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Trusting the IT within
Life & Health Sciences
LSIT Executive Briefing 30 July 2010
Guidelines
Discovery > > > The Life Sciences & Health Care Spectrum > > > Patient
Howard Asher President, CEO
Vision without execution is a day dream • • • •
Execution without Vision is a nightmare
Japanese proverb
Our vision is to safeguard public health by increasing trust in Life Sciences and Health Care Information Technology (IT) through the development of open, publicly available, best practice IT guidelines which will help organizations manage risk and adhere to optimal compliance standards.
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! The a-ha moment…
! Founded in 2003 by an initial grant from Sun Microsystems and matched by Pfizer & Novartis
! Incubated at UCSD—CONNECT
! Bylaws & Board Developed 2003/2004
! Public Debut by local San Diego TV May 2004*
! Working groups formed 2004/2005
! Global Survey conducted April through June 2005
! Grew & subdivided working groups into GIP chaptered structures
! Content development 2007 to current
! Release of new Good Informatics Practices, (GIP) Guidance Business Model white paper 8 April 2010†
* LSIT public debut video link http://www.scivee.tv/node/12332 † White Paper https://acrobat.com/#d=eRRI023Gsq51uHh8OZTWVQ 4
5 LSIT public debut video link http://www.scivee.tv/node/12332
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International Conference on Harmonisation
GaMP IEEE
CDISC ICH
HL7 Etc…
ISO • IEEE • cGLP •NIST • QSR • GALP• ICH •cGMP •NIST• ANSI • IETF • cGCP • 21 CFR 11 • OASIS • HIPAA • AER
Infrastructures • Security • API’s • Database Management• Secure Long-term Storage• Middleware • Ecosystem
current Good Informatics Practices (cGIP) Guidance
Discovery > > > The Life Sciences & Health Care Spectrum > > > Patient
LSIT References IT Standards & Best Practices
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! Business Continuity 24•7•365
! IT Governance & Compliance
! Entire IT Ecosystem Optimization
! Trusted IT Provisioning
! Data Document Retention
! Interoperability
! IT Simplicity
! Trust
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Global Survey conducted April through June 2005
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44%
62%
63%
66%
72%
72%
73%
74%
74%
0% 10% 20% 30% 40% 50% 60% 70% 80%
SOP "Autostart" for small or startup companies
Migration of legacy systems
"Massive Dataset" management
Vendor's standard development practices and methodologies
Auditing IT
Upgrading/ Replacing validated systems
Software implementation
Selection and implementation of standards and methods
Acquisition and implementation of commercial off-the-shelf applications or
systems
% That Somewhat Agree and Stongly Agree
Commercial Software
Selecting Standards and Methods
Software Implementation
Upgrading & Replacing Validated Systems
Auditing IT
Vendor’s Practices and Methods
Dataset Management
Migration of Legacy Systems
SOP for Small Companies
“Assuming your organization could be provided with clearly documented, globally-accepted (including regulatory agencies) GIP guidance, how likely would your organization be to adopt GIP specific to the following areas?”
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I. Good Informatics Practices (GIP)
II. IT Governance and Corporate IT Policy Management
III. Risk Management
IV. Training and Practices
V. Process Management
VI. Architecture
VII. Infrastructure Operations
VIII. Application Management
IX. Data Management
X. Verification and Validation
XI. Security (Defense and Countermeasures)
XII. Program and Project Management
XIII. Electronic Submissions
XIV. Computerized Machines and Instruments
XV. IT Strategy The Big 5
GIP Guidance ToC
Company Infrastructure Whole Ecosystem
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This white paper discusses the unique needs of trusted core data center services required by the heavily regulated health care and life sciences community. It shi;s the focus to trusted IT governances for all business IT services and business con<nuity over simply disaster recovery strategies. The white paper describes implementa<on mythologies and ra<onal to fully embrace Good Informa<cs Prac<ces (GIP) and ‘qualify’ the core-‐hub of the IT ecosystem.
The business value proposi<on and ROI occurs in shi;ing the IT professional applied resources from infrastructure management to IT business ini<a<ves.
Developing Good Informatics Practices to Assure Quality Governances
www.LSIT.org
Major Supporters
GIP Guidance @ the Core
Low
High
! Risk Identified & Managed ▼ Assessed & Reduced
! Variables Identified & Managed ▼ Controlled & Minimized
Risk & Variable IT Managed Systems
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LSIT Global Institute
Good Informatics Practices
GIP Guidance
LSIT’s Products
Infrastructure
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▶ Best Practices & Trusted IT Provisioning
▶ Risk-Based IT Business Systems
▶ Entire IT Ecosystem Optimization
▶ IT Governance & Compliance
▶ Business Continuity 24•7•365
▶ Data & Document Retention
▶ Verification & Validation
▶ Reference Standards
▶ Interoperability
▶ IT Simplicity
▶ Trust
▶ ROI The Big 5
GIP Guidance Document Development
Life Sciences Information Technology Global Institute www.LSIT.org
Life Sciences Information Technologies Global Institute
Developing Good Informatics Practices to Assure Quality IT Governance SM
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President Barack Obama 27 May 2009 The White House 1600 Pennsylvania Avenue NW
Washington, DC 20500
RE: Healthonomics and the Automated TeleMedicine — ATM
Dear President Obama,
The prosperity of a nation is directly related to the health
of its people
Healthy people contribute to the prosperity of a nation.
Unhealthy people deplete prosperity, or are unable to
contribute to the prosperity of a nation. We see this clearly by observing extremes at
both ends of the prosperity spectrum. First, look at deeply impoverished nations with
illnesses at the forefront of the majority of its people1. Now look at the healthiest
nations2, such as France, Italy, Japan or Singapore, who also enjoy some of the world’s
most prosperous economies.
The United States of America health care economic facts
U.S. spending for health care this year is expected to reach $2.5 trillion, a 17.6% share of
the economy, according to a CMS www.cms.hhs.gov 2009 report.
$2,500,000,000,000.oo or $2.5 trillion
The US, with 306,049,497 or 5% of the world’s population, will spend $2.5 trillion or
54% of the world’s total spend on health care. But 45.7 million people were uninsured in
2008 (as in zero health insurance) in the USA. The new number of uninsured is rapidly
rising due to unemployed and timed loss of cobra benefits.
1 The World Health Organization's, seven unhealthiest nations: Democratic Republic of the Congo,
Lesotho, Malawi, Botswana, Namibia, Zambia, Zimbabwe 2 www.who.int/en/
5 WORLDVIEW 09
A GLOBAL BIOTECHNOLOGY PERSPECTIVE!"#$%&'()
INTERNATIONAL STRATEGIES IN CHALLENGING TIMES
CUTTING-EDGE SCIENCE & TECHNOLOGY
SOCIAL & POLITICAL DIMENSIONS OF LIFE SCIENCE PROGRESS
FEATURING THE
WORLDVIEW SCORECARD
A country-by-country assessment of innovation climates across the globe
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CAN A NEW KIND OF ATM
CHANGE GLOBAL
HEALTHCARE?
70 SCIENTIFIC AMERICAN | WORLDVIEW SCIENCE & TECHNOLOGY 71
What sparked your interest in IT?
» MY INTEREST IN IT, essentially, occurred in the early eighties. In 1978, I founded Advanced Bioresearch Associates, ABA. We were helping a number of di!erent types of companies with a number of devices. One was the "rst human arti"cial heart, which came out of Stanford. #at arti"cial heart was actually in machine code. So I had to "gure out how to comfort the FDA with so$ware and hardware as it related to an arti"cial heart, which is a pretty signi"cant product as trust goes. So it really kind of brought me out of the closet of IT and really got me into the concepts of things like so$ware validation. In helping the FDA accept such technologies, I depended on a very simple word that’s guided me forevermore, and that’s trust. How do you trust the IT to do exactly what it claims it will, and—more important—that it wouldn’t harm somebody or cause a problem?
What range of issues gets impacted by trust in today’s com-putational information from biotechnology?
» IF WE TAKE A GLOBAL PERSPECTIVE and look at the global biotechnology centers, they develop around medical universities that spill out information and tech-nology and IP, intellectual property. So much of that IP is coming out of academic institutions that have used com-putational tools to characterize some of the IP. #e issue
Biomedical Information— A Matter of TrustA Q&A WITH HOWARD R. ASHER
Can a new kind of ATM change global healthcare?
Howard R. Asher, president and chief executive officer of Global Life Sciences in San Diego, Calif., not only watched, but participated in, the evolution of infor-
mation technology (IT). He started in product development at Pfizer, then Bax-ter and Bayer before founding a series of his own companies—now doing so for 30 years. During those years, Asher found that many technical advances depend on trust. Here, Worldview talks to Asher about trust in biomedical IT and how it might be enhanced. This is an edited ex-cerpt of that interview.
ILLUSTRATION BY CARMEN SEGOVIA
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Healthonomics and The Business of Life…
http://www.lsit.org/LSIT_Letter_to_President_Obama.pdf
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