Tag:
Food and Drug Administration
Latest Headlines
Latest Headlines
Reclassifying EHRs as medical devices would come at a cost
Just two weeks ago, I expressed concern that a cyber attack on unprotected medical devices can infect the electronic health records to which they are connected, causing the EHR to malfunction and the
U.S. marks up antivenom drug 5,000 times more
Getting treated for a scorpion sting in Mexico costs as little as $100. Just over the border in the United States, the identical treatment could be $50,000 or more, reports The Arizona Republic. The
IOM proposes new agency to oversee health IT safety
As concern over health IT-related safety issues mounts, the Institute of Medicine (IOM) has proposed the creation of a new watchdog agency to monitor these problems. This agency would investigate
A patient-safety argument for EHR data mining
Did you know that combining a drug commonly prescribed to treat depression (Paxil) with another popular medication to lower cholesterol (Pravachol) could create a dangerous reaction by raising blood
FDA approves quicker test for MRSA
Hospitals trying to get a step ahead in tackling Staphylococcus aureus infections within their facilities now may have another tool in their arsenal with the approval by the U.S. Food and Drug
Should EHRs be regulated like medical devices?
Will the Food and Drug Administration (FDA) decide to regulate electronic health records (EHRs) as medical devices--or will it decline? That's an interesting question that came up this past week at
New FDA rule tackles segment of mobile health, leaves others untouched
The Food and Drug Administration's new Medical Device Data Systems (MDDS) rule exempts a small portion of smartphone apps and wireless peripherals from the FDA's pre-review requirements. But that
Continua, Global Certification Forum partner to test mobile health devices
Is the mobile healthcare industry looking to head the FDA off at the pass? Might be. Two major mobile technology advocacy groups, Global Certification Forum and Continua Health Alliance, partnered
IOM kicks off study of EMR safety as FDA regulation looms
The Institute of Medicine is back on the EMR beat. This week, the IOM Committee on Patient Safety and Health Information Technology held its first meeting as it embarks on a yearlong study of medical
Smartphone-based ultrasound awaits FDA clearance
One of the developers of a prototype ultrasound probe that connects to a smartphone is involved in a startup company that could bring the phone-based ultrasound to market next year if the FDA grants
