Identity Management & Digital Signatures in the BioPharmaceutical Industry John Hendrix; Program Director CTST 2009
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1 Identity Management & Digital Signatures in the BioPharmaceutical Industry John Hendrix; Program Director CTST SAFE-BioPharma Association
2 Overview Conducting Business in the Electronic World Regulatory & Legal Issues Introduction to SAFE-BioPharma Association How SAFE-BioPharma Members Overcome these Hurdles Summary SAFE-BioPharma Association
3 Conducting Business in the Electronic World John Hendrix; Program Director CTST SAFE-BioPharma Association
4 Business Trends in the Biopharmaceutical Community Revolution in life sciences and medical technology: Changing the way we live Expensive, complex, geography, many players Need to improve safety, quality, development times: Paper costs must be reduced : 40% of R&D costs; 33% all healthcare costs Must look for ways to speed processes Need to improve efficiencies, reduce costs; Shift to eclinical eregulatory processes ehealthcare, e.g., UK, France, US There is a pressing need to better allocate healthcare resources to deliver more new medicines and services to patients, faster and safely SAFE-BioPharma Association
5 Business Drivers in the Electronic World Business Process Improvement Standards based Interoperate regardless of technology or vendor Identity Management Trust people s identities, how do I know who is on the other end of a transaction Establish risk based methods to confirm and authenticate identity Digitally sign documents Eliminate wet signatures Eliminate multiple user IDs & passwords Regulatory Requirements How is the ectd implemented? Legal Drivers Patent Protection Trust/Identity Management Drivers How do I know Interoperability with Business Partners and Regulators SAFE-BioPharma Association
6 Regulatory and Legal Issues John Hendrix; Program Director CTST SAFE-BioPharma Association
7 Regulatory Requirements PIPEDA Basel II EUDRALEX EU Directives US Bridge Sarbanes-Oxley HIPAA FDA 21 CFR Part 11 e-sign IDABC EU Bridge Import/Export JPKI Japan Privacy Policy alignment and consistency is essential Regulations all have an impact on your identity management strategy Conflicting regulations increase risks and costs especially depending on geography Control Frameworks: EAL, ETSI, ISO, NIST SAFE-BioPharma Association
8 E-sig & D-sig Definitions What is an Electronic Signature? Data in electronic form which is attached to or logically associated with other electronic data and which serve as a method of authentication. An electronic sound, symbol, or process, attached to or logically associated with a record and executed or adopted by a person with the intent to sign the record. What is a Digital Signature? A specific type of Electronic Signature. The Signature is based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified. Only specific digital signatures, generated under the requirements of the EU Directive will qualify as an advanced electronic signature in the EU Only advanced electronic signature are legal equivalent of handwritten signatures SAFE-BioPharma Association
9 A Comparison of Electronic and Digital Signature Features for the US and EU 2009 SAFE-BioPharma Association
10 Introduction to SAFE- BioPharma Association John Hendrix; Program Director CTST SAFE-BioPharma Association
11 Who is SAFE-BioPharma? SAFE-BioPharma is a strategic initiative of the global biopharmaceutical industry to facilitate transformation to fully electronic SAFE-BioPharma is a member-governed, not-for-profit enterprise SAFE-BioPharma standard Legal and contractual framework Bridge Trust infrastructure SAFE-BioPharma identity credentials Digital Signatures Authentication Multi-factor SAFE-BioPharma-enabled products SAFE-BioPharma-BioPharma Association Amgen - AstraZeneca - Premier BMS - GSK - Abbott Genzyme - J&J - Lilly Merck - Organon - MedNet World Pfizer - P&G - Novartis Roche - Sanofi-Aventis SAFE-BioPharma Association
12 The SAFE-BioPharma Standard The SAFE-BioPharma Standard is the Only Complete Set of Managed Business and Technical Policies, Procedures and Agreements for Digital Signing and Authentication in the Global BioPharma and Healthcare Communities to Foster Interoperability, Regulatory, and Legal Compliance Business Operating Policies Contracts Processes Technical & Identity Certificate Policy (PKI) Specifications Guidelines Agree to Accept digitally signed transactions Agree to limited liability caps Agree to dispute resolution Agree to identity assurance Agree to self-audit & meet SAFE- BioPharma requirements Identity verification Identity life cycle management Comply with referenced standards Follow security, audit & control requirements Certification SAFE-BioPharma Association
13 How SAFE-BioPharma Members Overcome These Hurdles John Hendrix; Program Director CTST SAFE-BioPharma Association
14 The SAFE-BioPharma Digital Certificate SAFE-BioPharma Association
15 SAFE-BioPharma Compliant Digital Signatures Help Members Overcome the Simple Electronic Signature Shortfalls such as SAFE- BioPharma Digital Signatures Overcome......While Enabling 1)Trust and Communication Among Members and All Stakeholders, 2) Platform/Program and Process Interoperability, 3) Regulatory and Legal Compliance, and 4) Risk Mitigation 2009 SAFE-BioPharma Association
16 Organizational Identity Management Issues Scalability Different risk factors may require different levels of certificate Differing methods of identity verification provide the ability to support multiple identity assurance levels Flexibility Two assurance levels, based on the identity verification process, and four certificate types Basic Assurance Software, Medium Assurance Software, Medium Assurance Hardware, Roaming Digital ID (Medium Assurance Software) As the level rises, so does the ability to strongly assert the identity Collaborative development and partnering opportunities Access to partner systems User name and password management Requirements for electronic submissions and electronic records Agencies establish e-submission guidance and regulations Current hybrid systems do not support Most built around scanned signatures to PDF but still require paper retention SAFE-BioPharma Association
17 Options for Flexible Use Two levels of trust: Basic Assurance for authentication Medium Assurance for trusted identity uniquely linked to authentication, digital signature and EU-qualified Three digital signing technologies: Software Hardware (zero footprint now undergoing FIPS certification) Roaming Three identity-proofing options Antecedent enterprise and on-line Trusted agent Notary including office/home notary services SAFE-BioPharma Association
18 Member Public Key Infrastructure Options Internal infrastructure Cross certified with SAFE Bridge BMS, J&J soon others Outsourced infrastructure Cross-certified with SAFE Bridge: Chosen Security Citibank IdenTrust Trans Sped Verizon Business/Cybertrust SAFE tiered services infrastructure (member-funded) External partners Regulatory uses Healthcare providers Members SAFE-BioPharma Association
19 The Global BioPharma ebusiness Challenge Ethics Committees EMEA Biopharma1 EU MS1 CRO(s) Research Sites/ Investigators Biopharma 2 Biopharma 3 EU MS2 EU MS n MHLW Trade/supply partner(s) FDA If tackled independently recipe for management nightmare SAFE-BioPharma Association
20 Simplifying Trust Cybertrust CITIGroup J&J EMEA MHRA UK Identrust SAFE- BioPharma Bridge BMS Sanofi- Aventis EU Bridge Transped Chosen France Germany HHS Netherlands AFSSAPS BfARM MEB US Federal Bridge FDA SAFE-BioPharma Association
21 SAFE-BioPharma Pilots & Implementations Abbott Organization ELN Pilots and Implementations Amgen AstraZeneca BMS CDC-MedNet-SAFE-BioPharma EMEA GSK J&J Eli Lilly Merck National Notary Association Pfizer P&G Premier Sanofi-Aventis ELN, Clinical Research Info Exchange (CRIX) ELN, esubmissions (US); Investigator Portal; Global infrastructure ELNs; Promotional material review (EU); esubmissions; alliances Cross-jurisdictional public health-disease surveillance EudraVigilance; ectds, regulatory submissions esubmissions, R&D docs; Global infrastructure 90,000+ employees; esubs; External partners; Records esubmissions ELN Digital Notary Signature ELNs; esubmissions; contracts/sows; investigator portal ELNs; contracts; HR Supplier and member contracts ELNs, esubmissions; Finance and Purchasing
22 Summary SAFE-BioPharma meets Requirements for ubiquitous IT adoption An Identity Management Trust Infrastructure Mitigate risk Secure infrastructure that ensures privacy & confidentiality Business process improvement for both industry and regulators Reduce cost Increase productivity Reduce cycle times Mandated globally accepted standards Develop Global Regulatory compliance strategy Vendor/technology neutral interoperable Legally enforceable Collaborate with Healthcare industry SAFE-BioPharma Association
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