We recently rolled out new email reporting features, taking deliverability depth and analysis to new levels. If you’re a current LuxSci customer and haven’t checked them out, now’s the time. If you’re new to LuxSci, learn more below, and don’t hesitate to reach out for more info – or a demo.
LuxSci secure communications solutions have always featured rich reporting on email deliverability, including volumes and percentages for emails:
in queue
opened
clicked
failed
secured
With our latest release, we made these powerful statistics easier to consume and analyze with an improved user interface for more efficiency and greater ease-of-use. Users can simply select the type of report they’d like and customize it using a range of filtering selections. This is great for diving deeper into your email performance to make adjustments on-the-fly, and to spot trends or opportunities for better engagement that you may have missed before.
New UI – Email Deliverability Statistics
Get more granular, ID trends in real time with Split Reporting
As part of this release, we are pleased to introduce our Split Reporting feature, which empowers users to drill down on email deliverability statistics across a range of parameters, including:
subject
from address
recipient domains
marketing ID or campaign
custom field
For example, users can analyze email deliverability statistics by subject to determine which ones are performing best, by use case to track results by campaign, or to track performance by recipient email domains. With split reporting, users also can analyze email volumes across queued, delivered, opened, failed and clicked parameters, and determine click-through rates (CTR) to measure effectiveness and ROI of campaigns.
New Feature Example – Split Reporting by Recipient Domain
If you’d like to learn more, reach out and connect with us today!
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.
Frequently Asked Questions
1. What are the most common HIPAA violations?
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.
With email security threats continuously increasing in number and sophistication, as well as healthcare companies requiring secure solutions to communicate with patients and customers, the need for HIPAA compliant email solutions has never been greater.
However, when looking for the right secure email services provider (ESP), healthcare organizations run the risk of making inaccurate assumptions about HIPAA compliance via what they learn from prospective vendors. This is due to the tendency for sales materials for HIPAA compliant email services, such as web pages or promotional videos, to highlight the strengths of the platform, while downplaying a healthcare company’s own role and responsibilities in securing protected health information (PHI).
With this firmly in mind, here are six key things that HIPAA compliant email salespeople don’t tell you about securing communications and achieving compliance.
1. The Shared Responsibility Model
Firstly, HIPAA compliant email salespeople are unlikely to emphasize the idea of shared responsibility when it comes to data security. This is the idea that two entities that share access to data, e.g., a healthcare company and their ESP, have a shared responsibility to preserve the privacy of that data.
In reality, most sales pitches explain the benefits and features of the solution, as opposed to stressing that compliance truly depends on how it’s configured and used. Now, that’s not to say that a salesperson is trying to hide this fact, as they’ll probably allude to training and configuration requirements. But, they’ll be less likely to make light of this and, more broadly, how shared responsibility factors into compliance.
2. A BAA Doesn’t Automatically Make You HIPAA Compliant
A business associate agreement (BAA) is essential for HIPAA compliance, but signing one doesn’t automatically make you compliant. Your organization still has to use the email delivery solution in a way that aligns with HIPAA regulations, which involves proper configuration, training, oversight, and reporting.
The misconception among some healthcare companies that a BAA equals compliance may be perpetuated by the term “HIPAA compliant email services provider”. This could give some the impression that the vendor is fully HIPAA compliant and, subsequently, in signing a BAA with them, the use of their services is fully compliant.
But, it’s not that simple.
Simply signing a BAA obscures the real effort involved in achieving compliance. There’s no official HIPAA seal of approval, and HIPAA compliant means that the solution is capable of being configured for compliant use, which is a shared responsibility. HIPAA compliant email salespeople are unlikely to volunteer this nuance, especially if their email solution requires considerable configuration or has a steep learning curve to use it securely.
3. Not All Solutions or Features Are HIPAA Compliant
Another key detail often underplayed by vendor sales materials of HIPAA compliant email solutions is that some of their features, or even entire services, aren’t covered by their BAAs, so they can’t be used to handle PHI.
These tools are referred to as “out of scope” and may include tools capable of integration with the emailservice, such as analytics or AI capabilities, but they don’t possess the cyber risk mitigation measures that align with HIPAA regulations. Perhaps the main reason for this is that many mass-market email delivery solutions, such as Microsoft 365 or Google Workspace, are designed for companies across all sectors. Consequently, while they can be HIPAA compliant, they weren’t developed from the ground up with the stringent regulatory demands of the healthcare industry in mind.
4. Solutions Are Not HIPAA Compliant “Out of The Box”
HIPAA compliant email salespeople may suggest that compliance is built into their platform, and healthcare organizations can use it to transmit PHI straight away, but this isn’t the case. Healthcare companies must still configure the email platform accordingly, as per the security requirements determined by their risk assessment, e.g., applying the right level of encryption.
Also, if the email service is difficult to configure for HIPAA compliance or if the vendor’s configuration documentation lacks detail, that presents another obstacle to its compliant use.
In addition to configuration, healthcare companies also have to implement access management controls and policies, establishing the extent to which each employee can access PHI in respect to their roles and responsibilities. From there, they will have to train their workforce on how to use the HIPAA compliant email solution securely, which may include those tools that fall outside the scope of your BAA with the vendor, and must not be used for the disclosure of patient data.
5. Essential Security Features Cost Extra
Another more egregious version of an ESP not being HIPAA compliant out of the box is having features required for compliance, such as encryption or audit logging, as premium add-ons and not included in the solution’s base pricing.
A vendor’s sales materials for its email service might list the necessary safeguards, but underemphasize the fact that only some versions of their platform are truly HIPAA compliant. Consequently, healthcare companies must confirm that the features required for HIPAA compliant email communications are included in the plan they’re purchasing.
6. The Importance of Staff Training on HIPAA
HIPAA compliant email salespeople are often remiss in stressing the need for additional workforce training alongside the deployment of their platform. A healthcare company’s employees must be trained on how to securely use the email client, how to ID potential threats, and best practices for including PHI in email communications, as well as the regulations tied to HIPAA and data security.
This includes educating users on the differences between regular and secure email, and what they must do to safeguard patient and customer data. Fortunately, secure email solutions from providers like LuxSci enable automated email encryption, and users do not need to take any additional actions to ensure encryption when sending emails.
Additionally, in some cases, employees will need to be trained on which tools or features do not align with HIPAA guidelines and must not be used to process PHI.
LuxSci: Fully HIPAA Compliant – No Hidden Surprises
LuxSci specializes in solutions that enable companies to carry out secure, personalized, and HIPAA compliant email communications and campaigns. With more than 20 years of experience and billions of emails sent for companies including Athenahealth, 1 800 Contacts, Lucerna Health and Rotech Healthcare, we’ve acquired invaluable experience in helping healthcare organizations enhance their engagement efforts, all while adhering to HIPAA regulations. In addition, LuxSci’s secure high-volume and marketing email solutions feature HIPAA-required security controls, including encryption, audit logging, and multi-factor authentication (MFA) by default, not as optional, hidden extras.
Contact us today to learn more about how LuxSci’s secure email solutions can help increase the ROI on your patient and customer outreach efforts, while safeguarding PHI in line with HIPAA requirements.
With the recent announcement of proposed changes to the HIPAA Security Rule, by the Office for Civil Rights (OCR), healthcare providers, payers, suppliers, and organizations of all sizes will have to tighten up their cybersecurity practices. In some cases, considerably.
However, with the announcement being so recent (and there not even yet being a clear timeline for when companies will have to implement the changes), it’s all too easy for organizations to view the proposed amendments as a challenge that’s far off in the future.
However, even at this early stage, the proposed changes to the Security Rule require careful consideration and important conversations. Soon, healthcare companies will have to implement or improve a series of cybersecurity controls designed to better safeguard electronic protected health information (ePHI).
In light of this, in this post, we’ll discuss some of the most important practical considerations that healthcare organizations will have to contend with to maintain HIPAA compliance when the proposed changes to the Security Rule go through.
What are the Key Proposed Changes to the HIPAA Security Rule?
First, a refresher on what the proposed changes to the Security Rule are:
More Comprehensive Risk Management: healthcare organizations must conduct more frequent risk assessments to identify, categorize, and mitigate threats to sensitive patient data.
Stricter Documentation and Evidence Retention Policies: similarly, stronger documentation and record-keeping practices to ensure organizations can demonstrate compliance with security requirements.
This includes:
Maintaining detailed records of how they assess threats and implement safeguard security controls (e.g., encryption policies, access controls, etc).
Retaining detailed audit logs of system access, data modifications, and security events, as well as reports from security solutions, such as firewalls and intrusion detection systems all must be securely stored, retained for a defined period, and made available for audits and compliance reviews.
By the same token, the proposed updates to the Security Rule may extend how long healthcare organizations must retain logs and other security documentation, allowing auditors to review historical compliance efforts in the event of an investigation.
Mandatory Encryption for All ePHI Transmission: healthcare companies will require end-to-end encryption for emails, messages, and data transfers involving ePHI. Like today, this means that patient data must be encrypted in transit, i.e., from one place to another (when collected in a secure form, sent in an email, etc.), and in storage, i.e., where it will reside.
Stronger User Authentication and Identity VerificationRequirements: healthcare providers must implement stronger identity access management IAM safeguards, such as Multi-Factor Authentication (MFA), for employees with access to patient data.
TighterThird-Party Security Controls: stricter security controls for business associates who have access to the healthcare company’s ePHI. One of the proposed changes to the HIPAA Security Rule is that vendor security audits will be mandatory instead of optional.
Updated Incident Response (IR) and Data Breach Reporting Rules: mandating stricter breach notification timelines for healthcare entities and their business associates, with them being obligated to inform parties affected by a security breach as soon as possible.
What Are The Practical Implications for Healthcare Companies?
So, what will healthcare companies have to do to comply with HIPAA regulations when the proposed changes to the Security Rule go through? Let’s look at the main practical considerations.
Cybersecurity Solution Deployment and Infrastructure Upgrades
Many healthcare companies will have to install (and subsequently, maintain) new IT infrastructure and deploy new cybersecurity tools to strengthen their authentication safeguards (e.g., MFA, Zero Trust, etc.) to meet new HIPAA’s heightened cybersecurity standards.
Expanded Vendor and Third-Party Management
As well as having to deploy new cybersecurity solutions, such as HIPAA compliant email services and continuous monitoring tools, healthcare organizations will have to be more diligent in their oversight of their third-party vendors.
Stricter Auditing and Documentation Requirements
In having to provide more details of their risk management practices and maintain real-time logs, healthcare organizations will have to develop processes, policies, and supporting documentation.
Staff Training
Healthcare companies will have to train their staff on the updates of the Security Rule, their implications, how to use the new applications and hardware deployed to harden their security posture, etc.
Increased Management and Administrative Burden
Dealing with proposed changes to the Security Rule is going to require all hands on deck.
Managers and stakeholders are going to make several important strategic decisions; procurement and product managers are going to have to research and purchase new solutions; IT will have to deploy the solutions; and everyone will need to learn how to use them.
With all this in mind, more will be required from everyone within your organization. Employees will be taken away from their work, which could affect the quality of the service provided to patients and customers.
That’s why it’s crucial to be prepared…
How Can You Prepare For the Proposed Changes to the Security Rule?
Conduct risk assessments: pinpoint vulnerabilities within your IT network and the ePHI contained therein. You should conduct risk assessments annually at the very least – or you upgrade your IT infrastructure. In light of the proposed amendments to the Security Rule, conducting a risk assessmenttoidentify thesecuritygaps in your network against the proposed rule changes is essential.
Evaluate your existing email and communication platforms: to accommodate the upcoming changes to the Security Rule, many healthcare companies will need to upgrade to HIPAA compliant email communication solutions, as well as encrypted databases for securely storing ePHI at rest. Deploying an email services solution designed for the healthcare industry from a HIPAA compliant email provider like LuxSci, best ensures compliance with encryption and the other new requirements of the Security Rule.
Improve your organization’s incident response planning and documentation processes: develop all the required documentation to track the movement of patient data, and refine your processes for handling security events. This also encompasses training your staff on your new security policies and procedures.
Improve your organization’s cybersecurity posture: by implementing end-to-end encryption, network segmentation, zero-trust security infrastructure, data loss protection (DLP) protocols, and other measures that will better protect patient data.
Perform vendor due diligence: ensure your third-party service providers meet HIPAA compliance standards and that you have a Business Associate Agreement (BAA) in place with each vendor that can access your ePHI.
How Luxsci Can Help You Navigate the Proposed Changes to the HIPAA Security Rule
With more than 20 years of experience in delivering best-in-class secure HIPAA compliant marketing solutions for the healthcare industry, LuxSci is a trusted partner for healthcare organizations looking to secure their email and digital communications in line with regulatory standards and the industry’s highest security standards.
LuxSci’s suite of HIPAA-compliant solutions includes:
Secure Email: HIPAA compliant email solutions executing highly scalable email campaigns that include PHI – send 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 get a head start on upgrading your cybersecurity stance to ensure future HIPAA compliance? Contact us today!
For years, multi-factor authentication (MFA) was considered one of the most effective ways to protect sensitive systems. By requiring a second verification step, such as a text message code or push notification, organizations could significantly reduce the risk of compromised passwords.
But the threat landscape has changed.
Today, attackers routinely bypass traditional MFA using techniques such as MFA evasion, token replay attacks, and consent phishing. These methods are no longer rare or highly sophisticated. They are widely used, automated, and increasingly effective.
As a result, regulators, auditors, and security frameworks are raising expectations for authentication security. For healthcare organizations in particular, traditional MFA alone may no longer satisfy the HIPAA requirement to implement “reasonable and appropriate safeguards.”
In the near future, email systems that rely only on basic MFA, without conditional access or phishing-resistant authentication, may increasingly be viewed as security gaps during risk assessments.
Why Traditional MFA Is No Longer Enough
Traditional MFA still improves security compared to passwords alone. However, many common MFA methods were designed before today’s phishing techniques and cloud authentication attacks became widespread.
Common MFA methods include:
SMS verification codes
Email-based authentication codes
Push notifications to mobile apps
While these mechanisms add friction for attackers, they can still be intercepted or manipulated during sophisticated phishing attacks. Because modern attackers now target authentication workflows directly, organizations relying solely on traditional MFA may be more vulnerable than they realize.
How Attackers Bypass MFA Today
Cybercriminals increasingly rely on tools that capture credentials and authentication tokens during login sessions. Three attack techniques are now especially common.
MFA Evasion and Phishing Proxies – Attackers frequently deploy adversary-in-the-middle phishing kits that sit between the user and the real login service. When users enter their credentials and MFA code on a phishing page, the attacker forwards the information to the legitimate site and captures the authentication session. The user successfully logs in—but the attacker gains access as well. If attackers capture those tokens, they can reuse them to access the account directly.
Token Replay Attacks – After successful authentication, systems typically issue session tokens that allow users to remain logged in without repeated MFA prompts. This technique has been widely observed in attacks targeting cloud email platforms such as Microsoft 365, allowing attackers to access email data even when MFA is enabled.
Consent Phishing – Consent phishing bypasses MFA entirely. Instead of stealing passwords, attackers trick users into granting permissions to malicious applications that request access to their mailbox or files. If users approve the request, the attacker’s application receives persistent access to the account through APIs—often without triggering security alerts.
Why Email Authentication Matters Most in Healthcare
Email remains one of the most critical systems in healthcare organizations. It supports patient communication, internal collaboration, and the exchange of sensitive information. Unfortunately, it is also the most frequently targeted entry point for cyberattacks.
Once attackers gain access to an email account, they can:
Impersonate healthcare staff
Launch internal phishing attacks
Access sensitive patient communications
Extract protected health information (PHI)
Because of this, email authentication controls are becoming a major focus for security teams and compliance auditors alike.
Evolving Regulatory Expectations
HIPAA does not prescribe specific technologies, but it requires organizations to implement safeguards that are “reasonable and appropriate” based on risk. As new attack methods emerge, the definition of reasonable security evolves.
Today, many security frameworks and regulatory bodies are emphasizing stronger identity protections, including:
Phishing-resistant authentication
Conditional access policies
Monitoring for suspicious login behavior
Controls for third-party application permissions
Organizations that rely solely on basic MFA may increasingly struggle to demonstrate that their authentication protections are sufficient.
The Shift Toward Phishing-Resistant Authentication
To address the weaknesses of traditional MFA, many organizations are adopting phishing-resistant authentication technologies, which can be enabled with tools like Duo and Okta. These solutions rely on cryptographic authentication tied to trusted devices, which prevents attackers from capturing or replaying login credentials.
Examples include:
Hardware security keys
Passkeys
Certificate-based authentication
Because authentication is tied to both the device and the legitimate website domain, these technologies significantly reduce the success rate of phishing attacks.
Why Conditional Access Is Becoming Essential
Conditional access adds another layer of protection by evaluating context and risk before granting access. Instead of treating every login the same, conditional access policies analyze signals such as:
Device security status
Geographic location
Network reputation
User behavior patterns
If something appears unusual, such as a login from a new country, the system can require stronger authentication or block the attempt altogether. This risk-based approach to authentication helps prevent many account compromise scenarios.
The Future of HIPAA Risk Assessments
As authentication threats evolve, healthcare security assessments are increasingly focusing on identity protection maturity. Organizations may begin seeing findings related to:
Weak or outdated MFA methods
Lack of conditional access policies
Insufficient monitoring of login activity
Unrestricted third-party application permissions
In particular, email systems without advanced authentication protections may be flagged as high-risk vulnerabilities, especially when PHI is accessible.
LuxSci’s Modern Approach to MFA
Modern threats require more than a simple second login factor. LuxSci approaches authentication security with layered identity protection designed specifically for healthcare environments.
Instead of relying solely on basic MFA methods like SMS codes or email verification, LuxSci supports stronger authentication controls and policies that align with evolving security expectations. These protections can include:
Strong multi-factor authentication options
Monitoring for unusual login behavior
Enhanced identity verification mechanisms
By combining multiple security layers within its HIPAA-compliant secure communications email and marketing solutions, LuxSci helps healthcare organizations protect sensitive email communications while maintaining usability for providers, health plan administrators, payment providers, and patient engagement teams.
Conclusion
Multi-factor authentication remains an important security control—but not all MFA is created equal. Attack techniques such as phishing proxies, token replay, and consent phishing have demonstrated that traditional MFA methods can be bypassed. As a result, regulators and auditors are increasingly expecting stronger identity protections.
For healthcare organizations that rely heavily on email communications, the implications are significant. Weak authentication controls can expose sensitive patient data and may soon appear as high-risk findings during HIPAA risk assessments. The organizations best positioned for the future will be those that modernize authentication strategies now, moving toward phishing-resistant methods, conditional access policies, and layered identity protection.
Reach out to LuxSci today to learn how HIPAA compliant email can support both your organization’s engagement and cybersecurity needs.
FAQs
1. What is traditional MFA?
Traditional MFA refers to authentication methods that require a second verification step, typically SMS codes, email codes, or push notifications.
2. Why can attackers bypass MFA today?
Modern phishing tools can intercept authentication sessions or steal login tokens, allowing attackers to access accounts even when MFA is enabled.
3. What is phishing-resistant authentication?
Phishing-resistant authentication uses cryptographic methods tied to trusted devices, preventing attackers from capturing login credentials.
4. Why is email security especially important for healthcare organizations?
Email systems often contain patient communications and sensitive information, making them a common target for cyberattacks.
5. How can organizations improve authentication security?
Organizations can strengthen identity security by adopting phishing-resistant authentication methods, implementing conditional access policies, and monitoring login activity.
Boston & Helsinki, February 12, 2026 – LuxSci, a provider of secure healthcare communications solutions in the United States, and Oiva Health, a Nordic provider of Digital Care solutions in social and healthcare services, today announced that the companies are joining forces. Backed by Main Capital Partners (“Main”), the combination brings together two complementary platforms and teams, forming a strong transatlantic software group focused on secure healthcare communications.
Founded in 1999, LuxSci is a U.S. provider of HIPAA‑compliant, secure email, marketing, and forms solutions. Its application and infrastructure software enable organizations to securely deliver personalized, sensitive data at scale to support a broad range of healthcare communications and workflows including care coordination, benefits and payments, marketing, wellness communications, after care and ongoing care. Certified by HITRUST for the highest levels of data security, LuxSci serves dozens of healthcare enterprises and hundreds of mid‑market organizations.
Founded in 2010, Oiva Health is a provider of digital care and communications solutions in the Nordics. Headquartered in Finland, with additional offices in Denmark, Norway, and Sweden, Oiva Health offers digital care and digital clinic solutions – including digital visits, secure messaging, online scheduling and appointments, and caregiver communications – serving the long-term care, especially elderly care, and occupational healthcare verticals. The company employs approximately 60 people and has recently expanded across the Nordic region, with a growing presence in Norway and Sweden.
The combination of LuxSci and Oiva Health creates a larger, cross Atlantic group with complementary solutions, serving the U.S. and European markets. Together, the companies offer healthcare providers, payers, and suppliers a comprehensive suite of tools to communicate securely and compliantly, spanning communications, workflows, and virtual care delivery.
Daan Visscher, Partner and Co-Head North America at Main, commented: “We are pleased to announce this cross Atlantic transaction, creating an internationally active secure communications player within the healthcare and home care space. The combined product suite enables healthcare organizations to drive much needed efficiency gains in healthcare provision addressing a global trend of rising costs, aging population, and increasing pressure on resources needed to provide high-quality care.”
Mark Leonard, CEO of LuxSci, said, “We are thrilled to join forces with Oiva Health and believe that together we can truly make a difference in healthcare coordination, access, and delivery. We see an exciting path forward with our customers benefiting from an end-to-end, secure and compliant approach to optimizing both healthcare communications and today’s frontline workers, which we need now more than ever.”
Juhana Ojala, CEO at Oiva Health, concluded, “We look forward to this new chapter together with LuxSci. We are very excited about the strong alignment between our solutions, which especially strongly positions us to expand our flagship Digital Care offering to the high-potential U.S. care market – from care coordination to care delivery to in-home and institutional care.”
Nothing contained in this Press Release is intended to project, predict, guarantee, or forecast the future performance of any investment. This Press Release is for information purposes only and is not investment advice or an offer to buy or sell any securities or to invest in any funds or other investment vehicles managed by Main Capital Partners or any other person.
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About LuxSci
LuxSci is a U.S.-based provider of secure healthcare communications solutions for the healthcare industry. The company offers secure email, marketing, forms and hosting, delivering HIPAA‑compliant communication solutions that enable organizations to safely manage and transmit sensitive data. Founded in 1999, LuxSci serves more than 1,900 customers across healthcare verticals, including providers, payers, suppliers, and healthcare retail, home care providers, and healthcare systems, as well as organizations operating in other highly regulated industries. LuxSci is HITRUST‑certified with example clients being Athenahealth, 1800 Contacts, Lucerna Health, Eurofins, and Rotech Healthcare, among others.
About Oiva Health
Oiva Health is a Digital Care provider in the Nordics, offering a comprehensive Digital Platform for integrated health and care services to digitalize primary healthcare, social care, hospital healthcare and long-term care services. The company was founded in 2010 and currently employs approximately 60 people in Finland, Denmark, Norway, and Sweden serving domestic municipalities, customers and partners, such as City of Helsinki, Keski-Suomi Welfare Region, Länsi-Uusimaa Welfare Region in Finland, and Viborg municipality in Denmark with its Digital Care platform. Annually over 5 million customer contacts are handled digitally through Oiva Health’s Digital Care and Digital Clinic platforms.
About Main Capital Partners
Main Capital Partners is a software investor managing private equity funds active in the Benelux, DACH, the Nordics, France, and the United States with approximately EUR 7 billion in assets under management. Main has over 20 years of experience in strengthening software companies and works closely with the management teams across its portfolio as a strategic partner to achieve profitable growth and create larger outstanding software groups. Main has approximately 95 employees operating out of its offices in The Hague, Düsseldorf, Stockholm, Antwerp, Paris, and an affiliate office in Boston. Main maintains an active portfolio of over 50 software companies. The underlying portfolio employs approximately 15,000 employees. Through its Main Social Institute, Main supports students with grants and scholarships to study IT and Computer Science at Technical Universities and Universities of Applied Sciences.
The sender of this press release is Main Capital Partners.
For more information, please contact:
Main Capital Partners Sophia Hengelbrok (PR & Communications Specialist)
