Navigating Direct-to-Consumer (DTC): 5 Targeting Strategies That Comply With PHI Advertising Regulations

Navigating Direct-to-Consumer (DTC): 5 Targeting Strategies That Comply With PHI Advertising Regulations

The rise of direct-to-consumer (DTC) advertising has revolutionized how treatment and services are promoted and accessed, but stringent Protected Health Information (PHI) advertising regulations play a pivotal role in dictating the ethical and legal boundaries of targeting strategies. Compliance with these regulations safeguards ethical practices, protecting individuals’ privacy rights and fostering a responsible and trustworthy relationship between healthcare providers and patients.

While the utilization of diverse data aggregation in healthcare marketing aids in targeting the right consumers and forming extensive patient profiles, the challenge lies in effectively segmenting audiences while complying with patient privacy regulations. To efficiently target patient populations, healthcare marketers must adopt a comprehensive strategy encompassing the collection and layering of varied data sets.

This article delves into five strategic data targeting approaches tailored to navigate the complex web of PHI advertising regulations within the DTC sphere. By examining these strategies, we aim to show how healthcare marketers can effectively target audiences while meticulously complying with PHI advertising regulations.

Key Takeaways

  • Direct-to-consumer advertising (DTC or D2C) in the pharmaceutical industry involves directly promoting prescription medications to the public to inform consumers about available treatments and potentially influence their choices. Read more.
  • Protected health information (PHI) is “individually identifiable health information” that is protected by the U.S. Department of Health and Human Services (HHS)’ HIPAA Privacy Rule. Read more.
  • HIPAA-compliant ad strategies like modeled claims targeting, behavioral targeting, seed URL targeting, keyword targeting, location-based targeting, and first-party survey data can help healthcare marketers collect target consumer data based on healthcare appointments, insurance information, search terms, and purchases while protecting patient privacy. Read more.

What is Direct-to-Consumer Advertising?

DTC advertising within the pharmaceutical industry is a marketing strategy where companies directly promote their prescription medications to the general public. DTC raises awareness of medical conditions and treatments to create a dialogue between patients and their doctors. Spreading awareness can lead to earlier diagnosis and treatment, less stigma surrounding certain medical conditions, and encouraging people to adhere to their medication courses.

These advertisements typically include both the benefits and potential risks or side effects of the medication. While DTC advertising can empower patients by providing information and possibly reducing the stigma around certain health conditions, it also raises concerns regarding the potential influence on patient-doctor relationships and the demand for specific drugs. Regulations on DTC advertising vary by country, with the United States imposing strict guidelines through HIPAA and the Food and Drug Administration (FDA) on the content and format of these advertisements to ensure that the information presented is accurate and not misleading to consumers.

3 Categories of DTC Advertising

Brand Awareness Ads

Brand awareness ads are the most common form of DTC advertising. It involves naming a drug and summarizing its benefits and potential side effects. Generating awareness and increasing script lift requires expert communication with all stakeholders throughout its product lifecycle.

Reminder Ads

Reminder ads give the drug’s name but not the drug’s use. The assumption behind reminder ads is that the audience knows what the drug is for and does not need to be told. A reminder ad does not contain risk information about the drug because the ad does not discuss the condition treated or how well the drug works.

Disease State Education Ads

Disease state education ads are unbranded ads that don’t specify a specific product or treatment. Instead, they include information about a medical condition to generate awareness and encourage individuals to seek more information from their healthcare professionals. 

What is PHI Advertising?

Defining Protected Health Information (PHI)

Protected health information (PHI) is “individually identifiable health information” that is protected by the U.S. Department of Health and Human Services (HHS)’ HIPAA Privacy Rule. The Privacy Rule protects this information “held or transmitted by a covered entity or its business associate, in any form or media, whether electronic, paper, or oral.”1

“Individually identifiable health information” pertains to any demographic data that relates to:

  • An individual’s past, present, or future physical or mental health or condition
  • An individual’s health care plan (e.g., a doctor’s appointment or a prescription medication)
  • Any past, present, or future payment information relating to an individual’s health care or information that identifies the individual, such as a name, address, birth date, or Social Security number (e.g., an invoice or bill)

For something to be considered PHI, two things must occur:

  • At least one of the 18 HIPAA identifiers has to exist
  • There is some identifiable health information (as indicated above)

PHI advertisers can’t share data that can be considered protected health information.2 PHI advertising must adhere to the Privacy Rule, which dictates that sharing an identifier combined with health information with a non-compliant destination, like any advertising platform that can track user’s data, will result in a HIPAA violation. Non-compliant destinations like these advertising platforms don’t offer an option to sign a business associate agreement (BAA), a contract mandated by HIPAA that enables a third party to gain access to PHI.

How the FDA Regulates Pharmaceutical DTC Advertising 

Under the Food, Drug, and Cosmetic Act, The Food and Drug Administration (FDA) requires DTC advertisements for prescription medications to include information on significant side effects and contraindications.3 The FDA also mandates ads must fairly represent associated benefits and risks with substantial evidence from clinical trials and other accredited sources. For example, display ads require ISI scrolling that explains the side effects and adverse side effects of medications. Moreover, on TV commercials, ads typically list significant side effects and direct consumers to a website for more information.

Compliant Targeting Methods That Narrow DTC Audiences

Multifaceted data aggregation helps healthcare marketers reach the appropriate consumers and amass a sufficiently large population base to construct patient profiles. Finely segmenting target audiences while maintaining patient privacy compliance can be challenging. When determining how to target patient populations, healthcare marketers should consider building a comprehensive approach that involves collecting and layering diverse data sets, including modeled claims data, behavioral data and seed URLs, keyword or contextual data, location data, and survey data.

These data sets offer a holistic perspective on each individual in the target audience by:

  • Identifying pertinent search terms for the targeted Direct-to-Consumer (DTC) audience.
  • Utilizing AI to pinpoint users based on their search intent and extract relevant keywords.
  • Opting-in users exhibiting the sought-after search intent to pose up to five specific questions.

1. Modeled-Claims Targeting

Modeled-claims targeting enables healthcare marketers to build audiences from millions of de-identified patient profiles and identify trends with diagnosis, prescriptions, procedural codes, and healthcare provider information collected from medical interactions, billing records, and insurance data.  This process involves categorizing audiences by healthcare provider specialty levels using ICD 10 and CPT codes.

To comply with PHI advertising regulations, de-anonymize a proportion of probable patients and merge them with another anonymous population, achieving a balanced mix to ensure 50% anonymity within the data pool. For instance, if the total population of patients with a condition is half a million, an additional half a million non-affected individuals should be integrated to anonymize the patient data. To further enhance targeting, amalgamate modeled claims data with top decile prescribing HCP data.

When to Use Modeled-Claims Targeting

Healthcare marketers should consider using modeled claims targeting in advertising when promoting products or services undergoing extensive testing or clinical trials. This approach is useful when the benefits of a healthcare product or service can be quantitatively demonstrated through statistical models or data-driven results.

2. Behavioral Targeting & Seed URL Targeting

Behavioral targeting captures interest data from users’ browsing habits, such as search terms of conditions and side effects, websites visited, and purchases made. With real-time data, you can build a target audience profile that is more likely to engage with and purchase a product if they’re searching related terms and websites. Marketers can gather this information by looking up specific keywords based on intents provided by demand-side platforms (DSP), which then populates data associated with particular demographics.

Seed URL targeting uses a seed list of URLs to create look-alike consumer profiles. A seed list of URLs can be matched by advanced data science to contextually similar websites in the network. This list is then used to generate an audience of users who visited those websites in the past 30 days. For example, suppose you have a list of the top five or ten websites with competitors or similar sites. In that case, marketers can see and create behaviors and different demographic profiles based on consumers who visit those websites.

When to Use Behavioral Targeting & Seed URL Targeting

Healthcare marketers should utilize behavioral targeting to reach individuals based on their online behaviors, tailoring messages to those interested in specific health-related topics. Seed URL targeting is valuable for reaching audiences visiting specific healthcare-related websites, allowing precise targeting of engaged individuals. These strategies combined enable marketers to efficiently connect with those most likely interested in the promoted healthcare solutions.

3. Keyword or Contextual Targeting

Keyword targeting means serving ads with keywords that are relevant to your product or service to individuals who are searching for specific terms. Keyword targeting provides contextual relevance by aligning content with desired topics, placements, and formats. Marketers use analytics tools to look up contextual keywords based on consumer search intent.

For example, suppose a consumer types “my back hurts” into a search engine. In that case, you can use contextual targeting to inform users of specific conditions associated with that pain. In turn, specific conditions can be related to certain specialists, leading the consumer to inquire about relevant prescriptions or medical devices.

When to Use Keyword or Contextual Targeting

Keyword or contextual targeting is most effective when reaching consumers actively searching for specific healthcare information or services so there is a match between the advertisement and the webpage or app.

4. Location-Based Targeting

Location-based targeting allows marketers to customize their messaging to be more relevant to a target audience and offer a personalized experience based on physical location. This data can be gathered through technologies such as GPS, IP addresses, Wi-Fi, and Bluetooth. Lilia Tse, an Adfire Health Co-Founder, affirmed, “Adfire Health uses this approach to find consumers more likely to have visited doctor’s offices, hospitals, or select facilities in a 50-meter radius of specific locations in the past 30 days.”

When to Use Location-Based Targeting

Utilizing location-based targeting when geographical precision significantly influences the relevance and effectiveness of advertising healthcare services or products. This approach becomes critical for reaching specific local audiences, aligning the marketed offerings with regional needs, and adapting messaging to local regulations or health concerns.

5. First-Party Survey Data

Survey-data-based targeting involves using survey information to tailor advertising and marketing strategies. This approach relies on data collected directly from users or consumers through surveys about their preferences, behaviors, interests, or demographics. Marketers use this data to create targeted campaigns, ensuring the advertising messages resonate more effectively with specific audience segments based on their survey responses.

Target condition-specific consumers who are more likely to try your brand based on this data. For example, if you are promoting a weight-loss drug, use first-party survey data to gather insights on individuals’ lifestyle habits, diet preferences, and weight management challenges. This data enables marketers to promote personalized solutions such as specialized diet plans or exercise programs that specifically address the identified needs of the audience dealing with obesity.

When to Use First-Party Survey Data

Utilizing first-party survey data is beneficial when precise insights into audience preferences, behaviors, or specific interests will appeal to target patient populations. This data is especially valuable when aiming to personalize ad content or promotions based on the directly obtained information from users.

Reach Patients While Adhering to PHI Advertising Regulations

Narrowing down your target audience to produce engaging ads while protecting their sensitive data requires expert tact and health marketing acumen. By following these strategies and prioritizing patient privacy, you can create effective healthcare marketing ads that not only reach your target audience but also respect and safeguard their sensitive information in compliance with HIPAA and FDA regulations. Adfire Health’s team of representatives can help you craft your target audience by building detailed consumer profiles that meet PHI advertising standards.

At Adfire Health, we work with healthcare marketers to create optimized, highly effective, data-based digital engagement strategies. With Thumbprint™, our segmented data ecosystem of over 8.2 million healthcare professionals, we can offer nationwide 1:1 engagement and access to healthcare professionals.

We bring our years of hands-on experience to every new campaign and work with you to get the best results possible. Contact us to learn more about what we can do for your business.


  1. Office for Civil Rights. (2022, October 19). Summary of the HIPAA Privacy Rule. U.S. Department of Health and Human Services.
  2. Mina, R. (2023, February 14). What is PHI? Ending the confusion. Freshpaint.
  3. Center for Drug Evaluation and Research. (2015, October 23). The impact of direct-to-consumer advertising. U.S. Food & Drug Administration. 

How can we help your marketing?