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Keeping you afloat admidst the rising sea of regulations

FDA Announces Innovation Plan to Reboot Digital Health Device Regulation

What’s New?Regulators are taking strides to focus their attentions on the digital health landscape, as we’ve recently seen from the FCC,

Tally-ho! Flurry of Legislative Activity Signals Ease on Federal Barriers to Telehealth

What’s New?In recent months, a number of bills have been introduced or passed in Congress that would ease federal health care programs’ restrictions on telehealth. Currently, Medicare has strict limitations on telehealth. But bipartisan groups of Senators have introduced two bills seeking to expand telehealth services covered by Medicare.

FCC Paving the Way for Advancement of Telehealth

What’s New?The Federal Communications Commission recently solicited public comment on how it can better facilitate broadband-enabled health care solutions by adopting new policies or removing existing regulatory barriers. Initial comments are due on May 24, while reply comments are due June 8 of this year. 

Approval of Privacy Shield Provides Framework for Transfer Personal Data between the US and EU

What’s New?After months of negotiations, it’s official: the EU-US Privacy Shield has been formally approved on both sides of the Atlantic, by the EU Commission and the US Commerce Department, despite concerns surrounding the adequacy of its earlier version.

IT Systems Put Security into Health Care Cybersecurity

*This article was originally published by The Journal of Health Care Compliance.

What Do Self-Driving Cars and Your Heart Monitor Have in Common? The Same Questions About Cybersecurity.

Arent Fox partner Sarah Bruno recently published a very interesting alert on new privacy and cybersecurity challenges facing the automotive industry in the age of autonomous vehicles, syncing software, and wearable devices that interact with your vehicle.

Health on the Move: FTC and HHS Release Guidance for Mobile Health App Developers

On April 5, 2016, Chairwoman Edith Ramirez of the Federal Trade Commission (FTC) announced the release of a new web-based tool to assist developers of mobile health apps in understanding what federal laws they must comply with. The FTC’s new tool joins several others released by other federal agencies designed to educate and guide app developers in their efforts to create compliant apps.   

Webinar: Text for Success- New Rules for Engaging Your Audience Amid Regulatory Changes

On February 17, Arent Fox Communications, Technology & Mobile partner Michael Hazzard and attorney Adam Bowser will be featured speakers for a webinar examining the intersection of HIPAA (Health Insurance Portability and Accountability Act) and the TCPA (Telephone Consumer Protection Act).