Regulation

By Jonah Comstock 08:51 am August 17, 2015
Israeli medical device company Integrity Applications has begun the process with the FDA to bring its noninvasive glucose monitoring device, GlucoTrack, to the United States. GlucoTrack allows users to monitor their blood glucose level without drawing blood. The user wears a clip on his or her ear, and GlucoTrack uses a combination of sensors to determine blood glucose level, then sends the data...
By Jonah Comstock 11:24 am August 10, 2015
CareScape V100, a GE patient monitor. Despite protestations from the American Hospital Association and a cadre of 16 Republican members of Congress, the FCC decided at its August meeting to allow unlicensed devices to use some of the spectrum previously reserved for medical devices. The AHA and the Representatives both sent letters to the FCC in the last days of July, urging them to postpone...
By Jonah Comstock 11:19 am August 10, 2015
As his time in office draws to a close, President Obama secured his reputation as our first geek president by hosting a tech startup demo day in the White House last week. Although the primary purpose of the demo day was to showcase diversity in tech entrepreneurship, a number of mobile health and wellness-focused companies filled out the ranks of Obama's invited startups. Here's a round-up of...
By Jonah Comstock 10:56 am August 5, 2015
Arizona Governor Doug Ducey carved out a place for mobile health in his plan for the state's new Medicaid plan this week, but some critics think the initiative could miss the mark for a low-income population less likely to have smartphones. Arizona's Medicaid system, the Arizona Healthcare Cost Containment System (AHCCCS), is a managed care system that operates on a special waiver from the...
By MHN Staff 07:21 am August 5, 2015
By Bradley Merrill Thompson Healthcare in America needs disrupting. The media has widely reported on the high cost of, and poor outcomes produced by, the US health care system. Fortunately, attracted by possible profit in a market that currently constitutes over 17 percent of GDP, quite a few startups are anxious to do the needed disrupting. Indeed, innovators from many places outside of...
By Aditi Pai 09:21 am August 4, 2015
Naperville, Illinois-based PhysIQ has received an FDA 510(k) clearance for its personalized physiology analytics system. The offering is categorized as a Class II device for patient monitoring under the product code: automated calculation of a summary index based on several individual measured vital sign inputs. PhysIQ's offering is an early warning detection platform that analyzes a user's...
By Jonah Comstock 07:52 am July 31, 2015
The US Department of Defense may soon start using smartphone-based diagnosis tools to detect traumatic brain injuries in soldiers on the battlefield. According to a post on its "Armed with Science" blog, the DoD is working with Bethesda, Maryland-based BrainScope to put its FDA-cleared Ahead 200 device into action. Currently, it takes a CT scan to definitively establish the presence of a...
By Jonah Comstock 10:42 am July 30, 2015
The App Association Executive Director Morgan Reed Yesterday the US House of Representatives Judiciary Committee held a hearing about the Internet of Things, and though the conversation was broad and far-reaching, mobile health and healthcare connectivity did hold some floor time. Both Morgan Reed, executive director of ACT The App Organization and Gary Shapiro, CEO and President of the...
By Jonah Comstock 08:46 am July 27, 2015
The National Cybersecurity Center of Excellence (NCCoE), a division of the National Institute of Standards and Technology (NIST) has penned a five-part draft guidance on cybersecurity for mobile devices that connect to electronic health records. The guidance includes a step-by-step how-to guide for improving data security that uses commercially available and open source tools and technologies, as...
By Jonah Comstock 07:35 am July 22, 2015
The regulatory battles for telemedicine continue to play out slowly in state legislatures across the country. This week, Mississippi's medical board shelved a rule that would have put strict limits on telemedicine usage while Colorado's state medical board updated draft guidelines that will determine what doctors are and aren't allowed to do via telemedicine. And the interstate compact proposed...