FDA Patient Engagement Advisory Committee

FDA Announces First-ever Patient Engagement Advisory Committee By: Nina L. Hunter, Ph.D., and Robert M. Califf, M.D., 9/18/2015 Although it may seem odd in retrospect, the development of new technologies intended to improve patients’ lives has largely relied upon expert opinions rather than asking patients and families directly what they consider most important. But that’s changing. We are entering an Read More …

5 reasons Digital Health Technologies need FDA oversight

By David Lee Scher, MD 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 . There was a recent piece in the Washington Times “The FDA’s Assault on Mobile Technologies” which, in my opinion, was misguided. No one in the healthcare Read More …

This $200 iPhone Case Is An FDA-Approved EKG Machine

By Mark Wilson Health Care is hurting, and the world is changing. More and more, Hospitals will fit in our Pockets.  Most iPhone cases just protect your phone from drops. If you’re getting fancy, it may have a fisheye camera lens or a screen-printed back. But what about diagnosing coronary heart disease, arrhythmia, or congenital heart defects? The AliveCor Heart Monitor is Read More …

FDA issues Guidance on Mobile Medical Apps

WASHINGTON – Sept. 24, 2013 – The American Telemedicine Association (ATA) is encouraged by the Food and Drug Administration’s (FDA’s) release of guidance on mobile medical apps. [Modern Health Talk is encouraged too.] “The FDA has chosen wisely to target its strict regulatory efforts on mobile applications that could pose a significant risk to consumers if used improperly.” said Jonathan Read More …

FDA to regulate Mobile Apps with Highest Risk

Health care can be delivered with better quality and less cost through mobile technologies, but unfortunately, the scope and uncertainty of proposed FDA rules is impeding progress and adoption of these new technologies. On 7/19/2011 the FDA announced that it is seeking public comment on proposed regulatory oversight of the mobile medical (mHealth) apps that pose the greatest risk to Read More …

FDA won’t regulate these mobile apps

The FDA final guidance lists several types of apps that may meet the definition of a medical device, but that pose lower risk to the public and will not be regulated. That should free developers to innovate and allow useful consumer products to come to market more quickly while ensuring that the mobile health apps are not only convenient, but safe. Read More …

FDA to regulate Mobile Medical Apps, seeks public input

Devices once used only by medical professionals in institutions are getting smaller and cheaper and finding their way into mobile devices. Some are also going into consumer households, so the U.S. Food & Drug Administration wants to regulate them to ensure the health, safety and welfare of citizens. On July 19, 2011 the FDA announced it is seeking input on Read More …

How to pick the good smartphone health apps

By Carol Maher (original here) With an estimated 100,000 health and fitness apps available on the two leading smartphone platforms, iOS and Android, it seems there is an app for everything – from tracking your bowel movements, to practising your pimple-popping technique. However, a number of apps are starting to raise the ire of government regulators. Brain-training juggernaut Lumosity was recently fined Read More …

Direct-to-Consumer Advertising of Pharmaceuticals

Guest article by Ray Collins The FDA has tolerated, regulated, and now seems to favor direct-to-consumer advertising by pharmaceutical companies, apparently as part the the judicial and regulatory trends toward corporate free speech. Susan Schwartz McDonald posts at National Analysts about her company’s view The very fact that this particular [FDA] survey [of health care professionals] is on the docket Read More …

Personal Exoskeleton cleared by FDA

This revolutionary technology, which allows people with Spinal Cord Injury to stand & walk, receives clearance for personal use in the U.S. Exoskeleton leader ReWalk Robotics has announced that the FDA cleared the company’s ReWalk Personal System for use at home and in the community. ReWalk is a wearable robotic exoskeleton that provides powered hip and knee motion to enable Read More …

FDA issues graphic cigarette labels

According to USA Today, the FDA will soon require tobacco companies to cover the top half of cigarette packs with very graphic anti-smoking images. Their goal is to encourage the nation’s 43 million smokers to quit and prevent millions more from starting, especially teens. It’s about time, and if this was done 30 years ago, my parents might still be Read More …

Are You Ready for Some Sensors… in Healthcare?

They’re Everywhere! They’re Everywhere! Sensors that is, and it seems they sense everything too. Here’s a tiny subset: Temperature (e.g. thermostat) Light (photocell) Sound & Vibration (microphone) Proximity (motion sensor, Doppler radar, stud finder) Pressure (altimeter, barometer, tire pressure) Magnetism (security contact switch) Chemicals (smoke, radon & CO2 sensors) Fluid Flow (water & gas meters) Electric Current (electric meter) Moisture Read More …

Too Much Hype in the Mobile Health App World?

By Barbara Ficarra, RN, BSN, MPA [Original post, “Too Much Hype in the Mobile Health App World?” published on The Huffington Post on 7/23/12 in the Healthy Living/Health News Section.] The Wild West of mobile health (mHealth) is taking the health care industry by storm, but “there are no rules to the game,” said Joseph C. Kvedar, M.D., founder and Read More …

Health Care Comes Home: The Human Factors

HUMAN–SYSTEMS INTEGRATION REPORT BRIEF, 2011 by the National Research Council (www.nationalacademies.org/bohsi) National Academy of Sciences • National Academy of Engineering • Institute of Medicine • National Research Council Health Care Comes Home: The Human Factors In the United States, health care practices and associated medical devices and information technologies are rapidly moving into the home. This transition, which is likely Read More …

Telemedicine and mHealth Converge

  Telemedicine and M-Health Convergence Market is a new market research report. EDITOR: I’ll mark highlights and add [occasional notes]. – London (PRWEB) November 20, 2013 — Clinical telemedicine services converge with m-health systems of engagement to lower cost of care and improve quality of care. Tele-medicine and M-Health Market Convergence driving forces relate to an overall trend toward ordinary people taking Read More …

Blood Pressure Monitor for iPad, iPhone and iPod touch

Withings Announces US Availability of its Connected Blood Pressure Monitor for iPad, iPhone and iPod touch Withings combines sophisticated technology and design to transform an ordinary blood pressure monitor into an accurate health self-monitoring device Paris, France – June 20, 2011 @ 9:00 AM EST– Today, French technology company Withings announced the US availability of its Blood Pressure Monitor (BPM) Read More …

Smartphone Based Medical Imaging

Today’s post summarizes an article on digital microscopy by Ariel Sabar for Smithsonian Magazine. In “Star Trek,” chief medical officer Leonard “Bones” McCoy wands a body with a medical “tricorder,” and seconds later it reports the patient’s condition. The device could do almost anything, including heart rate & EKG, brain scans & EEG, and more. Today we’re getting very close Read More …

Blood Glucose Meters: Monitoring Diabetes on Your Phone

Living with Diabetes requires frequent monitoring of blood glucose (blood sugar), an essential measure of your health. The American Diabetes Association can help you better understand Diabetes, select from the latest tools, learn how to manage your blood glucose levels, and prevent serious complications. We provide a guide to help you select a blood glucose meter, many of which are available at local drug Read More …

Zeo’s demise, a wakeup call for Sleep Wellness?

This article is based on a LinkedIn discussion that was started by Paul Sonnier, founder of the Digital Health discussion group. Zeo has closed shop. Mentioned here & here and shown in the video below, Zeo is the company that provided a well known direct-to-consumer (DTC) sleep monitoring and coaching system that claimed to take the “science of sleep out of the lab and Read More …

Wello iPhone case tracks several points of health

By Wayne Caswell I spoke briefly with CEO Hamish Patel at the opening of the SXSW Interactive yesterday and was impressed enough to write about his device today. The Wello iPhone case tracks several points of health with a variety of medical-grade sensors that measure things like like temperature, heart rate (pulse), heart rate variability (stress related), blood pressure, blood Read More …