Food and Drug Administration Safety and Innovation Act (FDASIA)

See the following -

FDA Won't Regulate Medical Device Data Systems

Dan Bowman | Fierce Health IT | June 20, 2014

Draft guidance published Friday by the U.S. Food and Drug Administration seemingly paves the way for smoother medical device interoperability by lowering the burden on developers of medical device data systems (MDDS) to comply with agency requirements...

Read More »

Government Asks Health IT Industry To Police Itself On Patient Safety

Zina Moukheiber | Forbes | July 5, 2013

In a plan published earlier this week, the government stopped short of establishing a new agency to investigate patient deaths related to health information technology, as recommended by the Institute of Medicine. [...] Read More »

HHS Publishes FDASIA Health IT Report

Brian Ahier | Advanced Health Information Exchange Resources | April 3, 2014

HHS released a draft report that includes a proposed strategy and recommendations for a health information technology (health IT) framework, which promotes product innovation while maintaining appropriate patient protections and avoiding regulatory duplication. The congressionally mandated report was developed in consultation with health IT experts and consumer representatives and proposes to clarify oversight of health IT products based on a product’s function and the potential risk to patients who use it.

Read More »

mHealth Regulatory Coalition Urges FDA To Release Final Apps Guidance

Greg Slabodkin | FierceMobileHealthcare | June 21, 2013

The mHealth Regulatory Coalition (MRC) on June 21 sent a letter to Department of Health and Human Services (HHS) Secretary Kathleen Sebelius urging HHS, through the U.S. Food and Drug Administration (FDA), to publish the final guidance on mobile medical applications (MMA) "as soon as reasonably possible." Read More »