As threats to email security are increasing, organizations are looking for ways to enhance their security and reduce risk. One option is a secure email gateway. In this article, we review what secure email gateways are and how they can be used to secure sensitive data as it flows into and out of your accounts.
Protect Your Accounts With A Secure Email Gateway
Secure email gateways are an excellent way to strengthen the security of your email accounts without a costly switch to a new email provider. They layer on top of your existing email accounts to encrypt messages, scan for threats, and even capture messages for archival or backup purposes. They can also hide the sender’s IP address because messages are routed through another email infrastructure before delivery to the recipient. If you are concerned about increasing risks to sensitive data, secure email gateways offer a simple and effective way to enhance your email security.
How Do Secure Email Gateways Work?
When using a secure email gateway, your messages are routed to a separate server before being sent or received. When sending an outbound message with LuxSci’s Secure Connector, it is routed through our SecureLine encryption before being securely delivered to the recipient. A copy of the message may also be sent to an independent email archive to help meet compliance requirements for message retention.
For incoming messages, the gateway can employ email filtering technology to quarantine suspicious messages. These technologies can scan incoming messages and prevent spammers and scammers from reaching employee inboxes and wreaking havoc. Just like with outbound email sending, the gateway can also capture a copy of inbound messages and retain them in an independent message archive.
The exact features of a secure email gateway will vary from vendor to vendor, but these represent some of the core functions that these tools provide. Simply put, a secure email gateway protects both incoming and outgoing messages to ensure that sensitive data is guarded from threats.
Why Choose a Secure Gateway?
There are two main reasons to implement a secure email gateway: the security and compliance benefits and their ease of use. Let’s look at each.
Compliance and Security Benefits
Many companies, like healthcare organizations, must comply with regulations for protecting patient or customer data. Many organizations grapple with the best way to secure potentially sensitive communications without interfering with or slowing down critical business workflows. Because secure email gateways layer on top of existing email accounts, they offer a speedy way to bring your organization into compliance with data security and retention guidelines.
As email continues to be an important channel for essential business communications, all organizations can benefit from protecting their employee accounts and reducing their risk and liability.
Easy to Administer and Use
Another benefit of using a secure email gateway is that your organization does not need to switch your primary email provider to enhance its security. Changing to a more secure email provider can be extremely challenging, especially if you have a lot of users with a lot of data that needs to be migrated to a new system. Add on the training time, and some organizations will find that switching email providers is a significant burden on the organization.
Installing a secure email gateway is very easy for account administrators and often does not require additional training or implementation for email users. Employees can continue to use their regular Microsoft or Google email accounts and do not need to take additional steps to learn an entirely new email program. With 73% of breaches in the healthcare industry caused by human factors, implementing tools that don’t rely on employee decision-making is essential.
Learn More About LuxSci’s Secure Connector
LuxSci’s Secure Connector is unlike other secure email gateways in that it encrypts every email automatically to reduce the risk of breaches caused by human errors. LuxSci provides the flexibility to opt-in to more secure methods of encryption for highly sensitive messages. Email filtering and archival tools are also available to reduce risk and improve resilience in the case of a cyber incident. Contact our sales team to learn more about our email security tools.
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.
Google Forms is not HIPAA compliant by default and cannot be used to collect protected health information (PHI) without additional measures. While Google Workspace can be configured for HIPAA compliance with a signed Business Associate Agreement (BAA), this agreement specifically excludes Google Forms from covered services. Healthcare organizations must use alternative form solutions designed for healthcare data collection to maintain HIPAA compliance.
Understanding HIPAA Requirements for Digital Forms
Digital forms used by healthcare organizations must meet specific security and privacy standards to comply with HIPAA regulations. Any platform collecting patient information needs encryption during transmission, access controls, audit logging, and secure data storage. Forms must include proper patient authorization language and maintain data confidentiality throughout processing. Google’s consumer products, including the standard version of Google Forms, lack many of these required security features. Healthcare providers who collect PHI through non-HIPAA compliant systems risk substantial penalties for HIPAA violations.
Google Workspace and Business Associate Agreements
Google offers a Business Associate Agreement (BAA) for its Google Workspace (formerly G Suite) business customers. This agreement establishes Google as a business associate under HIPAA and defines responsibilities for protecting healthcare information. However, Google explicitly excludes certain services from its BAA coverage, including Google Forms. The BAA typically covers Gmail, Google Calendar, Google Drive, and similar core services when properly configured. Healthcare organizations attempting to use Google Forms for PHI collection, even with a signed BAA, would violate their agreement terms and HIPAA regulations.
Security Limitations of Google Forms
Google Forms lacks several technical safeguards required for handling protected health information. The platform does not provide adequate access controls to limit form data visibility within organizations. Audit trail capabilities for tracking who has viewed or downloaded form responses do not meet HIPAA standards. While Google implements basic transport layer security, the form data storage and transmission methods were not designed for highly regulated healthcare information. The platform also lacks features for obtaining and documenting patient authorization as required under the HIPAA Privacy Rule.
Alternative HIPAA Compliant Form Solutions
Healthcare organizations have various compliant alternatives for collecting patient information electronically. Purpose-built healthcare form platforms include advanced security features like end-to-end encryption, detailed access logging, and healthcare-specific authorizations. These specialized systems integrate with electronic health records and secure messaging systems while maintaining compliance. Many vendors provide HIPAA compliant form solutions with documentation templates for common healthcare scenarios. Organizations can evaluate these alternatives based on factors like cost, ease of use, integration capabilities, and compliance certification.
Implementation Requirements for Compliant Forms
Regardless of the chosen platform, healthcare organizations must implement specific procedures when collecting patient information through electronic forms. Staff training on handling form data securely plays a crucial role in maintaining compliance. Organizations need documented policies for form creation, approval processes, and data retention schedules. Form systems require regular security assessments and updates to address emerging vulnerabilities. Compliance officers should review all form collection processes to ensure they meet current HIPAA requirements and organizational security standards.
Common Misunderstandings About Google Services and HIPAA
Many healthcare organizations misinterpret Google’s BAA coverage, incorrectly assuming all Google services become HIPAA compliant with a signed agreement. This misunderstanding leads to compliance violations when organizations use excluded services like Google Forms for patient information. Another common error involves using personal Google accounts rather than properly configured Google Workspace accounts with appropriate security settings. Organizations sometimes fail to recognize that collecting even basic patient information through non-compliant systems violates HIPAA when that information qualifies as protected health information under the regulations
No software is inherently “HIPAA compliant” without proper implementation and usage. To determine if software can support HIPAA compliance, evaluate whether the vendor offers a Business Associate Agreement, assess security features like encryption and access controls, review documentation about compliance capabilities, verify third-party certifications, and consider implementation requirements. Software only becomes part of a HIPAA compliant solution when configured and used according to healthcare privacy regulations.
Business Associate Agreement Availability
The most fundamental indicator of software’s compliance potential is whether the vendor offers a Business Associate Agreement (BAA). This legal document establishes the vendor’s responsibilities for protecting healthcare information under HIPAA regulations. Software vendors unwilling to sign a BAA cannot legally handle protected health information regardless of their security features. Healthcare organizations should request BAA information early in the evaluation process. The agreement typically states which software components fall under HIPAA compliant related coverage, as vendors may exclude certain features or modules. Organizations must obtain this agreement before storing any patient data in the software.
Security Feature Assessment
Software that works with HIPAA requirements includes necessary security capabilities aligned with regulatory standards. Encryption safeguards data during storage and transmission across networks. User authentication confirms identities through password requirements and multi-factor verification. Access controls limit information viewing based on job roles and responsibilities. Audit logging records who accessed information and what actions they performed. Backup systems preserve data availability while maintaining appropriate security measures. When evaluating software, healthcare organizations need to determine whether these features address their compliance requirements based on the patient information they handle.
Compliance Documentation Review
Reputable vendors supply documentation describing how their software supports regulatory requirements. Security white papers, HIPAA compliance guides, and implementation recommendations form part of this documentation package. Configuration guides detail how to set up the software to meet HIPAA security standards. Responsibility matrices explain which compliance obligations belong to the vendor versus the healthcare organization. Documentation quality generally reflects the vendor’s understanding of healthcare regulatory requirements. A thorough review of these materials helps organizations determine whether the software addresses their needs to become HIPAA compliant.
Third-Party Certifications and Audits
Many vendors seek independent verification of their security practices through formal assessments. SOC 2 reports examine security, availability, and confidentiality controls. ISO 27001 certification shows structured information security management. HITRUST certification addresses healthcare security requirements. Independent assessments provide objective evidence of security practices beyond what vendors claim themselves. Organizations benefit from verifying certification validity and reviewing scope statements to understand what was evaluated. While certifications don’t guarantee HIPAA compliance, they show the vendor follows established security practices relevant to healthcare environments.
Implementation Requirements Evaluation
Software compliance capabilities matter only when organizations can implement them effectively. Technical features like encryption may require particular hardware or additional components. Administrative functions might demand specialized knowledge to configure correctly. Integration with existing systems determines whether security controls function consistently across environments. Before selecting software, organizations need to assess whether they have resources and expertise to implement necessary security measures. Complex implementation requirements might indicate that general-purpose software won’t practically support healthcare compliance needs without considerable effort.
Support and Updates
HIPAA compliance depends on maintaining software security over time as threats and standards evolve. Vendors serving healthcare customers provide regular security updates addressing emerging vulnerabilities. Support offerings include help with compliance-related configurations and troubleshooting. Version upgrades maintain security while introducing new features. When selecting software, organizations should examine the vendor’s history of timely security patches and compliance updates. Without active security maintenance, software gradually becomes non-HIPAA compliant as new threats emerge and security standards change. Consistent vendor support remains important for maintaining HIPAA compliance throughout the software lifecycle.
Healthcare organizations can make Google Workspace HIPAA compliant by completing a Business Associate Agreement with Google, configuring advanced security settings, and training staff on proper data handling. Knowing how to make Google Workspace HIPAA compliant means understanding that compliance depends on both technology and human oversight. When these elements are managed carefully, Google Workspace can be used to handle Protected Health Information securely while maintaining efficiency and accessibility for healthcare teams.
The compliance framework
The process of learning how to make Google Workspace HIPAA compliant begins with recognizing that Google provides the infrastructure, but the healthcare organization is responsible for compliance. The HIPAA Privacy and Security Rules require administrative, physical, and technical safeguards that must be implemented through documented policies, technical configuration, and ongoing oversight. Google Workspace, when managed under the right plan, offers encryption, access management, and detailed audit logs. To make Google Workspace HIPAA compliant, administrators must use the business version, not free Gmail accounts, because only paid Workspace plans allow for proper control and a Business Associate Agreement. Documented internal policies should define how messages, files, and calendars containing patient data are stored and monitored. Establishing this structure early makes every later compliance step easier to maintain.
The Importance of the Business Associate Agreement
A Business Associate Agreement (BAA) is an unskippable step in how to make Google Workspace HIPAA compliant. Without it, compliance cannot be achieved regardless of system configuration. This legal contract specifies how Google protects healthcare data, reports incidents, and assists with investigations. The BAA covers key Workspace tools such as Gmail, Drive, Calendar, and Docs but excludes consumer products like YouTube and certain AI-based features. Administrators should disable any unsupported tools to prevent accidental data exposure. Reviewing and maintaining this agreement is essential to keeping Google Workspace HIPAA compliant as Google updates or expands its services. Many healthcare organizations include the BAA in their annual compliance review to confirm it still reflects current practices and security requirements.
Configuring strong security and access controls
Knowing how to make Google Workspace HIPAA compliant requires more than signing documents. It demands careful configuration of security controls that align with HIPAA’s technical safeguard requirements. Encryption should be enforced for all email traffic, and administrators commonly require two-step verification to strengthen account security and meet HIPAA access-control expectations. Device management policies can prevent unapproved computers or phones from connecting to accounts that contain Protected Health Information. Access privileges should be based on job roles so that staff only view the data they need to perform their duties. Audit logs can record sign-ins, file access, and configuration changes, giving compliance officers a clear view of user activity when logs are regularly reviewed. Each of these steps contributes to a Google Workspace HIPAA compliant environment that protects against both external threats and internal misuse.
Maintaining compliance through user awareness and training
Even the most secure configuration cannot replace good judgment. A key part of how to make Google Workspace HIPAA compliant is ensuring that every staff member understands their responsibility when handling patient information. Training should explain how to identify Protected Health Information, when and how encryption is used to protect it, and how to report security incidents. Consistent reminders help prevent accidental sharing or unauthorized forwarding of sensitive messages. Regular audits of user activity can identify risks such as unused accounts, weak passwords, or improper storage of files. By reinforcing awareness and accountability, organizations maintain their Google Workspace HIPAA compliant status while reducing the risk of human error that can lead to violations.
Compliance is not a static condition but a continuous process. Administrators who understand how to make Google Workspace HIPAA compliant know that monitoring and documentation are required to sustain it. Google Workspace offers audit reports, security dashboards, and alerts that track sign-ins and encryption status. Reviewing these reports ensures that no settings are altered without authorization and that user activity remains within policy limits. Keeping written records of policy updates, staff training, and audit results helps demonstrate compliance during inspections. These records also create accountability and give leadership confidence that the system continues to operate within HIPAA standards. With diligent monitoring, a Google Workspace HIPAA compliant setup can stay reliable even as teams and technologies evolve.
A lasting culture of compliance
Organizations that learn how to make Google Workspace HIPAA compliant build more than a secure system—they create a sustainable culture of responsibility. Google Workspace allows healthcare professionals to collaborate, communicate, and share resources efficiently while safeguarding patient data. Maintaining this balance requires consistent review of settings, updates, and employee practices. As new regulations appear and technology develops, compliance officers should revisit each requirement to ensure ongoing protection. A well-managed, Google Workspace HIPAA compliant configuration supports both privacy and productivity, proving that regulatory compliance and convenience can coexist when oversight and education remain priorities.
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.
