An effective trademark compliance policy may be good for your health.

Each year, healthcare providers are named unwitting defendants in trademark infringement suits in the U.S. district courts.  The same holds true for trademark opposition and cancellation proceedings brought before the U.S. Trademark Trial and Appeal Board.  So what is the good news?  Many lawsuits can be avoided through proper education and trademark compliance training.

By way of example, the National Institute of Health (NIH) has written trademark compliance policies and guidelines for its employees.  This U.S. government agency knows the importance of trademark rights and how to protect its vast array of brand names used in connection with its various services.  Equally important is its awareness of the risks that trademark infringement can bring, including disruption to public marketing and promotional initiatives.

So if you’re a health system or other healthcare provider, it’s a good idea to implement a trademark education and compliance program for employees.  General areas that should be included in a trademark compliance program are:

  • trademark definitions and concepts
  • explanation of the trademark clearance process
  • how to search, clear, and apply to register trademarks
  • trademark use guidelines
  • what is trademark fair use and what is not
  • employee roles, responsibilities, and procedure
  • creative and marketing vendor responsibilities and procedures
  • trademark usage in digital marketing, including paid search

In addition to the above, annual risk and compliance training should take place with all employees and key vendors that have responsibility for brand assets, marketing, and promotions.  Health systems literally spend millions of dollars a year in brand marketing and promotional efforts.  Making brand compliance an integral part of your compliance and risk strategy can help protect your valuable brand investments and mitigate your risks.

An ounce of prevention is indeed worth a pound of cure.

Editor’s Note:   To discuss your trademark compliance policy or how to design and implement one, please contact us.  

Failure to comply with the HIPAA Privacy Rule can have serious consequences to healthcare providers.

The HIPAA Privacy Rule gives individuals control over how their protected health information (PHI) may be used for marketing purposes.  With limited exceptions, the Rule requires that written authorization must be obtained prior to using an individual’s PHI for marketing purposes.

HIPAA Privacy Rule Basics

The Privacy Rule applies to the use and disclosure of health information for marketing by a qualified health provider.  For the Rule to apply, two criteria must be present: (1) marketing; (2) by a qualified health provider (also known as a covered entity).

What is marketing.   The HIPAA 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.  If the marketing is by a covered entity, it requires prior written authorization of the patient.  Examples of marketing communications that require prior written authorization are:

  1.   a hospital mailer informing former patients about a wellness clinic that is not part of the hospital, that can provide a health and wellness screening for $99.00, if the communication is not for the purpose of providing treatment advice.
  2.  an email communication from a health insurer promoting a home insurance product offered by the same company.

What else is considered marketing.  According to the HIPAA Privacy Rule, “marketing” also occurs where there is an an arrangement between a covered entity and any other party whereby the covered entity discloses protected health information of consumers to the other party in exchange for direct or indirect compensation.  This generally occurs in circumstances where the third-party or its affiliates are used to promote the covered entity’s products or services.  This part of the definition of marketing has no exceptions.  Covered entities may not sell lists of patients or enrollees to third parties without obtaining authorization from each person on the list.

What is not marketing.    The HIPAA Privacy Rule has three exceptions for permissible communications that will not be considered to be “marketing” for purposes of the Rule.  A communication is not marketing if it is made:

  1.  to describe a health-related product or service that is provided by or included in a plan of benefits of the covered entity
  2.  for treatment of the individual
  3.  for case management or care coordination for the individual, or to direct or recommend alternative treatments, therapies, health care providers, or settings of care to the individual.

The HIPAA Privacy Rule has many other features that will be discussed in future articles.

Editor’s Note:  Adherence to the HIPAA Privacy Rule should be part of an overall health marketing compliance strategy.  For further information on how to develop and manage a health brand and marketing compliance program, contact the author.

Digital health apps are growing in popularity.  According to a recent study, there are more than 325,000 mobile health apps available for upload to smart phones or tablets.

The marketing of digital health apps to consumers brings with it numerous legal compliance obligations.  Depending on the app and its functions, several federal laws and regulations may apply.  These include:

Health Insurance Portability and Accountability Act (HIPAA)

The U.S. Department of Health & Human Services (HHS) enforces the HIPAA rules, which protect the privacy and security of certain health information.  The HIPAA laws also require certain entities to provide notifications of health information breaches.

Federal Food, Drug, and Cosmetic ACT (FD&C Act)

The FDA enforces the FD&C Act, which regulates the safety and effectiveness of medical devices, including certain mobile medical apps.  Depending on the nature of the health app, FDA oversight may apply.  This may include health apps that pose a higher health risk if they do not perform as intended.

Federal Trade Commission Act (FTC Act)   

The FTC Act prohibits deceptive and unfair trade practices affecting interstate commerce.   These acts may include those relating to false and misleading health claims, representations regarding the performance of the app, as well as claims that impact consumer data security and privacy.

Health Breach Notification Rule (FTC)

This law applies to certain businesses that are required to provide notifications to consumers after a breach of personal health record information.

Lanham Act

The Lanham Act is the primary federal law that governs the registration and use of trademarks in the United States.  Health app providers must be sure that any trademarks that they adopt are properly cleared.  If third-party trademarks are used, then such uses should be permissive or in the context of fair use exceptions.

U.S. Copyright Act

U.S. copyright laws protect original works on authorship fixed in a tangible medium.  The written code of mobile health apps are considered literary works subject to registration, protection, and enforcement under the Copyright Act.

U.S. Patent Act

Certain digital health apps and its associated technology may be patentable.  This will depend, in large part, on the nature of the technology and whether the invention is new and non-obvious.

Editor’s Note:  Developing and marketing any health app requires careful legal compliance review.  To discuss your digital health app requirements, feel free to contact the author. 

A recent article by Healthcare Dive reports that nearly 90% of companies pay employees to participate in wellness programs.  This is a good thing.  Yet when it comes to ensuring their own brand protection health, most health brands and providers ignore their own advice.

Consider these legal health marketing scenarios:

Trademarks.  For every new health brand name or slogan that is adopted, chances are that most have not been properly cleared by a trademark attorney.   This is despite the fact that services rendered under the new trademark will in all likelihood earn millions of dollars of revenue for a provider and have six figure marketing budgets.  So how valuable is a healthcare name?  Certainly more than the few thousand dollars it will cost to properly search, clear, and apply to register the newly adopted trademark.

Copyright.  Marketing agencies produce millions of dollars in digital and print collateral for healthcare systems and providers annually.  Yet for many health brand owners, there is no legal compliance process in place to make sure that all creative materials comply with U.S. copyright laws and do not infringe the rights of third-parties.  And few have any system in place to catalog and protect all proprietary copyrightable subject matter and marketing materials on behalf of healthcare clients.

Social media.  The use of social media to promote patient testimonials and population health initiatives is increasing. With this growing trend is a heightened legal risk to health providers.  The social media marketing and promotional efforts of health providers must adhere to HIPAA Marketing Compliance and privacy rules as well as other federal laws applicable to truthful marketing and advertising.

As healthcare marketers continue to increase their spending on advertising, the associated legal risks of such activities continue to rise.  This is why it is vital for both healthcare providers and agencies to implement proactive legal wellness programs to prevent damage to their valuable brands and goodwill.

A recent survey by True North Custom confirms that content marketing continues to play a growing role in the marketing of healthcare brands.

The 2018 State of Healthcare Content Marketing Report provides a fascinating look into what healthcare marketers deem important.  It is a must read for those who wish to stay on top of trends and determine what is working and not working in the marketplace.  That being said, there is one question that we recommend be included in next year’s report:

Do you have a process in place to make sure that your marketing content is legally compliant?

Why should your organization have a marketing legal review process?  Here are some things to consider:

  • The cost of litigation can be expensive.   Any healthcare provider can attest to how litigation fees can severely impact the bottom line.  While healthcare system legal efforts often focus on regulatory and quality of care issues, missteps in marketing and brand protection can be just as deadly to brand reputation and budgets.
  • Brand reputation is worth the investment.   Brand names and reputation are some of the most valuable assets of any company, including those of healthcare providers.  So why not be proactive in protecting them?  When an issue arises that could tarnish your healthcare brand, it is often too late.
  • Marketing compliance makes sense.   When it comes to risk mitigation, an ounce of prevention is worth a pound of cure.  HIPAA marketing compliance, brand clearance, the proper use of patient testimonials, and other issues continue to face healthcare marketers every day.

Getting started with a Marketing Compliance Program

If you do not already have a health marketing compliance program in place, here’s what you can do:

  • Conduct a health marketing checkup.   Provide your brand protection attorneys with a selective sampling of your marketing materials.  Be sure to include examples from various channels, including social media, newsletters, video, and direct mail marketing.
  • Identify risk gaps in your marketing plan.   Your attorneys should be able to provide you with a diagnostic tool that helps identify marketing problem areas, together with recommendations to remediate problems and mitigate risks.
  • Make compliance easy to understand.   A red light, yellow light, and green light chart that indicates brand protection and marketing compliance risks from low to high often works best.  Recommendations should also be color-coded, based on low-priority to high priority tasks.

An effective healthcare brand protection and marketing compliance program need not be expensive or complicated.  But it is important that healthcare marketers partner with qualified health brand attorneys.  That way, there is a greater chance that your compliance efforts will be embraced by your organization and external marketing partners.  By doing so, it will help ensure the overall success of your health marketing strategies.

What’s new in healthcare marketing?  A greater focus on the law.

The evolution of healthcare marketing has resulted in greater legal obligations for the industry.  Today, more healthcare marketers are advertising directly to consumers.  Where traditional healthcare marketing was provider-centric, the modern approach emphasizes patient experience.  This model brings with it a multitude of new legal issues for the industry.

HIPAA Marketing rules.  HIPAA marketing rules require that patient health information (PHI) is adequately protected and not exploited for commercial purposes.  The rule generally requires covered entities to obtain permission to use PHI for marketing purposes, subject to certain exceptions.

Digital marketing trends.  According to a recent report article by Phase 2, digital health marketing efforts will continue to expand in 2018 and beyond.  The implementation of digital marketing campaigns require knowledge of various laws, including HIPAA privacy, social media, CAN-SPAM, and FTC regulations.  Digital health, the use of patient testimonials, and issues related to claims substantiation and HIPAA marketing bring with them unique challenges and risks.

Hospital rebranding.  Rebranding a hospital to a unified healthcare brand requires proper trademark search, clearance, and registration. Trademark clearance and registration of the unified brand is only the first step of the process.  Proper brand clearance planning and consideration must also be applied to slogans, sub-brands, and associated brand usage policies.

Social Media marketing.  Hospital advertising and promotional efforts have gone beyond quantitative performance metrics.  The rise of patient community websites and social media networks require greater scrutiny that health marketing and advertising claims are substantiated and patient privacy secured.

Healthcare brands are learning more about the importance of implementing brand and marketing compliance programs.   With greater competition comes the urge to explore new and bolder ways to market healthcare solutions.  The result is greater risk to the organization.   Your legal team should always be invited to be a key stakeholder in the marketing and promotions process.