News & Analysis as of

Federal Food Drug and Cosmetic Act (FFDCA) Mobile Health Apps

Lippes Mathias LLP

Medical Devices in the App Store? U.S. Regulation of Mobile Medical Applications

Lippes Mathias LLP on

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

Burr & Forman

COVID-19, Mobile Health & the Importance of Maintaining Legal Compliance in an Era of Explosive Growth

Burr & Forman on

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

Nossaman LLP

FDA Policy for Mobile Medical Applications

Nossaman LLP on

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

Sheppard Mullin Richter & Hampton LLP

New York AG Takes Enforcement Action Against Heart Monitoring Apps: Murmurs of Concern are Heard in mHealth App World

In a move sure to cause murmurs in the large and growing mobile health application industry, the Office of New York Attorney General Eric Schneiderman (OAG) has used state trade laws to extract concessions and monetary...more

Faegre Drinker Biddle & Reath LLP

Christmas in July for Wellness Apps and Devices

The Food and Drug Administration (FDA) released a final guidance on July 29, 2016, saying that it does not plan to require pre-market review for low-risk "general wellness products," such as wearable fitness monitors,...more

McDermott Will & Emery

Government Issues New Tool to Help Mobile App Developers Identify Applicable Federal Laws

McDermott Will & Emery on

This week, the Federal Trade Commission (FTC or Commission) released an interactive tool (entitled the “Mobile Health Apps Interactive Tool”) that is intended to help developers identify the federal law(s) that apply to apps...more

Foley & Lardner LLP

Federal Agencies Provide User-Friendly Guidance on Compliance with Data Privacy Laws

Foley & Lardner LLP on

How federal privacy laws apply to mobile health applications has been an area of significant ambiguity. Recently, the Federal Trade Commission’s (FTC), the U.S. Department of Health and Human Services (HHS) Office of Civil...more

Proskauer on Privacy

Regulators Offer Guidance on Privacy and Security for Health App Developers

Proskauer on Privacy on

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

McGuireWoods LLP

FTC Releases Mobile Health Apps Interactive Tool

McGuireWoods LLP on

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

Robinson+Cole Data Privacy + Security Insider

FTC, ONC, OCR and FDA release online tool for mobile health app developers

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

Cooley LLP

Blog: FTC Announces Guidance for Developers of Mobile Health Apps

Cooley LLP on

Chairwoman Edith Ramirez of the Federal Trade Commission (FTC) announced the release of new guidance directed towards developers of mobile health apps (the “Guidance”), while speaking today at the International Association of...more

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