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.  

Over 3,000 trademark oppositions are filed every year with the US Trademark Trial and Appeal Board.  Many of these oppositions involve applications for health trademark products and services.  Knowing how the trademark application process works can help healthcare providers determine how to best ensure that their selected trademark will be available for use and registration.

Trademark Examination Basics.   All trademark applications filed with the United States Patent and Trademark Office (USPTO) are assigned to a Trademark Examining Attorney.  The Examiner will review the application for procedural and substantive requirements.  As part of the examination process, the Examiner will also conduct a search of the USPTO records to determine if there are any existing trademark registrations that may be deemed to be confusingly similar to the applicant’s mark.   Assuming the application has met all filing criteria and there are no problematic registrations of record, the Examiner will approve the application for publication.  Once published, any third-party who believes that it could be injured by issuance of the registration can oppose the trademark application.

Trademark Opposition Rules.   Trademark Oppositions are heard before the US Trademark Trial and Appeal Board (TTAB) the adjudicative body of the USPTO.   The various stages of a trademark opposition proceeding consist of the following:

  1. Notice of Opposition.   An opposition proceeding is commenced by filing a Notice of Opposition that sets forth the grounds for the opposition.  In cases where a likelihood of confusion is alleged, the Opposer must establish that it has standing and priority rights.
  2.  Answer.   Within 40 days of being served with the Notice of Opposition, the Applicant must file an answer.  The answer generally denies all relevant allegations contained in the notice of opposition and often included affirmative defenses.
  3.  Discovery.   After the answer is filed, the discovery phase of the proceeding commences.  This may include interrogatories, request for production of documents, and depositions.  The goal of discovery is for the parties’ to gather information and documents that would support their claims and defenses.  An effective discovery strategy can narrow the issues for trial and possibly lead to a motion for summary judgment should there be no genuine issues of material fact for the Trademark Board to consider.
  4.  Trial.   TTAB trials are conducted via written submissions, although either party has the right to request oral argument.   Submissions include a Notice of Reliance, Testimony (by way of depositions or declarations), and trial briefs.  The Board will thereafter render a written decision either granting the opposition or dismissing it.  If an opposition is upheld, then the Applicant will be refused registration.

Health Marketer Tips:  Trademark oppositions are very expensive and may present a high risk to your brand. To avoid the risk of a trademark opposition, it is highly advisable to have a trademark attorney conduct a full trademark search prior to launching a new healthcare product or service.

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.

The trademark protection of health brands is often overlooked by health providers and marketers of health and wellness solutions. Trademarks are any name, slogan, or symbol used to distinguish the goods or services of a company.   In the health products and services sectors, trademarks are searched, approved, and registered for a wide-variety of products and services, including:

Healthcare

  • Hospitals
  • Health Systems
  • Urgent Care Clinics
  • Digital Health Apps
  • Physician Networks
  • Medical supplies
  • Pharmacies
  • Counseling
  • Chiropractors
  • Alternative health
  • Health Financing
  • Health Insurance
  • Long Term Care
  • Home Care

Health And Wellness Products

  • Vitamins and supplements
  • Food and Beverages
  • Personal Care
  • Beauty
  • Aromatherapy
  • Books and publications
  • Athletic Wear and Apparel
  • Athletic Equipment
  • Fitness Centers
  • Spiritual wellness
  • Travel
  • Occupational wellness, including ergonomic solutions
  • Environmental wellness
  • Home appliances

In each of the above examples, trademarks play a vital role in ensuring the company’s own health and well-being.  Trademark clearance and registration of health brands is the first step when considering the launch of new products or services.   Here’s why:

Brand name protection.  Each year, health providers invest millions of dollars into the development and promotion of their brands.  Quite often, brand owners fail to properly secure and register its trademarks.  The result is that in certain cases, the selected trademark could be susceptible to possible infringement or dilution by competitors.  When this happens, not only does the value of the brand diminish, but legal expenses increase due to the necessity to enforce the company’s trademark rights.

Business Risk and Infringement.  Trademark infringement occurs when a trademark of a junior user is confusingly similar to that of a senior user for the same or highly related goods or services.   Claims of trademark infringement can often be avoided through a proper trademark search and registration process.

Business Disruption.   When a company is accused of trademark infringement, one of the unfortunate results is that it may be forced to cease use of the allegedly infringing name.  In the healthcare field, this may also include the necessity of destroying product or service lines that feature the name.  Examples may include on-site signage, printed marketing and promotional materials, and employee-facing training materials.

Recommendations:   If your company does not have a trademark clearance and registration process in place it is not too late to start.   For further information about trademark protection of health brands, feel free to 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. 

Copyright infringement claims against health providers is a growing concern.  Unfortunately, many healthcare systems and hospitals neglect to implement a marketing compliance program until something goes terribly wrong.  The result?  Potential liability for copyright infringement.

What is copyright infringement?   Broadly speaking, copyright infringement is the unauthorized appropriation of original materials that are protected under U.S. copyright law.  In the context of healthcare marketing and advertising, the following materials are eligible for copyright protection and may be subject to claims of infringement:

  • Marketing and advertising copy of various digital and print collateral
  • Website copy
  • digital images and photographs
  • digital health software and platforms
  • diagnostic videos
  • medical journals and publications
  • medical illustrations

Examples of copyright infringement.  Many health providers believe that copyright infringement only occurs in the case of using a third-parties photographs or images without permission.  In fact,  there are several instances where a healthcare system may be liable for copyright infringement.  These include:

  • appropriation of copyrighted text that is incorporated into third-party health marketing collateral
  • unauthorized distribution of medical journal articles to several colleagues where a per copy license or subscription was not paid
  • unauthorized multiple uses of software products where only one license or no licenses were purchased or where the license had expired
  • unauthorized downloads or repurposing of health and wellness videos
  • use of patient testimonials without permission
  • use of digital images and photographs without the permission of the owner

Copyright infringement prevention.   Healthcare marketers and providers should be sure to establish a healthcare marketing and compliance program that consists of these important steps:

  • Conduct a health marketing audit.   An inventory of all marketing and advertising collateral that has been created or used by the health provider in the last year should be complied and assessed for compliance with copyright law and other laws related to trademark, advertising, marketing, and promotions, and privacy.
  • Rectify legal compliance errors.   Any health marketing materials compiled as part of the marketing audit process should be reviewed for legal compliance.  Those materials or processes that are non-compliant should be identified for immediate legal remediation on a priority basis.
  • Establish a health marketing compliance program.   Hospitals and health providers who do not already have a compliance program in place can get started with the help of a qualified health marketing and compliance attorney.  Providing education and training to internal marketing personnel and outside marketing agencies on legal compliance pitfalls is the first step in the process.

Recommended next steps:  To discuss implementing a health marketing and compliance program and training in your organization, you may contact the author of this blog.

It has been estimated that over the next decade, the United States will have 8-10 national health systems and approximately 150-200 regional systems.  Due to the fast pace of acquisitions and mergers, only 20%-25% of hospitals will remain independent.

When a hospital rebrand is being considered, legal issues arise that could have serious implications to the brand’s reputation and value.

Here are some legal tips for your marketing team when considering a hospital rebrand:

Step 1:  Select your brand architecture.   Many healthcare brands opt for the monolithic or umbrella brand naming model. This is usually the name of a larger health system that is acquiring a smaller, regional system.  Or, it could be a regional system that is acquiring independent hospitals and physician practices.  In either case, the umbrella brand is used as the primary name, with the name of a regional or local practice group secondary.  Health systems may alternatively opt for an endorsed brand format, where the name of a local hospital or practice group is dominant and the name of the regional or national healthcare system of which it is a part used as the tagline.

Step 2:  Conduct a trademark search.  Once the naming architecture is chosen,  a full search of the U.S. Patent and Trademark Office records (USPTO), state trademark office records, and unregistered common law uses should be conducted.  The purpose of this is to ensure the availability for use and registration of the preferred brand name.  Be sure to have the search conducted by experienced trademark counsel and ask for a written legal opinion. It is important to make sure that the chosen trademark is available in all states where the health system intends to do business.

Step 3:  File trademark applications.   A federal trademark application should be prepared and filed with the USPTO as soon as any new name or tagline is chosen.  The application may either be based on use in commerce, or an intent to use in commerce if the brand name is not yet in use.  As part of the application process, it is a requirement to list all of the goods and services on which you intend to use the mark.  The list should be as broad as possible at the category-level so as to be able to enjoy the broadest trademark protection.

Hospital rebrand note:  The above steps are the first in a series to ensure that all health brand marketing and advertising materials are protected and in compliance with applicable federal and state laws.  Consulting with a health marketing attorney early in the process will help to mitigate the risk associated with a hospital rebrand.

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.