December 20, 2014

regulation

Happtique Releases Final Standards for mHealth App Certification

Posted by: | Posted on: February 27, 2013
Today Happtique has published its final standards for the certification of mobile health apps under the Happtique Health App Certification Program (HACP). As we reported in the Fall Happtique has…

National Association Created for ACOs

Posted by: | Posted on: February 19, 2013
Sixty accountable care organizations (ACOs) from 15 states have come together to create a not-for-profit organization. The goal of the organization is to work to increase the quality of care,…

Congressman Details Plans for Office of Wireless Health

Posted by: | Posted on: February 12, 2013
Back in September of last year we reported that Representative Mike Honda (D-California) was going to introduce legislation to create an Office of Wireless Health within the Food and Drug…

Vulnerabilities in Cell Service Exposed by Sandy

Posted by: | Posted on: November 6, 2012
In addition to public safety concerns, many communities recently struck by Hurricane Sandy lost cell service leaving users unable to reach family and loved ones or reach out for help.…

FCC Issues Final Rules for Mobile Monitoring

Posted by: | Posted on: September 21, 2012
The Federal Communications Commission (FCC) issued it’s final rules for the implementation of Mobile Body Area Networks (or MBANs). This technology allows hospitals to monitor patients with wireless devices, giving…

Promise or Pitfall: 13,000 reasons the mobile app space can’t be ignored

Posted by: | Posted on: September 19, 2012
Guest Blog by Leslie Oley, MedtechWomen Editors Note: Leslie is a clinical and technical marketing consultant to medical device companies. She wrote this blog based on her experience putting together…

Science Lags the Market When it Comes to mHealth Apps

Posted by: | Posted on: August 10, 2012
An article the Smithsonian provides a good overview of recent trends and innovations in the mHealth space – as well as some of the risks. The piece echoes our observation…

Proteus Forges FDA Pathway

Posted by: | Posted on: August 3, 2012
As we reported on Monday, Redwood City’s Proteus Digital Health has received FDA 510(k) premarket approval for its ingestible sensor. http://proteusdigitalhealth.com/proteus-digital-health-announces-fda-clearance-of-ingestible-sensor/ What is particularly neat about this, other than the…

Many mHealth Apps Potentially Straddle Regulatory Grey Area

Posted by: | Posted on: July 26, 2012
When it comes to regulation of mHealth apps, intent matters according to Bakul Patel, policy director for the FDA’s Office of the Center Director, Center for Device and Radiological Health…

mHealth App Market to Diverge

Posted by: | Posted on: July 26, 2012
mhealth app market divergeThis article in HealthTechZone does a laudable job in contrasting consumer medical apps with medical apps for doctors and hospitals. However, like much recent commentary, it does not note the…