By Kaiser Wahab and Susanna Guffey
Information and data supplied by patients via smartphones and the Internet are poised to drastically lower costs associated with medical care and make it easier for doctors to treat patients, even remotely. However, developers should keep in mind the particular regulatory and compliance issues that arise when dealing with personal medical information.
This article provides a brief overview of the legal framework and best practices that developers should heed. First, it discusses the handling of health information under the Health Insurance Portability and Accountability Act, commonly referred to as “HIPAA”. Second, the article discusses potential Food and Drug Administration (FDA) regulation of certain medical applications or software that may also function as “medical devices.” Lastly, it discusses general concerns and best practices for mobile application or software developers.
I. Health Insurance Portability and Accountability Act (HIPAA)
What companies are regulated by HIPAA?
HIPAA establishes the rules that the U.S. Department of Health and Human Services uses to regulate the transmission of protected health information (PHI). PHI is any individually identifiable health information that is held or maintained by a Covered Entity or their Business Associates (defined below). Examples include demographic information past, present or future physical or mental health or condition of the patient; information pertaining to payment of healthcare services; and genetic information. For example, a mobile medical application that allows patients to transmit personal health information via their mobile devices would be handling PHI.
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