Government & Policy
mHealth advocates are giving good early reviews to the U.S. Food and Drug Administration's final guidance document on the regulation of mobile medical apps, with one expert calling it "an expansive document that truly seeks to deregulate our nimble and innovative industry, while ensuring patient safety."
Speaking at the Privacy and Security Forum, the man leading HIPAA violation investigations said there is a need for "assertive enforcement" based on clearly defined rules of the road.
When OCR Director Leon Rodriguez took the stage Sept. 23 at the HIMSS Media and Healthcare IT News Privacy and Security Forum, the timing was perfect. With the HIPAA Omnibus Final Rule taking effect on the same day, Rodriguez talked to the increased enforcement to come.
The U.S. Food and Drug Administration has issued final guidance for mobile medical application developers, promising limited regulation for most health and wellness apps while applying risk-based standards to diagnostic and quasi-medical device apps.
As mobile medical apps become more and more like medical devices, the FDA is finalizing plans to regulate them similarly.
The outgoing national coordinator also discusses the only day he plans to take off, how his views evolved during his ONC tenure and widespread misconceptions about healthcare policymakers.
OCR Director Leon Rodriguez offered new details on the Omnibus Final Rule as he took the stage at the two-day Healthcare IT News and HIMSSMedia Privacy & Security Forum in Boston.
The Food and Drug Administration today announced a long-awaited final rule for the unique device identification system intended to provide a consistent way to identify medical devices. But at least one healthcare organization says the government could have done better.
The HIMSS Interoperability Showcase, held on Capitol Hill Sept. 17 and 18 was a highlight of this year's annual National Health IT Week, educating some 500 members of the public, congressional staffers and members of Congress about health IT.
Mass shootings like the recent Navy Yard tragedy are actually more expected than they're portrayed to be. Could the healthcare community help police use more tools to prevent them?