Regulatory & Risk Management

Latest Headlines

Latest Headlines

Is it time to create a Mobile Health Administration?

There's been intense effort over the past several years to try to determine the best regulatory approach when it comes to mHealth technology. Thousands of hours have been spent in meetings, conferences, hearings and conversations, all in a quest to figure out how best to protect patients, foster innovation among developers and creators, and not hurt a burgeoning industry that could potentially be greater than the PC revolution. Much of it has been focused on figuring out how to wedge mHealth tools into regulatory parameters already in place within the U.S. Food and Drug Administration, the Federal Trade Commission, and dozens of other federal and state agencies tasked with making sure what's in the market doesn't hurt the consumer, protecting data privacy and securing information. But what if we stopped trying to wedge and just started from scratch in crafting a regulatory body specifically for mHealth?

Why FDA's role in mHealth oversight must be 'robust'

The U.S. Food and Drug Administration should be given robust oversight regarding mobile healthcare products and technology, states an article published July 24 in the  New England Journal of Medicine. Such a role, authors Nathan Cortez, J.D., I. Glenn Cohen and Aaron S. Kesselheim, M.P.H. say, will not hinder innovation but may be a necessary linchpin for safe mHealth tools, devices and platforms.

Health industry stuck on older communications tools

Much of the healthcare industry remains reliant on older communications systems, including pagers and paper-based processes, that can negatively impact patient safety and operational inefficiencies, according to a new Frost & Sullivan report.

BlackBerry subsidiary debuts OS for mHealth device development

BlackBerry subsidiary QNX Software Systems is debuting a new OS just for medical devices, one that promises to meet industry standards and cut the cost of mHealth device development.

What do patients want to see when it comes to mHealth solutions?

There has been little mention of device makers, app developers or mHealth services surveying consumers, polling patients and asking medical professionals about what specific products are wanted and needed, and what features should be a primary focus in wearable mHealth devices.

Apple to FDA: There's a 'moral obligation' to do more with health sensors

Apple officials expressed that the IT industry may have a "moral obligation" to "do more" with health sensors and other similar devices in a conversation held in December with U.S. Food and Drug Administration officials.

Arrival of tech titans in mHealth a big win for everyone

If the past two weeks are any indication, it seems that every technology and Internet company wants in on mobile healthcare devices, apps, services. That, of course, is a very good thing for patients, providers and payers, as well as the IT industry at large. Why? First, let's look at who exactly is jumping into the mHealth pool.

The imperative of safety in mHealth and why it can't be ignored

Technology is a wonderful thing, except when it's not. The wireless network crashes, the PC blows up, the tablet gets a virus, smartphones go missing. And in each of those scenarios, data and access to data is potentially compromised. It's no different with mHealth devices. Smartwatches, health fitness bands, wearable monitors woven into clothing, smartphones that feature blood testing capabilities--they all collect, share and house data. We believe it will be there when we need it, we believe it will be accurate and we believe it should be infallible, given all the technological advances.

FTC mobile health privacy revelations deserve more attention

A new Federal Trade Commission study reveals that data sharing from mobile health and fitness apps to third-party services providers is taking place, yet there seems to be little public outrage over the trend.

FTC: Health, fitness apps share user info with vendors

A Federal Trade Commission study revealed mobile health and fitness application vendors are sharing user data with third-party vendors. The data includes device use information, as well as personal health and fitness insight.