In a rather interesting move, it’s been revealed that Republican House members are urging both the FDA and FCC to move faster in approving mobile medical apps.

In a letter sent to both agencies last week, House members asked for easier regulatory hurdles facing mHealth app developers, in addition to helping speed up the process of getting new apps submitted, approved and available to users.  The authors pointed out that the number of health-related apps for iOS alone grew by more than 250% from 2010 to 2011.

Looking at the growth, legislators are concerned that the “complex regulatory framework” between the various agencies could “inhibit future growth and innovation in this promising market and could preclude tools that help patients better manage their care.”

Read the full story

It’s been announced that the Mayo Clinic has once again teamed with mobile app provider Preventice to create an mHealth solution.  Unlike the last partnership the two organizations aren’t working on an app, but rather a remote monitoring device called “Body Guardian” — which is being developed to monitor irregular heart rhythms.

The new device is meant to be worn unnoticeable under one’s clothing and tracks heart and respiratory rates, ECG, physical activity and other vital signs.  Using the patients smartphone, the data is transmitted back to a physician.  The system can be setup to monitor regular rhythms and only send data back to a physician when irregularities and/or cardiac events are detected.

Read the full story

GE Healthcare and AirStrip Technologies have debuted a new wireless patient monitoring solution during the HIMSS12 conference on Wednesday.

Dubbed AirStrip PATIENT MONITORING, the new solution securely delivers patient monitoring information to critical-care physicians through iOS devices including iPhones and iPads, while helping physicians interact with, manipulate and zoom in on more than 100 clinical measurements and access physiologic data anytime, anywhere.  AirStrip received FDA clearance for the platform that drives the new patient monitoring solution back in 2010 and announced it obtained the CE Mark just last month.

Read the full story

Proteus Biomedical, a California based health technology company, will receive US Patent Number 8114021 for its ingestible sensor technologies. The patented technology process is labeled “Body Associated Receiver and Method” and includes the creation of digital communication networks within and around the body using their sensors.

Mark Zdeblick, the Chief Technical Officer at Proteus describes the patent as covering “devices worn on the body that communicate with other sensor-enabled devices in an optimal frequency band for body area communication networks.” This patent joins the other 40 currently held by Proteus.

Read the full story

The mHealth Regulatory Coalition (MRC), who has been very vocal in terms of the guidelines being proposed for mobile medical apps, has asked the FDA to revamp and republish its proposed guidelines — but as a second draft instead of finalized regulation.

On January 20th, the MRC made its request to the FDA in a letter by founding member and attorney Bradley Thompson of Washington, D.C.-based law firm Epstein Becker Green, which has been published to its website.  In it, the MRC explains industry fears that the FDA will scale back its proposed guidelines after being overwhelmed with more than 500 pages of industry comments from more than 100 interested parties.

Read the full story

The CEO of the American Telemedicine Association (ATA), Jonathan Linkous, has published 7 predictions for telemedicine and the greater telehealth market as we enter 2012.

According to Linkous, his predictions relate to the latest trends that will “shape telemedicine and telehealth in the immediate future,” saying these trends represent “major changes from the existing norm, creating new challenges and opportunities for the industry.”  The ATA has done a lot over the past year to advance telehealth solutions, even offering suggestions and guidance to the FDA in terms of overall mHealth regulation.  Here’s the ATA’s biggest predictions for the coming year . . .

Read the full story

The Food and Drug Administration recently published draft guidelines for pharmaceutical and medical device companies on the use of “emerging electronic media,” A.K.A. social media marketing and communication.

Though the FDA notes the proposed guidelines aren’t comprehensive and rather the “first of many planned guidance initiatives,” the move marks the first time the FDA has clearly addressed rules for Pharma and medical device makers’ digital communication via social media and other channels — even specifically mentioning services like Twitter, Facebook and YouTube.

Read the full story