Category Archives: FDA

#DigitalHealth: Remote Patient Monitoring Part 3: The Ideal RPM System


Remote patient monitoring may serve patients who are in the post-acute care phase of recovery from a hospitalization as well as those with chronic diseases.  Monitoring may consist of communication tools or measurements of medication adherence, glucose measurements for diabetics, … Continue reading

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Posted in digital health, FDA, informatics, medical devices, mHealth, mobile health, remote patient monitoring, technology, telehealth | Tagged , , , , , , | Leave a comment

#DigitalHealth: Remote Patient Monitoring, Part 2- Operational Models


In my previous post, I discussed some generalities of remote patient monitoring (RPM).  The current value of the RPM market is estimated at $10.6B. There are diverse clinical and non-clinical environments in which RPM might be utilized.  The healthcare ecosystem is … Continue reading

Posted in digital health, FDA, Implantable Defibrillators, informatics, mobile health, remote patient monitoring, wireless health | Tagged , , , , , , | 2 Comments

#DigitalHealth: Five Fallacies of Remote Patient Monitoring


As defined in Wikipedia, remote patient monitoring (RPM) is: “a technology to enable monitoring of patients outside of conventional clinical settings (e.g. in the home), which may increase access to care and decrease healthcare delivery costs.”  I was a pioneer … Continue reading

Posted in mHealth, Healthcare IT, technology, mobile health, informatics, medical devices, wireless health, telehealth, digital health, FDA, medical apps | Tagged , , , , , , , , , , , | 5 Comments

Five Pitfalls of Designing a Medical App


There are an estimated 15,000 medical apps presently on the market and is expected to grow 25% per year according to one study.  There are issues which are common in the development of these apps and other categories of apps. … Continue reading

Posted in digital health, FDA, informatics, medical apps, mHealth, mobile health, smartphone apps, technology, telehealth, wireless health | Tagged , , , , , , , , , , , , , | 6 Comments

Business Models of Digital Health Technologies: Implications for ROI


In my last post I discussed problems with measuring the ROI of digital health technologies.  One of the problems is that the sector doesn’t fit neatly into traditional healthcare business models. There have been multiple articles  written about business models … Continue reading

Posted in digital health, FDA, Healthcare IT, healthcare vendors, medical devices, mHealth, mobile health, smartphone apps, technology, telehealth, wireless health | Tagged , , , , , , , , , , , | 2 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 Healthcare Cliff


The term ‘fiscal cliff’ is one familiar to most Americans and many outside observers of this periodic political posturing around the need to address hardcore financial issues facing the country.  If both political parties hashed out their differences and came … Continue reading

Posted in digital health, FDA, health insurance, healthcare economics, healthcare reform, informatics, medical apps, mHealth, mobile health, technology, wireless health | Tagged , , , , , , , , , , | 1 Comment

Why Payers are Critical to mHealth Adoption


     In previous posts I have talked about the importance of some of the major stakeholders in mHealth adoption (Physicians, non-physician providers,hospitals, and caregivers) in mHealth adoption. For a few reasons insurers will also play a pivotal role in … Continue reading

Posted in clinical trials, digital health, FDA, health insurance, healthcare economics, informatics, medical apps, mHealth, mobile health, smartphone apps, wireless health | Tagged , , , , , , , , , | 1 Comment

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 , , , , , , , , , | 4 Comments

The FDA and Medical Apps: Where are We?


In a previous post on this site I discussed my reasons for endorsing FDA oversight of mobile medical apps. Since we are nearing a final decision by the FDA concerning the matter, I thought it fitting to bring it to … Continue reading

Posted in digital health, FDA, Healthcare IT, healthcare reform, medical apps, mHealth, mobile health, smartphone apps, technology, telehealth, wireless health | Tagged , , , , , , , , | 3 Comments