by admin | Jan 10, 2013 | Medical, Regulatory
In a proposal released with the 2013 State of the State address, New York state Governor Andrew Cuomo called for the statewide establishment of standardized, evidence-based protocols to facilitate rapid and accurate diagnosis and treatment of sepsis in all New York...
by admin | Jul 27, 2012 | Regulatory
During the July 25th opening session of the 4th mHealth World Congress held in Boston, a heated discussion highlighted the level of interest in the upcoming FDA mobile app guidance, and the agency’s regulation of other new healthcare technologies. According to...
by admin | Jul 12, 2012 | Regulatory
On June 28th Congress approved and signed into law the Food and Drug Administration Safety and Innovation Act of 2012 (Bill S.3187). This Act renews and amends certain provisions of the Federal Food Drug and Cosmetic Act (FD&C) of 1938, the law that governs the...
by admin | Mar 21, 2012 | Regulatory
In a previous post we threatened you with a future post on HIPAA, the rules that govern healthcare privacy and the protection of individual health information in the US. So due to popular demand (actually only 2 mHealth geeks asked for it) here is our brief intro to...
by admin | Jan 30, 2012 | Regulatory
Last year the Federal Drug Administration (FDA) announced plans to release new guidance documents that define and expand the types of clinical decision support (CDS) systems it will regulate. In July of 2011, the FDA released for comment purposes a draft guidance...