The SHSMD annual conference continues with a great health brand communications presentation by Joel English, Managing Partner of BVK.  Joel succinctly shared the most important thing that every health marketer should know:

The valuation of a healthcare system’s brand is the highest asset on its balance sheet.

Here are some things to remember in protecting the integrity of your healthcare brand:

Health brands are goodwill.  Your health brand is an intangible asset. In the healthcare context, a brand includes health system and facility names, marketing campaign names, slogans, and logos.  It also includes marketing copy, images, and proprietary research, products and services.  A healthy brand is the result of cumulative goodwill cultivated at great cost and expense to an organization.

Health brands can be injured.   Healthcare brands, like other brands, are not immune to damage.  In the health marketing context, this often is the result of failure to follow HIPAA marketing rules, trademark and copyright clearance, or making unsubstantiated advertising claims.  So damage to a health brand is not just about attorney’s fees and monetary damages; it is about potential injury to your reputation.

Brand Health is your responsibility.   According to Joel, a brand is the responsibility of all members of the healthcare organization; including their outside agencies, and everyone who has contact or who influences an organization’s customers and communities.  Brand is the unified theory of everything; the context of how we act and communicate.

Editor’s Note:  Healthcare brands spends millions of dollars per year on marketing and advertising.  The overall goal of such efforts is to strengthen and differentiate the brand among relevant consumers.  Done right, health brand marketing can result in greater revenue and improved brand equity.  But if healthcare organizations fail to clear brand names or implement HIPAA marketing and related compliance training, their brand equity could quickly suffer from injury to brand reputation.  This is in addition to potential six-or seven figure monetary damages and attorney’s fees that could result from unaddressed marketing risks.

SHSMD 2018 continues with David Marlowe, CEO of Strategic Marketing Concepts, who provided an excellent presentation entitled Healthcare Marketing Plans That Work.

As a former President of SHSMD and health marketing expert and author, he provides practical insight. According to David, a good health marketing plan should include the following elements:

  • Executive Summary.   This is an overview of strategic plan priorities and goals.
  • Market Audit.   These are the key factors that influence the marketing situation facing the healthcare organization, service, or program.  It’s not just about data – its about good information.
  • Market Position.  Who you are and what differentiates your brand from your competitors.
  • Market Strategies.  Proposed strategies and initiatives for next 1-2 years.
  • Market Objectives.  An explanation of what you are trying to achieve as an organization.
  • Market Actions. The specific things you are going to do in the next year.

Here are some of David’s additional observations:

Does your organization have health marketing function policies in place and are they enforced?

  • Marketing is strategy.   Health marketing goals must be integrated into the business plan.  Yet, many healthcare systems and providers do not even include specific marketing goals as part of their formal strategy.
  • Content is what counts.  A health marketing plan needs to involve the entire organization.  The most effective plans are broad and holistic, including operations, management, and financial.   Involve every key internal client when planning.
  • Marketing must be measurable.   The days of wanting to improve brand reputation and visibility are past.  Looking at what is coming and how to prepare for it is one of the purposes of a good marketing plan.

An effective health marketing plan should include marketing compliance employee and vendor training.

Editor’s Note:  The David Marlowe publication, Healthcare Marketing Plans that Work, is now available for purchase at the SHMD Conference or on the SHMD website.

Dietary supplement compliance is a complex matter, requiring broad vetting of not only packaging but also all advertising and marketing materials. Unfortunately, many manufacturers and distributors still leave themselves open to legal risk. All too often, they focus on Food and Drug Administration (FDA) requirements and miss a crucial step in dietary supplement compliance, namely adhering to Federal Trade Commission (FTC) requirements.

FDA vs FTC.  While both the FDA and FTC have authority over marketing dietary supplements, they have distinctly different legal responsibilities. The two agencies work together to determine which one or both would pursue government investigation of a dietary supplement that makes dubious or not fully supported claims. The FDA primarily looks at packaging, labeling, content, purity, and safety. Many manufacturers of dietary supplements focus primarily on the required disclaimers for labeling pursuant to the Dietary Supplement Health and Education Act of 1994. One of the well-known disclaimers is: “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”

The FTC, however, has authority to go beyond the package and examine the truth and accuracy of all dietary supplements’ advertising and marketing material. Thus, all radio, tv, print, Internet, and social media campaigns must comply with Section 5 of the FTC Act. All claims must be truthful, not misleading, and substantiated. The FTC offers detailed guidance in its document, “Dietary Supplements: An Advertising Guide for Industry.”

Examples of Enforcement Actions.  Using unsubstantiated claims can have dramatic and costly results. In 2014, the FTC ordered Sensa’s marketers to pay more than $26 Million in redress to consumers who bought the supplement. The marketers, according to the FTC, had deceptively advertised that consumers could “sprinkle, eat, and lose weight” simply by using Sensa. In 2016, the FTC settled with the sellers of Supple, a glucosamine and chondroitin liquid settlement. The FTC alleged that the Supple sellers had falsely advertised the products’ ability to provide complete relief from arthritis and fibromyalgia joint pain. Part of the settlement included a $150 Million judgment.

The FTC is not the only player in town. The Council for Responsible Nutrition works collaboratively with the National Advertising Division of the Better Business Bureau (NAD) to ensure dietary supplement compliance with Section 5 standards. The NAD has investigated supplements over and over, recommending that sellers revise their advertising claims if they do not have sufficient clinical evidence. If a dietary supplement marketer does not comply with the NAD’s guidance, the NAD is likely to turn the matter over to the FTC.

Legal Vetting Best Practices.  Health marketers should be aware of the following dietary supplement compliance considerations:

* When creating marketing and advertising for a dietary supplement, let qualified legal counsel vet your materials for FTC and FDA compliance.

* Remember that both implied and express claims must meet the legal standards for commercial speech.

* Your clinical evidence requires careful legal analysis based on the advertising claims. It may not be sufficient to support your marketing claims if it does not match typical consumer experience or does not follow certain scientific standards.

* The FTC also often finds problems with consumer testimonials and expert or celebrity endorsements. Your marketers should ensure they fully understand the FTC’s requirements in these areas.

If you are a manufacturer, distributor, or marketer of dietary supplements and want to know more about legal requirements for advertising and selling these products, please contact Kyle-Beth Hilfer, Esq. 

Many healthcare companies believe that their U.S. trademark registrations are safe from trademark cancellation.  This can be a fatal mistake if you are not well-versed in trademark compliance law.

Trademark cancellation rules.  In the United States, trademark registrations enjoy a ten-year term, which can be renewed for additional ten (10) year periods upon a showing of use.  That being said, trademark registrations are subject to cancellation under the following conditions:

  1.  Administrative cancellation by the USPTO.   There are two times during the ten-year term that trademark owners must establish proof of either continuous use in commerce or excusable non-use.  These are between the fifth and sixth year post-registration and between the ninth and tenth year-post registration.  The failure to establish proof of use during these two statutory periods will result in your trademark registration being administratively cancelled by the U.S. Patent and Trademark Office.
  2.  Trademark cancellation by a third-party.   Any third-party who believes that it may be damaged by the continued registration of a trademark may seek to cancel the registration.  This is done by filing a petition for cancellation with the U.S. Trademark Trial and Appeal Board (“TTAB”).

How a cancellation proceeding works.   A trademark cancellation is a civil lawsuit filed before the U.S. Trademark Trial and Appeal Board (“TTAB”), the administrative body of the USPTO tasked with, among other things, adjudicating registration disputes between litigants.   Like other civil cases, trademark cancellation proceedings consist of three primary stages:  pleadings (which may include the petition for cancellation, answer, affirmative defenses, or counterclaims); discovery (which consists of interrogatories, requests for production of documents, admissions, and depositions); and trial.  Note that the TTAB’s jurisdiction applies to issues of registration only; it cannot order a party to cease using its trademark in commerce.  Nor can it award attorney’s fees and expenses.

Grounds for petition for cancellation.    A petition for cancellation of another party’s trademark registration may be filed on several grounds, including:

  • a likelihood of confusion with the Petitioner’s trademark;
  • abandonment of the trademark by the trademark owner through non-use;
  • that the Registrant’s mark is merely descriptive or has become generic
  • Registrant is not the rightful owner of the trademark
  • Registrant’s mark would dilute the distinctive quality of the Petitioner’s mark
  • Fraud on the USPTO

There are additional grounds for cancellation of a trademark registration.   One tactic that is being used more frequently by competitors is a petition for partial cancellation.  This is where the petitioner seeks to cancel entire classes of goods or services or specific goods and services from the trademark owner’s registration.

Trademark Cancellation Risk Compliance   To avoid your health trademark registrations from being cancelled, it is important to routinely file mandatory proof of continuous use with the USPTO.   This includes making sure that your company’s trademarks are still being used on all of the goods and services set forth in your trademark registrations.    

Responsible health marketing compliance starts with proper employee training.

Who needs training.   If you and your company are a provider of health and wellness products and services, you are obligated to comply with various health marketing laws.  This includes health systems, hospitals, clinics, and physician practices.  It also applies to the marketing of health products and solutions to the general public, such as medical and long-term care insurance, nutritional supplements, fitness products, and natural remedies and personal care.

Applicable laws and regulations.  There are several federal laws and regulations regarding the proper advertising and marketing of healthcare solutions.  Some help protect your own brand and marketing efforts, while others help you mitigate the risk of infringing the rights of third-parties, including patients and competitors.  These include:

  1.  HIPAA Marketing rules.  The HIPAA Marketing Rules are promulgated by the U.S. Department of Health and Human Services.  The Rules give patients and consumers important controls over whether and how their protected health information (PHI) is used and disclosed for marketing purposes.  The rule generally requires covered entities to obtain permission to use PHI for marketing purposes, subject to certain exceptions.
  2.  Stark Law.  The Stark Law governs physician referrals.  Under the law, physicians are prohibited from referring patients to receive “designated health services” payable my Medicare or Medicaid to entities which the physician or immediate family member has a financial relationship.  Certain exceptions may apply.
  3. Lanham Act.  The Lanham Act governs the laws of trademark and unfair competition.  Prior to adopting a new brand name, slogan, or logo design, health providers need to properly clear the trademark to ensure that it is available for use and registration.   After a clearance search and opinion is provided and approved, it is recommended that the entity file a trademark application with the United States Patent and Trademark Office.
  4.  Copyright Act.   The most common, and potentially costly area of compliance if not followed, is copyright law.  Under the U.S. Copyright Act, copyrightable subject matter such as stock photos,  images, illustrations, and marketing copy and brochures are protected from unauthorized use.  The law also applies to the unauthorized distribution of copyrighted materials to fellow employees or colleagues, such as medical journals, articles, or other content for which your company has no subscription or license.
  5. FTC Regulations.   The U.S. Federal Trade Commission is the primary agency that enforces advertising laws and regulations.  The Federal Trademark Commission Act (FTCA) prohibits false and deceptive advertising, and other unfair trade practices.   Companies that offer and market healthcare solutions are obligated to substantiate all the material health and other claims made in their marketing and advertising.

Penalties for non-compliance.   The penalties for violations of law due to not having a health marketing compliance program can be severe.  Examples include injunctions, destruction of marketing collateral, monetary damages, and in some cases, treble damages and an award of attorney’s fees to the prevailing party for intentional acts.  This is separate and apart from the costly legal fees and disruption to business and reputation that may result from non-compliance.

Editor’s Note:  If you are a healthcare provider or marketer of health and wellness products, setting up a proper health marketing compliance program need not be complicated.  To discuss your compliance program education and monitoring needs, please contact James Hastings.

This is part of a continuing series on health trademark compliance and training.  This installment reviews trademark basics and clearance considerations.

Many healthcare systems and providers still lack a basic understanding of how health trademarks are cleared, approved, and registered.  The root cause if often the failure of employee education and compliance training.   When health providers fail to properly clear the use or registration of a trademark before commencing such use, the risk to the organization almost always increases.  Here are some important things to remember.

Trademark Definitions.  A trademark is any word or symbol used to distinguish the goods or services of one party from those of another party.  A “service mark” is a trademark that is used exclusively in connection with services.  For example, CVS HEALTH may be a service mark for health and wellness education and a trademark for contact lens solution. Examples of trademarks that are eligible for protection include:

  1.   Word marks.  Word marks (without any logo or design element) often provide the broadest trademark protection.  This is because word marks can be used together with various logo or font variations at the brand owner’s discretion.  Examples include Anthem, Cleveland Clinic, Cardinal Health, and Johnson & Johnson.  When launching a new health product or service, it is often advisable to seek registration of the word mark alone in addition the word mark and combined design logo.
  2.   Logos.  Design marks are commonly referred to as logos.  These can be registered either alone (without any words) or in combination with the brand name to which it is associated.  Trademarks that incorporate logos can either be filed in black and white or in color.  Of the two, black and white affords the broadest trademark protection.
  3.   Slogans. Taglines and slogans are considered to be trademarks.  Like other forms of trademarks, taglines and slogans may be registered so long as they are not merely descriptive, generic, or cannot function as a trademark.

Trademark Search Advisory.  Prior to adopting a trademark for any goods, services, or marketing campaign, it is advisable to conduct a full search of the U.S. Patent and Trademark Office records and common law listings to determine the availability of the trademark for registration and use.  Once the trademark search is performed, it should be reviewed by a qualified health trademark attorney.  The attorney should provide a written opinion as to whether the proposed trademark is available for use and registration.   If the search results indicate a potential likelihood of confusion with a third-party trademark, then alternatives should be suggested on how to best mitigate any additional risks.

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.  

Health trademarks are of vital importance to the value of healthcare brands.  A recent study by Healthcare Global revealed that CVS Health was ranked the top healthcare brand in the United States based on revenue, with annual sales of $139.4 billion. Yet the availability of a health trademark for registration and use is never guaranteed.  It is therefore surprising that numerous U.S. health and wellness providers fail to properly conduct a trademark clearance search prior to launching a new product or service that could be worth millions of dollars in revenue.

The United States Patent and Trademark Office recommends conducting a trademark search of existing trademarks prior to filing a trademark application.

This is how the trademark application search and application process generally works.

  1.   Trademark search.   A trademark search of the USPTO database is the first-step to determine whether a mark is available for registration and use.  The search should consist of existing federal trademark applications and registrations as well as common law listings of unregistered marks that are not contained in the USPTO records.
  2.  Trademark clearance letter.   After the search is conducted, a qualified trademark attorney should review the search results for, among other things, whether the desired trademark is confusingly similar to any preexisting registrations or third-party uses.   The attorney should then create a written opinion setting forth whether the proposed trademark is available for use and registration.  The opinion should make recommendations on the business risk of proceeding or not proceeding.  If the risk is too great, then an alternative trademark should be considered.
  3.   Prepare and file application.   Once trademark clearance is performed, the trademark application should be prepared and filed with the USPTO.  Applications may be based on either use of the trademark in commerce, or if is not yet being used, an intent to use the mark.  The application must comply with all other requirements, including a statement that the applicant is the rightful owner of the mark and that it does not believe that any other party has the right to use the proposed trademark.
  4.  Trademark examination process.   Every trademark application is assigned to an Examining Attorney in the USPTO.  The Examiner will conduct a search of prior applications and registrations contained in the USPTO database.  The Examiner will also review the application for additional procedural and substantive requirements, and may initially refuse the application based on a likelihood of confusion with a preexisting trademark application or registration.
  5.   Additional requirements.   If the Examiner initially refuses the application, the trademark attorney can submit arguments against the grounds for refusal and request that the registration issue.  If the application is not refused and all other requirements are fulfilled, then the trademark will issue in due course.  Each trademark registration has a term of ten years, with subsequent ten year renewal periods should all statutory requirements be met.  In addition, the trademark owner will be required to file an affidavit showing continued use of the trademark in commerce between the fifth and sixth year post-registration.

Editor’s Note:  A full trademark search and clearance opinion letter should be part of an overall health brand risk and compliance program. To discuss how to develop a plan, or to conduct a health trademark search, please contact the author.

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.

Healthcare trademarks are everywhere, encompassing a wide-range of products and services.  For healthcare providers and sellers of health and wellness solutions, knowing how the trademark system classification works may be useful.

To apply to register a trademark in the United States and elsewhere, it is necessary to list the goods or services on which you either intend to use the mark or are currently using the mark.  A list of acceptable goods and services may be found in the Nice Classification, an international classification of goods and services that is used for the registration of trademarks.

The following Nice classification classes are used to designate health products and services:

Health and Wellness Goods 

Class 3.  Personal care and beauty products, including skincare, shampoos, and cosmetics

Class 5.  Nutrition and dietary supplements

Class 9.  Software, including digital health apps, medical software, and other healthcare related software

Class 16.  Printed publications used in the field of healthcare

Class 25.  Fitness apparel, running shoes, gym bags

Class 28.   Sporting equipment, including treadmills, exercise bikes, and aerobic gear

Class 29.  dried and cooked fruits and vegetables; jellies, jams, compotes; eggs; milk and milk products; oils and fats for food.

Class 30.  Coffee, tea; flour and preparations made from cereals; bread, pastries and confectionery; edible ices; vinegar, sauces, condiments, and spices

Class 31.   Raw and unprocessed grains and seeds; fresh fruits and vegetables

Class 32.   Beverages, including health and energy beverages

Health and Wellness Services

Class 35.   Business management in the field of health, hospital administration, mail order of pharmaceuticals

Class 36.  Health insurance, long-term care insurance, pharmacy benefit management services

Class 41.  Health education and training, including health marketing compliance training

Class 44.   Healthcare services such as hospitals, home health, medical services, and urgent care

The above list is illustrative and non-comprehensive.  Within each class, there are many goods and services that may be health and wellness related.

Recommendation:  Prior to filing a health trademark application, a full trademark search should be conducted by a qualified trademark and marketing attorney.  This should be part of an ongoing healthcare marketing compliance strategy.  To learn how to get started, contact the author.