Mail, support this natively.
Configure the client to use the certificate for both encrypting outgoing messages and verifying signatures on incoming ones.
Exchange public keys with anyone you intend to correspond with securely — typically by sending them a signed (but not necessarily encrypted) email first, which shares your public key automatically.
For Organizations
Determine the validation level your organization actually needs. Higher validation levels provide stronger identity assurance but involve more verification steps and cost.
Use centralized tools to manage the certificate lifecycle. Protocols like LDAP or endpoint management platforms (such as Microsoft Intune) can significantly reduce the manual burden of distributing and renewing digital certificates at scale.
Distribute certificates and provide clear installation guidance to every employee who needs S/MIME — this is often where organizations underestimate the support burden, particularly for less technical staff.
Set clear policies on when S/MIME is required versus when other encryption methods, like enforced TLS, are sufficient. Treating S/MIME as a blanket requirement across an entire organization typically creates more friction than protection, echoing exactly what practitioners report when they configure it without a clear need.
When Does S/MIME Actually Make Sense?
Given its administrative overhead — and the recurring, practical feedback from people who’ve actually configured it — S/MIME is best reserved for specific, high-sensitivity use cases rather than applied indiscriminately:
Clinician-to-clinician communication involving particularly sensitive diagnoses or treatment details, where both parties are known and willing to maintain certificates
Cross-organization referrals where a small, defined group of specialists regularly exchanges detailed patient information and can reasonably manage the certificate relationship
Legal, compliance, or executive correspondence where verifying the sender’s identity and confirming message integrity outweighs the setup cost
For everything else — appointment reminders, billing communications, marketing outreach, or high-volume patient correspondence — enforced TLS or a managed encryption platform that automatically selects the right method per recipient is almost always the more practical choice. This mirrors exactly what experienced IT practitioners consistently conclude on their own: it’s not about whether S/MIME can work, it’s about whether your specific communication actually needs it.
A Simpler Path: Automated, Per-Recipient Encryption
The tradeoff most organizations run into with S/MIME isn’t whether it works — it’s whether staff can reliably manage digital certificates for every relevant contact without errors slipping through, and without creating the kind of recipient friction practitioners describe so consistently.
Rather than requiring every sender and recipient to individually configure S/MIME, some HIPAA compliant email platforms automatically select the appropriate encryption method per recipient — TLS when it’s sufficient, a secure portal when the recipient’s system doesn’t support TLS, and PGP or S/MIME when the situation calls for genuine end-to-end protection and sender verification. This removes the burden of manually deciding — and manually maintaining certificates — from individual staff members, while still making S/MIME available for the specific cases where it’s the right tool.
What Should I Do Now? (revised with target-keyword anchor text)
S/MIME is a legitimate, well-established way to secure your email and verify the sender — but understanding when to use it, and when a simpler method is more appropriate, matters just as much as knowing how to configure it. Most healthcare organizations don’t need S/MIME everywhere; they need the right encryption method applied automatically, based on the situation.
Here’s where to go next:
Learn more about HIPAA compliant email encryption to see how encryption standards like S/MIME fit into a broader compliance strategy.
Explore Secure High Volume Email to see how automatic, per-recipient encryption — including S/MIME and PGP where appropriate — removes the manual certificate management burden from your staff.
Talk to a LuxSci expert if you’re evaluating which encryption approach fits your organization’s specific mix of high-sensitivity and high-volume email.
FAQs
1. Is S/MIME better than TLS for email security?
Neither is universally better — they solve different problems. TLS protects the connection a message travels over and suits high-volume, everyday email. S/MIME protects the message content itself, end-to-end, and suits specific, high-sensitivity communications between known parties who can manage digital certificates.
2. What happens if I send an S/MIME encrypted email to someone who doesn’t support it?
The message typically won’t deliver as encrypted, and depending on how the sending system is configured, it may bounce back to the sender or automatically fall back to TLS.
3. Do I need a separate digital certificate for every email address, or just one for my organization?
Each individual email address needs its own certificate issued by a certificate authority. A single organizational certificate doesn’t cover every employee — certificates are tied to specific addresses, not the organization as a whole.
4. Can I digitally sign an email without encrypting it?
Yes. Signing confirms the identity of the sender and that the message wasn’t altered, without requiring the recipient to have a certificate of their own. This is useful for situations like mailing lists, where full encryption isn’t practical but sender verification still adds value.
5. Is S/MIME a good fit for HIPAA compliant marketing emails?
Generally, no. S/MIME’s certificate and key exchange requirements don’t scale well to high-volume or one-to-many communication like marketing campaigns. Enforced TLS or a platform that manages encryption automatically per recipient is typically the better fit for that use case.
Few terms in healthcare get thrown around as loosely as “HIPAA violation.” It gets invoked when a nurse mentions a patient’s diagnosis to a friend outside of work, when a technician talks about a well-known patient who came through the clinic, or when a physician casually brings up a person’s rare diagnosos at a backyard barbecue — situations that sound like violations but often have nothing to do with the actual law. That confusion isn’t just an oversight, but rather, it points to a gap in understanding what HIPAA covers, who it applies to, and what genuinely puts an organization at risk.
For health care providers, compliance officers and IT professionals, the stakes behind that confusion are anything but casual. The Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has issued settlements ranging from a few thousand dollars to over $16 million for the same underlying failures, such as a missed risk assessment, an unencrypted laptop, a chart accessed by the wrong person. This guide breaks down what actually constitutes a HIPAA violation, the most common ways organizations end up on OCR’s radar, what genuinely falls outside HIPAA’s scope, and what to do if you’re managing risk or responding to an incident right now.
If your organization handles PHI over email — one of the highest-risk channels for exactly this kind of violation — our HIPAA Compliant Email guide is a useful next read once you’ve worked through this one.
What Is a HIPAA Violation?
A HIPAA violation occurs when a covered entity, business associate, or a member of either’s workforce fails to comply with a standard set out in the HIPAA Privacy Rule, Security Rule, or Breach Notification Rule — or fails to follow an internal policy implemented to support HIPAA compliance.
That definition matters because it draws a hard boundary around who can actually commit one. HIPAA applies to:
Covered entities — healthcare providers, health plans, healthcare suppliers, payers, and healthcare clearinghouses
Business associates — vendors and contractors that create, receive, maintain, or transmit protected health information (PHI) on a covered entity’s behalf
Workforce members — employees, volunteers, and contractors of either of the above
HIPAA does not apply to private individuals acting outside of a covered role — a distinction that trips up far more people than you’d expect, and one we’ll come back to later in this guide.
The Health Insurance Portability and Accountability Act (HIPAA) was designed to protect the confidentiality of medical records and patient data while still allowing healthcare organizations to function and share information when appropriate. A violation happens when that balance breaks down — when PHI is accessed, used, or disclosed in a way the law doesn’t permit, or when required safeguards simply aren’t in place.
The Three HIPAA Rules a Violation Can Break
Every HIPAA violation traces back to one (or more) of three core rules. Understanding which rule is in play helps clarify what actually went wrong — and what needs to be fixed.
Rule
What It Governs
Example Violation
Privacy Rule
Who can access, use, and disclose PHI, and under what circumstances
Sharing a patient’s diagnosis with someone outside their care team without authorization
Security Rule
Administrative, physical, and technical safeguards for electronic PHI (ePHI)
Failing to encrypt emails in transit or a laptop that stores patient information
Breach Notification Rule
Requirements for notifying affected individuals and HHS after a breach of unsecured PHI
Missing the 60-day deadline to notify patients after a data breach
Most real-world violations involve more than one rule at once, such as a stolen, unencrypted laptop is a Security Rule failure that can also trigger Breach Notification Rule obligations. Keeping the three rules distinct in your own documentation, though, makes it much easier to identify exactly where a gap exists.
Most Common Types of HIPAA Violations
These are the violation categories that show up most often in OCR settlements, and the ones every provider, payer, and supplier organization should actively guard against.
Unauthorized Access / Snooping
This is the violation most people have actually heard about, usually because of a celebrity or high-profile patient case that made headlines. A staff member accesses a patient’s medical record without a legitimate, job-related reason — often out of curiosity, not malice — and it still counts as a serious violation.
What’s easy to miss here: the violation is about the access itself, not just what happens to the information afterward. Looking at a chart you have no clinical reason to view is a violation the moment it happens, even if you never repeat, share, or act on what you saw. Hospitals take this seriously enough to flag high-profile patient charts automatically and audit access in real time — which is exactly why staff who snoop tend to get caught quickly, and why termination is the near-universal outcome when they do.
A useful way to think about it: the sensitivity of the underlying information isn’t what determines whether accessing it was a violation — the authorization to access it through that specific system is and if a job role requires it. Pulling PHI through a restricted system without a legitimate reason is a violation even in cases where the same information might, in theory, be available through some other, non-restricted channel. Improper access through the wrong door is still improper access.
Example: Dr. Huping Zhou was sentenced to four months in federal prison after accessing celebrity medical records 323 times with no legitimate reason. UCLA Health System was separately fined $865,000 related to similar unauthorized access incidents.
Failure to Conduct a Risk Analysis
The Security Rule requires covered entities and business associates to conduct an organization-wide risk analysis identifying vulnerabilities to the confidentiality, integrity, and availability of ePHI. Skipping this step — or doing a superficial version of it — is one of the single most commonly cited failures in OCR settlements, because it’s foundational: nearly every other safeguard depends on knowing where your actual risks are.
Example: Premera Blue Cross paid $6,850,000, and Excellus Health Plan paid $5,100,000, both tied in part to failures to conduct adequate risk analyses before major breaches occurred.
Insufficient Access Controls
Access controls determine who can view or modify ePHI, and they need to be granular enough that staff can only access the minimum information necessary for their role. When access controls are too loose, such as shared logins, no role-based restrictions, no automatic logoff, organizations lose the ability to actually enforce the “minimum necessary” standard HIPAA requires.
Example: Anthem Inc. paid $16,000,000, the largest HIPAA settlement to date, following a breach connected in part to access control failures affecting nearly 79 million individuals.
Failure to Encrypt ePHI on Portable Devices
Laptops, phones, and USB drives leave the building. When they’re lost or stolen without encryption, an isolated incident becomes a reportable breach — because unencrypted PHI on a missing device is, by definition, unsecured PHI.
Example: Children’s Medical Center of Dallas paid $3.2 million after multiple incidents involving lost, unencrypted mobile devices containing ePHI.
Missing or Incomplete Business Associate Agreements
Any vendor that creates, receives, maintains, or transmits PHI on a covered entity’s behalf — from a billing company to an email provider — is a business associate under HIPAA, and business associates are legally required to sign a Business Associate Agreement (BAA) before handling that data. Skipping this step, or using a vendor without one, is a violation regardless of whether anything actually goes wrong with the data itself.
Example: North Memorial Health Care of Minnesota paid $1.55 million after failing to enter into a BAA with a business associate that later experienced a breach.
Impermissible Disclosures of PHI
This category covers PHI shared with someone who wasn’t authorized to receive it — a press release naming a patient, a social media post, filming patients without consent, or telling family or coworkers more than they’re entitled to know.
Example: New York Presbyterian Hospital paid $2,200,000 after filming patients for a documentary without proper consent.
Improper Disposal of PHI
Paper records tossed in regular trash instead of being shredded, or old hard drives discarded without being wiped, both count as impermissible disclosures — PHI doesn’t stop being protected just because someone’s done using it.
Example: Parkview Health paid $800,000 after leaving patient medical records unattended in a driveway during a records transfer.
Exceeding Breach Notification Deadlines
Once a breach of unsecured PHI is discovered, the Breach Notification Rule sets a hard 60-day deadline to notify affected individuals (and HHS, for breaches involving 500+ records). Missing that window turns a bad situation into a compounding one.
Example: Presence Health paid $475,000 for failing to notify affected individuals within the required timeframe following a breach.
Denying Patient Access to Records
Patients have a right to access their own medical records, generally within 30 days of a request, without excessive fees or unreasonable barriers. Denying or delaying that access is one of the more consistently enforced violation categories in recent years.
Example: Cignet Health of Prince George’s County paid $4,300,000 for denying 41 patients access to their own medical records.
Every one of these categories comes back to the same underlying question: does your organization actually have documented, enforced processes for who can touch PHI, how it’s protected, and what happens when something goes wrong? If email is part of that picture — and for nearly every healthcare organization, it is — our HIPAA Compliance Checklist walks through exactly what needs to be in place.
What Is Not a HIPAA Violation (Common Misconceptions)
HIPAA gets invoked constantly in situations it has nothing to do with — and clearing up that confusion matters, because it helps healthcare professionals, IT and compliance teams focus their actual attention where it belongs.
A family member discussing your health isn’t a HIPAA violation. HIPAA governs covered entities, business associates, and their workforces — not private individuals speaking in a personal capacity. Your mother telling a relative about your diagnosis might be a breach of your trust, but it’s not a HIPAA violation, because she isn’t bound by HIPAA in the first place.
Confusing HIPAA with FERPA or the ADA is common, and usually incorrect. Educational records fall under FERPA (the Family Educational Rights and Privacy Act), not HIPAA — a teacher discussing a student’s grades or attendance isn’t a HIPAA issue. Similarly, questions about a disability accommodation, like a mask exemption or a service animal, generally fall under the Americans with Disabilities Act (ADA), not HIPAA.
Asking about someone’s health isn’t the same as disclosing it. HIPAA restricts what covered entities and their workforces can disclose, it doesn’t restrict what any individual, including a coworker, cashier, or stranger, can ask. Someone asking why you’re wearing a mask or requesting proof of a medical condition might be inappropriate or even illegal under a different law, but it isn’t itself a HIPAA violation.
Vague references aren’t the same as identifiable disclosures. HIPAA violations require that protected health information (PHI) be tied to an identifiable individual. Referring to “a patient” or “a young adult male” in casual conversation is too vague to trigger a violation. Naming a specific person — “my patient, Mike, who lives on Oak Street” — alongside health information crosses that line.
A simple way to keep the distinction clear:
A nurse telling friends a specific patient’s name, date of birth, and diagnosis → HIPAA violation.
A pharmacist telling a customer their prescription refill is delayed → not a HIPAA violation.
The line isn’t about whether something feels private. It’s about whether protected health information tied to an identifiable person was disclosed by someone bound by HIPAA in the first place.
HIPAA Violation Penalties: The 4-Tier Structure
OCR calculates civil penalties based on the violator’s level of culpability, not just the severity of the incident. Understanding which tier applies matters, because the same underlying mistake can result in wildly different consequences depending on whether it was a one-off oversight or a known, ignored risk.
Tier
Culpability Level
Fine Range (Per Violation)
Annual Cap
Example Scenario
Tier 1
No Knowledge
$100 – $50,000
$25,000
The organization could not have reasonably known about the violation
Tier 2
Reasonable Cause
$1,000 – $50,000
$100,000
The organization should have known, but the violation wasn’t due to willful neglect
Tier 3
Willful Neglect (Corrected)
$10,000 – $50,000
$250,000
Willful neglect occurred, but the issue was corrected within 30 days
Tier 4
Willful Neglect (Not Corrected)
$50,000 (fixed)
$1.5 million+
Willful neglect occurred and was not corrected in time
Penalty amounts are periodically adjusted for inflation, and current maximum penalties can exceed $2 million annually per violation category — figures worth confirming against HHS’s current published rates before citing specific numbers internally.
Criminal penalties sit outside this civil tier structure entirely. Knowing or willful violations can result in criminal fines ranging from $50,000 to $250,000, plus up to 10 years in prison for the most serious offenses — typically reserved for cases involving intent to sell, transfer, or use PHI for personal gain or malicious harm.
How Are HIPAA Violations Discovered?
Violations don’t usually surface because someone confesses. They’re found through a handful of consistent channels:
Audit logs and automated access-flagging. Most modern EHR systems automatically flag unusual access patterns — a chart accessed by someone outside the care team, or a spike in access to a high-profile patient’s record. This is precisely how most unauthorized-access violations come to light; systems are built to catch exactly this pattern.
Patient complaints. Patients can, and do, file complaints directly with HHS when they believe their information was mishandled.
Breach self-reporting. Covered entities and business associates are required to self-report breaches meeting certain thresholds.
OCR compliance audits. HHS periodically conducts proactive audits of covered entities and business associates, independent of any specific complaint or breach.
One nuance worth understanding: not every violation escalates the same way. A single, isolated mistake, such as an email sent to the wrong recipient or a chart accidentally opened, is often handled through internal correction and documentation. A repeated pattern of the same behavior is a different story entirely, and is far more likely to become something an organization is required to report to HHS. This is one of the most important distinctions for healthcare organizations and compliance teams to build into internal escalation policies: document every incident, but treat repetition as a signal that internal correction alone is no longer sufficient.
How to Report a HIPAA Violation
If you’re a patient, employee, or compliance officer who has identified a potential violation, there are two established paths ti report a violation, and they aren’t mutually exclusive.
Step 1: Report it to the employer or covered entity directly. Most healthcare organizations have an internal compliance officer or reporting process specifically for this purpose. Internal reporting is often the fastest way to get a genuine mistake corrected before it escalates.
Step 2: File a complaint with HHS’s Office for Civil Rights. If internal reporting isn’t appropriate, isn’t effective, or the violation is serious enough to warrant it, complaints can be filed directly through HHS’s official complaint portal. Complaints generally must be filed within 180 days of when the violation was discovered, though extensions are sometimes granted for good cause.
A few practical notes:
Anonymous reporting is possible, but limited. OCR accepts anonymous complaints, but the lack of contact information can restrict how thoroughly they’re able to investigate.
Retaliation against someone who reports in good faith is itself prohibited under HIPAA.
Not every complaint results in a formal investigation — OCR reviews each complaint to determine whether it falls within HIPAA’s scope before proceeding.
How to Avoid HIPAA Violations & Fines
For Organizations
Conduct — and document — a genuine risk assessment. This isn’t a one-time checkbox; risk assessments should be revisited whenever systems, vendors, or workflows change.
Sign a BAA with every vendor that touches PHI, including email, billing, and IT service providers — no exceptions.
Implement role-based access controls so staff can only access the minimum PHI necessary for their specific role.
Encrypt ePHI in transit and at rest, especially on portable devices and email, where enforced encryption remains one of the most consistently under-implemented safeguards.
Train staff regularly, not just at onboarding. A single training session at hire rarely holds up against years of evolving risk.
For Individual Staff Members
Only access patient records tied to a legitimate, job-related reason — never out of curiosity, even for patients you know personally.
Never discuss identifiable patient information outside of your care team, including with family, friends, or on social media.
Report suspected violations, including your own mistakes, immediately rather than waiting to see if anyone notices.
Treat every device and email containing PHI as if it could be lost, stolen, or misdirected tomorrow, because eventually, statistically, one will be.
Since email remains one of the highest-volume channels for exactly this kind of accidental exposure, secure, HIPPA compliant solutions, such as LuxSci’s SecureLine encryption technology, are built specifically to remove the guesswork — enforcing encryption automatically rather than relying on staff to remember to apply it correctly every time.
HIPAA vs. State Privacy Laws
HIPAA sets a federal floor, not a ceiling. States are free to enact privacy laws that are stricter than HIPAA, and when they do, the stricter standard generally governs. This matters for multi-state healthcare organizations especially, such as a provider, payer, or supplier operating across state lines may need to comply with HIPAA everywhere, plus additional, more stringent requirements in specific states.
This guide focuses on federal HIPAA requirements, but compliance officers should treat HIPAA as the baseline, not the finish line, when evaluating their organization’s full regulatory exposure.
What Should I Do Now?
Understanding what counts as a HIPAA violation is the first step. Actually closing the gaps that lead to one is the harder, ongoing work — and email is one of the most common places that work quietly falls through the cracks.
Here are three ways to keep moving forward:
Read our HIPAA Compliant Email guide to understand exactly what makes an email platform compliant — and where standard email tools like Gmail and Microsoft 365 fall short.
Work through our HIPAA Compliance Checklist to audit your organization’s current safeguards against what HIPAA actually requires.
Explore LuxSci’s SecureLine encryption technology to see how enforced encryption and a signed BAA work together to close the exact gaps that show up most often in OCR settlements.
The most common violations include unauthorized access to patient records, failure to conduct a risk analysis, insufficient access controls, failure to encrypt ePHI on portable devices, missing Business Associate Agreements, impermissible disclosures of PHI, improper disposal of records, and exceeding breach notification deadlines.
2. What’s the difference between a HIPAA violation and a FERPA or ADA issue?
HIPAA governs protected health information handled by covered entities and business associates in healthcare settings. FERPA governs education records, and the ADA governs disability discrimination and accommodation. A teacher discussing grades falls under FERPA, not HIPAA. A question about a disability accommodation typically falls under the ADA, not HIPAA.
3. How do I report a HIPAA violation?
Report it directly to the employer or covered entity first, if appropriate. If that isn’t effective or the violation is serious, file a complaint with HHS’s Office for Civil Rights within 180 days of discovering the violation, using the official HHS complaint portal.
4. Can I sue someone for violating HIPAA?
No. HIPAA does not provide a private right of action, meaning individuals cannot sue directly under HIPAA. Patients can file a complaint with HHS/OCR, and in some cases may have separate legal remedies under state privacy or negligence laws.
5. Is looking up a patient’s chart without a work reason a HIPAA violation, even if I don’t share the information?
Yes. Accessing a patient’s record without a legitimate, job-related reason is a violation the moment it happens — it doesn’t require sharing, saving, or acting on the information afterward. This is one of the most consistently enforced categories, particularly for high-profile or celebrity patients whose charts are routinely audited.
In healthcare IT, the term “secure email” gets thrown around loosely. Vendors slap the label on anything with a padlock icon, and internal teams often assume that because their provider offers TLS, they’re covered. They’re not, and the gap between what’s assumed and what’s actually required is where data breaches occur and HIPAA violations happen.
This guide breaks down exactly what secure email means from a technical and regulatory standpoint, why the email platform your staff uses every day probably isn’t compliant out of the box, and what to look for when evaluating a provider that needs to protect PHI at scale. If you want the full picture of what compliance requires beyond email specifically, our HIPAA Compliance Checklist is a useful companion read.
What Is Secure Email?
Secure email refers to an email system that protects the confidentiality, integrity, and availability of message content — specifically PHI — through a combination of technical safeguards and contractual protections. It’s not a single feature. It’s a stack of controls working together.
At minimum, secure email in a healthcare context includes:
Enforced encryption in transit, so messages can’t fall back to plaintext delivery
Encryption at rest, so stored messages remain protected on the server
Authentication protocols (SPF, DKIM, DMARC) that prevent spoofing and impersonation
Access controls and audit logs that track who accessed what, and when
A signed Business Associate Agreement (BAA) with the email provider
The distinction that trips up most organizations is this: encryption is a component of secure email, not the whole picture. A provider can offer encryption and still fail to meet HIPAA requirements if that encryption isn’t enforced, if there’s no BAA in place, or if audit logging doesn’t exist. Secure email is the combination of all these pieces functioning as a system, which is why it needs to be evaluated holistically rather than checked off feature by feature.
For healthcare provider, payer, and supplier organizations, this matters because email remains one of the highest-volume channels for PHI exposure, from clinical referrals to patient billing statements to routine staff communication. Getting the definition right is the first step toward closing the compliance gap.
Why Standard Email Is Not HIPAA-Compliant
Many healthcare organizations run on Gmail (Google Workspace) or Microsoft 365, and most assume they’re protected because encryption exists somewhere in the stack. That assumption is the single most common — and most dangerous — misconception in healthcare email security.
Here’s the problem: standard email services use opportunistic TLS by default. TLS is attempted between mail servers, but if the receiving server doesn’t support it, the message is delivered anyway — unencrypted, in plaintext. Neither the sender nor the recipient typically sees a warning. The email just goes through.
This isn’t a hypothetical edge case. IT professionals managing healthcare email infrastructure have flagged this exact issue directly: opportunistic TLS is often enabled by default and creates a false sense of security, since it offers no guarantee that a given message, including one containing PHI, won’t be transmitted in plaintext if the recipient’s mail server doesn’t support encryption. Organizations assume they’re protected simply because TLS is technically “on,” without realizing it isn’t enforced.
That gap has real consequences under HIPAA. The Security Rule currently treats transmission encryption as an “addressable” safeguard, meaning covered entities can, in theory, implement an equivalent alternative measure instead. In practice, regulators and auditors from the Office for Civil Rights (OCR) expect enforced encryption as the standard of care. “Addressable” has never meant optional — it means an organization needs a documented, defensible reason if it isn’t doing enforced encryption, and few reasons hold up under scrutiny. Finally, under OCR’s proposed changes to the HIPAA Security Rule for ePHI, scheduled for final publication in July 2027, email encryption moves from addressable to mandatory.
Beyond the encryption gap, standard consumer and even most business email plans typically lack:
A BAA that’s actually offered and signed (available on some enterprise tiers, but not automatic)
Audit logging sufficient to meet HIPAA Security Rule requirements
Built-in encryption at rest guarantees for stored messages
None of this means Gmail or Microsoft 365 are inherently insecure products. It means their default configuration is built for general business use, not for an environment where every misrouted or intercepted message carries breach notification liability. Making either platform HIPAA-appropriate requires layering on additional tools, policies, and critically, a provider relationship that includes a signed BAA covering the exact services in use.
The Technical Components of Secure Email
Secure email is built upon five technical layers. Understanding each one, and where it fails in standard email, clarifies exactly what a compliant solution needs to deliver.
Encryption in Transit (TLS)
Transport Layer Security (TLS) encrypts the connection between mail servers as a message travels from sender to recipient. There are two flavors, and the difference between them is the crux of most healthcare email compliance failures:
Opportunistic TLS attempts an encrypted connection but falls back to unencrypted delivery if the receiving server doesn’t support it. This is the default across most consumer and business email platforms.
Enforced TLS requires an encrypted connection for delivery to succeed. If encryption can’t be established, the message fails to send rather than going out in plaintext, or a link to secure portal can be sent to securely access the information.
HIPAA’s Security Rule lists encryption as addressable, but enforced TLS has become the de facto standard that auditors and OCR expect from covered entities and business associates handling PHI over email. As one healthcare IT professional put it while debating this exact tradeoff internally: the goal is to require TLS for all outbound email and then document the remaining controls around it, treating enforced TLS as the technical baseline, with policy and process built on top.
Encryption at Rest
Transit encryption only protects a message while it’s moving. Once it lands on a mail server — sender’s outbox, recipient’s inbox, backups, archives — it needs to remain encrypted in storage. This is encryption at rest, and it’s where many organizations underestimate their exposure.
Encryption in transit alone offers zero control over a message after it’s been delivered. If the destination server isn’t itself encrypting stored data, or if a backup snapshot is taken without encryption, PHI sitting in an inbox is exposed regardless of how securely it arrived. HIPAA’s Security Rule requires safeguards for ePHI both in transit and at rest, a compliant secure email provider needs to guarantee both, not just one.
End-to-End Encryption (S/MIME, PGP)
End-to-end encryption (E2EE) encrypts message content itself, not just the connection it travels over — meaning even the email provider can’t read the content. Two standards dominate here:
S/MIME uses certificate-based encryption and is common in enterprise environments, such as healthcare, particularly where organizations already manage a public key infrastructure.
PGP (Pretty Good Privacy) uses a public/private key model and is more common in technical or security-conscious communities, though it’s less frequently deployed at scale in healthcare due to key management complexity.
E2EE isn’t a baseline requirement for every PHI-containing email, enforced TLS plus encryption at rest satisfies most use cases. But it becomes necessary for especially sensitive communications, cross-organization data sharing where you don’t control the recipient’s infrastructure, or when a business associate agreement specifically requires it.
Authentication (SPF, DKIM, DMARC)
These three protocols work together to prevent domain spoofing and email impersonation, a growing attack vector against healthcare organizations specifically, given how often phishing campaigns impersonate providers, payers, or patients.
SPF (Sender Policy Framework) specifies which mail servers are authorized to send email on behalf of a domain.
DKIM (DomainKeys Identified Mail) adds a cryptographic signature verifying a message wasn’t altered in transit.
DMARC (Domain-based Message Authentication, Reporting & Conformance) tells receiving servers what to do when SPF or DKIM checks fail, and provides reporting visibility.
Without these configured correctly, an organization’s domain can be spoofed to send convincing phishing emails to patients or staff, creating a security failure that compounds the compliance risk of email interception.
Digital Signatures
Digital signatures verify sender identity and confirm a message hasn’t been tampered with between sending and receipt. Paired with encryption, they close the loop on message integrity, confirming not just that content was protected, but that it came from who it claims to have come from and arrived unaltered.
Standard Email vs. Secure Email: Feature Comparison
Feature
Standard Email
Secure Email (HIPAA-Compliant)
Encryption in Transit
Opportunistic TLS — attempted but not enforced
Enforced TLS — connection fails if encryption unavailable, can include delivery via secure portal option
Encryption at Rest
Not guaranteed; provider-dependent
Required — server-side encryption of stored messages
End-to-End Encryption
Not available
Supported via S/MIME and/or PGP
Digital Signatures
Not available
Included — verifies sender identity and message integrity
Authentication (SPF / DKIM / DMARC)
Optional, rarely enforced
Required — spoofing and impersonation protection
Business Associate Agreement (BAA)
Not provided on standard plans
Required — must be signed before sending PHI
Audit Logs
Basic or none
Full audit trail — required under HIPAA Security Rule
Access Controls
Basic password only
Role-based access, MFA, admin controls
Misdirected Email
Reportable HIPAA breach
Non-reportable if properly encrypted (safe harbor)
HIPAA Compliant by Default
No
Yes
What Makes Email HIPAA-Compliant Specifically
Technical safeguards alone don’t make email HIPAA-compliant. Compliance is a combination of technology, contracts, and documented processes — all four need to be in place simultaneously. This includes:
A signed BAA with your email provider – Any vendor that transmits, processes, or stores PHI on your behalf is a business associate under HIPAA, and business associates are legally required to sign a BAA before handling that data. Email providers have persistent access to ePHI — even end-to-end encrypted messages pass through their infrastructure at some point — which makes this requirement absolute, not situational. If a provider won’t sign a BAA, using them to send or store PHI isn’t a compliance risk you can mitigate; it’s a violation from the start.
Encryption as an addressable safeguard – Under 45 CFR §164.312(e)(2)(ii), the HIPAA Security Rule lists encryption of ePHI in transit as “addressable” rather than strictly “required.” In practice, this doesn’t mean optional, it means an organization must implement it, or document and justify an equivalent alternative safeguard. Enforced encryption has become the expected standard, and with the newly proposed HIPAA Security Rule planned for July 2027 publication, NPRM would formalize that expectation by making encryption of ePHI in transit and at rest mandatory rather than addressable. Organizations still relying on opportunistic TLS as their “equivalent alternative” should treat this as a closing window.
Access controls and audit logs – HIPAA requires the ability to track who accessed PHI, when, and what they did with it. This means role-based access permissions, multi-factor authentication, and a complete, retained audit trail — not just for compliance reporting, but for identifying and responding to incidents quickly.
The encryption safe harbor – This is one of the most consequential, and most underused, provisions in HIPAA. If PHI is sent via properly encrypted email and ends up misdirected to the wrong recipient, it is not a reportable breach under the Breach Notification Rule, because the encrypted content is considered unreadable and therefore not “unsecured PHI.” The exact same misdirection with unencrypted email is a reportable breach, triggering notification obligations to the individual and to HHS/OCR. Encryption isn’t just a security best practice here, it’s the line between a non-event and a formal breach investigation.
HITRUST certification as a trust signal – When evaluating vendors, HITRUST CSF certification is a strong external indicator that a provider’s security controls have been independently assessed against a recognized healthcare-specific framework. It’s not a HIPAA requirement in itself, but it meaningfully reduces the diligence burden on your side when vetting a provider.
Types of Healthcare Email That Must Be Secure
Not all internal debate here is about “should we secure email” — it’s about scope. Which specific email flows actually carry PHI, and therefore need to run through a compliant channel? In practice, the answer is broader than most teams initially assume.
The common thread: if a message references anything that could identify a patient in connection with health information — a name next to a diagnosis, an account number tied to a service date, an annual test reminder — it needs to move through a secure channel, regardless of whether it’s clinical, financial, or administrative in nature.
How to Evaluate a Secure Email Provider for Healthcare
Vendor evaluation in this category tends to go one of two ways: teams either take a provider’s “HIPAA-compliant” label at face value, or they get buried in RFP questions without knowing which answers actually matter. Ask these key questiosn to focus the evaluation on what’s operationally and legally significant.
“Does the provider sign a BAA? This is the first filter, not the last. If a vendor won’t sign a BAA — or offers a heavily limited one — everything else is irrelevant. Some organizations go a step further and negotiate indemnity or make-whole clauses into the BAA itself, seeking financial protection beyond the baseline liability allocation.
What encryption methods are supported? Confirm specifically whether the provider offers TLS only, or also supports S/MIME and/or PGP for end-to-end encryption where needed. TLS-only coverage is sufficient for most standard PHI communication; organizations with cross-border data sharing or especially sensitive use cases may need E2EE options available.
Is encryption enforced or opportunistic? This is the single most important technical question to ask directly, in those terms. A vendor that describes its encryption vaguely, without distinguishing enforced from opportunistic delivery, hasn’t answered the question. Push for specifics.
How are large attachments handled? Lab results, imaging files, and clinical documents often exceed standard attachment size limits. Confirm the provider has a secure, compliant method for large file transfer that doesn’t force users onto an unencrypted workaround.
What audit logging and reporting capabilities exist? You need visibility into delivery, access, and any failed encryption attempts, not just a generic sent/received log. Ask whether logs are retained for a period consistent with your organization’s HIPAA documentation requirements.
Do they support high-volume transactional email? Appointment reminders, billing notices, and patient communications at scale require infrastructure built for volume without sacrificing per-message compliance. Confirm the provider’s platform is built for this your specific pattern, not just person-to-person messaging.
Is the platform US-based with US data residency? For many healthcare organizations, where data physically resides — and under which jurisdiction — is a material factor in vendor risk assessment, particularly for payers and larger provider organizations with strict data governance policies.”
One operational factor worth weighing alongside these questions: secure email portals — the kind that require recipients to click through to a separate web page to read a message — solve the encryption problem but often create a real adoption problem. IT teams have reported a direct conflict between phishing-awareness training and portal-based workflows: staff and patients trained not to click suspicious links in emails are, understandably, reluctant to click the “secure link” a portal email contains. This is a legitimate reason many organizations increasingly prefer platforms that enforce encryption transparently in the background — like LuxSci’s SecureLine encryption technology — rather than routing every message through a separate portal experience.
Secure Email Checklist for Healthcare Organizations
Every safeguard covered in this guide comes down to a handful of concrete, verifiable actions. Use the checklist below as a working reference for what needs to be in place across your legal agreements, technical controls, and internal processes. This is not a one-time setup task, but something worth revisiting as your email volume, vendors, and regulations evolve. Share it across your compliance and IT teams as a starting point for an internal audit.
Legal and Contractual – BAA signed with email provider and all third-party vendors handling PHI.
Encryption – Forced TLS, not opportunistic only for emails in transit and all stored data encrypted with AES-256 bit encryption.
Access and Audit – Unique user IDs, role-based access, and login monitoring with advanced MFA enabled for all email accounts; audit logs active and maintained.
People and Processes – Staff trained in PHI handling, established breach response plan, annual email security policy review.
What Should I Do Now?
Secure email isn’t a single setting you switch on — it’s a combination of enforced encryption, a signed BAA, access controls, and documented process working together. Get any one piece wrong, and the rest doesn’t hold up under an OCR audit or a breach investigation.
If your organization is still relying on opportunistic TLS, an unsigned or incomplete BAA, or a patchwork of workarounds to move PHI through email, now is the time to close that gap, especially with the proposed 2025 HIPAA Security Rule update poised to make encryption a mandatory requirement rather than an addressable one in 2027.
Below are three ways you can continue your journey to securing your healthcare email:
Email can be HIPAA compliant, but only when the right safeguards are in place — enforced encryption, a signed BAA with your email provider, access controls, audit logs, and staff training on PHI handling. Standard email without these safeguards is not compliant.
2. Do I need to sign a BAA with my email provider?
Yes. Email providers have persistent access to ePHI — even encrypted messages pass through their servers — making them Business Associates under HIPAA. A signed BAA is required. If your provider won’t sign one, you cannot legally use them to send or store PHI.
3. What is the difference between opportunistic TLS and enforced TLS — and which does HIPAA require?
Opportunistic TLS attempts encryption but falls back to plaintext if the recipient’s server doesn’t support it. Enforced TLS stops delivery rather than sending unencrypted. HIPAA’s Security Rule treats transmission encryption as an addressable specification, in practice, enforced TLS is the standard auditors and OCR expect. The proposed 2025 HIPAA Security Rule NPRM would make encryption of ePHI in transit a mandatory requirement in 2027.
4. What happens if I send PHI in an unencrypted email?
It is an impermissible disclosure under HIPAA’s Privacy Rule and triggers the Breach Notification Rule, requiring you to notify the individual and HHS/OCR within 60 days. Penalties range from $100 to $50,000 per violation. Had the email been properly encrypted, the same incident would qualify for HIPAA’s encryption safe harbor, meaning no notification required.
5. Is Gmail or Microsoft 365 HIPAA compliant for sending patient emails?
Neither is compliant in their default configuration. Both use opportunistic TLS, meaning PHI can be sent in plaintext if the recipient’s server doesn’t support encryption. A signed BAA is available on enterprise plans but doesn’t close the technical gap alone. A purpose-built HIPAA-compliant email platform is the reliable solution.
If you’ve been waiting for the final word on the new HIPAA Security Rule before you touch your email encryption strategy, you now have an official reason to keep waiting.
Our advice: Don’t do it.
What is the new HIPAA Security Rule for ePHI?
The Department of Health and Human Services’ Office for Civil Rights had targeted May 2026 for a final rule implementing the most significant update to the HIPAA Security Rule in over two decades. The proposal eliminates the “addressable” standard and makes encryption of ePHI in transit and at rest mandatory for every covered entity and business associate. That deadline came and went quietly. Now we know why: an updated federal regulatory agenda shows OCR’s timeline has moved to July 2027, with the rule-making downgraded from “final rule stage” to “long-term action.” OCR is still working through more than 4,700 public comments on the January 2025 proposal.
For an industry that had been expecting a tighter deadline, a year-plus delay is the kind of news that invites a collective exhale — and a shelved project plan. At LuxSci, we think that would be a mistake, for three reasons:
The current rule already requires you to address encryption. “Addressable” was never “optional.” It has always meant you must implement the safeguard, implement an equivalent alternative, or document in writing why neither is reasonable for your organization. Most healthcare organizations have never done that documentation rigorously, and OCR’s existing enforcement authority applies today, not in 2027.
Breach costs haven’t waited for the rule.IBM’s 2025 Cost of a Data Breach Report puts the average healthcare breach at $7.42 million, still the highest of any industry. At the same time, email remains the number one attack vector into healthcare organizations. None of that risk is paused by a regulatory delay.
Delay is not withdrawal.OCR has not signaled it’s abandoning the encryption mandate, only that it’s taking longer to finalize it. Organizations that build now toward the standard already proposed will be ahead (and more secure) regardless of exactly when, or in what final form, the rule lands. Organizations that wait risk a compressed scramble once it does.
What should healthcare IT and compliance leaders actually do with this news?
Reevaluate your ePHI security posture, recalibrate its urgency, and use the extra runway to do the job right, instead of racing against a deadline. This includes:
Getting a real inventory of where ePHI moves by email today, inbound and outbound, and where encryption is inconsistent or absent.
Closing the documentation gap on “addressable” now, while you have time to do it well rather than defensively.
Pushing your email vendor for concrete answers on encryption standards, MFA enforcement, audit logging, and breach notification — the same technical controls the proposed rule would make mandatory.
Building (or updating) a written, enforcement-ready posture: policies, vendor agreements, certifications and verifications, test results, and training records that would hold up under an OCR investigation today, not just in a future compliance deadline.
Get LuxSci’s new Definitive Guide on the new HIPAA Security Rule
From Addressable to Mandatory: Email Encryption Under the New HIPAA Security Rule provides the latest update on the rule, what it means for healthcare email encryption, and what you can do now to properly prepare for what’s coming in 2027. The guide also includes an interactive scorecard that lets you evaluate your current email set up and vendor across seven security and compliance dimensions in under two minutes, no email address required.
If you want a second set of eyes on where your organization stands, our team offers a free 30-minute compliance assessment of your current email environment against the proposed rule’s requirements.
There are many crucial factors to consider when developing and executing successful healthcare communication campaigns. First and foremost, you must ensure the protected health information (PHI) under your organization’s care is handled securely, as mandated by Health Insurance Portability and Accountability Act (HIPAA) regulations, which begins with selecting the right HIPAA compliant email provider for your company’s needs.
With the right email services provider (ESP) in place, healthcare providers, payers, and suppliers can confidently use PHI in their patient and customer engagement campaigns – safe in the knowledge they’re aligned with HIPAA’s tight regulatory guidelines.
To help you choose the best HIPAA compliant email provider for your healthcare organization’s email outreach objectives, this post compares two of the most well-known HIPAA compliant services on the market: LuxSci and Zix Webroot (from here, simply referred to as Zix).
Comparing each email provider’s performance on several criteria, we’ll help you decide which solution best fits the needs of your healthcare organization and will help you better engage with your patients and customers.
LuxSci vs. Zix: Evaluation Criteria
In our evaluation of LuxSci vs. Zix, we’ll be using the following criteria:
Data Security and Compliance: undoubtedly the most important factor when it comes to ensuring HIPAA-compliant email communication within healthcare organizations, this reflects the extent to which each platform secures sensitive patient data as per HIPAA’s regulations.
Performance and Scalability: the email platform’s ability to facilitate high-volume email communication campaigns, which also, subsequently, encompasses the platform’s throughput and how well they’re able to scale in line with an organization’s needs.
Infrastructure: if the email service provider has the necessary security infrastructure in place to both adequately safeguard PHI and support bulk email marketing campaigns.
Marketing Capabilities: if the platform provides features that allow you to personalize and refine your patient engagement strategies.
Ease of Use: how easy each email service is to use; a deceptively important factor in light of the urgent need for employee cyber threat awareness training.
Other HIPAA-Compliant Products: if the platform offers complementary features that aid healthcare organizations with their broader patient engagement, and growth, objectives.
Now that we’ve covered the criteria by which we’ll be assessing each email platform, let’s compare LuxSci vs Zix to determine which is the best fit for your company’s needs.
LuxSci vs. Zix: How Do They Compare?
Data Security and Compliance
LuxSci prides itself on being a fully HIPAA-compliant email service provider, offering end-to-end, flexible, and automated encryption, giving it an advantage in the protection of patient data in the event of its exfiltration by cyber criminals. Additionally, LuxSci is HITRUST-certified, illustrating its additional commitment to data privacy legislation and the securing of PHI.
Zix is also fully HIPAA-compliant and, consequently, enables the use of PHI to personalize your email communications. That said, Zix doesn’t offer as many encryption options as LuxSci. Most notably, Zix doesn’t enforce Transport Layer Security (TLS) encryption or enable automated encryption. The absence of these features means that a healthcare organization’s security teams must perform more manual oversight when it comes to encryption of PHI, increasing the chance of human error.
Performance and Scalability
While Zix supports large email campaigns and provides detailed reporting functionality, LuxSci is the more prudent choice for high-volume email marketing campaigns.
LuxSci maintains the necessary infrastructure to ensure the reliable delivery of hundreds of thousands to millions of emails per month (i.e., throughput – 1000s of emails per hour), all while adhering to HIPAA’s strict guidelines on preserving patient privacy.
Infrastructure
In the same way that LuxSci have advantages over Zix on data security capabilities, it performs well in this category too, which makes sense, as the two factors are interwoven.
While offering a range of customary multi-tenancy infrastructure setups, Zix doesn’t accommodate dedicated, or single-tenancy, infrastructure options – for companies who can’t afford to depend on the security postures of the companies with whom they share servers. Zix, in line with its ability to facilitate large patient or customer engagement campaigns, provides enterprise-scale scalability.
Zix also provides high availability and robust disaster recovery capabilities, so healthcare organizations can retain their operational capabilities in the event of a cyber attack. Or, alternatively, an unforeseen physical disaster that compromises a company’s infrastructure (power outages, fires, storms, intentional damage, etc.).
That said, LuxSci possesses all these features in addition to more comprehensive single-tenancy options, scalability, and secure email hosting.
Marketing Capabilities
As with our comparisons of LuxSci against email platforms like Paubox and Virtru, it’s somewhat futile to compare each platform’s marketing capabilities – as neither LuxSci or Zix are marketing platforms, in the vein of Adobe Campaign or Oracle Eloqua, for example.
That said. LuxSci provides a HIPAA compliant marketing solution, offering automation, for streamlining email marketing campaigns, and, personalization options, for more engaging email communication campaigns.
Ease of Use
Both LuxSci and Zix perform admirably in this category, but the edge goes to Zix, as LuxSci implementations often involve the complexities that come with large-scale, high volume use cases.
LuxSci, however, is known for offering best-in-class customer support backed by HIPAA security experts, honed as a result of over 25 years of facilitating and supporting email communication strategies for healthcare organizations of all sizes.
Other HIPAA-compliant Products
With secure texting functionality, secure forms for HIPAA compliant data collection, and secure file sharing, LuxSci ranks well in this category. Zix, in contrast, provides only secure file sharing – though, because of Zix Webroot’s capabilities, offers superior secure file sharing to LuxSci.
Get Your Copy of LuxSci’s Vendor Comparison Guide
To discover how LuxSci and Zix stack up against the other leading email providers on the market when it comes to HIPAA compliance, take a look at our Vendor Comparison Guide. Evaluating 12 email delivery platforms, the guide offers comprehensive insights on what to consider when selecting a HIPAA compliant provider, and how to choose the best solution for you.
SMTP TLS encryption is popular because it provides adequate data protection without creating a complicated user experience for email recipients. Sometimes, though, the experience is too seamless, and recipients may wonder if the message was protected at all.
Luckily, there is a way to tell if an email was encrypted using TLS. To see if a message was sent securely, we can look at the raw headers of the email. However, it requires some knowledge and experience to understand the text. It is actually easier to tell if a recipient’s server supports TLS than to tell if a particular message was securely transmitted.
To analyze a message for transmission security, we will look at an example email message sent from Hotmail to LuxSci. We will explain what to look for when decoding the message headers and how to tell if the email was transmitted using TLS encryption.
An Example Email Message
First, we must understand how an email message typically travels through several machines on its way from the sender to the recipient. Roughly speaking:
The sender’s computer talks to the sender’s email or WebMail server to upload the message.
The sender’s email or WebMail server then talks to the recipient’s inbound email server and transmits the message to them.
Finally, the recipient downloads the message from their email server.
It is step 2 that people are most concerned about when trying to understand if their email message is transmitted securely. They usually assume or check that everything is secure and OK at the two ends. Indeed, most users who need to can take steps to ensure that they are using SSL-enabled WebMail or POP/IMAP/SMTP/Exchange services so that steps 1 and 3 are secure. The intermediate step, where the email is transmitted between two different providers, is where messages may be sent insecurely.
To determine if the message was transmitted securely between the sender’s and recipient’s servers (over TLS), we need to extract the “Received” header lines from the received email message. If you look at the source of the email message, the lines at the top start with “Received.” Let’s look at an example message from a Hotmail user below. The email addresses, IPs, and other information are obviously fake.
LuxSci:
The Outlook email was sent to a LuxSci user. The Received headers appear in reverse chronological order, starting with the server that touched the message last. Therefore, in this example, we see the LuxSci servers first.
Received: from abc.luxsci.com ([1.1.1.1])
by def.luxsci.com (8.14.4/8.13.8) with ESMTP id r7JEfLgH003867
(version=TLSv1/SSLv3 cipher=DHE-RSA-AES256-SHA bits=256 verify=NOT)
for <user-xyz@def.luxsci.com>; Mon, 19 Aug 2019 10:41:21 -0400
Received: from abc.luxsci.com (localhost.localdomain [127.0.0.1])
by abc.luxsci.com (8.14.4/8.13.8) with ESMTP id r7JEfK0Z030182
for <user-xyz@def.luxsci.com>; Mon, 19 Aug 2019 09:41:20 -0500
Received: (from mail@localhost)
by abc.luxsci.com (8.14.4/8.13.8/Submit) id r7JEfKXD030178
for user-xyz@def.luxsci.com; Mon, 19 Aug 2019 09:41:20 -0500
Received: from dispatch1-us1.ppe-hosted.com (dispatch1-us1.ppe-hosted.com [2.2.2.2])
by abc.luxsci.com (8.14.4/8.13.8) with ESMTP id r7JEfIkK030002
(version=TLSv1/SSLv3 cipher=DHE-RSA-AES256-SHA bits=256 verify=NOT)
for <someone@luxsci.net>; Mon, 19 Aug 2019 09:41:19 -0500
Proofpoint:
LuxSci uses an email filtering service, Proofpoint. Messages reach Proofpoint’s servers before being delivered to LuxSci. Here’s what their servers report about the email transmission:
Received: from unknown [65.54.190.216] (EHLO bay0-omc4-s14.bay0.hotmail.com)
by dispatch1-us1.ppe-hosted.com.ppe-hosted.com
(envelope-from <someone@hotmail.com>);
Mon, 19 Aug 2019 08:41:18 -0600 (MDT)
Outlook:
And finally, here’s what we see from Oultook’s server.
Received: from BAY403-EAS373 ([65.54.190.199]) by bay0-omc4-s14.bay0.outlook.com
with Microsoft SMTPSVC(6.0.3790.4675);
Mon, 19 Aug 2019 07:41:19 -0700
How to Use Received Message Headers to Tell if the Email is Encrypted
The message headers contain information that can help us determine if an email is encrypted. Here are a few helpful notes to help you decode the text:
We said this above, but the message headers appear in reverse chronological order. The first one listed shows thelast server that touched the message; the last one is the first server that touched it (typically the sending server).
Each Received line documents what a server did and when.
There are three sets of servers involved in this example: one machine at Hotmail, one machine at Proofpoint, where our Premium Email Filtering takes place, and some machines at LuxSci, where final acceptance of the message and subsequent delivery happened.
Presumably, the processing of email within each provider is secure. The place to be concerned about is the hand-offs between Hotmail and Proofpoint and between Proofpoint and LuxSci, as these are the big hops across the internet between providers.
In the line where LuxSci accepts the message from Proofpoint, we see:
This section, typical of most email servers running “sendmail” with TLS support, indicates that the message was encrypted during transport with TLS using 256-bit AES encryption. (“Verify=not” means that LuxSci did not ask Proofpoint for a second SSL client certificate to verify itself, as that is not usually needed or required for SMTP TLS to work correctly). Also, “TLSv1/SSLv3” is a tag that means that “Some version of SSL or TLS was used;” it does not mean that it was SSL v3 or TLS v1.0. It could have been TLS v1.2 or TLS v1.3.
So, the hop between Proofpoint and LuxSci was locked down and secure. What about the hop between Hotmail and Proofpoint? The Proofpoint server’s Received line makes no note of security at all! This means that the email message was probably not encrypted during this step.
Hotmail either did not support opportunistic TLS encryption for outbound emails, or Proofpoint did not support receipt of messages over TLS, and thus, TLS could not be used. With additional context, you can know which server supports TLS and which does not.
In this case, we know that Proofpoint supports inbound TLS encryption. In fact, from another example message where LuxSci sent a message to Proofpoint, we see the Received line:
Received: from unknown [44.44.44.44] (EHLO wgh.luxsci.com)
by dispatch1-us1.ppe-hosted.com.ppe-hosted.com
(using TLSv1.2 with cipher ECDHE-RSA-AES256-GCM-SHA384 (256/256 bits))
with ESMTP id b-022.p01c11m003.ppe-hosted.com
(envelope-from <from@domain.com>);
Mon, 02 Feb 2009 19:28:27 -0700 (MST)
The red text makes it clear that the message was indeed encrypted. Based on the additional context, we can deduce that the Hotmail sending server did not securely transmit the email using TLS.
How To Tell if an Email is Encrypted With TLS
When analyzing your message headers, consider the following items to determine if the email is encrypted:
The receiving server will log what kind of encryption, if any, was used in receiving the message in the headers.
Different email servers use different formats and syntax to display the encryption used. Look for keywords like “SSL,” “TLS,” and “Encryption,” which will signify this information.
Not all servers will record the use of encryption. While LuxSci has always logged encryption use, not every email service provider does. It is possible to use TLS encryption and not log it. Sometimes, there is no way to tell from the headers if a message is encrypted if it is not logged.
Messages passed between servers at the same provider do not necessarily need TLS encryption to be secure. For example, LuxSci has back-channel private network connections between many servers so that information can be securely passed between them without SMTP TLS. So, the lack of TLS usage between two servers does not mean the transmission between them was “insecure.” You may also see multiple received lines listing the same server: the server passes the message between different processes within itself. This communication also does not need to be TLS encrypted.
If you are a LuxSci customer, you can view online email delivery reports to see if TLS was used for any particular message. We record the kind of encryption in the delivery reports, so it’s easy to see which emails were encrypted.
How can you Ensure Emails Are Securely Transmitted?
With some servers not recording TLS in message headers, how can you determine if a message was transmitted securely from sender to recipient?
To answer this question accurately, you must understand the properties, servers, and networks involved. It may be easy to determine that the message was transmitted securely if included in the header information. However, the absence of information does not necessarily mean the message was insecurely transmitted. You can only know this if you know what each system’s servers record.
In our example of a message from Hotmail to LuxSci, you need to know that:
Proofpoint and LuxSci will always log the use of TLS in the headers. We can infer that the Hotmail to Proofpoint transmission was not secure as nothing was recorded there.
The transmission of messages within LuxSci’s infrastructure is secure due to private back channel transmissions. So, even though there is no mention of TLS in every Received line after LuxSci accepts the message from Proofpoint (in this example), transferring the messages between servers in LuxSci is as secure as using TLS. Also, the same server can add multiple received lines as it talks to itself. Generally, these hand-offs on the same server will not use TLS, as there is no need. In the LuxSci example, we see this as “abc.luxsci.com” adds several headers.
We don’t know anything about Hotmail’s email servers, so we don’t know how secure the initial transmissions within their network are. However, since we know they did not securely transmit the message to Proofpoint, we are not confident that the transmissions and processing within Hotmail (which may have gone unrecorded) were secure.
Was the email message sent and received using encryption?
We skipped steps 1 and 3 and focused on step 2 – the transmission between servers. Steps 1 and 3 are equally, if not more, necessary. Why? Because eavesdropping on the internet between ISPs is less of a problem than eavesdropping near the sender and recipient (i.e., in their workplace or local wireless hotspot). So, it’s essential to ensure messages are sent securely and received securely. This means:
Sending: Use SMTP over SSL or TLS when sending messages from an email client or use WebMail over a secure connection (HTTPS).
Receiving: Ensure your POP or IMAP connection is secured via SSL or TLS. If using WebMail to read your email, be sure it is over a secure connection (HTTPS).
WebMail: There is generally no record in the email headers to indicate if a message sent using WebMail was transmitted from the end-user to WebMail over a secure connection (SSL/HTTPS).
You can typically control one side and ensure it is secure; you can’t control the other without taking extra steps. So, what can you do to ensure your message is secure even if it might not be transmitted with encryption or if the recipient tries to access it insecurely?
You could use end-to-end email encryption (like PGP or S/MIME, which are included in SecureLine) or a secure web portal that doesn’t require the recipient to install or set up anything to get your secure email message. These methods meet HIPAA and other regulatory compliance requirements for secure data transmission and provide complete confidence that the message will be sent and received securely.
LuxSci’s SecureLine offers flexible encryption options, including TLS, secure web portal, PGP, and S/MIME. Its dynamic capabilities can determine what types of encryption the recipient’s server supports to ensure your emails are always sent securely. Contact our team today to learn more about how to secure your emails.
A HIPAA compliant message securely transmits protected health information while meeting the Security Rule requirements for confidentiality, integrity, and availability. These messages include proper encryption during transmission, verification of recipient identity, access controls, and audit logging capabilities. Healthcare organizations must implement appropriate protections and establish usage policies governing how staff communicate protected health information to maintain compliance with HIPAA regulations.
Requirements for Secure Messaging
A HIPAA compliant message must incorporate several protections to safeguard patient information. Encryption during transmission prevents unauthorized interception of message contents while traveling between sender and recipient. Authentication mechanisms verify the identity of both senders and recipients before allowing access to message contents. Access controls restrict message viewing to authorized individuals with legitimate need for the information. Audit logging creates records of message sending, receipt, and viewing activities with timestamps and user identification. Message integrity protections prevent undetected alterations during transmission or storage. Organizations must implement these safeguards across all platforms used for sending HIPAA compliant messages, including email systems, patient portals, and secure messaging applications.
Message Content Considerations
]The content within a HIPAA compliant message must follow several guidelines to maintain regulatory compliance. Messages should include only the minimum necessary information required for the intended purpose, avoiding excessive disclosure of patient details. Identifiable patient information must be clearly separated from general communication content for proper protection. Message subjects and headers should avoid revealing protected health information that might be visible in notification previews. Disclaimers typically appear at message ends stating confidentiality requirements and instructions for unintended recipients. Healthcare organizations develop content templates that help staff compose a HIPAA compliant message with appropriate structure and security notices. Proper content structuring ensures information remains protected throughout its communication lifecycle.
Acceptable Messaging Platforms
Healthcare organizations can send HIPAA compliant messages through various platforms that meet security requirements. Secure email systems with encryption and access controls provide one common method for protected communications. Patient portal messaging offers a controlled environment where both providers and patients access information through authenticated sessions. Secure text messaging applications designed for healthcare use encrypt communications between clinical staff members. Telehealth platforms include messaging components that maintain security during virtual visits. Fax transmissions to verified numbers remain acceptable for many healthcare communications when received by authorized recipients. Regardless of platform choice, organizations must verify that protections, Business Associate Agreements, and usage policies align with HIPAA requirements for their selected communication channels.
Patient Authorization Requirements
HIPAA compliant messages containing protected health information must adhere to patient authorization requirements. Communications for treatment, payment, and healthcare operations generally proceed without specific patient permission. Messages for other purposes often require documented patient authorization before sending. Patient preferences for communication methods should be recorded and respected for all messages. Some patients may authorize unencrypted communications after being informed of the risks, though organizations should document these preferences carefully. Authorization requirements apply regardless of the security measures implemented for message transmission. Healthcare organizations must train staff to recognize which communications require patient authorization and how to properly document these permissions.
HIPAA Compliant Messaging Documentation
Healthcare organizations must maintain documentation about their HIPAA compliant messaging practices. Policies should clearly define what constitutes appropriate message content and which communication channels may be used for different information types. Procedure documents need to outline steps for sending protected information through various platforms. Training records demonstrate that staff understand proper messaging protocols and security requirements. Technology configurations for messaging systems should be documented to demonstrate appropriate security settings. Audit logs from messaging platforms provide evidence of compliance with access and monitoring requirements. This documentation helps organizations demonstrate their compliance efforts during regulatory reviews or investigations of potential violations.
Messaging Security Breach Prevention
Preventing security breaches represents a crucial aspect of maintaining HIPAA compliant messaging systems. Staff education about phishing threats and social engineering helps prevent credential theft that could lead to unauthorized message access. Message recall capabilities allow addressing accidental disclosures before they become reportable breaches. Automatic lockout after failed login attempts prevents password guessing attacks against messaging accounts. Message expiration and automatic deletion policies reduce the risk window for stored communications. Regular security assessments identify potential vulnerabilities in messaging systems before they can be exploited. Healthcare organizations combine these preventive measures with monitoring systems that detect potential messaging security incidents early, allowing rapid response before patient information becomes compromised.
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 SecurityRule 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:
Administrative Safeguards
Riskmodeling: frequent risk assessments to identify, categorize, and manage security risks.
Workforcesecuritypolicies: including role-based access controls.
Contingency planning for emergency access to ePHI: i.e., disaster recovery and business continuity planning.
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.
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.
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.
