FDA Director Scott Gottlieb has announced big changes in how the FDA approaches digital health, including plans for third party certification.
30-person Digital Healthcare Council made up of physicians, industry representative, and policy makers aims to make the entire state a digital health hub.
Determine if your medical app will require FDA regulation.
In an increasingly complex healthcare environment seeking to reduce expenditures, increase quality, and improve health, mobile health apps for consumers and the health care industry may offer some useful solutions. 2015 may be the year that some of these solutions come to light.
A recent flurry of FDA approvals suggests a higher priority on speeding the pace of innovation.
Happtique recently announced the suspension of their App Certification Program after health IT expert Harold Smith, CEO of Monkton Health, disclosed several security flaws in apps he had randomly selected for evaluation from Happtique’s first round of “certified” apps. Coming nearly two years after they announced their intention to create a certification program for health […]
American Medical News (amednews.com) recently reported on statements made in February by FDA officials regarding regulation of medical software.