Regulation

By Aditi Pai 10:11 am April 16, 2015
New Jersey's Division of Consumer Affairs has launched a new app for iPhones that will allow authorized users of the state’s prescription monitoring program, prescribers and pharmacists licensed in New Jersey, access to the database via their smartphone. The database is managed by the New Jersey Prescription Management Program (NJPMP), a program under the Division of Consumer Affairs. The NJPMP...
By Aditi Pai 07:50 am April 14, 2015
A recent study conducted by Mathematica Policy Research and Public Health Institute found that Text4baby subscribers are engaged with the texting program, would recommend it to others, and have gained knowledge about critical maternal and child health topics after using it. The report was produced for the U.S. Department of Health and Human Services (HHS) and Health Resources and Services...
By Jonah Comstock 12:44 pm April 13, 2015
A brain training game fined by the FTC earlier this year. Developers of mobile health apps need to be mindful of regulation from a number of different quarters. Among others, developers need to be aware of the FDA, OCR (HIPAA), and the FTC, which is increasingly regulating areas that would seem to be the purview of one of the other two groups. At a HIMSS session on mobile and digital health...
By MHN Staff 07:03 am April 13, 2015
By Bradley Merrill Thompson With the growth of health apps, entrepreneurs often need to determine if FDA regulates their particular mobile app. As I’ve explained in other posts and indeed in a book, that question has a number of facets to it, but in this post I want to focus on the most important – the intended use of the app. This concept of intended use is indeed not just the determining factor...
By Jonah Comstock 08:56 am April 9, 2015
In March, Roche received FDA clearance for its Accu-Chek Connect companion app, and, less than a month later, issued a recall of that app. App recalls, which are becoming more common as more and more apps receive FDA clearance, are less severe than device recalls because they can often be ameliorated with a quick software patch. The app, available only on Android at present, helps patients track...
By Aditi Pai 08:52 am April 9, 2015
Rochester, Minnesota-based Mayo Clinic spin-off Ambient Clinical Analytics has received FDA 510(k) clearance for a software-based decision support tool, called AWARE. AWARE stands for Ambient Warning and Response Evaluation. It’s an interface for EMR data that prioritizes and organizes a patient’s medical information in three ways: by organ, chronologically as a timeline, or as a customized...
By Aditi Pai 09:49 am April 8, 2015
A few months ago, Accenture reported that 19 of the 25 states developing state health innovation plans (SHIPs) were planning to invest more in telehealth this year. Now, the Office of the National Coordinator for Health Information Technology (ONC) has published online resources to help the states that are participating in the State Innovation Models initiative make better use of digital health...
By Jonah Comstock 10:05 am April 1, 2015
Sense4Baby, the maternal and fetal monitoring product developed by West Health and then acquired by AirStrip Technologies, has received a second FDA 510(k) clearance, which will allow pregnant mothers to perform non-stress tests in their homes. The technology was previously only cleared for use by providers in clinical settings. The Sense4Baby offering is a packaged kit that includes the wearable...
By Jonah Comstock 09:43 am March 30, 2015
According to a posting on ClinicalTrials.gov, the US Department of Veterans Affairs is embarking on a new clinical trial of its PTSD Coach app, to test whether the app is more effective with clinician support. After a first phase of interviews with primary care and mental health practitioners, investigators will move onto a small 16-week study of 30 veterans with post-traumatic stress disorder (...
By Aditi Pai 08:09 am March 30, 2015
Israel-based Voyant Health, a subsidiary of Germany-based medical technology company Brainlab, received FDA clearance for its iPad app, called TraumaCad Mobile, which helps orthopedic surgeons with their pre-operative surgical planning. “For over a decade, thousands of orthopedic surgeons have been using our TraumaCad technology to plan surgery," Brainlab General Manager of Orthopedics Marc...