Rep. Mike Honda (D-CA) has just reintroduced the Healthcare Innovation and Marketplace Technologies Act (HIMTA) in the U.S. House of Representatives.
If passed into law, Rep. Honda says the legislation will stimulate innovation in the realm of mobile health and modernize the nation’s current healthcare delivery system, primarily through the cultivation of various marketplace incentives, grants, and extensive workforce retraining.
The bill was originally introduced by Honda in late 2012.
Among the centerpiece attributes of the bill is the creation of a new Office of Wireless Health, which would be governed by the FDA.
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Posted in Regulation, Technology
Extension, Inc. today announced its admission to the mHealth Regulatory Coalition (MRC).
The mHealth Regulatory Coalition (MRC), formed in 2010, has become “the voice of the mHealth technology stakeholders in Washington.”
The coalition’s purpose is to serve as a thought leader in the mHealth ecosystem to provide its expertise on what mHealth technologies should be regulated and how they should be regulated.
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Posted in Regulation, Technology
Apple is apparently raising the bar for makers of mobile health apps looking to gain access to the Apple App Store.
As calls for greater regulation and oversight echo loudly in the ears of the Cupertino, California-based iDevice maker, it looks as though Apple is cracking down on mHealth apps that are of questionable quality, accuracy, or utility.
iMedicalApps reports that Apple “might be tightening restrictions on medical app developers… It appears that a number of developers have struggled recently to get medical applications into the App Store.”
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Posted in Mobile App, Regulation, Technology
It’s a first for the FDA.
This week, the U.S. Food and Drug Administration initiated what appears to be the agency’s first official probe of a mobile health smartphone application.
Amidst growing public concern about the safety of unregulated mobile health apps, news of the FDA’s inquiry comes as a surprise to no one.
The inquiry relates to the uChek app, manufactured by an Indian company and designed to work with urinalysis test pads.
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Posted in Mobile App, Regulation, Technology
This week, U.S. Senators Michael Bennet (D-Colo.) Richard Burr (R-N.C.) Tom Harkin (D-Iowa) and Lamar Alexander (R-Tenn.) put forward what’s being called a bipartisan plan “to strengthen and improve our nation’s drug distribution supply chain.”
For now, the lawmakers have only issued a discussion draft of a bill that would improve patient safety by replacing today’s patchwork of state product tracing laws with a “strong, uniform standard” that would ultimately result in electronic, interoperable unit level product tracing for the entire country.
“Over the past few years, we’ve had a record number of recalls and reports of tainted or ineffective drugs reaching our hospitals and drug store shelves,” Senator Bennet said. “In fact, right now, we know more from a barcode on a gallon of milk than from a barcode on a bottle of pills, which could mean the difference between life and death. This draft bill would put steps in place to prevent and reduce those problems and help ensure our drug supply is safe.”
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Posted in Regulation, Technology
The rate at which mobile health care apps are introduced into the app stores of the world is accelerating very quickly.
According to the latest industry data available, there are presently 31,000 health, fitness, and medical related apps on the market today.
But not all are of value or potentially even safe. A new report from Health Leaders Media explores this persistent concern in the medical community.
“There are hundreds of apps that really work and are completely legitimate,” explains Mark Anderson, CEO of The AC Group, a healthcare IT consulting firm. “But there are also a lot of apps manufactured by snake oil salesmen who promote them with a lot of misleading information.”
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Posted in Mobile App, Regulation, Technology
The American Telemedicine Association says Medicare beneficiaries in 97 counties—across 36 states and territories—are slated to lose telehealth benefits.
Blame for the loss falls on updated federal delineations of Standards Metropolitan Statistical Areas (SMSAs). The new federal urban/rural categorization effectively revokes the option for Medicare recipients to receive healthcare services via videoconferencing—one of the most common and cost-effective forms of telehealth.
The ATA suggests that hundreds of thousands of beneficiaries will be negatively impacted by this “statistical realignment.”
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Posted in Regulation, Technology