ActiveCampaign is a cloud-based marketing automation platform that helps organizations manage their email marketing, customer relationships, and sales automation, and it can be HIPAA compliant for enterprise deployments. The platform’s automation capabilities enable organizations to streamline their workflows and carry out marketing campaigns with less administrative overhead, saving both time and money. Additionally, ActiveCampaign’s advanced segmentation tools allow companies to personalize campaigns according to demographics, behavior, and past interactions.
While these capabilities are highly sought after by healthcare organizations who want to enhance their engagement with patients and customers, they require one characteristic above all in their marketing platform of choice: HIPAA compliance.
More specifically, for a company to send electronic protected health information (ePHI) through an email marketing platform, it must comply with the Health Insurance Portability and Accountability Act (HIPAA).
Let’s take a closer look…
Is ActiveCampaign HIPAA Compliant?
Firstly, to address the question directly – is ActiveCampaign HIPAA compliant? – it is notHIPAA-compliant by default. Healthcare organizations can only conduct HIPAA compliant marketing campaigns if they are signed up for the Enterprise version of the solution.
Our findings revealed that companies are required to configure ActiveCampaign accordingly to ensure HIPAA compliance. Again, that healthcare organizations need to ensure compliance themselves – and how they do so – isn’t made 100% clear in any of the company’s literature.
ActiveCampaign’s Security Features
ActiveCampaign does not provide message-level encryption for outbound campaign emails (e.g., portal-based pickup or enforced encryption to recipients), so you generally should not put PHI in the body of campaign emails. This limits your ability to engage patients with personalized and relevant messages that result in more opens, clicks and conversions.ActiveCampaign’s sole mention of HIPAA compliance is on their security features page, on which they state:
“ActiveCampaign is heavily focused on GDPR, SOC 2, and HIPAA compliance. We constantly improve our security to go above and beyond compliance standards.”
Now, while they don’t go into further detail, ActiveCampaign does indeed feature some security controls that lend themselves towards HIPAA compliance. These include:
Single Sign-On (SSO): users can sign into ActiveCampaign through an existing identity provider, such as Google, without requiring a separate set of credentials. This helps protect data through stronger access control and allows for simpler user authentication.
Multi-Factor Authentication (MFA): ActiveCampaign supports MFA, requiring users to verify their identity through text or time-based one-time password (TOTP) authentication. This adds another layer of security, in line with HIPAA regulations, and is something that could be more emphasized if changes to the Security Rule come into effect later this year.
Automatic Session Timeouts: idle sessions are automatically logged out after a short amount of time: protecting them from session hijacking and related cyber threats.
Additionally, users are responsible for setting up the proper email authentication protocols themselves, including:
SPF (Sender Policy Framework): Specifies authorized mail servers for your domain.DKIM (DomainKeys Identified Mail): Adds a digital signature to your emails, verifying their authenticity.DMARC (Domain-based Message Authentication, Reporting & Conformance): Provides instructions to email providers on handling messages that fail SPF or DKIM checks.
Setting up these protocols helps fight against email spoofing and phishing attacks, ensuring that your emails are recognized as legitimate by recipients’ mail servers.
Will ActiveCampaign Sign a BAA?
Now, even with some security features and stating they are focused on compliance, a marketing platform can’t truly comply with HIPAA regulations unless they sign a Business Associate Agreement (BAA).
ActiveCampaign’s BAA availability appears limited and may depend on plan level; confirm directly with ActiveCampaign.
Discover HIPAA Compliant Alternatives to ActiveCampaign
As this post illustrates, while it is possible to make ActiveCampaign HIPAA compliant, it’s not straightforward. Fortunately, there are alternative email and marketing solutions that are fully HIPAA-compliant – out-of-the-box – removing the guesswork and ambiguity from securing your digital communications and allowing you to focus on engaging with your patients and customers. This includes LuxSci Secure Marketing, which enables healthcare organizations to proactively reach patients and customers with HIPAA compliant email marketing campaigns that can securely include PHI for increased engagement, lead generation and sales.
Discover how LuxSci can elevate your secure healthcare engagement efforts with PHI data, resulting in better health outcomes for your patients, in addition to enhancing your brand identity and achieving your company’s growth objectives. Reach out today for a call or demo.
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.
So – you’ve just been told that your email marketing program is putting your company at risk of violating HIPAA.
Ok. What now?
If you want to continue your email-based patient engagement efforts – without the risk of the financial, operational, and reputational risk that accompanies the exposure of sensitive patient data, you must implement HIPAA compliant email marketing practices.
This is comprised of two components: becoming HIPAA-compliant, setting up the required systems and procedures to ensure your PHI (PHI) and EPHI (EPHI) are protected, and your marketing objectives, who you want to reach and what to communicate.
However, you don’t have to let your marketing objectives suffer for the sake of security.
Implementing a HIPAA-compliant marketing program can actually help you achieve better marketing results.
Asking yourself these 12 questions ensures your email marketing campaigns align with your business goals and are HIPAA-compliant.
If your organization requires HIPAA-compliant email, start by using these questions to inspect your email marketing for compliance. Note that while we can’t provide legal advice, the below questions will help you identify some of the most common points of vulnerability and non-compliance.
1. Do you have security controls to protect access to your email marketing system?
Email security is an essential component of being HIPAA-compliant. As a starting point, check your internal security processes for access restrictions. This includes:
A robust password policy, i.e., changed frequently (e.g., 30 days), has to contain a mixture of characters, etc.
Multi-factor authentication (MFA), i.e., users verifying their identity in multiple ways, e.g., username/password and sent number codes (text, email, key fob, etc.), biometrics, etc.
Role-based access controls, i.e., granting access to individuals based on the responsibilities of their job role.
Zero Trust Architecture (ZTA), i.e., “never trust, always verify” – where users are required to reconfirm their identity on a case-by-case basis, as opposed to once when logging on, which mitigates session hijacking and similar threats.
2. Do you have a documented procedure to guide you HIPAA-compliant email marketing?
“Winging it” simply doesn’t cut it when it comes to HIPAA-compliant email marketing; you must develop a comprehensive documented process detailing how you intend to safeguard PHI throughout your email marketing campaigns.
This should include:
Specifying the HIPAA-compliant email delivery service you’ll use to execute your marketing campaigns
The processes and controls you’ll use to encrypt data for ePHI at rest and in transit
The access and authentication controls you have in place
How you’ll implement data minimization: only using the minimum necessary PHI in communications – and not including sensitive PHI unless it’s essential.
How you’ll securely dispose of data: Implement a process for securely deleting emails containing ePHI once they’re no longer needed, to comply with retention policies.
Staff training: educating employees involved in email marketing on how to securely handle PHI and other HIPAA requirements.
Incident response plan, i.e., an additional documented plan for how you’ll respond to data breaches and other cyber attacks; this also includes notifying any affected parties as mandated by HIPAA.
If you’re starting from scratch, the information contained in the answers to the questions in this article provides a useful starting point for creating your first procedure.
3. Can you send encrypted emails?
If you are sending highly sensitive data or PHI in your emails, be aware that HIPAA requires the data to be encrypted a rest, i.e., the storage medium where it resides, and in transit, when being sent to recipients.
To the surprise of many healthcare organizations, most major email marketing providers, such as Mailchimp and Constant Contact are unable to provide encryption for data in transit and only protect data in their systems. To avoid falling foul of HIPAA regulations, ensure that the email delivery platform you use to transmit messages containing PHI offers end-to-end encryption.
4. Do you have a complete understanding of your organization’s PHI and ePHI?
Much of the time, when we, as well as healthcare providers, talk about PHI, we’re actually referring to electronic protected health information (EPHI). While PHI is a catch-all term to account for all sensitive health information, in truth, in the digital age, the vast majority is stored electronically in data centers – and the patient data handled is EPHI.
You can discover “PHI” and “ePHI” within the context of your organization’s context by identifying and categorizing the PHI and ePHI typically handled in your business. It’s an absolutely crucial tenet of data protection that you simply can’t protect what you’re not aware of.
Comprehensive PHI categorization will help your staff navigate HIPAA-compliant email requirements.
5. Do you have a required training process in place for anyone sending HIPAA-compliant marketing emails?
Your HIPAA compliance program, as with your company’s overall cybersecurity posture, is only as strong as your weakest link. In light of this, it’s essential to educate the staff within your company who are involved in your healthcare engagement campaigns on the secure use of ePHI and HIPAA-compliant marketing practices.
Additionally, this needs to be reflected in your onboarding process, so new hires are made familiar with HIPAA regulations, should their role require it.
6. Do you have effective protection against malware?
In the unlikely event you need any further encouragement to revisit your company’s anti-malware (viruses, ransomware, Trojans, etc.) measures, there are always HIPAA compliance requirements!
To better protect your sensitive customer data against a slew of increasingly sophisticated cyber threats, start with these three key considerations:
Do you have anti-malware protection running on all of your organization’s devices? Additionally, does this extend to your employee’s personal devices on which they handle PHI?
How frequently do you update your anti-malware solution?
Does your email marketing provider have sufficient protection malware mitigation measures in place, as per HIPAA requirements?
7. Do you have valid Business Associate Agreements (BAA) in place?
It’s normal to outsource activities like email marketing to a third party, but for the service they provide to be HIPAA-compliant, you must have a business associate agreement (BAA) in place.
A BAA documents how two organizations will share PHI and under what circumstances. A BAA also details the legal responsibilities of each party in the event of a serious issue. With a BAA being a core component of HIPAA compliance, failure to have one in place with your email service provider is an immediate HIPAA violation – and one that can result in serious consequences for a healthcare company.
Getting Better Results from HIPAA-Compliant Email Marketing
Now that you’ve confirmed your systems are HIPAA-compliant, let’s move on to making sure your email marketing strategy aligns with your overall business objectives.
In pursuit of this, the following questions serve as a handy “monthly review” for refining the effectiveness of your email-based patient outreach efforts .
8. Why am I sending this email?
First and foremost, for the best results, each email you send should have a single, clearly defined purpose.
I know what you’re thinking – “my customers and patients are smart, they can handle multiple points in a single message.” And while that’s true, at whatever point your email reaches a recipient, they’re already juggling several different priorities at once. While they’re capable of juggling multiple points in a message – they’re unlikely to want to; when it comes to email marketing, a single goal is the best way to go.
Similarly, it’s important to remember that your email is one of dozens – or hundreds – received by your patient that day. So, if your message is long and overly complicated, the reader will likely skip over or delete it.
9. Is my email’s subject line standing out?
Following on the above point, is your email subject line impactful enough to stand out amidst the pile of messages that will land in the patient’s inbox that day? The email subject line is the most important part of your email because it’s responsible for persuading the reader to open your message.
Despite this, many marketers still use terrible, ineffective subject lines and wonder why their emails are failing to produce results!
For the best results, write up three to ten subject lines for your next email, step away for 5-10 minutes, and then choose the headline you determine as best.
Consider these examples to check your understanding:
Ineffective Email Subject Lines
Blank (no subject): writing nothing in the subject line
Clinic Newsletter (tell them more, e.g., the subject or theme for the month)
Overusing exclamation marks!!!
Effective Email Subject Lines (examples based on a dental practice)
BRAND-NEW Dental Product Released Today
How to Cut Down on Your Health Insurance Paperwork
[Case Study] How We Helped 3 Ex-Smokers Get White Teeth
10. What is the recipient’s brand and product awareness level?
Whether promoting medical devices, new digital solutions technology, or any healthcare product or service, understanding the prospect’s awareness level is essential.
If your email is designed to introduce a brand-new product, stick to high-level features and benefits while avoiding technical jargon and granular product details. Conversely, if you’re writing an email to experienced, highly knowledgeable readers, going into greater depth makes sense.
Advanced list management and segmentation tools, as offered by Luxsci Secure Marketing, are key for ensuring the communications you send match the reader’s awareness level.
11. Have I tested my message for readability?
Do you know one of the reasons that Hemingway was popular? He was skilled at writing short phrases and phrases. Consequently, his writing was easy to understand and appealed to a wide variety of people. When in doubt, keep your writing short and free of jargon, abbreviations and “insider” terms.
When you’re deeply involved in the details of your business, it’s so easy to overlook just how much specialized jargon and language you frequently use. However, if you want your communications to engage with patients and customers, they need to be as accessible as possible.
Fortunately, there are simple solutions to this, with tools like the Text Readability Calculator that are designed to quickly enhance the readability of your emails.
12. Have I sent my message to a test email account?
Finally, if you’ve followed all of the above advice, you’re almost ready to hit SEND…there’s just one more thing you need to check.
Determine how your email will look to recipients, including its clarity, and readability by simply sending a test email to one of your own email accounts once it is received.
In particular, pay attention to how the subject line looks and test all the links in the email to ensure they take the reader through to the intended destination, such as a product or service page. A broken link will only frustrate the recipient – who was interested enough to click through, no less – and lower your conversion rate.
Better still, send the test email to a colleague somebody and ask for their opinion about the quality of the message and whether it creates the desired impression.
Demystifying HIPAA-Compliant Email Marketing
As the most experienced HIPAA-compliant email provider, LuxSci specializes in providing secure and HIPAA-compliant solutions for companies aiming to send hundreds of thousands – or millions – of emails. Our hypersegmentation tools allow you to precisely target an unlimited number of patient sub-populations to maximize the efficacy of your messaging.
Are you interested in discovering how LuxSci’s secure email marketing platform will streamline your healthcare engagement efforts?
Contact us to learn more about our products and pricing.
Effective patient engagement is increasingly becoming a top priority for many healthcare organizations – and for good reason.
First and foremost, the more a patient or customer is engaged in their healthcare journey, the better their health outcomes and quality of life. With increased communication and engagement, patients are more likely to have potential conditions diagnosed sooner, take preventative measures to prevent illnesses, and educate themselves on ways to manage and improve their health.
However, the benefits don’t end there and aren’t restricted to the patient. Engaged patients pay bills faster, are more open to new products and services, and report higher levels of satisfaction with the companies that contribute to their health and well being. For healthcare providers, payers, and suppliers, this results in higher revenue, more opportunities for growth, and the attainment of long-term organizational goals.
Digital Patient Engagement Is Easier than Ever
Fortunately, advances in technology and their rapid adoption by patients and customers (expedited by the COVID-19 pandemic) have made it easier for healthcare organizations to achieve successful digital interactions and engagement. Healthcare companies have more tools and channels than ever before to help conduct personalized engagement campaigns that meet patients on their terms, making it easier to capture their attention. Secure email takes it even further with the ability to include protected health information in messages to personalize
Despite these advancements, however, there are still several barriers that prevent healthcare companies from engaging with patients and reaping the associated benefits. Fortunately, each barrier can be overcome to help patients and customers feel more included and instrumental in their healthcare journeys.
With this in mind, this post discusses the main barriers to digital patient engagement and how to overcome them to drive better healthcare outcomes for your patients and growth for your organization.
The Main Barriers To Digital Health Engagement
The four key barriers to digital health engagement that we’ll explore in this post are as follows:
Low Health Literacy
Privacy And Security Concerns
Age And Cultural Differences
Lack Of Personalization
Let’s review each barrier in turn, while offering potential solutions that will contribute to greater digital health patient engagement for your healthcare organization.
Low Health Literacy
The first barrier to successful digital health patient engagement is your patients having insufficient health or medical knowledge. Healthcare is laden with terminology, including medical conditions, pharmaceuticals, the human anatomy, and many patients simply don’t understand enough to get more involved with their healthcare journey. Worse still, few patients will admit they don’t understand, as people are often embarrassed at their lack of knowledge.
Consequently, if your digital health patient engagement campaigns are heavy with medical jargon and lack personalization, patients won’t act on the information to drive better outcomes.
Solution: Create Educational Health Content
Develop simple educational resources for your patients that apply to their unique needs and condition. This will help them understand their state of health and make better sense of subsequent communications they’ll receive from you and their other healthcare providers.
This educational content could be in the form of periodic email newsletters, giving you a great reason to keep in touch with your patients. Alternatively, they could take the form of blog posts or articles on a patient portal, which could be supported by an email marketing campaign to let patients know about the article. In helping to increase your patients’ health literacy, you offer additional value as a healthcare provider, payer or supplier.
Additionally, keep the medical jargon in your email communications and other patient engagement channels to a minimum. Empathize with the fact that some patients won’t understand as much as others when it comes to healthcare provision and explain things as plainly as possible.
Data Privacy And Security Concerns
Unfortunately, due to its sensitivity and critical nature patient data, i.e., protected health information (PHI) is highly prized by cybercriminals. Subsequently, there have been many high-profile healthcare breaches, such as the Change Healthcare breach, in early 2024, which affected 100 million individuals, that make patients increasingly wary about sharing health-related information via email, text, or other digital communication channels.
That said, their wary attitude is the right one to adopt, but not at the expense of enhancing engagement and improving their health outcomes.
Solution: Invest In HIPAA Compliant Communication Tools
Ensure that the digital tools you use to engage with patients possess the security features required for HIPAA compliance. The Health Insurance Portability and Accountability Act (HIPAA) provides a series of guidelines that healthcare organizations must comply with to best safeguard PHI. Consequently, solutions that promote their commitment to HIPAA compliance, such as LuxSci, will understand the privacy, security, and regulatory needs of healthcare companies and have developed their tools accordingly.
Most importantly, a HIPAA compliant vendor will sign a Business Associates Agreement (BAA), the legal documentation that outlines your respective responsibilities regarding the protection of PHI. Safe in the knowledge that the patient data under your care is secure, you can concentrate your efforts on personalizing your digital communication campaigns for maximum effect.
Age And Cultural Differences
Ineffective patient engagement efforts (or a complete lack of engagement, altogether) can reinforce cliches about the use of digital tools within particular patient groups. The reality, however, is that many healthcare organizations don’t account for age differences and channel preferences in their patient engagement strategies.
Subsequently, if you only engage with patients on a single communication channel, you risk alienating others because it’s not their medium of choice.
Solution: Adopt a Multi-Channel Engagement Strategy
Instead of focusing on one communication medium, diversify your approach and adopt a multi-channel engagement strategy. This could encompass email, SMS, and phone outreach, for instance. This covers the more proverbial bases and gives you a chance to engage with patients on their preferred terms.
Lack Of Personalization
One of the main reasons that healthcare organizations fail to engage with their patients is that they adopt a “one-size-fits-all” approach, attempting to craft communications that appeal to as many people as possible. Unfortunately, this has the opposite of the desired approach, not connecting anyone in particular and engaging few patients as a result.
Solution: Personalize Your Patient Engagement Campaigns with PHI
With a HIPAA compliant solution, you can use PHI to personalize patient engagement, leveraging their health data to craft messaging that reflects their specific condition, needs, and where they are along their healthcare journey. PHI also can be used to segment patients into subgroups, grouping them by specific commonalities such as age, gender, health condition, and lifestyle factors.
Successful Digital Health Patient Engagement with LuxSci
With more than 20 years of experience in delivering secure digital healthcare communication solutions to some of the world’s leading healthcare providers, payers and suppliers, LuxSci is a trusted partner for organizations looking to boost their patient engagement efforts, while protecting patient data and remaining compliant at all times.
LuxSci’s suite of HIPAA compliant solutions include:
Secure Email:HIPAA compliant email solutions for executing highly scalable, high volume email campaigns that include PHI – millions of emails per month.
Secure Forms: Securely and efficiently collect and store ePHI without compromising security or compliance – for onboarding new patients and customers and gathering intelligence for personalization.
Secure Marketing: proactively reach your patients and customers with HIPAA compliant email marketing campaigns for increased engagement, lead generation and sales.
Secure Text Messaging: enable access to ePHI and other sensitive information directly to mobile devices via regular SMS text messages.
Interested in discovering more about LuxSci can help you upgrade your cybersecurity posture for PHI and ensure HIPAA compliance? Contact us today!
Email is an essential channel for most healthcare marketers, but HIPAA compliance requirements can make it challenging to execute effective engagement campaigns without violating patient privacy.
HIPAA is a complicated set of regulations that while offering a lot of guidance, does not mandate the use of any specific technologies to protect patient privacy. This ambiguity causes a lot of confusion for marketers looking to integrate email into their healthcare engagement campaigns.
With this in mind, this article addresses some frequently asked questions (FAQs) about HIPAA-compliant email marketing and offers advice for securing patient data and future-proofing your marketing.
Some marketers assume newsletters from a healthcare provider or supplier do not contain health information and, therefore, do not fall under HIPAA requirements. This assumption, however, is often incorrect, with many surprised to learn that protected health information (PHI) can be implied from seemingly innocuous information.
As a result, many generic email newsletters often indirectly contain PHI due to the very fact that they are sent to lists of current patients or customers. This is because email addresses count as individually identifiable data and when combined with the message therein, it’s pretty simple to infer that they are patients or customers.
Let’s say, for example, that you send a newsletter to the patients of a dialysis clinic. An eavesdropper could infer that the recipients receive dialysis. Consequently, as the email reveals information about an individual’s health treatment, it contains PHI and should be secured in compliance with HIPAA regulations.
For the fundamental reason that it can be difficult to determine what classifies as PHI, it’s safer to skip the ambiguity entirely and use a HIPAA-compliant email marketing solution to ensure security.
What is an email API?
An Application Programming Interface (API) is a collection of protocols, or rules, that enable different applications to communicate with each other. APIs are a crucial aspect of modern applications – as they spare developers the considerable effort of creating application features from scratch – they can just connect to the API of an existing application.
For example, how many websites have you used that utilize Google Maps? This is because they have connected their site to the Google Maps API – integrating it into their application and providing another feature for their users.
In the case of an email API, it is a way for applications, such as customer relationship management (CRM) platforms, customer data platforms (CDP) and electronic health record (EHR) systems, to connect to email service providers. This then allows marketers to send emails through the application, using the ePHI (electronic protected health information) collected and stored within the application.
Additionally, marketers can view and further utilize campaign data through the powerful dashboards and analysis tools found in CRM systems and similar applications. Trigger-based transactional or marketing emails are ideal for sending with an email API, whereby emails are sent when pre-determined conditions in the application are met. Healthcare organizations may use email APIs to send appointment reminders using electronic health records system data about a patient’s upcoming appointments, check ups or treatments.
As invaluable as email APIs are, however, especially for streamlining and automation communication workflows, they are no substitute for a comprehensive email marketing platform. Email APIs do not include the contact management systems standard in most email marketing platforms, as all the data resides within the application they connect to. Additionally, email API tools do not typically include drag-and-drop editor tools and other design features that enable you to make your emails stand out and boost patient engagement.
Does HIPAA allow healthcare providers and companies to send unencrypted emails with PHI to patients?
Encryption is an addressable standard, i.e., it must be implemented by the organization unless a risk analysis concludes that implementation is not reasonable and appropriate, under the HIPAA Security Rule. This does not mean it is optional. The HIPAA Security Rule does not explicitly forbid unencrypted email. Still, it does state that “other safeguards should be applied to protect privacy reasonably, such as limiting the amount or type of information disclosed through the unencrypted email.”
In addition, the Department of Health and Human Services also states that “covered entities are permitted to send individuals unencrypted emails if they have advised the individual of the risk, and the individual still prefers the unencrypted email.” in response to this, some organizations use waivers to inform patients of the risks and acquire permission to send unencrypted emails.
However, we do not recommend this approach for several reasons:
Keeping track of waivers over time and recording status changes and updates is challenging – and increases your administrative overhead.
Signed waivers do not insulate you from the consequences of a HIPAA breach.
Using waivers to send unencrypted emails doesn’t absolve you of your other HIPAA obligations, such as data retention and disposal. Subsequently, using a HIPAA-compliant email solution is more manageable and eliminates ambiguity.
Can patients exercise their right of access of receiving PHI voa unencrypted email?
Yes, but they must be fully informed of the risks and sign waivers acknowledging them; the caveats detailed in the above answer apply. Consequently, it’s always best to use an encryption tool to protect patient data.
Is Microsoft 365 with encryption sufficient for sending marketing emails?
Microsoft 365 can be configured with Office Message Encryption (OME) to comply with HIPAA. However, it is not well-suited for sending marketing emails. OME primarily relies on portal pickup encryption, in which the message is stored securely on a server and requires the recipient to log in to the portal to read the email. As a result, the portal adds friction to the marketing process that prevents optimal engagement and constrains ROI.
Marketing messages containing light-PHI, i.e. low-risk data, are best sent using Transport Layer Security (TLS) encryption. TLS-encrypted messages arrive in the recipient’s inbox just like a regular email and do not require them to complete an additional step.
Additionally, Microsoft 365 is not configured to send high volumes of email. If you plan on executing large scale marketing campaigns, you could unintentionally disrupt regular business communications by sending all the messages through the same infrastructure. Instead, you should separate your business and marketing email delivery activities to protect your IP reputation, i.e., the trustworthiness of your IP addresses and how likely it is your emails end up in a spam folder, and achieve your desired sending throughput.
What are the common email marketing use cases for healthcare?
Email marketing in healthcare is not restricted to boring general practice newsletters and other communications that fail to engage patients. When you successfully harness tools that enable you to use ePHI to better target and personalize your healthcare engagement campaigns – the sky is the limit. With consumer preferences shifting toward digital communications, marketers who know how to best utilize HIPAA-compliant email marketing – and tactics like segmentation and personalization – will prove more effective at reaching patients.
Examples of ways that healthcare marketers can use email include:
Lead generation campaigns
Promotions
Verifications
Order confirmations
Notifications
Upsell & cross-sell
Collecting data on the patient experience
How do I find a HIPAA-compliant email vendor?
Using popular email marketing platforms, such as Mailchimp, is not recommended. Many of these platforms were designed for businesses, but are simply not secure enough to meet HIPAA requirements. We do not recommend using a solution not specifically equipped to meet the healthcare industry’s unique security and compliance needs. To determine if your email marketing provider is compliant, they must meet three broad criteria at a minimum.
The vendor must sign a Business Associate Agreement (BAA) outlining how they plan to secure your data and what they will do in the event of a breach.
Encrypt data at rest when it is stored in their systems.
Encrypt data, i.e., email messages, in transit as sent to the recipients.
Not all vendors will be up to the task. Carefully vet your email marketing vendors to ensure they are taking steps to secure data and protect patient privacy.
Conclusion
Admittedly, HIPAA can be difficult to understand – but choosing the right tools and adequately vetting your vendors makes it far easier to successfully execute HIPAA-compliant email marketing campaigns.
As the most experienced HIPAA-compliant email provider, LuxSci specializes in providing secure and scalable communications for companies aiming to send hundreds of thousands – or millions – of emails. In light of this, we place security, compliance and personalization considerations front and center when building our solutions.
Interested in discovering how LuxSci’s secure healthcare communications solutions can transform your healthcare marketing and engagement efforts?
A website can be HIPAA compliant when it incorporates security measures, privacy protections, and data handling practices that meet HIPAA regulatory requirements. Healthcare organizations must implement encryption, access controls, audit logging, and secure data storage for websites that collect, store, or transmit protected health information. A well configured HIPAA compliant website helps healthcare providers maintain patient privacy while offering online services.
HIPAA Website Requirements
Websites handling protected health information must meet the standards established in the HIPAA Security Rule. These requirements include encryption for data transmission using protocols like TLS 1.2 or higher. Access controls limit website data viewing to authorized personnel with appropriate login credentials. Audit logging tracks all user activities and data access attempts across the website. Session timeouts automatically log out inactive users to prevent unauthorized access. Regular security testing identifies and addresses potential vulnerabilities. These measures work together to protect patient information from unauthorized access or disclosure.
Website Hosting and Infrastructure
HIPAA compliant hosting provides the foundation for a secure healthcare website. When selecting a hosting provider, healthcare organizations look for companies willing to sign a Business Associate Agreement (BAA). This legal document establishes the hosting provider’s responsibilities for protecting health information. The physical location of servers matters, with many HIPAA compliant services using data centers with restricted access, environmental controls, and monitoring systems. Network protection typically includes firewalls, intrusion detection, and regular security updates. Organizations often choose dedicated hosting environments rather than shared servers to maintain data separation.
Patient Data Collection and Forms
Most healthcare websites collect information through online forms. HIPAA compliant websites include appropriate authorization language on these forms before gathering protected health information. Well-designed websites explain how patient data will be used in clear, accessible language. Form data requires protection both during transmission and after submission. Many websites use secure database connections and encryption for stored information. Healthcare organizations determine what information they actually need to collect, following the minimum necessary standard from HIPAA regulations. User-friendly form design can improve completion rates while maintaining compliance.
Secure Patient Portals and Interaction
Patient portals on HIPAA compliant websites allow secure access to medical records, appointment scheduling, and provider communications. These portals employ authentication measures like password requirements and account recovery processes. Many implement automatic timeout features that log out inactive users after a set period. Secure messaging features enable patient-provider communication without using standard email. The best patient portals maintain detailed logs of all system access and actions. Healthcare organizations integrate these portals with their electronic health record systems for data consistency and accuracy.
Mobile Responsiveness and App Integration
Modern HIPAA compliant websites function across various devices while maintaining security protections. Mobile responsive design allows patients to access information securely from smartphones and tablets. When healthcare organizations develop companion mobile apps, these applications need the same HIPAA compliance measures as their websites. Integration between websites and mobile applications requires secure API connections and consistent authentication methods. Many healthcare providers test their digital platforms across multiple devices to ensure both functionality and security. The mobile experience influences patient satisfaction with digital healthcare services.
Compliance Maintenance
Healthcare websites require regular updates and monitoring to maintain HIPAA compliance over time. Technology changes quickly, and security measures that worked previously may become outdated. Website administrators perform regular security scans and vulnerability testing. Organizations document these maintenance activities as evidence of compliance efforts. Staff training helps ensure everyone handling website data understands privacy requirements. As regulations evolve, websites need corresponding updates to privacy notices and security features. Many healthcare organizations work with compliance consultants who specialize in digital healthcare requirements.