healthcare marketing compliance

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.

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.