US Food and Drug Administration (FDA)

Last month, the nation’‍s largest union of registered nurses sent a letter to the FDA asking for broader and more stringent oversight of electronic records systems and of computerized physician-order entry systems, which allow clinicians to log treatment instructions for patients. The National Nurses United, as part of its broader campaign highlighting the potential dangers of “unproven medical technology,” says FDA officials should test electronic medical records as rigorously as they might a new drug or an artificial hip implant...

Read More »

Today the U.S. Food and Drug Administration is announcing the MyStudies app, a new mobile technology to foster the collection of real world evidence via patients' mobile devices. Real world data can be collected from a variety of sources, such as electronic health records, claims and billing activities, and product and disease registries, as well as from patient-generated data including in home-use settings, or from data gathered from other sources, such as mobile devices. As part of the agency's work to foster greater opportunities around real world evidence, the FDA partnered with Kaiser Permanente on a pilot study to measure the functionality and engagement of the MyStudies app.

Read More »

A doctor’s work isn’t all done in examination rooms. Many specialists spend lots of time alone with the lights out, examining photographs that reveal their patients’ internal workings. That might soon change. A paper by Google published in the Journal of the American Medical Association details an algorithm that can detect when someone has developed blindness as a result of diabetes, trained and tested by board-certified ophthalmologists. It shows algorithms can, at least in the case of this particular affliction, make a diagnosis with an accuracy on-par with medical professionals...

Read More »

There are myriad apps, tools and technologies entering the healthcare marketplace--but most lack proof that they are helping consumers battle disease and stay healthy, according to an article in Fortune. To that end, hospitals must be very careful when adopting health IT, according to Richard Milani, chief clinical transformation officer at Ochsner Health System. "You want to be comfortable that the technology you're utilizing is reliable and accurate," Milani tells Fortune. "That's a genuine concern. If you have some scientific data or peer-reviewed data to back it up, that certainly makes it a little easier."

Read More »

Ellie Lobel was 27 when she was bitten by a tick and contracted Lyme disease. And she was not yet 45 when she decided to give up fighting for survival. Caused by corkscrew-shaped bacteria called Borrelia burgdorferi, which enter the body through the bite of a tick, Lyme disease is diagnosed in around 300,000 people every year in the United States. It kills almost none of these people, and is by and large curable - if caught in time...

Read More »

...This worrying problem causing as much global concern as terrorism is antibiotic resistance. Antibiotics, the wonder drugs that made surgery safe and stopped disease outbreaks by preventing and curing all infections four decades ago, can no longer do so...

Read More »

The FDA is focusing on safety and effectiveness of interconnected medical devices with the issuance of final guidance on medical device interoperability, released last week. As the FDA notes, medical devices are becoming increasingly connected to one another and to other technologies, and it is critical to address their ability to exchange and use information safely and effectively. For device manufacturers, this guidance provides clarity on how the FDA is thinking about interoperability and patient safety in the premarket submission process and provides considerations for manufacturers in the development and design of interoperability medical devices...

Read More »