In today’s connected world with millions of messages bombarding people every second of the day, personalized engagement over digital channels is a requirement for any business – especially in healthcare. However, ensuring that your marketing efforts comply with the Health Insurance Portability and Accountability Act (HIPAA) can be a daunting task that never quite gives you the peace of mind you need. The good news is that you don’t have to lose sleep at night worrying about whether your marketing campaigns are secure and protected from data breaches and outside threats. With the right strategies and solutions, you can create HIPAA-compliant marketing campaigns that not only keep data protected, but also boost lead conversions, improve outcomes, and reduce costs.
Here are some simple but necessary steps to get you off and running with HIPAA-compliant marketing campaigns today:
Understand HIPAA Requirements
Before embarking on any marketing campaign, it’s crucial to have a thorough understanding of HIPAA regulations. HIPAA sets strict guidelines for keeping protected health information (PHI) safe. Ensure your marketing team is well-versed in these regulations to avoid any compliance failures. If you’re not sure, check out this recent LuxSci blog post on understanding encryption requirements for HIPAA-compliant email.
Leverage Automated Data Encryption
Safeguarding protected health information (PHI) is a requirement with HIPAA. Use advanced encryption methods – including dedicated cloud infrastructures and automation that encrypts every email sent with no user intervention required – to secure patient and customer data both in transit and at rest. This ensures that any data shared during marketing campaigns remains confidential and secure from breaches.
Implement Consent Management
Obtaining explicit consent from patients and customers before using their information in marketing campaigns is a also requirement and non-negotiable. Make sure you have a consent management system that records, stores, and manages patient and customer consent effectively and efficiently.
Personalize and Hypersegment Campaigns Using PHI Data
HIPAA does not need to hold you back. In fact, using PHI data can take your email targeting and messages to the next level. Personalized marketing can significantly improve patient and customer engagement and increase your lead conversions. Use PHI data to tailor your marketing messages to the specific needs and preferences of precise segments to ensure content is relevant and valuable – and actionable.
Utilize Encryption for All Healthcare Communications
Communicating with patients and healthcare customers through secure channels is essential for ALL communications, not just those that require HIPAA compliance. Use flexible encrypted email services, secure messaging apps, and patient portals to share sensitive information, and protect yourself from the latest cybersecurity threats at all times.
Monitor, Analyze and Improve Marketing Campaigns
Regularly test, monitor and analyze your marketing campaigns to ensure ongoing HIPAA compliance and the best results, using data on emails delivered, opened, clicked and secured. Take action in real-time to improve segmentation and results based on your latest business needs and deliverability requirements.
Improved healthcare experiences – Personalized and secure communications build trust and strengthen relationships with patients and customers.
More lead conversions – Hypersegmentation and automation drive higher conversion rates and improve patient and customer engagement.
Increased sales opportunities and revenue – Targeted, timely communications and campaigns drive the best results for growing your business.
Call to Action: ‘How-To’ Webinar on HIPAA-Compliant Marketing
Embracing HIPAA-compliant marketing is not just about avoiding penalties; it’s about delivering superior patient and customer experiences – and achieving business success. With HIPAA-compliant marketing, you can create powerful campaigns that protect PHI data, drive lead conversions, and improve patient and customer outcomes.
Are you ready to transform your healthcare marketing strategy – in a HIPAA-compliant way?
Join us for a webinar on How to Harness HIPAA-Compliant Marketing and Workflows, taking place on Tuesday, August 6 at 12:00PM Eastern Time. We’re joining forces with the experts over at Compliancy Group for an informative ‘how-to’ session on the latest best practices, success stories and easy-to-use tools for ensuring compliance across your organization – with a focus on marketing, workflows and automation. This includes:
Effectively and efficiently managing compliance across multiple standards
How to increase engagement and drive sales with HIPAA-compliant marketing
Optimizing workflows with secure forms and automation
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.
Due to the fact that it’s simple, instantaneous, cost-effective, and nearly universally adopted, email is an essential part of all healthcare marketing engagement strategies. However, consistent, personalized email engagement – particularly at scale – can be challenging.
Fortunately, Automated Workflows offer a solution, allowing healthcare companies to deliver the right messages to the appropriate individuals at the right time, based on their individual engagement with emails..
In this post, we’ll explore the concept of Automated Workflows, the considerable benefits they offer healthcare companies, and the variety of ways they can be used to increase engagement and result in greater satisfaction and better healthcare outcomes for your patients and customers.
What Are Automated Workflows?
An Automated Workflow is a sequence of actions, known as’ Steps’ in LuxSci Secure Marketing, that a Contact (i.e., a patient or customer) moves through over time, based on a series of pre-defined rules or triggers.
Each Step is programmed to automatically perform a specific function, such as sending an email or updating a Contact, when certain conditions are in place. These conditions could include:
A Contact opening a message.
A Contact clicking through on a link.
A specified amount of time having elapsed..
A data update via an API call
By evaluating conditions to initiate the appropriate Step, Automated Workflows facilitate more timely, consistent, and personalized communication with Contacts (patients and customers ). As a result, healthcare companies can effectively harness Automated Workflows to develop dynamic, personalized email engagement journeys that adapt according to your patients and customers’ needs and prior interactions.
What Are the Benefits of Automated Workflows?
Let’s look at the various advantages that Luxsci Automated Workflows offer.
Reduced Administrative Workload
Arguably, the most significant benefit of Automated Workflows is the extent to which they lower the administrative burden of email engagement campaigns for healthcare organizations.
First and foremost, Automated Workflows eliminate the need for an employee to manually send your Contacts messages. As well as the manual effort, it removes a great deal of thought from the process – as someone isn’t required to remember to send an email.
By the same token, this reduces the scope for human error, preventing the possibility of an employee neglecting to send an important message, sending it to the wrong person, or worse, accidentally exposing patient data, i.e., electronic protected health information (ePHI).
The effort that Automated Workflows reduce is typically repetitive work that staff are glad to be free of, giving them additional time to focus on tasks that provide greater value and better contribute to better patient care and/or the customer experience.
Enhanced Scalability
The time saved by employing Automated Workflows increases with the size of your Contact List and the scale of your engagement campaigns. In fact, enterprise-scale campaigns, with volumes of hundreds of thousands to millions of emails, are only feasible through the use of automation.
Similarly, Automated Workflows enable healthcare organizations to run differing, personalized email campaigns aimed at unique patient or customer segments. As well as automatically sending each message at the appropriate time, they provide tracking capabilities to determine the outcome of each message.
Increased Consistency in Communication
Because Automated Workflows remediate the risk of emails going unsent, they facilitate more timely and consistent communications with patients and customers. This makes healthcare providers, payers, and suppliers appear more reliable and consistent, building trust and greater levels of satisfaction from Contacts. More importantly, recipients are better able to track what’s happening with their healthcare and assume a more proactive role overall healthcare journey..
Finally, creating an Automated Workflow requires healthcare organizations to carefully consider how they communicate with different Contact segments. Namely, the likely journey, or communication path, different types of Contacts take, i.e., information they need to know at a particular stage in their healthcare journey, the optimal order in which information needs to be presented, etc. This allows healthcare companies to become more in-tune with their patients’ and customers’ needs, enabling them to craft more valuable email communications that boost engagement.
Personalized Healthcare Engagement
Perhaps the most significant benefit of Automated Workflows is that they enable adaptive, personalized engagement for healthcare marketing and communications campiagns. Instead of manually tracking where each Contact is in a given engagement sequence, or worse, merely having to guess, you know precisely where they are. Consequently, you’re acutely aware of their needs and the exact nature of the emails you need to send them next.
This, in turn, enables more effective Contact nurturing, i.e, strengthening your organization’s connection with each individual. When at its most effective, this may allow you to anticipate your Contacts’ needs, enabling you to send them communications, such screening or testing recommendations, educational materials, or product and service suggestions, that support their healthcare journey and enhance their quality of care.
Automated Workflow Use Cases
Automated Workflows are a powerful tool for increasing healthcare marketing and communications engagement because they can be applied to a wide range of use cases. Let’s take a look at some of the most common and impactful ways email automation can be used by healthcare companies.
New Product Announcements: keeping patients and customers in the loop on your company’s latest offerings, as well as improvements to existing products and services that are likely to be of interest, based on their data and past actions.
Personalized recommendations: suggesting products or services based on the recipient’s past purchases or engagement history.
Re-Engagement Campaigns: Automated Workflows can also be used to reconnect with Contacts with whom engagement has waned or was never completely established, sending them personalized messages to encourage specific actions or reignite interest.
New Member Onboarding: welcoming new patients or customers with a structured series of emails that introduces your services, provides technical assistance (where applicable), details subsequent steps, and explains how to get the most value from your products or services.
Appointment Reminers and Follow-Ups: sending reminders, care instructions, medication adherence advice, or details on how to book subsequent appointments, for instance, after a patient visit.
Patient Education Campaigns: taking patients through a structured curriculum on managing their medical condition or required lifestyle changes to improve their health..
Preventative Care Communications: proactively sending reminders for screenings, check-ups, vaccinations, etc., based on PHI such as a patient’s age, gender, health condition or lifestyle risk factors.
Milestone Communications: sending personalized messages to acknowledge birthdays, enrollment anniversaries, and other pertinent dates. These can also be combined with preventative care communications, to send recommendations or other advice, based on the contact’s age, for instance.
Feedback Collection: acquiring patient and customer feedback by sending follow-up surveys a set amount of time after a visit, procedure, purchase, etc.
How Automated Workflows Work in LuxSci Secure Marketing
To round off this post, let’s take a deeper look at how Automated Workflows work within LuxSci’s Secure Marketing solution. LuxSci’s Automated Workflows enhance your organization’s HIPAA compliant healthcare marketing and email campaigns by giving you complete control of:
When each email is sent
Which Contacts receive particular communications according to their behavior, needs, and other PHI-based attributes
Which engagement path or branch a Contact takes based on their email actions
Here’s a look at LuxSci’s Automated Workflows key capabilities in greater detail.
Smart Event-Based Branching and Conditions
You can branch Workflows to trigger targeted messaging based on a Contact’s attributes or certain engagement events, resulting in more relevant and effective healthcare journeys with more desirable outcomes.
User actions:
Mailing list sign-ups
Form completion
Downloading a resource.
Time-based triggers:
A set period after a visit or procedure
A defined period of inactivity or lack of contact
Milestones, e.g., birthdays, anniversaries.
Behavioral triggers:
Email opens
Clicking on links
Visiting particular pages on a site or
A lack of engagement with previous emails.
Transactional triggers:
Purchasing a product or service
Signing up for an event
Order confirmations or shipping updates after a purchase.
API-triggered events
Lab results or similar correspondence becoming available
Changes to data in EHR systems, CDP platforms, or CRM systems..
Automated Segment Management
Automated Workflows can be used to dynamically add Contacts to segments based on demographics, past behavior, purchase history, and similar events. This enables more precise targeting and email personalization as they progress through specific Steps in each Workflow.
Navigation Across Steps
Automated Workflows are also capable of navigating Contacts across different Steps or completely different Workflows depending on engagement outcomes and updates to a Contact’s PHI. Better still, if a Step has already been visited, LuxSci Secure Marketing automatically prevents repetition and infinite loops.
Automate Your Healthcare Marketing and Engagement Efforts
LuxSci Secure Marketing is a HIPAA compliant healthcare marketing solution especially designed for the stringent security and regulatory requirements of the healthcare industry. Our solution enables healthcare organizations to confidently communicate with patients and customers at scale without risking compliance violations, driving increased engagement and boosting the ROI of their marketing campaigns in the process.
The latest version of LuxSci’s Secure Marketing solution with Automated Workflow functionality streamlines your company’s outreach efforts, saving considerable time, reducing human effort, and facilitating intelligent Contact management.
What’s more, LuxSci’s reporting capabilities empower you to carefully track the results of your healthcare engagement campaigns, gaining insights at every step, including:
Which Contacts received particular messages
Who engaged with email communication, and how
Precise points where drop-offs in engagement occur
The engagement achieved with each Step in the Workflow
To learn more about LuxSci’s Secure Marketing solution and how Automated Workflows boost engagement for your healthcare marketing and communications campaigns, contact us today.
Modern-day healthcare organizations rely on a growing array of partners and vendors to provide them with the tools they need to effectively serve patients and customers.
However, while new digital solutions and healthcare ecosystems often result in greater productivity and efficiency, they also increase the number of third parties a company must communicate with and share protected health information (PHI), requiring a business associate agreement (BAA). Unfortunately, this increases the risk of PHI being exposed, as it increases a healthcare organization’s supply chain network and the number of external organizations with access to their data, significantly raising the risk of a security breach.
This is where the concept of shared responsibility comes in.
In this article, we explore the shared responsibility model for data security, explaining the concept, the role of a BAA in shared responsibility, and why healthcare companies need to know how it works and where it factors into their HIPAA compliance efforts.
What Is The Shared Responsibility Model?
Shared responsibility is a core data security principle that divides the responsibility for protecting data between a company that collects the data and a vendor that supplies the infrastructure or systems used to process said data.
The shared responsibility model grew in prominence as more companies moved to cloud-based environments and applications. In the past, when companies kept their systems and data onsite, they had more control over who could access their data and, subsequently, a better ability to mitigate data security risks.
However, in adopting cloud-based infrastructure and applications, companies have to process and store their data in the cloud – often in shared infrastructure with other vendors using the same cloud – which consequently shifts some of the responsibility of information security to the cloud service provider (CSP) itself. This marked a profound shift in the way data was handled, transmitted, and stored – necessitating an evolved approach to data security.
This fundamental shift in the way companies consume infrastructure and use apps ushered in the shared responsibility model: Where the cloud vendor provides the infrastructure or application, including HIPAA compliant and high secure environments, but it’s still the responsibility of the client to configure and use it securely.
Business Associate Agreements (BAAs) and Shared Responsibility
By detailing the respective responsibilities of healthcare companies or Covered Entities (CEs) and their vendors or Business Associates (BAs) in securing PHI, a Business Associate Agreement is a prime example of shared responsibility.
For example, the Business Associate shoulders the responsibility of providing the data safeguards required by HIPAA to secure patient data, such as infrastructure, encryption, audit logging, and even physical onsite security.
The Covered Entity, meanwhile, is responsible for conducting risk assessments, defining access control policies and processes, configuring services accordingly, workforce training, and continuous monitoring.
Additionally, both parties have the obligation to report security incidents to each other, as well as being independently accountable to the U.S. Department of Health and Human Services (HHS).
Why Shared Responsibility Is Essential for HIPAA Compliance
For healthcare companies, having a firm grasp of the shared responsibility model for safeguarding and securing PHI, and how they fit within your overall security posture is essential (for two key reasons).
Security Gaps
Firstly, clearly understanding the shared responsibility decreases the likelihood of security gaps. If CEs are under the impression that the vendor handles all aspects of data security, they won’t be as vigilant. They’ll be less inclined to configure services, educate their staff accordingly, pay appropriate attention to vendor security alerts, etc.
But the same is also true for BAs: If they assume their client does most of the heavy lifting in securing the data disclosed to them, they could be remiss in their duties to protect it. Without shared responsibility, each side simply assumes the other is covering a safeguard, opening the door for security gaps that malicious actors can exploit.
Fortunately, by detailing both parties’ (CEs and BAs) responsibilities and liabilities regarding data protection, a BAA removes this ambiguity and, more importantly, reduces the risk of security gaps. It’s critical to know the details and work with vendors building products for compliance versus implementing a tick-box approach to compliance that places too much burden on the CE.
Covered Entities (CEs) Are Ultimately Accountable
Subsequently, the second reason why it’s essential for CEs to understand the shared responsibility model, and increase their cybersecurity readiness accordingly, is that it’s the CE that’s ultimately held accountable for data breaches.
Mistakenly thinking that a BAA automatically makes them compliant may result in healthcare companies underinvesting in training, monitoring, and incident response. Conversely, understanding that even with a BAA in place, they’re the ones primarily accountable for protecting PHI gives them a greater sense of urgency to properly implement HIPAA compliant security measures.
The Covered Entity’s Role Within Shared Responsibility
Let’s look at the ways that healthcare companies have to hold up their end in the shared responsibility model.
Choose Compliance-Conscious Vendors
First and foremost, companies have to choose the right vendors to supply them with HIPAA compliant services and solutions.
Look for companies that market themselves as HIPAA compliant and display a detailed understanding of HIPAA requirements, particularly the HIPAA Security Rule. Do your due diligence and perform deeper dives on potential vendors, researching their stated security features, reviews from existing clients, whether they have certifications like HITRUST – and if they’ve been involved in any data breaches.
Naturally, a core prerequisite of being a HIPAA compliant vendor is being willing to sign a BAA, so you can immediately rule out any vendors not willing to do so. For instance, some healthcare companies may assume they can use widely adopted solutions such as SendGrid, Mailchimp, but they don’t offer a BAA.
Once you’ve confirmed a vendor offers a BAA, look through it to establish its terms and determine if it covers the services you’re interested in.
Configuration
Another core component of shared responsibility is comprehensive configuration management. While the BA’s responsibility is to provide a secure solution that satisfies HIPAA requirements, it’s the CE’s responsibility to configure it securely to fit within their IT ecosystem.
Features that often require configuration include:
Access control: Role-based access, Zero Trust, Multi-Factor Authentication (MFA).
Feature restrictions: Disabling default configurations that enable integration with non-compliant tools.
Auditlogging: Enabling audit logging and configuring log formats.
Retention settings: How long to retain audit logs and who is permitted to review them.
Finally, establishing a patch management strategy, i.e., when and how your organization applies software updates, is an important element of configuration. While the vendor must release updates to fix security vulnerabilities discovered in their solutions, it’s up to healthcare companies to deploy the patches.
Training
Regardless of how many security features a vendor bakes into their solutions, once deployed by a healthcare company, the tool is only as secure as the practices of their least security-conscious employee. Consequently, companies must train their staff on how to properly use a solution to process protected health information and sensitive data. The more an employee is required to handle PHI, the more thorough and frequent their training should be.
Key aspects of comprehensive cybersecurity training include:
Common cyber threats: what the most prevalent cyber threats are and how to recognize them.
Incident response: how to report a suspected security incident, i.e., who to contact and when.
Specific solution training: how to securely use systems that process PHI
Scope awareness: knowing which services within your organization’s IT ecosystem are HIPAA-compliant and which are not
Reporting
Although both healthcare companies and BAs have notification obligations to the HHS in the event of a data breach involving PHI, it’s the CE that bears most of the investigative burden.
Firstly, while a BA may report a security incident, it’s the CE’s responsibility to conduct a risk assessment to determine the probability of compromise of PHI, assess risk, and determine whether an official notification of a breach to HHS is necessary.
Secondly, BAs must notify the CE without unreasonable delay and no later than 60 days after discovery. Although BAs often wait to complete internal investigations before notifying the CE, the CE’s 60-day clock starts upon the BA’s discovery, not upon the BA’s report. Therefore, BA delays can create compliance risks for the CE.
To prevent this, where possible, you can include stricter contractual reporting timelines in the BAAs. This constantly keeps your company in the loop, ensuring you have sufficient lead time to complete your own investigations and your HIPAA-regulated deadlines.
LuxSci – Secure Healthcare Communications
Developed specifically to fulfil the stringent regulatory and ever-evolving data security needs of the healthcare sector, LuxSci’s secure email, text, marketing and forms solutions help companies protect PHI and personalize communications.
Equally as importantly, instead of leaving you to “figure it out” – pushing additional responsibility back onto your company – LuxSci has a reputation for the best customer support in the business, offering onboarding, detailed documentation, secure default configurations, and ongoing support to help navigate the murky waters of HIPAA compliance, while getting best-in-class performance out of your solution.
As in any industry, the healthcare sector is eager to embrace any new technology solution that increases productivity, enhances operational efficiency, and cuts costs. However, the rate at which healthcare companies – and their patients and customers – have had to adopt new software and digital tools has skyrocketed since the pandemic. And while a lot of this software is beneficial, a key question arises: is it HIPAA compliant? While an application may serve an organization’s needs – and may be eagerly embraced by patients – it also needs to have the right measures in place to safeguard protected health information (PHI) to determine if it is indeed HIPAA compliant.
Whether you’re a healthcare provider, software vendor, product team, or IT professional, understanding what makes software HIPAA compliant is essential for safeguarding patient data and insulating your organization from the consequences of falling afoul of HIPAA regulations.
With this in mind, this post breaks down the key indicators of HIPAA compliant software, the technical requirements you should look for, and best practices for ensuring your software is HIPAA compliant.
What Does It Mean for Software to Be HIPAA-Compliant?
The Health Insurance Portability and Accountability Act (HIPAA) sets national standards for safeguarding PHI, which includes any data related to a patient’s health, treatment, or payment details. In light of this, any applications and systems used to process, transmit, or store PHI must comply with the stringent privacy, security, and breach notification requirements set forth by HIPAA.
Subsequently, while healthcare organizations use a wide variety of software, most of it is likely to be HIPAA-compliant. Alarmingly, many companies aren’t aware of which applications are HIPAA-compliant and, more importantly, if there’s a need for compliance in the first place.
However, it’s important to note that HIPAA itself does not certify software. Instead, it’s up to software vendors to implement the necessary security and privacy measures to ensure HIPAA compliance. Subsequently, it’s up to healthcare providers, payers, and suppliers to do their due diligence and source HIPAA compliant software.
How to Determine If Software Is HIPAA Compliant
So, now that we’ve covered why it’s vital that the applications and systems through which sensitive patient data flows must be HIPAA compliant, how do you determine if your software meets HIPAA requirements? To assess whether software is HIPAA compliant, look for these key indicators:
1. Business Associate Agreement (BAA)
A HIPAA compliant software provider must sign a Business Associate Agreement (BAA) with covered entities, i.e., the healthcare company. A BAA is a legal contract that outlines the vendor’s responsibility for safeguarding PHI. If a software provider doesn’t offer a BAA, their software is NOT HIPAA compliant.
Now, if a vendor offers a BAA, it should be presented front and center in their benefits, terms or conditions, if not on their website homepage as part of their key features. If a vendor has taken the time and effort to make their infrastructure robust enough to meet HIPAA regulations, they’ll want to make it known to reassure healthcare organizations of their suitability to their particular needs.
2. End-to-End Encryption
A key requirement of the HIPAA Security Rule is that sensitive patient data is encrypted end to end during its transmission. This means being encrypted during transit, i.e., when sent in an email or entered into a form, and at rest, i.e., within the data store in which it resides.
In light of this, any software that handles PHI should use strong encryption standards, such as:
Transport Layer Security (TLS – 1.2 or above): for secure transmission of PHI in email and text communications.
AES (Advanced Encryption Standard) 256: the preferred encryption method for data storage as per HIPAA security standards, due to its strength.
3. Access Controls and User Authentication
One of the key threats to the privacy of patient data is access by unauthorized parties. This could be from employees within the organization who aren’t supposed to have access to PHI. In some, or even many, cases, this may come down to lax and overly generous access policies. However, this can result in the accidental compromise of PHI, affecting both a patient’s right to privacy and, in the event patient data is unavailable, operational capability.
Alternatively, the exposure of PHI can be intentional. One on hand, it may be from employees working on behalf of other organizations, i.e., disgruntled employees about to jump ship to a competitor. More commonly, unauthorized access to patient data is perpetrated by malicious actors impersonating healthcare personnel. To prevent the unintended exposure of PHI, HIPAA compliant infrastructure, software and applications must support access control policies, such as:
Role-based access control (RBAC): the restriction of access to PHI based on their job responsibility in handling PHI, i.e.., an employee in billing or patient outreach. A healthcare organization’s security teams can configure access rights based on an employee’s need to handle patient data in line with their role in the company.
Multi-factor authentication (MFA): this adds an extra layer of security beyond user names and passwords. This could include a one-time password (OTP) sent via email, text, or a physical security token. MFA is very diverse and can be scaled up to reflect a healthcare organization’s security posture. This could include also biometrics, such as retina and fingerprint scans, as well as voice verification.
Zero-trust security: a rapidly emerging security paradigm in which users are consistently verified, as per the resources they attempt to access. This prevents session hijacking, in which a user’s identity is trusted upon an initial login and verification. Instead, zero trust continually verifies a user’s identity.
Robust password policies: another simple, but no less fundamental, component of user authentication is a company’s password policy. While conventional password policies emphasize complexity, i.e., different cases, numbers, and special characters, newer password policies, in contrast, emphasize password length.
4. Audit Logs & Monitoring
A key HIPAA requirement is that healthcare organizations consistently track and monitor employee access to patient data. It’s not enough that access to PHI is restricted. Healthcare organizations must maintain visibility over how patient data is being accessed, transferred, and acted upon (copied, altered, deleted). This is especially important in the event of a security event when it’s imperative to pinpoint the source of a breach and contain its spread.
In light of this, HIPAA compliant software must:
Maintain detailed audit logs of all employee interactions with PHI.
Provide real-time monitoring and alerts for suspicious activity.
Support log retention for at least six years, as per HIPAA’s compliance requirements.
5. Automatic Data Backup & Disaster Recovery
Data loss protection (DLP) is an essential HIPAA requirement that requires organizations to protect PHI from loss, corruption, or disasters. With this in mind, a HIPAA-compliant software solution should provide:
Automated encrypted backups: real-time data backups, to ensure the most up-to-date PHI is retained in the event of a security breach.
Comprehensive disaster recovery plans: torapidly restore data in case of cyber attack, power outage, or similar event that compromises data access.
Geographically redundant storage: a physical safeguard that sees PHI. stored on separate servers in different locations, far apart from each other. So, if one server goes down or is physically compromised (fire, flood, power outage, etc.,) patient data can still be accessed.
6. Secure Messaging and Communication Controls
For software that involves email, messaging, or telehealth, i.e., phone or video-based interactions, in particular, HIPAA regulations require:
End-to-end encryption: for all communications, as detailed above.
Access restrictions: policies that only enable those with the appropriate privileges to view communications containing patient data.
Controls for message expiration: automatically deleting messages after a prescribed time to mitigate the risk of unauthorized access.
Audit logs: to monitor the inclusion or use of patient data.
7. HIPAA Training & Policies
Even the most secure software can be compromised if its users aren’t sufficiently trained on how to use it. More specifically, the risk of a security breach is amplified if employees don’t know how to identify suspicious behavior and who to report it to if an event occurs. With this in mind, it’s prudent to look for software vendors that:
Offer HIPAA compliance and cyber safety awareness training for users.
Implement administrative safeguards, such as usage policy enforcement and monitoring.
Support customizable security policies to align with your organization’s compliance needs.
Shadow IT and HIPAA Compliance
Shadow IT is an instance of an application or system being installed and used within a healthcare organization’s network without an IT team’s approval. Despite its name, shadow IT is not as insidious as it sounds: it’s simply a case of employees unwittingly installing applications they feel will help them with their work. The implications, however, are that:
IT teams are unaware of said application, and how data flows through it, so they can’t secure any PHI entered into it.
The application may have known vulnerabilities that are exploitable by malicious actors. This is all the more prevalent with free and/or open-source software.
While discussing the issue of shadow IT in general, it’s wise to discuss the concept of “shadow AI” – the unauthorized use of artificial intelligence (AI) solutions within an organization without its IT department’s knowledge or approval.
It’s easily done: AI applications are all the rage and employees are keen to reap the productivity and efficiency gains offered by the rapidly growing numbers of AI tools. Unfortunately, they fail to stop and consider the data security risks present in AI applications. Worse, with AI technology still in its relative infancy, researchers, vendors, and other industry stakeholders have yet to develop a unified framework for securing AI systems, especially in healthcare.
Consequently, the risks of entering patient data into an AI system – particularly one that’s not been approved by IT – are considerable. The privacy policies of many widely-used AI applications, such as ChatGPT, state the data entered into the application, during the course of engaging with the platform, can be used in the training of future AI models. In other words, there’s no telling where patient data could end up – and how and where it could be exposed.
The key takeaway here is that entering PHI into shadow IT and AI applications can pose significant risks to the security of patient data, and employees should only use solutions vetted, deployed, and monitored by their IT department.
Best Practices for Choosing HIPAA Compliant Software
Now that you have a better understanding of how to evaluate software regarding HIPAA compliance, here are some best practices to keep in mind when selecting applications to facilitate your patient engagement efforts:
✔ Look for a BAA: quite simply, having a BAA in place is an essential requirement of HIPAA-compliant software. So, if the vendor doesn’t offer one, move on.
✔ Verify encryption standards: ensure the software encrypts PHI both at rest and in transit.
✔ Test access controls: choose HIPAA-compliant software that allows you to restrict access to PHI based on an employee’s role within the organization.
✔ Review audit logging capabilities: HIPAA compliant software should track every PHI interaction. This also greatly assists in incident detection and reporting (IDR), as it enables security teams to pinpoint and contain cyber threats should they arise.
✔ Ensure compliance support: knowing the complexities of navigating HIPAA regulations, a reputable software vendor should provide comprehensive documentation on configuring their solution to match the client’s security needs. Better yet, they should provide the option of cyber threat awareness and HIPAA compliance training services.
✔ Create a List of Software Vendors: combining the above factors, it’s prudent for healthcare organizations to compile a list of HIPAA compliant software vendors that possess the features and capabilities to adequately safeguard PHI.
Choosing HIPAA Compliant Software
Matching the right software to a company’s distinctive workflows and evolving needs is challenging enough. However, for healthcare companies, ensuring the infrastructure and applications within their IT ecosystem also meet HIPAA compliance standards requires another layer of, often complicated, due diligence.
Failure to deploy a digital solution that satisfies the technical, administrative, and physical security measures required in a HIPAA compliant solution exposes your organization to the risk of suffering the repercussions of non-compliance.
If select and deploy the appropriate HIPAA compliant software, in contrast, your options for patient and customer engagement are increased, and you’ll be able to include PHI in your communications to improve patient engagement and drive better health outcomes. Schedule a consultation with one of our experts at LuxSci to discuss whether the software in your IT ecosystem meets HIPAA regulations. and how we can assist you in ensuring your organization is communicating with patient and customers in a HIPAA compliant way.
