The complete healthcare marketing compliance playbook

Top 5 Points

1. Understanding which rule and compliance frameworks apply to your organization is the first step in any healthcare marketing strategy.
2. Develop comprehensive, legal-approved standards for anything marketing related, including: emails, paid campaigns, traditional media, print media, digital marketing content, and social media.
3. Make sure your team knows who the compliance officer is, who needs to approve marketing materials, and how they can escalate issues when needed. 
4. One of the most common HIPAA violations involves using patient information for marketing without explicit authorization.
5. It can be helpful to get professional feedback on your healthcare marketing strategy, website, or compliance processes to ensure they work correctly.

With regulators paying closer attention to healthcare marketing in recent years, it’s time to get serious about healthcare marketing compliance. The HHS Office for Civil Rights recently issued guidance outlining how tracking technologies that share PHI with third parties may actually violate HIPAA, which can be problematic for the thousands of sites that deploy those technologies unwittingly or because it’s the common standard. To make sure you stay off the radar and protect patient information, we’ve put together a healthcare marketing and advertising compliance playbook to break down the complexity of the myriad of rules and regulations around and deliver actionable steps.  

Understand your organization’s applicable guidelines

Unfortunately, and somewhat surprisingly, there isn’t a single set of regulatory guidelines for healthcare marketing. So, understanding which rule and compliance frameworks apply to your organization is the first step in any healthcare marketing strategy.

HIPAA’s Privacy Rule governs how you use protected health information in your marketing efforts, but it doesn’t prohibit all marketing communications. You can send appointment reminders, provide treatment alternatives, and describe health-related products, all without patient authorization. However, the moment you receive payment from a third party to promote their product or service, you need written patient consent: a very important distinction to understand.

The FTC Act Section 5 applies to all industries but holds healthcare claims to heightened scrutiny. Essentially, all marketing must be truthful, not misleading, and substantiated by competent scientific evidence. You don’t need to conduct your own clinical trials, but you do need reliable evidence supporting any health-related claims you make.

And, finally, the FDA governs marketing for drugs, medical devices, and certain health products. If you’re promoting FDA-regulated products, you’re bound by strict rules about off-label promotion, required disclosures, and a fair balance between benefits and risks.

Adhere to the seven elements of effective healthcare compliance guidelines from the US Office of the Inspector General

The Office of Health and Human Services created a very simple marketing compliance checklist of the necessary elements of a compliance program, but it leaves a lot to interpretation. To make it more applicable and useful for marketers, we’ve added actionable steps and guidance:

1. Implement written policies and procedures: Having written policies can go a long way in protecting your organization and employees if anything were to happen. We suggest developing comprehensive, legal-approved standards for anything marketing related, including: emails, paid campaigns, traditional media, print media, digital marketing content, and social media. Be very clear about what is and what is not acceptable, and set up a clear process for approvals and reviews to catch problems before they end up in the public sphere. Make this an integral part of team onboarding.
2. Designate a compliance officer and committee: There might be a general compliance officer for the broader organization, but it can also be helpful to have a person well-versed in healthcare marketing compliance. The marketing compliance officer should understand meta health and wellness policy, Facebook ad policy, Google Ads personalized advertising health conditions, and programmatic health advertising guidelines at a minimum. You want this expert to be able to speak to upcoming new rules, the level of enforcement on different platforms, past issues and how they were resolved, and best practices for each platform. All of these very specific channels may not be as readily understood by a general compliance officer. 
3. Training and education: Make sure to share healthcare marketing rules with the entire team and leadership, which helps ensure everyone is on the same page. It might also be worthwhile to schedule regular healthcare marketing refreshers so new campaign ideas and content can be reviewed in a timely fashion, and problematic content can be used as a training tool. Depending on your channels, you may need to provide regular training for different healthcare and medical advertising policies from Meta, Google, or others.
4. Ensuring open and consistent communication: Along with robust training, make sure your team knows who the compliance officer is, who needs to approve marketing materials, and how they can escalate issues when needed. 
5. Conduct internal monitoring and auditing: Here is where you devise a clear process for approvals. You can implement strict controls in project management tools and have the compliance officer give final approvals. It might also be worth reviewing problematic cases to avoid making the same mistakes twice. 
6. Enforcing standards: The whole marketing team should be aligned and agree to enforce the rules. 
7. Responding promptly to problems: Marketers know how to move fast, especially when poor reviews or offenses are on the line! When problems arise, have clear channels for dealing with them, and never wait. HIPAA violations are expensive and can damage brand equity very fast, so it’s important to act quickly. 

Common challenges in healthcare marketing

Issues will pop up, and when they do, you want to be prepared. The steps above will help create a broad foundation for success, but also keep in mind some common challenges that healthcare marketers face with pharmaceutical advertising, marketing medical products, and advertising medicines, so you can catch them before they become expensive problems. 

Challenge 1: Guaranteeing Outcomes

Healthcare marketing frequently crosses into problematic territory by guaranteeing specific results without the data to back it up. Statements like “completely eliminate your pain,” “guaranteed weight loss,” or “100% success rate” misrepresent healthcare’s inherent variability and likely violate advertising regulations. So, instead of guarantees, focus on the process, the organization’s specific expertise, and document outcome data with appropriate context. 

Challenge 2: Using Patient Information Without Authorization

One of the most common HIPAA violations involves using patient information for marketing without explicit authorization. Many healthcare organizations assume that because someone is their patient or they have left a review, they can use their information however they want. The rules distinguishing healthcare operations from marketing are nuanced. For example, if you’re using patient data to create targeted health advertisements, you most likely need to get patient approval. This also brings up the nuance surrounding tracking pixels on websites and how that information is shared. Review your website analytics, Google ads for healthcare, and other advertising technologies to ensure they’re not inadvertently sharing PHI with third parties, and make sure you have the appropriate documentation on your sites and profiles.

Challenge 4: Minimizing or Omitting Risk Information

In the drive to create persuasive marketing, some healthcare organizations downplay or omit risk information, making treatments sound more appealing than a balanced presentation would allow. To ensure compliance, you need to present the benefits and risks equally, not hidden behind landing pages or links. 

Challenge 5: Patient Testimonials Without Proper Disclosures

Patient testimonials are powerful marketing tools, but they’re also compliance minefields. You must clearly disclose any material connection between your organization and the person providing the testimonial. That means you must be very clear if you have compensated them in any way, or if they are a paid professional and not a patient.

Challenge 7: Inadequate Accessibility

One that often gets overlooked in marketing is website accessibility, which is required under the ADA. Healthcare organizations face particular scrutiny because accessible healthcare information is essential for people with disabilities to make informed medical decisions. This means your website must have accessibility settings such as alternative text for images, work with a screen reader, feature color contrast adjustment options, and other detailed features. 

Challenge 8: Ignoring State-Specific Requirements

California is notorious for having very strict compliance rules and regulations. If your organization works in different states, you will also need to be clear about the state-specific regulations. For example, some states restrict before-and-after photos, require specific disclaimers, or limit how you describe credentials and outcomes.

When it’s time to ask the experts 

Investing in expert guidance is probably much cheaper than the cost of a HIPAA violation for your organization. Sometimes it can be helpful to get a professional set of eyes on your marketing strategy, website, or compliance processes to ensure they work correctly. 

Overall, if you can look at compliance as a framework to protect your patients and valued audience, it will seem far less restrictive and much more personal. After all, we’d all like to know that someone is looking out for us and our health.