Category Archives: medical devices

Five Reasons Why Digital Health Technologies Need FDA Oversight


A draft proposal of the FDA guidelines for regulating mobile medical applications was released in July, 2011. In response, the mHealth Regulatory Coalition sent detailed comments on the proposal (http://mhealthregulatorycoalition.org/wp-content/uploads/2010/06/MRC-Comments-on-FDA-Draft-MMA-Guidance.pdf). There was a recent piece in the Washington Times “The … Continue reading

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Posted in clinical trials, digital health, healthcare economics, Healthcare IT, healthcare reform, informatics, medical devices, mHealth, mobile health, pharma, smartphone apps, technology, telehealth, wireless health | 6 Comments

Five Reasons Why mHealth Success is Tied to Healthcare IT


In his book The Creative Destruction of Medicine, Dr. Eric Topol describes the importance of what he calls a superconvergence of six areas of digital technology (wireless sensors, genomics, information systems, mobile connectivity, the Internet and social networking, and the … Continue reading

Posted in digital health, Healthcare IT, healthcare reform, healthcare vendors, informatics, medical apps, medical devices, mHealth, mobile health, smartphone apps, technology, wireless health | Tagged , , , , , , , , , , , , | Leave a comment

BYOD: The Elephant in the Digital Health Technology Room


The Wikipedia definition of BYOD (Bring Your Own Device) is: “the recent trend of employees bringing personally owned mobile devices to their place of work, and using those devices to access privileged company resources such as email, file servers, and … Continue reading

Posted in digital health, Healthcare IT, healthcare reform, informatics, IT security, medical apps, medical devices, mHealth, mobile health, smartphone apps, technology, wireless health | Tagged , , , , , , , , , , | 2 Comments

Adoption of mHealth: Can we see the Forest through the Trees?


In previous posts, I have highlighted many drivers and stakeholders (patient advocates, healthcare providers, insurers, hospitals, Pharma, and others) as key to the success of the adoption of digital health technologies (. There was a recently proposed amendment to the … Continue reading

Posted in digital health, Election 2012, FDA, health insurance, Healthcare IT, healthcare reform, media coverage, medical apps, medical devices, mHealth, mobile health, pharma, politics, technology, wireless health | Tagged , , , , , , , , , , | Leave a comment

The Medical App is a Patient Advocacy Tool


In his book ‘The Creative Destruction of Medicine’, Dr. Eric Topol highlights a few areas important to the transformation of medicine; wireless sensors, genomics, information systems, mobile connectivity, the Internet, social networking, and computing power. I believe that all of … Continue reading

Posted in digital health, Healthcare IT, medical apps, medical devices, mHealth, pharma, technology, telehealth, wireless health | Tagged , , , , , , , , , , , , , , | 1 Comment

Can an EHR Save Your Life?


Every year it is estimated that 400,000 people die of sudden cardiac arrest (SCA), the number one cause of death, in the USA. There are usually no warning signs or symptoms. This is different than a heart attack, a … Continue reading

Posted in Implantable Defibrillators, medical devices, mHealth, sudden cardiac arrest, technology, telehealth, wireless health | Tagged , , , , , , , | Leave a comment

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

Five Big Untapped Opportunities for mHealth


1. Patient Advocates. Professional patient advocates are a growing sector of healthcare stakeholders, borne out of a need for a person to navigate billing problems, a newly diagnosed complex condition, or difficulty in communicating with providers, and clinical problems after … Continue reading

Posted in digital health, Healthcare IT, medical devices, mHealth, mobile health, smartphone apps, technology, travel, wireless health | Tagged , , , , , , , , , , , , , | Leave a comment

Five Reasons Why Digital Health Technologies Need FDA Oversight


A draft proposal of the FDA guidelines for regulating mobile medical applications was released in July, 2011 (http://www.regulations.gov/#!documentDetail;D=FDA-2011-D-0530-0001). In response, the mHealth Regulatory Coalition sent detailed comments on the proposal (http://mhealthregulatorycoalition.org/wp-content/uploads/2010/06/MRC-Comments-on-FDA-Draft-MMA-Guidance.pdf). There was a recent piece in the Washington Times … Continue reading

Posted in digital health, FDA, Healthcare IT, healthcare reform, healthcare vendors, medical devices, mHealth, mobile health, pharma, smartphone apps, technology, telehealth, wireless health | Tagged , , , , , , , , , , , , , , , , , | 4 Comments

How Do Digital Health Technologies Get to Older Patients?


Much of the digital health technologies on the market today are wellness products utilized by the relatively younger segment of the population. Technologies which are focused on chronic diseases have found it much harder to reach their intended … Continue reading

Posted in digital health, healthcare economics, Healthcare IT, healthcare reform, healthcare vendors, medical devices, mHealth, mobile health, smartphone apps, telehealth, wireless health | Tagged , , , , , , , , , , , , , , | Leave a comment