The following is a guest post by Big Market Research. It does not represent the views, advice, or opinions of Mobile Health.
Early this month on April 05, 2016, the interactive web based tool ‘Mobile Health Apps Interactive Tool’, was released by the Federal Trade Commission. This tool was aimed at imparting clarity on the applicable federal laws for the mobile health apps that intend to stay in the market. The compilation of question and answers in conjunction with provided guidance from Health and Human Services Department (HHS), underscores applicability of the Health Insurance Portability and Accountability Act (HIPAA) and its rules. The tool development has been a combined effort from Federal Trade Commission (FTC), Food and Drug Administration (FDA), HHS’s Office of the National Coordinator, and HHS’s Office for Civil Rights.
The user-friendly tool has a basic approach to identify the exact rules that hold relevance to a mobile health app. More importantly, it acts as a regulatory guide to realize whether or not the app is going to be affected by any of the rules at all. This is crucial when one is reminded of various organizations that contribute to the vast set of regulations, such as Federal Food and Drug Cosmetics Act (FFDCA), FTC’s Health Notification Breach Rule, or the Federal Trade Commission Act.
During the course of ten inquisitions, the ‘if and which’ factors of federal regulations are determined with regard to mobile health apps. It tests the app if user information is being received or transmitted, has been designed for a specific disease, risks held by it, and if a public or private organization is the provider. The first question covers the handling of personal information, while the next three confirm the provider is a covered entity or a business associate under HIPAA. App developers, during the next three questions, establish if their app conforms with any of the medical devices that the FDA has chosen to regulate. The extent up to which the developer is exposed to the FTC regulations is realized through final three questions.
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The release could be seen in the positive light of bridging the information gap between the software developers and the mobile health apps market. However, the Federal Health Policy counselors demand further clarification on effects of federal privacy rules and regulations from the HHS. An air of uncertainty remains around exactly how the rules are applicable for the health information stored on personal devices.
“Relationships between providers and app developers are often complex, and the OCR’s recent guidance, while helpful, might not fit all cases,” Meg Marshall, director of policy for EHR vendor Cerner and co-chairwoman of the API task force commented on the previous informal guidance released by OCR in February.
Josh Mandel, co-chairman of the API task force remarked, “Both actions fall short of what app developers really want: a clear dividing line between what is, and what isn’t covered under HIPAA and other health privacy laws.”
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