Tag Archives: FDA

Why Clinical Trials Need Mobile Health Tools: Can CROs be Replaced?


I have previously written why mobile technologies need clinical trials.  I would now like to discuss why clinical trials need mobile technology. For readers not familiar with clinical research, a CRO (clinical  research organization)  is “…an organization that provides support … Continue reading

Posted in clinical trials, digital health, FDA, health insurance, healthcare economics, Healthcare IT, healthcare reform, informatics, medical apps, medical devices, mHealth, mobile health, pharma, remote patient monitoring, smartphone apps, technology, telehealth, wireless health | Tagged , , , , , , , , , , , , , , | Leave a comment

Takeaways from The #DigitalHealth Conference 2013


I recently attended and moderated at my first Digital Health Conference in New York, hosted by the New York e Health Collaborative. I was impressed with the quality of the speakers but more impressed with how this year, in my … Continue reading

Posted in digital health, healthcare economics, Healthcare IT, healthcare reform, healthcare vendors, IT security, medical devices, medical education, mHealth, mobile health, patient advocacy, remote patient monitoring, smartphone apps, technology, telehealth, wireless health | Tagged , , , , , , , , , , , , , | 7 Comments

Five Big Developments for Digital Health in 2013


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

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


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 , , , , , , , , , | 5 Comments

Five Ways the SCOTUS Decision on ACA Will Affect mHealth


          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


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


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