Elizabeth Antoinette Milos - Comment

This comment is to provide the FDA with a warning regarding MediBabble, a mobile medical app that claims to assist medical providers to communicate with Limited English Proficient patients (LEP). Its intended use is patient history taking by medical providers. It is downloaded free into an iPhone and has a touch screen with questions about symptoms that are "voiced" to a patient in their language. The patient can only provide a yes/no response or point to a body part or a calendar to indicate where and when the body part hurts. This App presents a clear danger since it leads the provider to think that he/she is being understood and does not give the patient meaningful access to medical care as required by law under the Title VI Civil Rights Act of 1964 or Executive Order 13166 of 2000. In fact, federal recipients for Medicaid and Medical are required to provide patient centered care and abide by CLAS (Culturally and Linguistically Appropriate Services) Standards and users of this App would be violating these standards. The USD HHS has produced a report on ways to reduce disparities in health care delivery to racial and ethnic minorities, and the Office of Minority Health has just awarded a grant to the national Certification Commission for Healthcare Interpreters to further its national credentialing program. The Medical Intepreter profession has been in existence for many decades and the national associations of interpreters and other stakeholders have established national standards and measures of language competencies, interpreter protocols and ethical standards, just like any other health profession. An App such as MediBabble is not conducive to good medical practice nor does it achieve the level or quality of communication required in a medical environment. Please review accompanying documentation uploaded to your site.