Health Tech Podcast - Episode 2: Best Practices for Health App Development
Section 1557 of the Affordable Care Act (ACA) prohibits providers and health plans that receive reimbursement from the federal government from discriminating against individuals in the Covered Entities’ health programs. Such...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
On April 26, the Federal Trade Commission (FTC) announced its final rule (Final Rule) making changes to the Health Breach Notification Rule (HBNR)....more
On June 23, the DOJ and FTC announced the government has obtained substantial injunctive relief, and that the department will collect $100,000 in civil penalties, from an Illinois-based healthcare corporation pursuant to a...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
On May 17, District of Colombia Attorney General Brian Schwalb announced the settlement of an investigation into Easy Healthcare Corporation, requiring the company to change its privacy practices involving the ovulation...more
The Washington My Health My Data Act (the MHMD Act) was signed into law on April 27, 2023, creating new restrictions on the collection and disclosure of "consumer health data" by companies in Washington or that is related to...more
In Part I, we provided a high-level overview of Health Insurance Portability and Accountability Act of 1996 (HIPAA) and its provisions. In Part II, we discuss how HIPAA is applied to mobile health (mHealth) application...more
The Federal Trade Commission (FTC) recently issued a policy statement confirming that vendors of apps and other connected devices that collect personal health information, such as glucose levels, heart rate, or fertility or...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
Since the start of the COVID-19 pandemic, more people than ever have downloaded and used mobile applications, or apps, to communicate with their doctors, manage prescriptions, and streamline much of the healthcare activity...more
During the COVID-19 pandemic, many Americans have increasingly relied on digital health apps to manage their personal health and wellness. These apps include traditional telehealth apps through which patients can complete...more
Slaughter discusses the FTC’s priorities under the new administration, including ed-tech, health apps, and racial equity. On February 10, 2021, in her first major speech as acting chair of the Federal Trade Commission...more
It is increasingly important for mobile app developers to ensure their products comply with all governing state and federal laws, and it is critical to understand which business changes might place your product under a...more
New York and New Jersey release “COVID Alert NY” and “COVID Alert NJ,” apps designed to alert their users when they have been exposed to someone who tested positive for COVID-19. These apps follow those released in...more
A recent Marketplace Tech podcast episode on the spike in demand for mental health apps caught our attention. As shocking headlines and stay-at-home orders rolled across the country, demand for mental health apps increased...more
The start-up segment of our healthcare regulatory practice is focused on companies bringing digital health tools to market. As part of the efforts of the U.S. Food and Drug Administration (“FDA” or the “agency”) to clarify...more
Individuals who use healthcare apps such as fitness trackers, weight loss, wellness, exercise, etc., BEWARE! A couple of recent developments have highlighted the fact that most apps are not subject to HIPAA, which means that...more
The pace of innovation in healthcare today has produced an amazing increase in the number of available mobile apps for health-related information. More than 300,000 healthcare apps are available online. These apps are...more
In this internet age, "smart" children’s products—those that collect, transmit or store electronic data—are on the rise. By some estimates, the smart toy market will reach $11.3 billion in sales by 2020. Manufacturers of...more
Roughly 3,500 miles on the other side of the Atlantic Ocean, the British government is contemplating an idea which will marry the national healthcare industry with the gig economy. Such an idea could send a ripple toward the...more
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
The Department of Health and Human Services (HHS) will soon launch a healthcare focused cybersecurity initiative modeled on the Homeland Security Department’s National Cybersecurity and Communications Integration Center...more