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The capabilities and sophistication of digital health technologies are constantly expanding, especially with the integration of artificial intelligence and machine learning. Many companies, both existing and start-up, are...more
The health care industry is increasingly adopting mobile apps for a variety of purposes, including tracking patient health conditions and sharing patient data. Privacy and security are important considerations, and it is...more
The FTC is closing out 2022 with additional guidance for mobile health app developers signaling its continued interest in this industry. Since 2021, we have seen several steps from the agency demonstrating a focus on...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
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
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
This month, the Federal Trade Commission (FTC) issued guidance on privacy and security best practices for health-related mobile apps, such as fitness apps connected with wearables, diet and weight loss apps, and health...more
Consider this: A 42-year-old man arrives at the emergency room showing signs of a heart attack. The ER doctors, using the patient’s activity tracker—in this case, a Fitbit® —are able to pinpoint when the patient’s normal...more
While attending the International Association of Privacy Professionals annual global event, and listening to Chairwoman Edith Ramirez discuss the Federal Trade Commission’s (FTC) concerns about consumer privacy, the FTC, the...more
On February 09, 2015, the FDA issued final guidelines[1] to outline its regulatory enforcement approach to mobile medical applications (or “apps”). The FDA is taking a risk-based approach, focusing its oversight on apps that...more
On January 20, 2015, the FDA issued draft guidelines designed to give developers whose products and applications promote healthy lifestyles (so-called “general wellness products”) direction on when such products qualify as...more
Last week, The U.S. Food and Drug Administration (the “FDA”) issued long-awaited final guidance for the mobile medical applications (“Apps”) industry and FDA staff (the “Guidance”). The Guidance notes that it contains...more
On September 23, 2013, the Food and Drug Administration (FDA) published the final guidance on its regulation of “mobile medical applications (or apps).” The guidance finalizes FDA’s 2011 draft guidance, adding numerous...more
Last week, the U.S. Food and Drug Administration (FDA) sent an enforcement letter to a mobile medical app developer for failing to obtain a 510(k) clearance before marketing the app, which the FDA said appears to be a...more
The Food and Drug Administration has taken its first action against a mobile app maker for failure to obtain pre-marketing clearance. ...more