www.healthdatamanagement.com

www.healthdatamanagement.com
Share

Nebraska on January 1 became the first state to require pharmacists and pharmacies to report all dispensed prescriptions daily to the state’s prescription drug monitoring program, not just controlled substances. “A year ago, we implemented the first stage of this law,” says Ashley Newmyer, an injury epidemiologist and director of PDMP enhancements...

www.healthdatamanagement.com

 •  December 8, 2017

The Food and Drug Administration has issued draft guidance on clinical decision support software for healthcare providers to clarify what types of systems will no longer be defined as medical devices and therefore will not be regulated by the agency, based on provisions of the 21st Century Cures Act. Under the Cures Act signed into law late last...

www.healthdatamanagement.com

 •  February 14, 2017

The Food and Drug Administration is fast-tracking qualifying medical devices to patients with life-threatening or irreversibly debilitating conditions that lack treatment and diagnostic options. The FDAs new Expedited Access Pathway (EAP) program covers certain medical devices that demonstrate potential to address unmet medical needs that are...

www.healthdatamanagement.com

 •  February 14, 2017

As part of the Food and Drug Administrations recently launched openFDA initiative, the regulatory agency is for the first time offering an application programming interface providing web developers and researchers direct access to millions of reports on drug adverse events and medication errors that have been submitted to the FDA since 2004. The...

www.healthdatamanagement.com

 •  February 14, 2017

Researchers at Rice University have developed a big data technique that could have a significant impact on healthcare through “clustering” and the ability to reveal information in complex sets of data like electronic health records. “Health records include a person’s age, white blood cell count, weight, and they are starting to have proteomics data...

www.healthdatamanagement.com

 •  February 14, 2017

During March 13 testimony before a Senate committee, Food and Drug Administration Commissioner Margaret Hamburg, M.D., defended the length of time it takes the regulatory agency to review and approve medical devices. "I can assure you that the FDA review teams take their job very, very seriously, going through in a systematic way the data that's...