Keyword: Epstein Becker & Green
The FDA is making progress with its Pre-Cert program, but one attorney says "there is conflict."
The FDA's approval of an app that uses AI to notify specialists of a potential stroke offers new possibilities for triage software that uses CDS.
The digital health industry waited six years for the FDA to release CDS guidance. Now that it's here, some say the agency didn't push far enough.
The FDA has outlined basic concept of its new software precertification program, but companies selected for the pilot will have an outsized influence.
A new pilot program lays the groundwork for the FDA to overhaul its approach to regulating digital health companies that "fosters, not impedes, innovation."
The FDA will launch a Digital Health Innovation Plan that will redefine its approach to digital devices, prompting excitement from industry experts.
In the aftermath of the eClinicalWorks settlement, providers are unlikely to face legal action.
Following a $155 million settlement, former ONC officials told FierceHealthcare eClinicalWorks is not the only EHR vendor that has sidestepped certification.