Email marketing can be a powerful tool for healthcare organizations, but it requires careful planning and execution because of HIPAA compliance requirements. In this blog post, we will discuss email marketing best practices to help healthcare marketers achieve their goals.
1. Define Your Campaign Goals
The success of any email marketing campaign depends on the goals you want to achieve. However, because healthcare organizations are often not selling products to their patients, marketers can be confused about how to set measurable goals for their campaigns that aren’t tied to revenue generation.
Healthcare marketers want to use email marketing campaigns for various purposes, including patient engagement, education, and retention. Some possible objectives of your campaigns could be:
New patient acquisition
Re-engaging lapsed patients
Spreading awareness about vaccines, treatments, or medical conditions
Increasing treatment or medication adherence
Collecting survey responses or patient-reported outcomes
All of these campaign objectives will correlate with different metrics. Identifying the campaign goal and the corresponding metrics you need to track is critical before selecting the audience and crafting the content.
2. Select Your Audience
Gone are the days of sending giant email blasts to your entire contact list. The best email marketers are creating highly targeted campaigns for specific audiences. Healthcare marketers using patient data in their audience targeting efforts are at an advantage. They can use patient information to create distinct audience segments. Targeting a patient population with common attributes makes it easier to craft a relevant message to drive clear results. For example, marketers can create more relevant campaigns when they can divide their patient population into subgroups based on shared characteristics like diagnoses, risk factors, and demographic data.
3. Personalize Your Content
Once you have clearly defined your goal and your audience, it’s essential to use personalization techniques to craft relevant messaging. Healthcare consumers expect more personalization from their providers and want to receive messages that tie into their past experiences. Generic, irrelevant messaging is more likely to annoy patients than get them to act. Healthcare marketers are lucky to have a wealth of data points to use in their messaging, but they must be aware of patient privacy and take steps to secure their messaging. When you have taken the appropriate steps to secure patient data, including protected health information in email messages is possible. This improves the patient experience and makes it easier for healthcare marketers to achieve their objectives.
4. Use A Clear Call-to-Action
Your emails should include a clear call-to-action (CTA) that encourages your audience to take the desired action. These actions may include scheduling an appointment, downloading a resource, logging into a patient portal, filling out a survey, or contacting your organization. Ensure that your CTA is prominent, stands out from the rest of your content, and ties back to the goal of your campaign. Most importantly, implement appropriate tracking technologies so you can see how many email recipients followed through on the CTA.
Don’t include too many calls to action in one message! Including multiple prompts may confuse the recipient and make it more difficult for your team to understand how the campaign performed.
5. Review Your Data
Finally, it’s essential to monitor your email metrics to evaluate the success of your campaigns. Some key metrics may include open rates, click-through rates, surveys completed, successful logins, appointments scheduled, and other relevant metrics that tie back to your goals. Use this data to refine your email marketing strategy, trigger follow-up campaigns and marketing activity, and optimize future campaigns. Use APIs or webhooks to ensure your email campaign statistics are tied into marketing dashboards to get a holistic view of how your campaigns are performing.
6. Choose an Email Marketing Platform Designed for Healthcare
Finally, to use the tactics recommended above, it’s necessary to use a HIPAA-compliant email marketing platform. Segmenting audiences and personalizing content requires the use of protected health information. Therefore, it must be secured in compliance with HIPAA. You must select a platform that can protect data both at rest and in transit to utilize the power of your data fully.
LuxSci’s HIPAA-compliant Secure Marketing was designed to meet the needs of healthcare marketers and enables the use of PHI at scale. Contact our sales team to learn more about our capabilities and email marketing best practices.
Pete Wermter
As a marketing leader with more than 20 years of experience in enterprise software marketing, Pete's career includes a mix of corporate and field marketing roles, stretching from Silicon Valley to the EMEA and APAC regions, with a focus on data protection and optimizing engagement for regulated industries, such as healthcare and financial services.
Pete Wermter — LinkedIn
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.
Creating secure web forms starts with creating a secure website. This process is more complex than creating web pages and adding an SSL Certificate. A certificate is a solid first step, but it only goes so far as to protect whatever sensitive data necessitates security in the first place.
Naive attempts at security can ultimately make the data less secure and more likely to be compromised by creating an appetizing target for the unscrupulous.
So, what do you do beyond hiring a developer with significant security expertise? Start with this article. Its purpose is to shed light on many of the most significant factors in creating secure web forms and how to address them. At a minimum, reading this article will help you intelligently discuss website security with the developers you hire.
We’re pleased to share our latest designations and recognition for being “best-in-class” when it comes to email security, including from SecurityScorecard, SSL Labs and the Cybersecurity Excellence Awards.
As you may know, our commitment to email security is unwavering, playing a central role in everything we do. Most of all, this commitment focuses on our customers – and ensuring PHI data is secure at all times. We do this via product innovation, best practices and staying ahead of the latest threats.
With that in mind, now’s a great time to highlight our company’s core values – which are anchored in security – to give you an idea of what it’s like to work with us. Together, they make up what we call the The LuxSci Way with a focus on the following:
Secure – We protect the security and privacy of our customers’ data and their systems by taking a security-first approach.
Responsible – We are focused on cybersecurity and ensure our software and systems are continually updated for the latest threats.
Smart – We proactively apply our knowledge and deep expertise in cybersecurity to provide efficient, responsive customer support.
Trust – We sustain partnerships with our customers, and we are committed to their long-term protection and success.
Read more to see the results!
98/100 on SecurityScorecard
LuxSci recently scored 98/100 and received an A rating on SecurityScorecard, a leading cybersecurity ratings firm. SecurityScorecard has ranked more than 21,000 unique vendors in the healthcare space with an average score of 88 and a B rating, placing LuxSci at the top end of the rankings in our industry.
SecurityScorecard ratings offer easy-to-read A-F ratings across a range of risk factors, including network, endpoint and application security, DNS health, and IP reputation. In total, SecurityScorecard has rated more than 11 million organizations worldwide and supports thousands of organizations with its rating technology for self-monitoring, third-party risk management, board reporting, and cyber insurance underwriting.
A+ on SSL Labs TLS Support Check
In related news, LuxSci achieved an overall A+ rating for its latest Qualys SSL Labs TLS support check. SSL Labs performs a deep analysis of the configuration of any SSL web server on the public Internet to better understand how SSL is deployed, scoring vendors across key areas, including certificate, protocol support, key exchange and cipher strength.
SSL Labs is a non-commercial research effort, welcoming participation from any individual and organization interested in SSL.
LuxSci Receives Cybersecurity Excellence Award for Healthcare
Finally, LuxSci recently received a 2024 Cybersecurity Excellence Award for healthcare products. The annual awards recognize excellence, leadership, and innovation in cybersecurity across a range of categories and industries. LuxSci was recognized for its Secure Marketing product for HIPPA-compliant marketing, which features industry-leading email security.
Part of the LuxSci Secure Healthcare Engagement Suite of software, LuxSci Secure Marketing empowers healthcare providers, payers and suppliers to use protected health information (PHI) to create secure and personalized email campaigns that increase patient engagement and improve outcomes. The highly flexible LuxSci Secure Marketing solution can securely send millions of emails per month, featuring list management, automation, easy-to-use templates, detailed reporting & analytics, and API connectivity to easily integrate with data and applications.
If you’d like to learn more about LuxSci email security, and our HIPAA-compliant healthcare communications solutions for email, marketing, forms and text, reach out to us today and schedule a call with an expert.
SSL and TLS play critical roles in securing data transmission over the internet, and AES-256 is integral in their most secure configurations. The original standard was known as Secure Sockets Layer (SSL). Although it was replaced by Transport Layer Security (TLS), many in the industry still refer to TLS by its predecessor’s acronym. While TLS can be relied on for securing information at a high level—such as US Government TOP SECRET data—improper or outdated implementations of the standard may not provide much security.
Variations in which cipher is used in TLS impact how secure TLS ultimately is. Some ciphers are fast but insecure, while others are slower, require a greater amount of computational resources, and can provide a higher degree of security. Weaker ciphers—such as the early export-grade ciphers—still exist, but they should no longer be used.
The Advanced Encryption Standard (AES) is an encryption specification that succeeded the Data Encryption Standard (DES). AES was standardized in 2001 after a five-year review and is currently one of the most popular algorithms used in symmetric-key cryptography. It is often seen as the gold standard symmetric-key encryption technique, with many security-conscious organizations requiring employees to use AES-256 for all communications. It is also used prominently in TLS. (more…)
Google Drive can be HIPAA compliant when used with Google Workspace (formerly G Suite) under a Business Associate Agreement (BAA) and with proper configuration. Standard consumer Google Drive accounts do not meet HIPAA requirements. Healthcare organizations must implement specific security settings, access controls, and usage policies to maintain Google Drive HIPAA compliant status. These measures help ensure protected health information remains secure while benefiting from cloud storage capabilities.
Google’s Business Associate Agreement
Healthcare organizations must obtain a Business Associate Agreement from Google before storing any protected health information in Google Drive. This agreement establishes Google as a business associate under HIPAA regulations and outlines their responsibilities for protecting health data. Google offers this BAA as part of Google Workspace (formerly G Suite) business plans, but not for personal Google accounts. The agreement specifically covers Google Drive among other Google services. Organizations should review the BAA carefully to understand which Google services are covered and what responsibilities remain with the healthcare organization. This legal foundation is essential for any Google Drive HIPAA compliant implementation.
Required Security Configurations
Making Google Drive HIPAA compliant requires enabling several security features available in Google Workspace. Two-factor authentication adds an additional verification layer beyond passwords. Advanced protection program features defend against phishing and account takeover attempts. Drive access controls restrict file sharing to authorized users within the organization. Data loss prevention rules can identify documents containing patient information and apply appropriate protection policies. Audit logging must be enabled to track file access and modifications. Organizations need to configure these settings through the Google Workspace admin console rather than relying on default configurations.
File Sharing and Access Controls
Proper management of file sharing is a large aspect of Google Drive HIPAA compliant usage. Healthcare organizations should establish policies restricting how files containing protected health information can be shared. External sharing controls can prevent staff from accidentally exposing patient data outside the organization. Domain-restricted sharing limits file access to users within the organization’s Google Workspace account. Link-based sharing should be disabled for sensitive documents or carefully restricted with additional authentication requirements. Role-based access permissions ensure users can only view files necessary for their job functions. These access controls prevent both accidental exposure and unauthorized access to patient information.
Encryption and Data Protection
Google Drive HIPAA compliant implementation relies on proper encryption to protect healthcare information. Google provides encryption for data in transit between users’ devices and Google servers using TLS. Data at rest in Google Drive receives encryption with AES-256 bit keys. Organizations should use Google Workspace Client-side encryption for particularly sensitive files to maintain control of encryption keys. Staff should avoid downloading protected health information to local devices unless absolutely necessary and with appropriate security measures. Encryption serves as a fundamental protection layer that helps maintain confidentiality even if other security measures fail.
Audit and Monitoring Capabilities
HIPAA regulations require tracking who accesses protected health information. Google Workspace offers audit logging features that support HIPAA compliance. These logs record user activities including file access, sharing changes, and document modifications. Organizations should configure appropriate retention periods for these logs to support compliance verification. Security monitoring tools can analyze these logs to identify unusual access patterns or potential policy violations. Regular review of these logs helps identify potential security issues before they lead to breaches. These monitoring capabilities also provide documentation during compliance audits.
Staff Training Requirements
Technical controls alone cannot ensure compliance without proper staff education. Organizations using Google Drive HIPAA compliant configurations must train staff on appropriate usage policies. Training should cover what types of information can be stored in Google Drive, appropriate sharing practices, and security feature usage. Staff need to understand the risks of downloading sensitive information to personal devices. Regular refresher training helps maintain awareness as features and threats evolve. Documentation of this training provides evidence of compliance efforts during regulatory reviews. Even with robust technical controls, human behavior remains a critical factor in maintaining HIPAA compliance.