FDA considers new FDASIA workgroup recommendations for regulating health IT
On 4 September 2013, a working group tasked with making recommendations for optimal regulation of health information technology (HIT) delivered its final report to the Food and Drug Administration (FDA or the agency), the Office of the National Co-ordinator for Health Information Technology (ONC), and the Federal Communications Commission (FCC).
The final report recommends only very low-level regulation for low-risk HIT products and requests that the FDA expedite the final guidance on medical mobile applications for smartphones and other mobile devices (medical mobile apps). FDA officials say that the agency is considering the recommendations and will work with other agencies to issue a report on overarching regulation of HIT by January 2014.
The FDASIA Workgroup was formed by the three government agencies in response to the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), which called on these agencies to propose a comprehensive, risk-based regulatory framework for HIT by January 2014. The FDA, along with the FCC and ONC, created the Workgroup to make recommendations that will guide development of the framework…
If you are registered and logged in to the site, click on the link below to read the rest of the DLA Piper briefing. If not, please register or sign in with your details below.
Sign in or Register to continue reading this article
It's quick, easy and free!
It takes just 5 minutes to register. Answer a few simple questions and once completed you’ll have instant access.Register now
Why register to The Lawyer
In-depth, expert analysis into the stories behind the headlines from our leading team of journalists.
Identify the major players and business opportunities within a particular region through our series of free, special reports.
Receive your pick of The Lawyer's daily and weekly email newsletters, tailored by practice area, region and job function.
More relevant to you
To continue providing the best analysis, insight and news across the legal market we are collecting some information about who you are, what you do and where you work to improve The Lawyer and make it more relevant to you.
News from Hogan Lovells
News from The Lawyer
Briefings from Hogan Lovells
The decision of the US Court of Appeals has raised questions about how issuers should present their disclosures on conflict minerals under Exchange Act Rule 13p-1 and Form SD.
An interesting judgment was delivered by the Honourable J Majiki on 19 November 2013 in the Eastern Cape High Court, Port Elizabeth.
Analysis from The Lawyer
As international firms question their future in these small, closely linked markets, local lawyers too are eyeing the business environment with caution
Beyond the headline infrastructure projects, UK construction work is still recovering from the clobbering it took during the slump