There are significant differences in disease incidence and severity between ethnic groups in the United States. Maria Canfield from Alliance Healthcare Information provides the following examples among the U.S. Hispanic population, a segment that has a high prevalence of chronic diseases.

• Mexican-American (subset of Hispanic) adults are twice as likely as white adults to be diagnosed with diabetes by a physician.


• Hispanic men and women have a higher incidence of and mortality rates for stomach and liver cancer than the white population.


• Hispanic women were more than twice as likely as white women to be diagnosed with cervical cancer.

The reasons for these differences are what you may expect. Genetic factors play a part, but lifestyle factors are essential, too – for example diet and screening for early detection. While there is some awareness of this in the general public, there is a significant opportunity for pharmaceutical companies and healthcare organizations to reach ethnic groups, such as the Hispanic community, through effective print advertising, the establishment of medical contact centers to handle inbound calls, and community outreach. Beyond opportunity and awareness are the many laws and standards that dictate how this information is communicated and in what language (English vs. Spanish, etc.).

U.S. Health and Human Services Standards
In the United States, there are national standards on Culturally and Linguistically Appropriate Services (CLAS), developed by the Office of Minority Health, US Health and Human Services. These standards are primarily directed at healthcare organizations (i.e. hospitals, clinics) but individual providers are also encouraged to use the standards to make their practices more culturally and linguistically accessible.

The concept behind many of these standards has applicability to the thought process that goes into developing an awareness campaign that is either directed to a specific ethnic group or crosses ethnic lines. The CLAS standards include:

Culturally Competent Care

• Care compatible with cultural health beliefs and preferred language


• Diverse staff reflective of demographic characteristics of service area


• Train staff in culturally and linguistically appropriate service delivery

Language Access Services

• Provide language assistance services at no cost


• Provide patients services in their preferred language


• Must assure competence of language assistance provided


• Must make available easily understood patient-related materials

Organizational Supports for Cultural Competence

• Must have written strategic plan relative to providing CLAS


• Conduct initial and ongoing organizational CLAS self-assessments


• Data on patient’s race, ethnicity and spoken/written language collected in health records


• Maintain demographic, cultural and epidemiological (study of factors affecting health and illness) profile of community and plan to respond to cultural and linguistic characteristics


• Develop participatory, collaborative partnerships with communities


• Ensure conflict and grievance resolution processes are culturally and linguistically sensitive.


• Encouraged to make available their progress in implementing CLAS standards.

Additionally, there is mandated protection for patients with Limited English Proficiency (LEP). Regarding clinical research, translation guidelines have been set by the Office for Human Research Protections (OHRP) and the FDA. There are FDA regulations that also govern language translation for medical device and pharmaceutical product marketing.

GC Note: Inna Kassatkina co-presented with Maria Canfield at the 44th Annual DIA Meeting. Their presentation, “Drug Development in a Multicultural Environment,” expanded on the topics covered in this article. Kassatkina and Canfield will contribute an article focused on this topic for a future issue of DIA Forum. For more information about regulations and guidelines related to healthcare and language, please contact us.