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HIPAA Compliant Marketing in 2025: Basics, Guidelines, and Updates

HIPAA Compliant Marketing in 2025: A Guide to Fundamentals, Digital Guidelines, and Updates

HIPAA compliance—it’s the big bad wolf of the healthcare world, and no covered entity escapes it. As of 2024, the Office for Civil Rights has settled or imposed civil monetary penalties totaling a staggering $144,878,972. According to the HHS, the top two most common types of covered entities alleged to have committed violations are general hospitals and private practices & physicians.

Physician practice owners are in a uniquely vulnerable position: unlike hospitals, most practices don’t have in-house legal teams to handle HIPAA violations. Yet one of the most common oversights we see is a lack of safeguards in protecting protected health information (PHI)—particularly for marketing activities.

In this article, medical practice leaders will learn what HIPAA-compliant marketing entails, best digital practices to maintain compliance, and key updates to HIPAA laws.

Back to Basics: PHI and HIPAA-Compliant Marketing Explained

Below, we break down what PHI includes, how HIPAA regulations apply to marketing, and what you need to watch for to remain compliant.

What Qualifies as Protected Health Information (PHI)?

PHI refers to any health information that could potentially identify a patient, including:

  • Name
  • Address
  • Birth date
  • Social Security Number
  • Medical record number
  • Health plan beneficiary number
  • Any other unique identifying number, characteristic, or code

When this information is created, received, maintained, or transmitted electronically, it becomes electronic PHI (ePHI)—a subset of PHI specifically regulated under HIPAA’s Security Rule, which went into effect in April 2005.

What Happens If PHI Isn’t Protected?

Privacy Rule Violation: If a form collects PHI and transmits or stores it without safeguards (like consent, proper authorization, or privacy policies), it may be considered an unauthorized disclosure.

Security Rule Violation: If a form doesn’t use encryption, secure storage, or proper access controls, it violates the technical requirements for protecting ePHI.

Both violations are subject to civil monetary penalties, potential lawsuits, and long-term reputation damage.

PHI in Marketing: What the HHS Says

Marketing falls under the HIPAA Privacy Rule, which gives individuals control over how their protected health information (PHI) is used or disclosed.

The Privacy Rule defines marketing as “a communication about a product or service that encourages recipients of the communication to purchase or use the product or service.”

Generally, if the communication is “marketing,” then the communication can occur only if the covered entity obtains an individual’s authorization.

Marketing that required authorization according to the HHS:
  1. Any communication that encourages the recipient to purchase or use a product or service unless it relates to treatment or healthcare operations.
    • Exceptions to authorization: There are two instances where prior authorization is not required.
      • Face-to-face communication between your organization and the individual.
      • It’s a promotional gift of nominal value. (Note: Nominal value refers to items of minimal worth. While there isn’t a clearly defined price point, this typically refers to promotional items such as pens or notepads.)
  2. Any disclosure of PHI with another company in exchange for payment so that that company can advertise its product or service to the patient.
    • No exceptions apply to this type—the individual must always authorize these marketing communications before they occur.
The following types of health-related communications are NOT considered marketing:
  • Describing health-related products or services provided by your organization or included in your benefit plan.
  • Communications about your organization’s health-related services, like plan changes or new specialties and equipment.
  • Treatment-related communications, such as prescription refill reminders and drug samples.
  • Communications for care coordination, case management, or suggesting alternative care options.

Examples of Healthcare Communications that Do and Do Not Require Authorization

DOES Require Authorization:
  1. A dermatology practice mails its patients $30 wellness kits personalized to their diagnoses.
    • This requires authorization because:
      • It’s non-face-to-face communication that encourages the recipient to use a service.
      • The practice used their patients’ PHI (names, addresses, and diagnoses) for this marketing.
      • It’s a gift of non-nominal value.
  2. A cardiology clinic shares its patient list with a supplement company. The company pays the clinic and then targets digital ads promoting heart health supplements to patients with high blood pressure.
    • This requires authorization because:
      • The clinic disclosed PHI (condition or treatment history) for marketing purposes.
      • The clinic received payment (direct or indirect) for disclosing PHI.
      • The other company is using the PHI to promote its product.
  3. A pain management practice sends a digital brochure to patients via email, highlighting the benefits of their regenerative medicine treatment.
    • This requires authorization because:
      • It’s non-face-to-face communication that’s intended to encourage the recipient to use their services.
        • The treatment may not be covered under the patient’s existing healthcare plan, solidifying its status as a marketing effort rather than a care coordination communication.
      • The clinic used PHI (patient names and emails) to promote these services.
Does NOT Require Authorization:
  1. A dentist gives out free toothbrushes and floss at discharge. While this encourages the use of certain oral care brands, it’s allowed without patient authorization because:
    • It’s face-to-face (handed directly to the patient).
    • The items are minimal (nominal) in value.
  2. A psychology practice trains front desk staff to mention transcranial magnetic stimulation (TMS) services to patients during check-in or checkout, regardless of their insurance coverage.
    • This is considered a form of marketing because it involves promoting additional services, but it does not require authorization because:
      • The communication happens face-to-face, directly between staff and patients.
      • There is no disclosure of PHI to third parties.
  3. A hospital emails a newsletter to its patients, describing the new pediatric services it offers and the latest treatments available for pediatric care.
    • This falls under health-related communications, not marketing, and does not require authorization so long as:
      • The newsletter focuses on the hospital’s own services; i.e., they are not using the communication to promote third-party products or services.
      • It includes information about how these services are part of the patient’s healthcare plan, i.e., the services are covered benefits or part of the patient’s ongoing care.
      • It does not include or expose PHI beyond what is necessary—the patient’s name and email.
  •  

Navigating Marketing Compliance in the Digital Age

Digital healthcare marketing has rapidly evolved, challenging traditional practices. HIPAA, however, was not originally designed with these new digital dynamics in mind, creating a need for greater compliance awareness. Below are key areas to consider:

Protecting Electronic PHI

The HIPAA Security Rule includes three sets of safeguards that must be complied with by covered entities and business associates:

  • Administrative – covering risk analyses, workforce clearance, security training, access management, and contingency planning.
  • Physical – covering topics such as physical access to devices maintaining ePHI, device security, data back-ups, and the secure disposal of data and devices.
  • Technical – covering password management, automatic logoff, data encryption, audit controls, and transmission security.

A failure in any of these areas can result in a data breach and steep fines.

Digital Marketing Channels With HIPAA Violation Risks

Website Forms

Contact or intake forms collecting name, email, appointment type, symptoms, or diagnosis must be HIPAA-compliant:

  • Use encrypted forms (HTTPS and end-to-end encryption)
  • Include a link to your privacy policy and HIPAA Notice of Privacy Practices
  • Store submitted data securely
  • Obtain patient consent where applicable
  • Avoid non-compliant tracking technologies
Real-World Case:

Kaiser Permanente disclosed a data breach affecting 13.4 million patients. The breach stemmed from tracking technologies previously installed on its websites and mobile applications, transmitting personal information to third-party vendors. The collected data showed advertisers how these patients moved around the platform, engaged with services, and used the devices. While this breach wasn’t directly tied to malicious activity, it still exposes vulnerabilities in how personal data is shared and stored online.

Email Marketing

Emails that include PHI must be encrypted, and you must obtain explicit consent before sending marketing emails. Additionally, email marketing campaigns must provide an opt-out option for recipients, and any personal data collected through email lists must be securely stored and handled to prevent unauthorized access.

Real-World Case:

Northcutt Dental was fined $62,500 for sharing patient information without consent to support Dr. David Northcutt’s political campaign. Over 5,300 patients’ details were used in mail and email outreach.

Pay-Per-Click (PPC) Advertising

In Google PPC campaigns, healthcare practices need to be mindful of several compliance factors to avoid violating HIPAA regulations:

Avoid non-compliant language: Ads should not reference personal health conditions or specific patient testimonials without proper consent.

Tracking technologies: Tracking tools (like Google Analytics) collect and process user data in ways that might conflict with HIPAA regulations.

Privacy policies: Make sure landing pages have clear privacy policies and data protection measures in place.

Real-World Case:

In 2023, BetterHelp paid $7.8 million to settle charges brought by the Federal Trade Commission (FTC). The FTC alleged that BetterHelp disclosed consumers’ email addresses, IP addresses, and health questionnaire information to Facebook, Snapchat, Criteo, and Pinterest for advertising purposes without authorization.

Reputation Management

When engaging in reputation management for a healthcare practice, it’s important to ensure that patient reviews or feedback are managed carefully to avoid violations of HIPAA.

  • Never disclose a patient’s PHI in your review responses.
  • Use general, non-identifying language.
  • Get written authorization if highlighting a specific testimonial or story.
Real-World Case:

A North Carolina dental practice, UPI, was fined $50,000 for violating HIPAA by disclosing a patient’s protected health information in a response to a negative Google review. The practice named the patient and shared medical details publicly.

Digital Marketing Agencies & Business Associate Agreements (BAAs)

With the advent of digital marketing agencies, practices now have access to a wealth of tools and strategies to engage with patients online. However, it’s critical to ensure these agencies comply with HIPAA regulations.

If your medical practice works with a marketing agency that has access to PHI—either directly through patient data or indirectly through tools like form submissions, email systems, or website tracking—they are considered a business associate under HIPAA.

You must have a signed Business Associate Agreement (BAA) with them. Without one, any disclosure of PHI to that agency—even inadvertently—can trigger a HIPAA violation and expose your practice to steep penalties.

Key reminders:

  • You must have a signed business associate agreement in place before your marketers handle any data involving PHI
  • Verify that your marketing agency understands HIPAA requirements
  • Ask how they secure patient data and which third-party tools they use

HIPAA Updates Medical Practices Need to Know in 2025

Online Tracking Technologies Declared Non-Compliant by CMS

Tracking technologies are a cornerstone of digital marketing. Tools like Google Analytics and Meta Pixel collect user data to provide actionable insights.

On December 1, 2022, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued new guidance clarifying that HIPAA regulations apply to online tracking technologies used on healthcare websites. When protected health information (PHI) is collected or shared with tracking vendors without authorization, such as through web forms, patient portals, or IP address tracking, that is in violation of HIPAA.

As a result, many common uses of tracking technologies on healthcare websites, including Google Analytics, have now fallen out of compliance.

CMS’s Ruling Challenged by the American Hospital Association (AHA)

In American Hospital Association v. Becerra, the AHA—alongside the Texas Hospital Association, Texas Health Resources, and United Regional Health Care System—challenged the OCR’s guidance on tracking technologies.

On June 20, 2024, a federal court in the Northern District of Texas ruled that the OCR guidance exceeded the agency’s authority under HIPAA. As of this latest blog update, the court’s ruling remains unchallenged.

Key Takeaway:

HIPAA obligations won’t automatically be triggered just by tracking a user’s IP address or visits to pages related to health conditions. However, if your tracking technologies collect data related to a patient’s PHI without the necessary safeguards, you could be in violation of HIPAA. It’s crucial to work closely with your marketing agency to ensure that your practice stays on top of the evolving regulations and remains compliant.

The HITECH Act Amendment

Originally enacted in 2009, the HITECH Act aimed to accelerate the adoption of certified electronic health records (EHRs).

In 2021, the HITECH Act was amended through H.R. 7898 to include a safe harbor for healthcare organizations that adopt recognized cybersecurity best practices (e.g., NIST or HITRUST frameworks).

This means that when healthcare organizations face audits or penalties from the government, their efforts to improve cybersecurity will be considered, potentially helping them avoid severe consequences.

Key Takeaway:

Adopting frameworks like NIST or HITRUST would be highly beneficial for your practice to safeguard against the risks of non-compliance and lower any potential penalties.

HHS Steps Up Cybersecurity Efforts in Healthcare

In December 2023, HHS released a Healthcare Sector Cybersecurity Concept Paper, proposing new strategies to mitigate the rising threat of healthcare cyberattacks. The four pillars of the plan include:

  • Set Voluntary Cybersecurity Goals – Establish industry-specific standards to guide future regulations.
  • Provide Financial Support – Offer funding for cybersecurity improvements, particularly for smaller providers.
  • Strengthen Oversight – Enhance enforcement of cybersecurity practices through updated regulations.
  • Centralize Support – Create a centralized hub within HHS for resources and guidance on cybersecurity.

Although voluntary, HHS has stated that regulatory changes are forthcoming, as voluntary measures alone are unlikely to drive widespread adoption.

Key Takeaway:

Now is the time for physician practices to evaluate their cybersecurity measures and begin aligning with the proposed standards before they become mandatory.

Proposed HIPAA Security Rule Update in 2025

The U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (NPRM) on December 27, 2024, to strengthen the HIPAA Security Rule and improve cybersecurity protections for electronic protected health information (ePHI). This update is expected to align HIPAA requirements with the cybersecurity goals outlined in the Cybersecurity Concept Paper.

Key proposed updates include:

  • Standardizing security requirements by removing the distinction between “required” and “addressable” specifications, making all specifications mandatory with limited exceptions.
  • Enhancing documentation by requiring written policies, procedures, and risk analyses.
  • Mandating regular cybersecurity actions, such as updating technology inventories, performing vulnerability scans, and implementing encryption for ePHI.
  • Enhancing business associate responsibilities to ensure cybersecurity compliance, including encryption and multi-factor authentication.
Key Takeaway:

The proposed 2025 HIPAA Security Rule will make all cybersecurity safeguards mandatory, require stronger documentation, and increase accountability for business associates. Now is the time for physician practices to tighten protocols.

Conclusion

For healthcare practices in 2025, HIPAA-compliant marketing and cybersecurity are more critical than ever. With evolving rules, especially around online tracking technologies, practices must stay vigilant about safeguarding PHI across all marketing activities. By adopting cybersecurity best practices, securing PHI in digital channels, and ensuring all marketing efforts are compliant, practices can avoid costly penalties and protect both patient privacy and their reputation.

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