Latest Headlines

Latest Headlines

US Food and Drug Administration: 'There are no regulatory restrictions to using these technologies'

Leonard Sacks, associate director of clinical methodology at the U.S. Food and Drug Administration, gave a very interesting presentation at the N.Y. Academy of Sciences's "Mobile Health: The Power of Wearables, Sensors and Apps to Transform Clinical Trials" event. The big (and most welcomed) surprise to me was his assertion that "there are no regulatory restrictions to using these technologies." Here's what else he had to say regarding the collection of patient data through new devices and apps:

Post-marketing data analysis of pharmaceuticals discovers side effects not previously known

Big data is delivering many breakthroughs in medicine at a breathtaking pace. One of the latest examples is in post-marketing data analysis of prescription drugs. 

New legislation seeks to limit FDA oversight of e-health records

Senators Michael Bennett and Orrin Hatch are strategizing over a bill that would exempt some electronic health records from the reaches of the FDA.

Infographic: FDA's multi-layer regulatory structure for mobile medical apps

Despite the security and privacy risks that mobile apps pose for medical use, the Food and Drug Administration is "leading the way in defining a regulatory path for mobile medical apps", explains an infographic from high-tech product design and development consultancy Sagentia.

The FDA's big data hunt for drug problems in your medical records

Mini-Sentinel is a government project that proactively seeks evidence of adverse events that can be linked to drugs on the market in an effort to find and stop problems as fast as possible. It's a big data project on a specific mission and it's hunting through huge databases of medical records--and yours is probably in there somewhere.

FDA putting a halt to off-label marketing fraud with big data

We've all seen the escalation of drug ads on television and the laundry list of warnings that come with them. But some ads go too far and push products as remedies for conditions for which they were not approved.

Dynamics Research Corp. wins $50 million FDA analytics award

The U.S. Food and Drug Administration continues to expand as more products are put under its purview. Yet, each new product leads to more data and more stress on its IT infrastructure.

FDA issues rules for mobile medical devices

A new U.S. Food and Drug Administration (FDA) rule that governs how hardware manufacturers can introduce new mobile medical devices for use by health care providers has gone into effect. The new

FCM coverage at AIIM/info360 2011

As we attend sessions and stroll the expo hall at AIIM/info360 2011, we want you to be part of the action--even if you're not in Washington, D.C. with us. Ron Miller and I will be attending the