Blog
Modifications to the HIPAA privacy, security, enforcement, and breach notification rules
On January 17, HHS released the Final Rule entitled: Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules under the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules.
It’s 563 pages long and contains 7 themes:
EHR: Meaningful abuse
Primer on U.S. FDA’s new 510(k) refuse to accept policy
By Stewart Eisenhart, Emergo Group
U.S. FDA publishes revised list of recognized medical device standards
By Stewart Eisenhart, Emergo Group
The US Food and Drug Administration (FDA) has announced changes to the list of recognized standards the agency uses in the medical device regulatory process.
Mexico readies GMP, technovigilance requirements for medical devices
By Stewart Eisenhart, Emergo Group
The Mexican Ministry of Health now has in place two new processes that will impact medical device manufacturers registered or planning to register with COFEPRIS.
Cost savings from EMRs: A path to salvation
Details of Russian medical device regulatory changes emerge
By Stewart Eisenhart, Emergo Group
Revised regulations (in Russian only) for the Russian medical device market have been in effect since January 1, 2013, and Emergo Group has now learned more details of these changes, although some specifics of the new rules are still needed.
New law in France targets advertising of high-risk medical devices
By Stewart Eisenhart, Emergo Group
On 1 January, 2013 France implemented a new law which regulates the advertisement of several high-risk medical devices and IVDs to healthcare professionals. The new law also applies to dermal fillers and IVDs (intended for self-testing) that are advertised to the public. Devices falling under the new law include cardiovascular implants, coronary and intracranial stents, and breast implants.
New EU electronic labeling rules for medical devices coming in March 2013
By Stewart Eisenhart, Emergo Group
The EU Commission Regulation on electronic labeling will come into effect on 1 March, 2013.
The new cognitive dissonance of medicine
The 30-something teacher stood before a room of leaders, neatly dressed, wearing black-rimmed hipster glasses, articulate, poised. He never stuttered, his words precise. His expertise was educating big rooms of leaders – it was all he knew:summa cum laude, three majors, and impeccable youthful credentials for a corporate consultant. Meeting rooms and corporate board rooms were his theater and comfort zone, flip charts and PowerPoint graphics his instruments.