Welcome to the definitive guide on HIPAA compliant email marketing for healthcare providers and business associates.
This guide provides practical tips and best practices so healthcare professionals can secure their marketing emails and meet HIPAA regulations.
We'll cover how to create HIPAA compliant marketing emails, what to look for in a HIPAA compliant email marketing solution, effective email encryption methods, potential HIPAA violations and fines, and an added FAQ section to address common concerns.
In this guide:
A marketing email must meet HIPAA compliance standards when it includes protected health information (PHI) and is sent by any entity governed by HIPAA regulations.
PHI represents any information that can identify an individual and connects directly to their health status, the medical care they receive, or their payment details for healthcare services.
The organizations required to uphold the standards set by HIPAA include healthcare providers, health plans, and healthcare clearinghouses, as well as the business associates who offer them supportive services.
Go deeper:
The HIPAA Privacy Rule defines Marketing as communications that serve "to make a communication about a product or service that encourages recipients of the communication to purchase or use the product or service…" When communicating for marketing purposes, you need a secure email marketing platform, like Paubox, that encrypts emails both in transit and at rest.
Most popular email marketing platforms, like MailChimp, aren't fully HIPAA compliant and don't secure email newsletters in transit, even if they secure patient data at rest. Always double-check that sending PHI is covered by the business associate agreement (see FAQs below).
Go deeper: Top 12 HIPAA compliant email services
The main types of marketing emails sent that need to be HIPAA compliant include:
It is recommended that any email sent by a covered entity or business associate meets the standards for HIPAA compliance, whether or not it contains PHI. As a practice, it reduces the likelihood of a violation through human error.
Emails promoting health-related products or services target patients who might benefit from them. For example, a healthcare provider might inform patients about a new wellness program, medical device, or special discount on health checkups.
These are emails sent by healthcare providers or their business associates on behalf of third parties like pharmaceutical companies to promote specific products.
Marketing emails promoting products or services unrelated to the patient's current treatment may involve sharing the patient's PHI with third parties. For example, a health plan might share a list of its members with a company selling health supplements. HIPAA requires explicit written authorization from patients before sharing their PHI for this purpose.
Go deeper: Communications that must remain HIPAA compliant
For a marketing email sent by a covered entity or business associate to be HIPAA compliant, the provider needs to:
The Department of Health and Human Services explains, "Except as discussed below, any communication that meets the definition of marketing is not permitted, unless the covered entity obtains an individual's authorization."
A few steps necessary to consider when receiving consent include:
Go deeper: What is marketing consent in healthcare?
There are exceptions to authorization requirements. All emails must be HIPAA compliant, but some types of email content are considered "opt-out" rather than "opt-in."
When choosing a HIPAA compliant email marketing solution, prioritize ease of setup and use for both you and your staff. Ensure that your email service is convenient for your patients as well. Patients should not have to log into portals or complete extra steps to read their emails.
Any service chosen needs to encrypt emails in transit. Encryption during transmission protects sensitive information from being intercepted by unauthorized parties. Also, emails stored on servers should be encrypted, adding an extra layer of security in case of data breaches or unauthorized access.
The marketing services available should be both innovative and easy to use. Choose a service that supports automated email campaigns and automated workflows, including trigger-based emails like welcome messages. Look for advanced audience segmentation and targeted email lists based on behavior and demographics. Dynamic content can further personalize your messaging and improve engagement.
While there's no official HIPAA certification, HITRUST certification means that a company has taken extensive measures to ensure the security of sensitive data. Working with HITRUST-certified vendors can lower insurance premiums and minimize legal liability.
We recommend Paubox for HIPAA compliant email, but here are some other questions to ask before making your decision.
Before signing up to an email marketing solution, consider the following:
Setting up HIPAA compliant email marketing with Paubox Marketing is simple and efficient. Start by signing up for free and adding your first 100 contacts. You can securely store and use PHI to personalize your messages.
Use the free templates and the intuitive drag-and-drop builder to create your first email. No experience is necessary, and you can get complimentary design help if needed.
Track your results in real-time with the analytics reporting tool to see who is engaging with your emails. Paubox Marketing makes it easy to keep your marketing effective and compliant.
Start by choosing a HIPAA compliant email marketing platform like Paubox Marketing, which ensures secure handling of PHI. First, gather explicit written consent from your patients to receive marketing emails explaining how their data will be used.
Next, segment your email list based on patient demographics, treatment history, or engagement levels to tailor your messages effectively. Use the platform's customizable templates and drag-and-drop builder to create visually appealing and personalized emails that resonate with your audience.
Regularly update your content to keep it fresh and informative, and always include an easy opt-out option to respect patient preferences. Finally, leverage the platform's analytics tools to track open rates, click-through rates, and other key metrics, allowing you to refine your strategy based on real-time feedback.
We've created a HIPAA compliant email marketing checklist to guide you through the necessary steps. While the high-level steps are outlined below, each step includes several sub-tasks to ensure full compliance.
Download the HIPAA compliant email marketing checklist here:
The right HIPAA compliant email marketing service will assist with the more complex tasks like setting up DKIM and SPF records.
We showcase 12 impactful email examples that you can
incorporate into your marketing strategy.
Failing to send HIPAA compliant marketing emails isn't just a bad practice—it's a violation of the law. The U.S. Department of Health and Human Services (HHS) Office for Civil Rights enforces severe penalties for such violations. Civil penalties for breaches that fall under reasonable cause can range from $100 to $50,000 per breach. However, cases involving willful neglect can result in fines from $10,000 to $50,000 per violation and often lead to criminal charges.
Civil penalties are structured in tiers based on the level of negligence and the nature of the violation:
In addition to civil penalties, HIPAA violations can result in criminal penalties if the violations are committed knowingly. Criminal penalties are more severe and can include both fines and imprisonment, depending on the nature and intent of the violation:
Go deeper:
Healthcare emails that are purely transactional or related to treatment, payment, or operations without marketing intent typically do not fall under CAN-SPAM but must comply with HIPAA.
However, when a healthcare email involves marketing, it must comply with both sets of regulations. The Federal Trade Commission simplifies it as, "If the message contains only commercial content, its primary purpose is commercial, and it must comply with the requirements of CAN-SPAM."
For example, if you send an email promoting a new wellness program or medical service, the email must comply with CAN-SPAM by including an opt-out option, a truthful subject line, and a physical address.
At the same time, if the email contains any PHI, it must also comply with HIPAA requirements by securing the PHI and only sending it with the patient's consent.
Go deeper:
HIPAA stands for the Health Insurance Portability and Accountability Act. It is a federal law enacted in 1996 that sets standards for protecting sensitive patient health information and ensures patient privacy. HIPAA applies to healthcare providers, health plans, and healthcare clearinghouses.
The Privacy Rule is a component of HIPAA that establishes national standards for the protection of individuals' medical records and other personal health information. It requires appropriate safeguards to protect the privacy of personal health information and sets limits on the use and disclosure of such information without patient authorization.
Yes, separate consent is necessary for marketing-related emails if they involve the use of PHI. Patients must provide explicit written authorization for their PHI to be used for marketing purposes.
A Notice of Privacy Practices is a document that healthcare providers and health plans must provide to patients. It explains how their PHI will be used and disclosed, their rights regarding their health information, and the provider's privacy practices and obligations under HIPAA.
No, an email header should not contain PHI. The email header, which includes the subject line, sender, and recipient information, should be free of any sensitive health information to avoid unauthorized disclosure.
Yes, healthcare providers must disclose if a third party is paying them to promote specific health-related products.
Under HIPAA, patients have the right to:
A violation of CAN-SPAM occurs when a commercial email does not comply with the act's requirements. This includes failing to provide a clear opt-out mechanism, using deceptive subject lines, not including the sender's physical address, and continuing to send emails to recipients who have opted out.
A BAA is a contract between a HIPAA-covered entity and a business associate. It outlines the business associate's responsibilities for safeguarding PHI, ensuring compliance with HIPAA regulations, and detailing how PHI will be used and protected.
Examples of PHI include:
Yes, if a foreign marketing agency handles PHI on behalf of a U.S.-based healthcare organization, it must comply with HIPAA regulations. The agency must sign a BAA and ensure it implements the safeguards to protect PHI.
Yes, conduits like email service providers that transmit PHI but do not store it long-term or have regular access must comply with HIPAA.
Mailchimp is not inherently HIPAA compliant.