December 8, 2013
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...
July 26, 2012
With the bring-your-own-device trend showing no signs of abating and mixed messages coming from government regulators, healthcare organizations are struggling mightily with how to secure patient data on tablets, smartphones, laptops and even wireless medical devices.
Different federal agencies see security through different prisms. The Drug Enforcement Agency, part of the Department of Justice,...
July 12, 2012
This week Happtique, the healthcare-specific appstore and mobile app prescription technology vendor, published its draft document for the mobile health app certification process its panel of advisors has been developing over the course of the past few months. Happtique is looking for public comments on its draft, which certainly seems a lot like the process the FDA used for its draft guidance on...
July 9, 2012
In developing policies for managing data handled by and stored on mobile devices, healthcare organizations should look beyond privacy and security and consider the legal ramifications of mobile health information, the American Health Information Management Association (AHIMA) says.
"While much has been written stressing how extremely important security and privacy issues are in the use of mobile...
September 9, 2011
This week the Federal Trade Commission made an unprecedented move to remove two medical apps from the Apple AppStore and Android Market on grounds that they made unsubstantiated efficacy claims. The apps both offered "light therapy" to treat a user's acne. Both developers were ordered to pay back the monies they made by selling the apps to consumers.
While app stores have offered a number of apps...
September 9, 2011
By Brian Dolan and Chris Gullo
In a watershed moment, the FTC this week fined two app developers who falsely advertised that their smartphone apps could treat acne. The apps, AcneApp and Acne Pwner, were sold in the iTunes App Store and Android Marketplace, respectively. The settlements ban the developers from stating certain health-related claims without scientific evidence. AcneApp's...
June 25, 2010
By Jon Linkous, CEO, American Telemedicine Association
The funny thing about “mHealth” is that it has taken on such a cult-like status among investors, industry and the media. Certainly the potential for the use of mHealth in the delivery of healthcare is huge and it may have an impact on other parts of healthcare such as chronic care management, emergency response services and the role and...
August 18, 2009
While it has yet to rule on whether PHRs should be covered under HIPAA, the Federal Trade Commission (FTC) has voted 4-0 and issued a final rule that requires certain "Web-based businesses" to alert consumers if there is a security breach of their electronic health information. If 500 or fewer consumers' health information is breached, then the health service provider must alert the consumers...