May 4, 2020
Following numerous reports of underperforming COVID-19 antibody tests, the FDA has raised the bar for these products in a revision to its emergency testing policy.
As of today, commercial manufacturers that notify the agency of their intent to submit a test for Emergency Use Authorization are required to do so within 10 business days from the date of notification. Further, the FDA has recommended...
Photo Credit: Alex Wong/Getty Images
March 9, 2020
This morning the US Department of Health and Human Services dropped its long-awaited final rules on interoperability, information blocking and patient access.
While the two final documents from the HHS Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS) specify a number of new requirements laid out in the 21st...
January 17, 2020
As 2020 gets underway, the federal government has set its sights on bringing innovation to an area of health that affects one in seven Americans and costs the government more than NASA and the Department of Commerce combined, yet hasn’t seen major innovation since the 1970s.
That area is kidney disease. Both HHS Chief Technology Officer Ed Simcox and HHS Deputy Secretary Eric Hargan addressed the...
December 5, 2019
The FDA and National Institutes of Health are tapping the clinical community and a newly launched mobile platform in its search for novel infectious disease interventions.
Called CURE ID, the online data repository will allow clinicians to report instances in which existing FDA-approved drugs are used to successfully treat infections.
In particular, the tool captures clinical outcomes in cases...
November 5, 2019
Friday marked the end of Dr. Ned Sharpless’ time as acting commissioner of the FDA, with President Donald Trump pointing to Dr. Stephen Hahn, currently the chief medical officer of MD Anderson Cancer Center, as his official appointment for the role on Friday. Assistant Secretary for health at HHS Dr. Brett Giroir will act as the agency’s new acting head.
“With Dr. Sharpless at the helm, the FDA...
September 6, 2019
Abhinav Shashank is the cofounder and CEO at Innovaccer Inc. Abhinav has led the San Francisco-based healthcare data activation platform company since its inception in 2014. Under his supervision, Innovaccer developed its proprietary healthcare data activation platform.
We dream of a healthcare system that encircles all citizens and connects them to the common thread of care, which is built on...
January 18, 2019
The government shutdown was well underway for the entirety of JP Morgan week in San Francisco last week, but that didn’t stop HHS leaders from dropping by auxiliary events in the Bay Area.
National Coordinator Don Rucker delivered the opening address to HIMSS’s own Health 2.0 VentureConnect event, while HHS Chief Data Officer Dr. Mona Siddiqui swung by the StartUp Health Festival for a fireside...
January 2, 2019
As America rises to greet the new year, its leaders remain in a funding dispute over border security that has so far resulted in 13 days of a partial government shutdown. While the deadlock is certainly having a prolonged impact on more than 420,000 government employees who are working without pay, and the 380,000-plus who have been furloughed, each passing day threatens greater challenges for...
October 24, 2018
September 27, 2018
Focus on Innovation
In September, we take a deep dive into the cutting-edge development and disruption of healthcare innovation.