Northrop Grumman Corporation · NYSE:NOC
Northrop Grumman — SAFE-BioPharma Association — Internet2 Presentation (April 2006)
23 slides from Northrop Grumman's conference presentation, Apr 26, 2006
Slide 1: SAFE-BioPharma Association
SAFE-BioPharma Association A Cooperative Model for Technology Enablement of Health-Related Communities by: Terry Zagar SAFE-BioPharma Core Team April 26, 2006 1 SAFE-BioPharma Association
Slide 2: What is the SAFE-BioPharma Association?
What is the SAFE-BioPharma Association? A health industry sponsored association Focused on supporting the health industry’s migration from paper to electronic transactions Built on: – Common operating policies – Digital signature & signed e-record standard (including infrastructure & practices) – Le
Slide 3: SAFE-BioPharma – the Association
SAFE-BioPharma – the Association Not for profit entity: – Issued digital signature standard in 2004 under PhRMA – Created industry association in 2005 – Not about financial return to SAFE; return delivered to members through the use of the system – Ensure open access to all within the broad healthca
Slide 4: The Business Case for a Cooperative Model in Health-Related Communities
SAFE-BioPharma Association The Business Case for a Cooperative Model In Health-Related Communities April 26, 2006 4 SAFE BioPharma Association
Slide 5: What's Wrong With a Signature on Paper?
What’s Wrong With a Signature on Paper? Signatures & signed content can be fabricated or modified – Possible to create a fabricated copy as good as, or better than, original – Possible to undetectably remove key items from medical record Growing expense – Signed record management, retrieval & storag
Slide 6: Financial Impact in Today's Environment - Biopharmaceuticals
Financial Impact in Today’s Environment - Biopharmaceuticals Industry spends > $1 billion per year on independent identity credentialing models – Over 200,000 clinical investigators sites – 1,500 contract research organizations – 1,000 university medical centers – 1,000 medical labs – Approximately
Slide 7: Financial Impact in Today's Environment – Health Care
Financial Impact in Today’s Environment – Health Care New England Journal of Medicine, 2004, et al. – Paperwork = 31% of all health costs / $500 billion in 2004 • Emergency Department: 1 hr. care / 1 hr. of paperwork • Surgery & Inpatient Acute Care: 1 hr. care / 36 min. paperwork • Skilled Nursing
Slide 8: So What's Hindering the Industry?
So What’s Hindering the Industry? Regulatory Concerns – Good clinical, lab, safety, and manufacturing practices; global digital signature requirements; privacy protection; data quality Legal Concerns – Global operations; legal liabilities; regional acceptance; intellectual property protection Trust
Slide 9: The Global Identity Challenge - Biopharmaceuticals
The Global Identity Challenge - Biopharmaceuticals EMEA Ethics Committees Biopharma EU NCA 1 1 Contract Research Orgs 4-5x user overlap EU NCA 2 Research Sites/ Biopharma Investigators 2 10x+ EU NCA n user overlap Biopharma NIH 3 MHLW Trade/supply partner(s) FDA April 26, 2006 9 SAFE BioPharma Assoc
Slide 10: The Global Identity Challenge - Healthcare
The Global Identity Challenge - Healthcare Hospital 1 RHIO 1 Hospital 2 HCN 1 Hospital 5 Lab 1 Patient 1 State/Local Health Svc 1 Physician 1 Lab 3 AHRQ Physician 2 CDC State/Local Health Svc 1 DEA Patient 2 Hospital 3 Med Ctr 1 CMS RHIO 2 Pharmacy 1 Payer 1 Lab 2 Basic recognition 2: Managing the p
Slide 11: Enter SAFE ...
Enter SAFE ... SAFE-BioPharma Association Health industry partnership to address regulatory, legal, trust, & infrastructure concerns April 26, 2006 11 SAFE BioPharma Association
Slide 12: SAFE community represents over $400B in annual revenues
SAFE Today • Small management & support team Business Members • SAFE Central Services: Partners 9 Product Certification 9 Workshops 9 Working Groups 9 Universal SAFE Signing Interface (pilot mode) Government Vendor 9 Identity Credentialing Regulators Partners (May 2006) • SAFE Bridge operational SAF
Slide 13: SAFE Participation Drivers
SAFE Participation Drivers Members Business Partners Merck, Johnson & Johnson, Abbott Labs, Labs, Investigators , CROs, Bio-Techs, AstraZeneca, Sanofi-Aventis, Bristol Manufacturing Supply Chain, Sales Myers-Squibb, Pfizer, GlaxoSmithKline, Procter & Gamble Drivers Drivers • Simplified end user expe
Slide 14: The SAFE Standard
The SAFE Standard Business Accept digitally signed – Operating Policies transactions Agree to limited liability caps – Agreements (Member, Issuer) Agree to dispute resolution – Processes process Agree to self-audit & meet SAFE requirements Technical Manage identity life cycle – Certificate
Slide 15: How the SAFE Simplifies Trust Relationships
How the SAFE Simplifies Trust Relationships Prior to today establishing trust As of today we can bridge trust and meant individual agreements reduce complexity Company A Company A Issuer Issuer Y Company F Company B Z Company F Company B SAFE Bridge SAFE Company E Company C System Company E Company
Slide 16: SAFE Directions
SAFE Directions Expanding Membership – Shared service model Æ more members = lower cost to each member – Enhances ubiquity of digital credential approach – Broaden beyond biopharmaceutical companies to all healthcare & related entities Expanding new business process opportunities – Move beyond clini
Slide 17: Using SAFE
Using SAFE April 26, 2006 17 SAFE BioPharma Association
Slide 18: Issuing SAFE Credentials
Issuing SAFE Credentials Registration of Subscriber Pr o Issuer Trusted Ide of of Issuer Agent nti ty System For Subscriber Digital File Public Certificate d Pa i gne nt Ph ss Key S eme ras re Subscriber e Ag John Jane S. Doe, MD Subscriber Hardware Agreement Token April 26, 2006 18 SAFE BioPharma A
Slide 19: Binding of Subscriber & Subscriber's Private Key
Binding of Subscriber & Subscriber’s Private Key “KV- generated & Subscriber’s SH5” protects Private Key controls via Hardware generated pass phrase Token Subscriber’s provided Public Key linked via knows to public key Subscriber issues & can revoke Public Digital Certificate Issuer’s Certification
Slide 20: Signing with a SAFE Credential
Signing with a SAFE Credential Signer: 1. Selects document to sign 2. Acknowledges SAFE signature rules 3. Provides reason for signing (if needed) 4. Inserts hardware token 5. Enters pass phrase to complete signing operation April 26, 2006 20 SAFE BioPharma Association
Slide 21: Validating a SAFE Signature
Validating a SAFE Signature Just Click On it ... Validation: Confirms Integrity of Signed Document & Validity of Signer’s Digital Certificate April 26, 2006 21 SAFE BioPharma Association
Slide 22: Becoming a SAFE Member
Becoming a SAFE Member Visit: http://www.safe-biopharma.org April 26, 2006 22 SAFE BioPharma Association
Slide 23: Questions?
Questions? April 26, 2006 23 SAFE BioPharma Association
SAFE-BioPharma Association — Internet2 Presentation (April 2006) on 6ix