Tag Archives: FDA

Five Big Developments for Digital Health in 2013

Posted on December 31, 2012 by

I read with interest a few articles discussing predictions for digital health technologies for 2013.  One such amusing article in informationweek.com had some which were in more detailed described as  By the end of 2013, the implementation of such a … Continue reading →

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Posted in FDA, healthcare economics, Healthcare IT, healthcare reform, informatics, medical apps, medical devices, smartphone apps, telehealth | Tagged , , , , , , , , | 5 Comments

The Future of Medical Apps: A Call to Arms For the End of Flimsy Science

Posted on November 19, 2012 by

A recent article in the Washington Post raises concerns about the legitimacy of mobile health apps.  As Chair of the committee which developed Draft Standards for the Happtique App Certification Program, I applaud the author for taking a critical look … Continue reading →

Posted in clinical trials, digital health, FDA, healthcare economics, medical apps, medical devices, mHealth, mobile health, smartphone apps, technology, telehealth, wireless health | Tagged , , , , , , , , , | 4 Comments

Five Ways the SCOTUS Decision on ACA Will Affect mHealth

Posted on June 28, 2012 by

          The upholding of the majority and key points of the ACA by the Supreme Court was a monumental step in changing healthcare in the USA.  It is reform.  It is not the creative destruction that is necessary in … Continue reading →

Posted in FDA, health insurance, healthcare economics, Healthcare IT, healthcare reform, informatics, medical apps, mHealth, mobile health, politics, technology, wireless health | Tagged , , , , , , , , , | 3 Comments

Medical Device Recalls: Implications for Digital Health Technologies

Posted on April 12, 2012 by

Everyone has heard of a recall of a consumer product such as a component of an automobile, child’s toy, or an over the counter medication. A recall of those types of products often implies taking them off the market as … Continue reading →

Posted in digital health, FDA, healthcare reform, Implantable Defibrillators, medical devices, mobile health, technology, wireless health | Tagged , , , , , , , , | 5 Comments

Crowdsource-derived Data for Post-Market Surveillance of Drugs and Medical Devices

Posted on April 5, 2012 by

Recently,Oregon’s Senator Jeff Merkley, with Senators Chuck Grassley (R-IA), Michael Bennet (D-CO) and Herb Kohl (D-WI), introduced the bipartisan Ensuring Safe Medical Devices for Patients Act. It requires the FDA to issue a Unique Device Identifier rule by the end … Continue reading →

Posted in clinical trials, digital health, FDA, mobile health, wireless health | Tagged , , , , , , , | 1 Comment