New Tool for Developers of Health Apps to Determine Regulatory Requirements

by | Apr 11, 2016

In an ongoing joint effort by the Federal Trade Commission, the Office of the National Coordinator for Health Information Technology, the Food and Drug Administration and the Office for Civil Rights, a new tool was just approved and released that is aimed at providing information on whether or not specific regulations would apply to the app they are developing. With so many new health apps on the market, this should provide clear and concise information on laws that would apply to the apps in question, according to the director of the Bureau of Consumer Affairs within the FTC, Jessica Rich.

Consumer Protection a Priority
The collaboration between the FTC, the ONC, the FDA and the OCR is a collaboration that has one particular goal in mind and that is consumer protection. According to Ms. Rich, developers of mobile apps have a need of obtaining information that is clear and precise when developing mobile health apps. She states that in working with “partner agencies” it is hoped that this web-based tool will help those developers design apps that are in compliance with the law so that consumers are better protected.

How the App Works
The new tool being released by the FTC asks the developers a series of questions, up to as many as 10, in regards to the app they are developing. Upon answering the questions, developers are then advised whether or not their mobile health app is at all governed by Federal laws and/or Federal regulations. These laws and regulations include:

  • HIPPA – Health Insurance Portability and Accountability Act
  • Health Breach Notification Rule of the FTC
  • FTC Act
  • FD&C Act – Federal Food, Drug and Cosmetics Act

Also included in the web tool are definitions of any applicable laws and a glossary of any terms (legal or otherwise) that might be used within those laws. Some of the ‘jargon’ used in those laws would include such things as PHI, protected health information and phrases like HIPPA business associate. Those would need to be defined and/or clarified.

FDA’s Input on the New Tool
According to the FDA’s Associate Director for Digital Health, Bakul Patel, there are so many new apps being developed that developers need clear information on regulations within government bodies that would apply to their health apps. He further states that this is an ongoing effort by the FDA to remain committed to protecting the safety of patients while also offering encouragement in the field of digital health innovations.

With so many false claims being made about what health apps can and can’t do, the FTC is now issuing strong warnings and orders to cease and desist being levelled against companies such as the marketers for UltimEyes that claimed “scientific proof” that this app could improve eyesight. It is clear that mobile health app developers and their marketing associates will need to adhere to Federal guidelines and laws in all claims being made in regard to their apps. This new tool should greatly help to clarify what they can and cannot say and also go a very long way towards consumer protection.

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