Dear Friends,
We've all heard it before, the healthcare industry has been painfully slow in its adoption of information technology. However, there is now growing sentiment that IT spending in healthcare is poised to skyrocket. The importance of technology continues to grow in the healthcare industry, and IT will certainly be at the heart of any solution to the health-care crisis. The federal government is also beginning to push the healthcare industry towards the adoption of electronic medical records (EMRs), and that initiative is attracting several prominent high-tech companies. One recent article from The Economist looks at the trend and at those who are beginning to take notice. As more and more of the public's health information goes digital, there will be an even greater demand for strict guidelines to govern the underlying technology.
As you've probably noticed, over the last few months LSIT has focused on using he risk-based approach when identifying best practices for including into the GIP Guidance Documents. The Drug Information Association (DIA) recently published an article that I thought was particularly appropriate on the subject as it relates to systems validation and part 11 compliance. They have graciously allowed us to make the article available on our website.
LSIT has exposed me to a number of thoughts and opinions from industry insiders, and one thing has become clear: the decision makers are waking up to emerging tech's potential impact on global health as well as the cost of doing business in the life sciences. As this awakening turns into action, the question will be asked more and more: can we trust these new technologies? Thanks to the work of our tireless (and brilliant) volunteers, LSIT believes the answer is "absolutely."
- Anette
Briefly:
- The Economist: From Clipboards to Keyboards
- DIA's RAMP (Risk Assessment & Mgmt. Process)
- Biotech Demystified
- Tech & Execs: Like Oil & Water? Maybe not.
- BIOCOM Survey: Industry and FDA Playing Nicely
From Clipboards to Keyboards
The Economist magazine recently weighed in on the state of technology within the healthcare industry. From the article:
You can read the full article at the magazine's website.
RAMP (Risk Assessment and Management Process): An Approach to Risk-Based Computer
System Validation and Part 11 Compliance
DIA Summary: "Risk-based computer system validation is a process many companies developed long before the August 2003 Guidance for Industry document on Part 11 Scope and Application was issued by the US Food and Drug Administration. The main differences between prior existing risk models and this guidance is the emphasis on patient and product safety, product quality, and record integrity, as required in the Part 11 Scope and Application Guidance. When computerized systems are used to collect data on which decisions are made on drug efficacy and patient safety or are used to control the quality of drug during a manufacturing process, the point of focus has to change. This article outlines a consistent and justifiable method for determining the risk of a computerized system with the emphasis on patient and product safety, product."
You can download a pdf of the full article from LSIT's web site. And a special thanks goes out to our friends at the Drug Information Association for allowing us to make it available.
Rady School Demystifies the Biotech Industry
LSIT members may be interested in an upcoming course from the UCSD Rady School of Management, "Biotech Demystified: the Science Behind the Business." The program is designed for non-scientist executives and professionals and is offered in collaboration with the UCSD's Division of Biological Sciences.
The course addresses the technical gap for many professionals interfacing with the life sciences industry with an intensive coverage of the basic sciences combined with exposure to upcoming cutting-edge technologies. To optimize the learning experience, this interactive course incorporates both laboratory and classroom components including business scenarios, case discussions and role plays. The program's faculty comprises both leading academics and industry experts, including LSIT Founder and CEO of Global Life Sciences, Howard Asher.
The course will run from June 18-21, and more information can be found here.
Tech Talk at the Top
Optimize Magazine has a good article looking at the role of CIO as a "CEO decision-support specialist," and offers some tips on being more effective in communicating technical issues with non-technical executives. You can read the article at Optimize.
