The publication in July of the FDA Draft Guidance on mobile medical apps was a major milestone in the evolution of mobile medicine. The blazingly rapid growth in interest among physicians, medical software publishers and device manufacturers has made it clear that the mHealth revolution will be a major turning point, not just in health information technology, but likely in many aspects of physician-patient interactions.
Last week (Sep 12-13), the FDA is held an important public workshop near its Washington DC headquarters to help it answer some key questions raised within the Draft Guidance and gather feedback from important stakeholders in mobile health. We are proud that iMedicalApps was invited to participate as one of the panelists.
We want to hear from you iMedicalApps readers – what do you want the FDA to consider in regulating mobile medical apps ?
Please add your voice in the comment section below and we will assemble them for submission to the official FDA docket on the Draft Guidance. Hurry because the deadline is just a few weeks away.
The FDA needs input from clinicians and others interested in mobile medicine and has identified two topics in particular as needing further specification:
How to assess the risks inherent to clinical decision support software and
How to classify mobile software that works in concert with a medical device.
The University of California-San Francisco (UCSF) has made a significant announcement that could be a watershed moment for how medications are given to hospital patients in the United States.
In a typical hospital setting, patients are receiving many different types of prescription medications — ranging from mundane vitamins to more intense drugs such as chemotherapy. In the thousands of times medications are given to patients, and with the high number of humans handling the process of organizing and giving the medications, human error is bound to occur. And medication errors can be life threatening — especially if related to a chemotherapy agent.
UCSF wants to make the rate of error for medication administration to be zero. In order to do this, they are using robot technology to prepare and track medications, with the main goal, obviously, being to improve patient safety. In the phase-in of the project, not a single error occurred in the 350,000 doses of medication prepared — remarkable.
Once computers at the new pharmacy electronically receive medication orders from UCSF physicians and pharmacists, the robotics pick, package, and dispense individual doses of pills. Machines assemble doses onto a thin plastic ring that contains all the medications for a patient for a 12-hour period, which is bar-coded.
There are some key advantages this system brings to the workflow of a hospital setting:
— The robots can do chemotherapy dosing, one of the toughest and most sensitive things to do. They can also do complex IV medication dosing.
— There is no touching of the medications by hand. The medications come from the manufacturer, are processed by the robots, and then sent to the nurses and the patient’s bedside in sterile packaging.
— The robots allow for pharmacists and nurses to be more efficient by taking away repetitive tasks. While they do not replace either, they enable a healthcare system already stretched for resources to increase productivity.
— The system costs $15 million, but with the payoff in regards to improved patient outcomes, as well as time saved, the investment should make this endeavor by UCSF more than worthwhile.
The word cancer comes from the greek word for crab “karkinos,” so named by Hippocrates who visualized the tumor and its surrounding vessels looking like a crab, dug stubbornly into the sand with its legs. We know far more about cancer today than the ancient Greeks, but the vision of an entrenched opponent, almost impossible to extract whole, appears to be vividly prescient.
What we have realized over the last half century is that removal of the visible tumor is not enough. Even as we learned how to do bigger and more destructive surgeries, the cancer still managed to sneak back in, growing later at different locations. The crab’s legs are still embedded in the patient.
Thus the discovery that certain chemicals could extinguish these rogue cells opened the modern era of cancer therapy and led to the first “cures” from cancer. Many of these compounds were exquisitely toxic. Early experimenters even used nitrogen mustard, quite literally a poison, as Siddhartha Mukherjee tells in his excellent history of cancer, “The Emperor of All Maladies.”
To many, the battle looked grim. For the founder of CollabRx, who himself was living in the shadow of advanced melanoma, this was the signal to take his expertise in internet information technologies and apply it to cancer. Thus a “biomedical software company” was founded, with the mission:
…to save lives by using information technology to personalize cancer treatments and accelerate research.
The rapid proliferation of knowledge about the molecular underpinnings of different cancers, has brought hope for a new age of “targeted” therapies. These drugs are designed to find and destroy cells with aberrant biochemical pathways, while bypassing the normal body tissues. Immense hopes rest on them. Read more »
The cost of managing chronic diseases is the largest portion of healthcare expenditures in developed countries. For example, the prevalence of adult acquired diabetes has been rising in the United States, in concert with increasing rates obesity. The CDC has termed it an “epidemic,” especially in light of the massive costs incurred by the healthcare system due to diabetes.
The deleterious health effects of many chronic conditions can be diminished by behavior modifications. While few would underestimate the difficulty of having patients lose weight or exercise more, good management of blood sugar in diabetes is both objectively measurable and strongly correlated with reduced end-organ damage.
This is among the reasons why Research2Guidance has recently nominated diabetes as the condition most likely to be most targeted by mobile medical software and devices (mHealth). This finding is part of their recently published Global Mobile Health Market Report 2010-2015. This is the same report that also predicted that, in the future, medical apps are likely to be distributed by physicians and healthcare institutions.
This time Research2Guidance is highlighting the portion of the survey where they looked into where mobile devices have the most potential to affect health outcomes. While other chronic conditions such as hypertension and obesity have larger populations, the market researchers felt diabetes had the largest market potential due to the huge cost saving potential, the demographic and geographic overlap between smartphone users and people with diabetes, and the real potential to improve blood sugar management using mobile devices. Read more »
The potential of mobile phones to improve health is most acutely visible in developing countries. iMedicalApps covered the recent mHealth Summit, where there were many inspiring demonstrations of how voice and simple text messages can have a profound effect on the health of those countries’ citizens. Jhpiego has successfully worked on these problems for three decades and was recently awarded a $100m grant. James Bon Tempo has extensive experience in this field and we are thrilled that he is sharing his insights with the readers of iMedicalApps.
This is a guest post from James BonTempo.
Mobile Health In Developing Countries
I am a user and an implementer of technology, not an inventor or developer, so my constraints, challenges and requirements are different than those of many attendees of the recent mHealth Summit. And for others like me who work in international aid and development, mobile technology is simply a tool, and one of many in a large toolbox that includes various best practices and proven approaches. At Jhpiego (an affiliate of Johns Hopkins University), we have piloted a number of different mobile interventions — from simple SMS to Java & smartphone-based applications — but the challenge for us is to identify the most appropriate technologies, the tools that will help us to strengthen health systems in limited resource settings most effectively and most efficiently. Read more »
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