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This year marks a pivotal shift from the era of rapid, unregulated health-tech innovation to one of stringent governance. The proliferation of wearable devices, health applications and remote monitoring tools has led to an...more
As we previously reported, the Federal Trade Commission (FTC) recently announced its final changes to the Health Breach Notification Rule (HBNR), vastly expanding the scope of the Rule’s coverage....more
The Federal Trade Commission’s (FTC) years-long effort to modernize its Health Breach Notification Rule (HBNR) in the midst of a swiftly changing technological landscape appears to be coming to an end. On Thursday, May 30,...more
The Federal Trade Commission has published a detailed blog post on health information, setting the stage for future enforcement … and not just regarding health information. There is some eye opening takeaways in it, making...more
The 21st Century digital age has provided women with numerous sexual and reproductive health tools that track periods, ovulation, and pregnancy. By simply plugging certain health data inputs into these apps, women can now...more
In May, the Federal Trade Commission (“FTC”) proposed changes (the “Proposed Rule”) to the Health Breach Notification Rule (the “Rule”), which, among other items, emphasize that the Rule applies to mobile health applications...more
On May 18, the Federal Trade Commission (FTC) proposed changes to the Health Breach Notification Rule (the HBNR or the Rule), including clarifying the rule’s applicability to health apps and other similar technologies. These...more
The Federal Trade Commission seeks to clarify how the Health Breach Notification Rule applies to health records collected by health apps and similar consumer health technologies. ...more
On May 17, 2023, the Federal Trade Commission (the “FTC”) reached a settlement with Easy Healthcare Corporation (“Easy Healthcare”), for its fertility-tracking app, Premom. The agency alleged that Easy Healthcare failed to...more
The U.S. Department of Health and Human Services' (HHS) Office for Civil Rights (OCR) published a Notice of Proposed Rule Making (Proposed Rule) on April 12, 2023, proposing amendments to the Health Insurance Portability and...more
The Health Insurance Portability and Accountability Act of 1996 may be the most well-known privacy law in the United States, but it is also one of the most misunderstood....more
Under federal law, much of the health data recorded from wearable devices, health care applications, and health IoT devices is beyond the reach of the Health Insurance Portability and Accountability Act (HIPAA), which...more
As we start 2022, as part of our Spotlight series, we connect with Reece Hirsch, the co-head of Morgan Lewis’s privacy and cybersecurity practice, to discuss the recent policy statement issued by the US Federal Trade...more
The Federal Trade Commission (“FTC”) recently issued guidance clarifying protections applicable to consumers’ sensitive personal data increasingly collected by so-called “health apps.” The FTC press release indicated it has...more
In this episode, Rebecca Schaefer interviews Gina Bertolini and Desiree Moore about the recent Federal Trade Commission (FTC) policy statement regarding the FTC Health Breach Notification Rule and its applicability to vendors...more
A new Policy Statement from the US Federal Trade Commission places companies that offer consumer-facing health apps and connected health and wellness devices on notice that they may be covered by a Health Breach Notification...more
The FTC issued a policy statement on Sept. 15, 2021, emphasizing that developers of health apps and other connected devices and their service providers have breach notification requirements under the Health Breach...more
The Federal Trade Commission (“FTC”) recently issued an important policy statement to health apps and other connected devices that collect or use consumers’ health information. The FTC’s policy statement effectively...more
As the collection and use of health data drastically expands, the agency issued a recent guidance to officially put health apps and connected medical devices “on notice.” On September 15, the Federal Trade Commission...more
On September 15, 2021, the Federal Trade Commission (“FTC”) issued a policy statement affirming the applicability of its Health Breach Notification Rule (the “Rule”), 16 CFR Part 318, to health apps and connected devices that...more
The Federal Trade Commission (FTC) adopted a policy statement on Sept. 15, 2021, emphasizing that developers of digital health apps, connected devices and other health products have obligations under the Health Breach...more
The Federal Trade Commission ("FTC") recently announced its intent to "vigorously" enforce its 2009 Health Breach Notification Rule (the "Rule") via a policy statement that sheds light on the Rule's scope. The policy...more
The Federal Trade Commission (“FTC”) issued a policy statement clarifying that health apps that collect or use consumers’ health information are subject to the Health Breach Notification Rule’s notification requirements when...more
The U.S. Federal Trade Commission (FTC) issued a policy statement on Sept. 15, 2021, warning that the decade-old Health Breach Notification Rule (the rule) – which applies to companies that handle personal health records or...more
Last week’s Federal Trade Commission (FTC) Open Commission Meeting (Open Meeting) featured a number of agency developments that will drive its approach to privacy, data security, and AI/algorithmic decision-making during...more