Later this week, I’m joining a healthsystemCIO.com webinar about security and health information exchange.
Blog
Bzzzzaaaap
Imagine: doctors everywhere using cellphones.
Better yet, imagine doctors using cellphones to help care for patients.
It’s a beautiful thing, really: efficient, timely, graphical. Doctors, like most people, love the convenience and utility of their smartphones.
The vision thing
What is regulatory science?
The November HIT Standards Committee meeting
The 42nd meeting of the HIT Standards Committee began with an inspirational introduction from Farzad Mostashari. He told us that the HIT Standards Committee members should keep their "eyes on the prize and feet on the ground".
We should be aspirational in reviewing the Meaningful Use Stage 3 criteria, identifying standards recommendations for 2016 which are likely, which are possible with focus, and which are unrealistic.
Regulatory science is not boring
By: Susan Kelly
I’m a relative newcomer to government work, joining FDA about 18 months ago after decades of being a journalist. My job is to assign, write and edit FDA Consumer Updates, news stories posted on fda.gov that are designed to give consumers important information in language that’s easy to understand. Not too technical or bureaucratic.
New AHWP harmonization goals set for Asian medical device markets
By Stewart Eisenhart, Emergo Group
The Asian Harmonization Working Party (AHWP), a group of medical device regulatory authorities and industry participants from 23 countries worldwide, has issued a strategic framework (PDF) to develop more uniform and harmonized regulatory structures for medical device markets in Asia.
Modernizing FDA’s information technology
By: Eric D. Perakslis, Ph.D.
As I look back at my first year as chief information officer and chief scientist (informatics) at FDA, I am gratified with all of the progress that has been made. But I am also eager to transform initial wins into consistent and sustained success.
On being bombarded
I have used the Electronic Medical Record (specifically EPIC) since 2004. I have grown accustomed to its nuances, benefits and quirks. There are parts about it I really like. There are parts of it I’d like to do without but accept that they are necessary evils in our current health care climate. I know that there will always be parts of any modified computer system that will suffer growing pains. For any new and adapting technology this is understandable.
Major changes to Russian medical device regulations planned for 2013
By Stewart Eisenhart, Emergo Group
Significant changes to how medical devices are regulated in the Russian Federation are slated for early 2013, but final implementation of the new rules remains tentative.
IMDRF issues draft criteria for medical device auditing organizations
By Stewart Eisenhart, Emergo Group
The International Medical Device Regulators Forum (IMDRF), the successor organization to the Global Harmonization Task Force, has proposed draft criteria (PDF) for use by medical device market regulators to recognize qualified auditing organizations.