Many organizations are predicting that mobile devices will continue to explode and because of this growing trend, federal agencies are assessing their regulatory and non-regulatory roles relative to mobile health technology, according to an American Health Information Management Association report.
Each federal agency has a unique view and approach to monitoring mobile device usage in healthcare. All of the below agencies were present at a recent roundtable discussion held by the Office of the National Coordinator for Health IT. Despite their different perspectives on mobile device regulation, each agency emphasized the importance of privacy and security, according to the report. Here is how each agency relates to mobile health regulation.
Federal Communications Commission — The FCC's scope includes authorizing carriers whose networks are used by mobile devices to access or store information, which includes health information. According to the report, the FCC also authorizes radio frequency medical devices such as implanted medical devices and patient monitoring devices.
Food and Drug Administration — The FDA promotes and protects public health by regulating any technology, including phones and mobile devices, that are used to treat disease in patients. For this reason, the FDA published a report titled "Draft Guidance for Industry and Food and Drug Administration Staff on the Regulation of Mobile Medical Applications" that seeks to regulate three types of mobile devices: apps that connect a medical device to display, store, analyze or transmit patient medical data; apps that transform into a medical device when attached to a mobile platform; and apps that utilize algorithms to transform patient information into a result, diagnosis or treatment recommendation.
The Federal Trade Commission — The FTC combats unfair or deceptive practices related to healthcare mobile device applications, which could include false or misleading claims or omissions of facts related to a mobile device or app.
The Office for Civil Rights — OCR recommends precautions for securing mobile devices such as encryption, user authentication and role-based access.
The National Institute of Standards and Technology — NIST is a non-regulatory federal agency within the U.S. Department of Commerce concerned with measurement, standards and testing. NIST provides publications related to computer security, including mobile security guidance.
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Each federal agency has a unique view and approach to monitoring mobile device usage in healthcare. All of the below agencies were present at a recent roundtable discussion held by the Office of the National Coordinator for Health IT. Despite their different perspectives on mobile device regulation, each agency emphasized the importance of privacy and security, according to the report. Here is how each agency relates to mobile health regulation.
Federal Communications Commission — The FCC's scope includes authorizing carriers whose networks are used by mobile devices to access or store information, which includes health information. According to the report, the FCC also authorizes radio frequency medical devices such as implanted medical devices and patient monitoring devices.
Food and Drug Administration — The FDA promotes and protects public health by regulating any technology, including phones and mobile devices, that are used to treat disease in patients. For this reason, the FDA published a report titled "Draft Guidance for Industry and Food and Drug Administration Staff on the Regulation of Mobile Medical Applications" that seeks to regulate three types of mobile devices: apps that connect a medical device to display, store, analyze or transmit patient medical data; apps that transform into a medical device when attached to a mobile platform; and apps that utilize algorithms to transform patient information into a result, diagnosis or treatment recommendation.
The Federal Trade Commission — The FTC combats unfair or deceptive practices related to healthcare mobile device applications, which could include false or misleading claims or omissions of facts related to a mobile device or app.
The Office for Civil Rights — OCR recommends precautions for securing mobile devices such as encryption, user authentication and role-based access.
The National Institute of Standards and Technology — NIST is a non-regulatory federal agency within the U.S. Department of Commerce concerned with measurement, standards and testing. NIST provides publications related to computer security, including mobile security guidance.
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