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EU-US Privacy Shield Updates: Parliament Criticizes US Actions, and FTC Settlement with ReadyTech

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There were two recent noteworthy developments related to Privacy Shield from both sides of the Atlantic.

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FTC Staff Provides Recommendations to Consumer Product Safety Commission on IoT Safety

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In March 2018, the Consumer Product Safety Commission (CPSC) issued a Notice of Public Hearing and Request for Written comments on The Internet of Things on Consumer Product Hazards.  The CPSC expressed interest regarding existing safety standards on existing IoT devices, how to prevent hazards, and the role of government in the effort to promote IoT safety.

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Eleventh Circuit Vacates FTC LabMD Order but Does Not Challenge FTC Authority

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The U.S. Circuit Court of Appeals for the 11th Circuit vacated the LabMD Federal Trade Commission order but did not challenge the Commission’s ability to use its unfairness authority to challenge inadequate data security practices in  a closely watched case that tested the commission’s enforcement powers.

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FTC Warns Two Foreign-Based App Developers of Possible COPPA Violations

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The FTC staff recently sent two warning letters to Gator Group Co., Ltd., and Tinitell, Inc., which marketed mobile apps directed to children and appear to be violating the Children’s Online Privacy Protection Act (COPPA). The FTC warning letters were also sent to the Apple App Store and Google Play Store, which make the apps available to consumers.

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Senate Confirms All Five Nominees to the FTC

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The Senate officially confirmed the five nominees to the Federal Trade Commission on April 26.  As noted in previous blogs, Joseph Simons will become the new chairman and Joshua Phillips, Rebecca Slaughter and Rohit Chopra will join the Commission immediately.

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US FDA Approaches to Artificial Intelligence

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Artificial Intelligence (AI) can be employed in a health care setting for a variety of tasks, from managing electronic health records at a hospital, to market research at a benefits management organization, to optimizing manufacturing operations at a pharmaceutical company. The level of regulatory scrutiny of such systems depends on their intended use and associated risks.

In the U.S., for medical devices using AI, one of the key regulatory bodies is the Food and Drug Administration (FDA), especially its Center for Devices and Radiological Health (CDRH). CDRH has long followed a risk-based approach in its regulatory policies, and has officially recognized ISO Standard 14971 “Application of Risk Management to Medical Devices.” That standard is over 10 years old now, and therefore is currently undergoing revisions – some of which are meant to address challenges posed by AI and other digital tools that are flooding the medical-devices arena.

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