regulation

Happtique Releases Final Standards for mHealth App Certification

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…

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National Association Created for ACOs

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,…

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Congressman Details Plans for Office of Wireless Health

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…

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Vulnerabilities in Cell Service Exposed by Sandy

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.…

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FCC Issues Final Rules for Mobile Monitoring

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…

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

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…

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Science Lags the Market When it Comes to mHealth Apps

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…

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Proteus Forges FDA Pathway

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…

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Many mHealth Apps Potentially Straddle Regulatory Grey Area

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…

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mHealth App Market to Diverge

This 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…

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