27Feb/07

Steve Ballmer shares views on “what technology can do to positively revolutionize healthcare”

By Daniel R. Matlis

On February 26, 2007 Microsoft’s CEO, Steve Ballmer, offered his view on the role of technology in healthcare during his remarks at the Healthcare Information and Management Systems Society (HIMSS) in New Orleans, Louisiana.

He commented: “we take a look at the whole area of health and we say this is the largest segment of the world’s economy, it’s one of the fastest growing, it’s one in which information plays and will play an increasingly large role, and really the opportunities for information technology to make an incredible difference is the way and the quality of health that people have a right to pursue is stunning.” 

During his remarks, Mr. Ballmer touched the following of key issues facing the Healthcare industry:

1. The explosion in the amount of clinical data available
2. The growing  interest and opportunity for patients to participate in their own healthcare
3. The need for Healthcare providers to fully leverage automation and information technology
4. The imperative for Healthcare firms to harness technology successes from industries like Airlines, Banking and Finance
5. The need to standardize and embrace XML as the set of standard protocols
6. Information Technology industry must build the tools that will allow healthcare to advance to the next level.
7. The need for an aggregated view of patients, so that practitioners can not only look at an individual patient, but what the experience has been with groups of patients
8. The challenge to let people communicate securely in a clinical context
9. The need to centralize records, and allow the data that’s in them to be mined

“We need to see policy that really talks about cooperation, group access to information, privacy, ownership of information. That needs to continue to evolve. Standardization of healthcare records, CCR, the NHIN initiative is very important, HL7, and, of course, the work that has gone on with XML Web services needs to be continued and extended” said Ballmer.

“Service-oriented architecture is a new technology, and one that I think will be more important in this industry than in any other” Ballmer added.

To meet these challenges, Microsoft announced the release of the Connected Health Framework, a set of tools and technologies that are designed to facilitate interoperable systems and the movement of information across the Healthcare spectrum.

I am pleased to see that many of the issues discussed by Mr. Ballmer have been covered in Life-Science Panorama. It’s good to know we are on the right track.

15Feb/07

Are you ready for Virtual Clinical Trials?

By Daniel R. Matlis 

The Kaiser Permanente Northern California Division of Research announced yesterday, February 14 2007,  that it is launching one of the largest research projects in the United States to examine the genetic and environmental factors that influence common diseases such as heart disease, cancer, diabetes, high blood pressure, Alzheimer’s disease, asthma and many others.

The goal of the Kaiser Permanente Research Program on Genes, Environment and Health (RPGEH) is to discover which genes and environmental factors are linked to specific diseases.

During the Press Conference David Kessler, former commissioner of the U.S. Food and Drug Administration and current dean of the University of California at San Francisco School of Medicine (UCSF), commented: “Increasingly we are moving into a world of personalized medicine. What does that mean? Right person, right disease, right drug and right dose”

Researchers hope to explain how genes and environmental factors work together to influence the risk of getting a disease or affect its severity or outcome. The Research Program will also include studies of genetic and non-genetic factors that affect how people respond to specific medications, including the occurrence of side effects.

Cathy Schaefer, PhD, director of the RPGEH and a research scientist at the Kaiser Permanente Division of Research in Oakland, added “Our research could help us identify not only what diseases a person may be at risk for, but also identify how to reduce that risk, or how best to treat the disease. This research program provides an exciting opportunity to make significant progress toward improvements in health and medical care.”

The RPGEH initiative represents a major step towards virtual, life-long clinical trails and personalized medicine.

How?

Imagine the level of knowledge researchers and healthcare practitioners will gain from running clinical trials in-silico based on the data gathered by projects like RPGEH.

We would all benefit from safety and efficacy profiles that are orders of magnitude more precise than those available today. Product testing would shift from clinical trials run on 5-10 thousand volunteers to trials run on millions of virtual volunteers based on real people and the environmental condition surrounding them.

This level of knowledge does not come without its problems. To address security and disclosure issues, Kaiser Permanente said that participation in the RPGEH is completely voluntary. Individual’s genetic information will not be used in genetic studies without their written consent. Furthermore, no research data is stored with identifying information.

11Feb/07

Are You Ready for Y2K7

By Daniel R. Matlis

Remember Y2K?  Well, the world didn’t end, companies spent large budgets in Y2K remediation projects, and computer systems continued to function. 

Just when the memories of Y2K begin to fade, along came the government and instituted Y2K7.

What is Y2K7?

The Energy Policy Act of 2005 included a provision that extends standard daylight time (DST) from the second Sunday of March to the first Sunday of November (currently it runs from April to October).  The change goes into effect March 11, 2007, and will be implemented across the United States except for Arizona, Hawaii, Puerto Rico, the U.S. Virgin Islands, and American Samoa.

Y2K7 will impact automated and computerized systems utilizing functions including:  

  • Calendar and scheduling
  • Date and time calculations (current and historical) 
  • Transaction logs (Coordinated Universal Time vs. Local Time) 
  • Computer generated audit trails

Most enterprise application vendors are providing patches, hot fixes or service packs to address issues resulting from DST change.

Addressing Y2K7 becomes more complex when dealing with departmental, standalone and customized or homegrown applications. Real-time systems, like manufacturing automation and bench-top equipment may require more substantial efforts to address the DST change. In some cases, systems may need to be manually updated, while in others, the application may rely on the date and time from the underlying system that it resides on.

But wait, don’t start downloading patches yet. Given the broad range of technology in use in Life-Science companies today, and the level of integration between them, it is imperative to begin the process by conducting an assessment.  This assessment should identify whether systems use date and time functionality for business or compliance activities (remember, your robot does not care what time it is, it’ll keep working as long as you maintain it properly).  Based on the results of this assessment, firms should determine what actions should be taken to mitigate the affects of DST 2K7.

The biggest issue with Y2K7 is the lack of broad awareness of its impact on computerized systems. As a result, many companies have not developed or implemented action plans to address the upcoming DST change in their computerized systems.

It would be interesting see the number of date/time related helpdesk calls on March 12th. Is anyone willing to share their experience?

04Feb/07

Drug Safety Takes Center Stage in Washington DC

On September 22, 2006, the Institute of Medicine (IOM) issued a report in response to growing public concern with health risks posed by FDA approved drugs. In the report, IOM made substantive recommendations on how the FDA can improve its drug safety efforts. (See “FDA Drug Safety System Needs Fixing, IOM Report Says“)

This week, the FDA issued its own report, entitled “The Future of Drug Safety“, in response to the recommendations made by IOM. In its report, the FDA identified three key efforts to strengthen the drug safety system:

  • Strengthening the science that supports the FDA’s medical product safety system at every stage of the product life cycle from pre-market testing and development through post-market surveillance and risk management
  • Improving communication and information flow among all stakeholders engaged in promoting the safe use of medical products
  • Improving operations and management to ensure implementation of the review, analysis, consultation, and communication processes needed to strengthen the U.S. drug safety system

In addition, The FDA has made additional recommendations tied to Congress’ reauthorization of the Prescription Drug User Fee Act (PDUFA).

The Pharmaceutical Research Manufacturers Association’s (PhRMA) Deputy Vice President, Alan Goldhammer, issued the following statement on FDA’s IOM response:
“When it comes to patient safety, there is always room for improvement. But the FDA, in its IOM response, makes clear that important efforts to improve drug development and safety have been underway for years and more promising initiatives have been proposed as part of the reauthorization of PDUFA.”

However, PDUFA reauthorization may come with strings attached. Senator Edward M. Kennedy, Chairman of the Health, Education, Labor, and Pensions (HELP) Committee along with Senator Mike Enzi, HELP Committee Ranking Member, have re-introduced the “Enhancing Drug Safety and Innovation Act”. 

The issue of drug safety will be taken up by the HELP Committee in early Spring, when the committee considers the reauthorization of the Prescription Drug User Fee Act. Provisions in the Enhancing Drug Safety and Innovation Act of 2007 include:

  • Risk Evaluation and Mitigation Strategy (REMS)
  • Clinical Trials Databases
  • Establishment of the Reagan–Udall Institute for Applied Biomedical Research
  • Conflicts of Interest Disclosure

Drug Safety requires the attention of all constituents in the health care continuum. Above all, we must ensure the availability of complete and transparent information regarding drug use, interactions and side effects. 

But all these proposals are for not, if we are not proactive in our own health care. As consumers, we must remember that there are no completely safe substances, even water has side effects. Drink enough H2O and you’ll get water intoxication.

31Jan/07

FDA Moves Closer To Becoming An Information Broker

By Daniel R. Matlis

FDA Commissioner Dr. Andrew C. von Eschenbach recently announced the creation of the Office of the Chief Medical Officer. The position will be held by Dr. Janet Woodcock, a strong advocate for modernization and transformation at the FDA.

“FDA is a science-based agency and science-led Agency; science provides the foundation for our regulatory decisions and the work we do on a daily basis to promote and protect the nations’ health,” said Dr. von Eschenbach. “Creation of this office, and position, will better ensure we achieve this mission with the highest scientific quality and effectiveness needed.”

As the Deputy Commissioner and the Chief Medical Officer, Dr. Woodcock will oversee scientific and planning-related operations for FDA. In this capacity, Dr. Woodcock shares responsibility and collaboration with the Commissioner of FDA in planning, organizing, directing, staffing, coordinating, controlling, and evaluating the agency’s scientific and medical regulatory activities in order to achieve the mission of FDA.

John R. Dyer, MPH, will take Dr. Woodcock position as the agency’s Deputy Commissioner for Operations and the Chief Operating Officer (COO). Mr. Dyer will concentrate on strengthening the management, business processes, and information technology of the agency. In addition, Mr. Dyer will work with the other Deputy Commissioners and the Chief of Staff to provide management leadership and oversight to FDA.

“With almost 24 percent of the products in the marketplace regulated by FDA it is imperative we apply and incorporate modern management tools and techniques to our regulatory decisions. Mr. Dyer’s deep experience in management is ideally suited to meet the emerging challenges and opportunities involved in protecting and promoting the health of the American public in the 21st century” said Dr. von Eschenbach.

Mr. Drier brings significant experience in Information Technology to this position. From 2001-2003, Mr. Dyer worked in the private sector for information technology and executive leadership companies. In his federal career from 1972 to 2000, Mr. Dyer held increasingly responsible executive positions with the Social Security Administration (SSA), including the Chief Information Officer and Principal Deputy Commissioner where he assisted the agency by leading the effort to automate and modernize systems and improve the level of customer service.

These appointments represent an important step by the agency in implementing Dr. Woodcock stated goal to transform the FDA into an information provider as well as a regulator.