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Stinson LLP

Health App Vendors Be Warned: You Could Be Subject to FTC's Health Breach Notification Rule

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The surge in new health apps and connected devices, which only increased during the pandemic, continues to raise many legal and ethical questions. As a result, lawmakers have been scrambling to define the obligations...more

Rivkin Radler LLP

OCR Updates Mobile Health App Resources

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The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) recently unveiled a new website with updated guidance and resources for mobile health app developers regarding the HIPAA Privacy, Security, and...more

Mintz - Health Care Viewpoints

Building a Health App? Part 3: What You Need to Know About FDA’s Regulation of Mobile Apps

This is our third installment in our series about the legal issues involved in launching a health app, which the U.S. Food and Drug Administration (“FDA”) refers to as “mobile apps.” The goal of this post is to provide you...more

Troutman Pepper

AGs Weave Themselves Into Patchwork of Digital-Health Regs

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There are more than 165,000 mobile health applications available for download in Apple’s App Store or Google Play. This number will likely keep rising, and a body of federal and state regulators, including state attorneys...more

Goodwin

FDA Issues Final Guidance on Mobile Medical Applications

Goodwin on

Last week, the FDA issued guidance on its approach to regulating mobile apps. FDA intends to regulate only those mobile apps that meet the agency’s definition of “device” and are considered higher risk in that they could...more

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