Unlike other industries, healthcare marketing has the unique challenge of developing strategies that are compliant with the many healthcare regulations that vary by country and state. The legal ramifications of non-compliance are expensive not just to your company’s budget but also to your brand.

Healthcare marketers should view this challenge as an opportunity more than an obstacle. Laws designed to protect patients’ information and safety force us to think outside the box and not take the easy road in generating leads and creating marketing materials. Being aware of these regulations and making sure your strategy prioritizes consent, scientific integrity, and long-term patient relationships elevates your brand and builds a contact database you can rely on.

Before talking about strategy options, it’s important to understand what you can and cannot do in your marketing efforts.

What Is and Isn’t Marketing?

First, what is the legal definition of marketing in healthcare? The HHS website defines marketing as “a communication about a product or service that encourages recipients of the communication to purchase or use the product or service.” It describes a few exceptions to this definition, which involve communications that describe products or services that the consumer’s plan covers or for a patient’s proposed treatment.

Their second definition of marketing is “an arrangement between a covered entity and any other entity whereby the covered entity discloses protected health information to the other entity, in exchange for direct or indirect remuneration, for the other entity or its affiliate to make a communication about its own product or service that encourages recipients of the communication to purchase or use that product or service.” In other words, one entity cannot sell protected health information to a third party for the entity’s own purposes or without the authorization of every individual on the list.

Healthcare Regulations: The Federal Trade Commission (FTC)

The Federal Trade Commission is the governmental body that enforces many of the healthcare marketing standards. Traditionally, the FTC has valued the role advertising plays in disseminating important health information to the public.

“I see both advertising and the regulation of advertising in a more positive light, as a means of improving the ability of consumers to make informed purchasing choices.”

Former FTC Commissioner Mary Azcuenaga

Their advertising enforcement focuses on deceptive practices that are likely to mislead. They established 3 criteria for determining if an advertisement or a practice is deceptive:

• The representation must mislead or be likely to mislead the consumer;
• The consumer’s interpretation must be reasonable under the circumstances; and
• The misleading misrepresentation, omission or practice must be material.

As a recent example, a Florida health system was sued as part of a medical negligence action that resulted in the death of a bariatric surgery patient. The hospital had advertised that it was awarded the American Society Bariatric Surgery Seal of Excellence. To be eligible to receive the certification, doctors must have performed 50 bariatric surgeries and completed 20 hours of continuing education. The physician who performed the surgery that resulted in the patient’s death had only performed 21 bariatric surgical procedures.

Marketing departments must pay this level of attention to their content and how it aligns with actual practice. Whether you’re in pharmaceuticals or not, making sure the science backs up your claims is key in healthcare marketing.

Healthcare Regulations: HIPPA

If you work in the healthcare field in any role, you’ve definitely heard of HIPAA. It’s important to understand all of its rules and policies. 

HIPAA stands for the Health Insurance Portability and Accountability Act of 1996, which is the law that aims to improve the national standards for how businesses secure protected health information (PHI). PHI refers to any information used to identify a patient from their medical file. That could be an address, identifiable photos, and many other forms of data. Since HIPAA compliance deals with how organizations access and share PHI, healthcare marketers must abide by them when creating their campaigns and communications.

HIPAA gives individuals greater access to and control over their personal health information. For marketers, that most often means getting written authorization before you use their PHI or patient story. 

Healthcare Regulations: Truth in Healthcare Marketing Act of 2017

The Truth in Healthcare Marketing Act of 2017 protects consumers from deceptive and potentially misleading marketing practices by healthcare businesses. It covers all communications between patients and healthcare providers, extending to the marketing campaigns implemented on behalf of healthcare businesses.

It prohibits you from taking part in any practice that isn’t fair, truthful, and backed by evidence. This is where scientific integrity comes in play. If you can’t guarantee as truth the information on your website, social media accounts, or directory listings, you’re potentially making a mistake that could cost you financially and taint your reputation.

It doesn’t matter if you outsource blog posts to writers who aren’t familiar with HIPAA or the truth-in-advertising regulations. If you violate those rules, you may eventually be held accountable for those mistakes. That’s why working with a healthcare-focused marketing partner like Connect Healthcare Consulting can be critical to your success.

Other Well-Known Statutes to Know

While the list is long and varies by state, here are some other general healthcare regulations to get familiar with if you’re not already:

• Anti-Kickback Statute (AKS) – Healthcare providers are prohibited from exchanging anything of value for referrals to any product or service that is payable under federal programs like Medicare and Medicaid.
• Ethics in Patient Referrals Act (Stark) – This law prohibits healthcare providers from making referrals to other providers with whom they have a financial relationship. Any shared financial interest that sparks a referral could fall under this law.
• Civil Monetary Penalties Law (CMPL) – The CMPL prohibits healthcare providers from committing a variety of healthcare frauds and abuses. Specifically, it heavily penalizes enticing consumers with kickback offers from a physician.
• State-level self-referral laws – Many states prohibit medical providers from making referrals based on financial arrangements that benefit them personally, especially for programs that fall under Medicare or Medicaid programs.
• Fee-splitting laws – Healthcare providers cannot split fees with other providers in exchange for patient referrals.
• Patient brokering laws – Many states refer to buying referrals in any way as patient brokering. These laws are similar to fee-splitting laws, but various forms of compensation may be involved in a brokering deal.

Building a Compliant Healthcare Marketing Strategy

So, let’s get back to strategy. Rather than viewing these healthcare regulations as additional baggage that restrict agility and hinder organizational growth, leaders of marketing departments should see a new opening to gain advantage and achieve goals.

Lead Generation

It is worth noting that lead generation through inbound marketing is still a possibility. You just need to be more cognizant of consumer consent, as it is an essential step before collecting personal and confidential data from consumers and patients. This is an opportunity to gain information and make connections in a meaningful way, which is more valuable than getting cheap, cold leads through other means anyway.

Consent involves using simple and easy-to-understand language to outline what data you are collecting and why. You then provide a standard call to action, like a checkbox, which prompts users to give their informed consent. Steer clear of pre-checked boxes or automatic opt-ins.

Note that this consent-based approach can change the brand-consumer data relationship in many ways. For example, it helps create a clear value exchange for the way the healthcare data will be used and what healthcare consumers may get in return.

Use Other Measurements for Campaign Success

Data privacy laws create difficulties for measuring marketing campaigns. When the consumer exercises the “right to be forgotten,” for example, the attribution approach fails. As a result, you can’t see the full picture of your customer identity and accurately report on how your ads are performing. Also, you are not able to manage how many times people see your ad; therefore, you risk irritating the user and damage the brand.

This is a difficult problem to go around. Some recommendations to improve your marketing plan include:

1. Prioritize personalized content as it allows you to earn data, rather than gathering it through questionable means and practices.
2. Create various innovative incentives and loyalty programs. They will renew a sense of urgency to develop a first-party relationship.
3. Stop measuring marketing and sales qualified leads and start measuring the contribution you are making to the brand value. This is a perfect time to concentrate and advocate long-term brand value, not short-term leads. Look at the large picture of value building.

Let’s Connect: A Marketing Partner Who Knows the Industry

After considering all the factors that go into a compliant and successful healthcare marketing strategy, the value of having a partner who understands both health science and business development is obvious. For a business and marketing strategist who is deep-rooted in the medical industry, look no further than Connect Healthcare Consulting.