A brain training game fined by the FTC earlier this year.
Developers of mobile health apps need to be mindful of regulation from a number of different quarters. Among others, developers need to be aware of the FDA, OCR (HIPAA), and the FTC, which is increasingly regulating areas that would seem to be the purview of one of the other two groups.
At a HIMSS session on mobile and digital health...
A recent Supreme Court decision could have a profound impact on the ability of state medical boards to prevent telemedicine companies from offering their services, according to some experts familiar with the case.
North Carolina Board of Dental (NCBD) Examiners vs Federal Trade Commission was decided by a 6-3 vote last month. The case ruled that medical boards comprised of private professionals (...
First Derm, a dermatology question-and-answer app that is available in the Apple AppStore and Google Play Store, has reached 100,000 downloads.
The app launched a little more than a year ago: January 2014.
First Derm allows users to anonymously take pictures of external skin problems and send them to a licensed dermatologist, who will respond to inquiries within 24 hours of receiving the pictures...
The Federal Trade Commission has taken action against two melanoma detection apps: MelApp and Mole Detective. Some of the marketers behind the apps have agreed to settle with the FTC, while two additional marketers of Mole Detective have refused. Total settlements for the two apps came to just north of $20,000. Both apps claim to provide an "automated analysis of moles and skin lesions for...
Days after the FDA issued new draft guidance that may be softer on devices making certain kinds of medical claims, the FTC has reminded companies that it also has regulatory power over health claims and might be stepping up to the plate.
The FTC announced an administrative complaint against Focus Education, a company that makes a brain training game for children called Jungle Rangers. The...
About a week ago Fitbit hired a lobbyist firm to represent its interests on the Hill, as the National Journal reported. According to the official lobbyist registration form, Heather Podesta + Partners will help Fitbit "educate lawmakers regarding health and fitness devices". The form also lists two general issues of interest to Fitbit: health care issues and consumer issues around safety and...
At a Tech in Policy event sponsored by Washington, D.C. newspaper The Hill, FTC Commissioner Julie Brill made it clear that the FTC is aware of recent concerns about health app data privacy and security and is looking into new ways to police the industry.
"The law is, on some level, always going to lag behind technology," she said. "Technology is moving at lightning speed. Our job at the...
By Brian Dolan
"The issue of consumer generated health data is on that is near and dear to my heart," Federal Trade Commission Commissioner Julie Brill told attendees at an event focused on the protection of such health data earlier this month. "...Big picture, consumer generated health information is proliferating, not just on the web but also through connected devices and the internet of...
Sharon Klein and Dayna Nicholson
Even though the FDA guidance on mobile medical apps is now finalized, it only represents a portion of the regulation mobile medical app developers need to concern themselves with, according to Pepper Hamilton lawyers Mark Kadzielski, Sharon Klein, and Dayna Nicholson, who presented a webinar on the topic last week. Particularly in the areas of privacy and...
AcneApp, one of the mobile medical apps the FTC removed in 2011.
Correction: A previous version of this article said the ONC, not the OCR, released the HIPAA omnibus rule.
This year has been a big year for health app regulation: FDA released its final guidance on regulation of mobile medical apps earlier this year, and the Office of Civil Rights released its final HIPAA omnibus rule in January...
