Category Archives: FDA

Five Imperatives for Pharma’s Digital Health Strategy

Posted on September 26, 2014 by davidleescher

Few would argue that today digital technology represents a critical part of marketing in any business sector.  Though all healthcare stakeholders are usually late to the technology table, market and customer pressure are rapidly accelerating this adoption. It needs to … Continue reading →

Posted in clinical trials, digital health, FDA, healthcare economics, Healthcare IT, medical apps, mHealth, patient advocacy, patient engagement, pharma, technology, telehealth, wireless health | Tagged , , , , , , , , , | 5 Comments

Five Ways Digital Health Technology Can Impact Risk Management

Posted on September 9, 2014 by davidleescher

There has been a significant amount of well-deserved publicity regarding HIPAA violations arising from security breaches of electronic health records (EHRs). Even a well-intentioned company which developed a certification process (which included privacy and security) for mobile medical apps encountered … Continue reading →

Posted in digital health, FDA, Healthcare IT, IT security, malpractice law, mHealth, mobile health, patient engagement, remote patient monitoring, risk management, smartphone apps, telehealth | Tagged , , , , , , , , | 1 Comment

Aging at Home: A Necessary Synergy with Digital Health Technology

Posted on August 18, 2014 by davidleescher

References to new healthcare delivery models today generally refer to systematic changes which reflect reimbursement strategy shifts. Some even go so far as to refer to them as innovations in healthcare design. I would take issue with labeling these new … Continue reading →

Posted in digital health, FDA, health insurance, Healthcare IT, medical apps, medical devices, mHealth, mobile health, patient advocacy, patient engagement, remote patient monitoring, smartphone apps, technology, telehealth | Tagged , , , , , , , , , , , , , , , , | 1 Comment

Five Ways Mobile Health Technologies can Change Healthcare Now

Posted on August 11, 2014 by davidleescher

There is growing healthy skepticism about the past promises of mobile technologies.  Issues concerning safety after the release of the FDA Guidance of mobile medical apps, privacy and security, and efficacy. Followers of the sector are poised for the rubber … Continue reading →

Posted in clinical trials, FDA, healthcare economics, Healthcare IT, healthcare reform, healthcare vendors, informatics, medical apps, mHealth, mobile health, remote patient monitoring, smartphone apps, telehealth | Tagged , , , , , , , , | 2 Comments

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

Posted on January 8, 2014 by davidleescher

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 , , , , , , , , , , , , , , | 1 Comment

Five Benefits of Crowdsourced Medical Research Funding

Posted on August 7, 2013 by davidleescher

Crowdsourced clinical studies have been the subject of previous posts by this author.  The Wiki definition of crowdfunding is: “the collective effort of individuals who network and pool their money, usually via the Internet, to support efforts initiated by other people … Continue reading →

Posted in clinical trials, digital health, FDA, health insurance, healthcare economics, Healthcare IT, healthcare reform, medical apps, medical devices, mHealth, mobile health, pharma, technology, telehealth, wireless health | Tagged , , , , , , , , , , , , | 2 Comments

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

Posted on March 29, 2013 by davidleescher

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 →

Posted in digital health, FDA, informatics, medical devices, mHealth, mobile health, remote patient monitoring, technology, telehealth | Tagged , , , , , , | 5 Comments

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

Posted on March 25, 2013 by davidleescher

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

Posted on March 15, 2013 by davidleescher

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

Five Pitfalls of Designing a Medical App

Posted on January 31, 2013 by davidleescher

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 , , , , , , , , , , , , , | 7 Comments