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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