Electronic Submission of Medical Documentation (esMD) Digital Signature and Author of Record Pre-Discovery Wednesday May 16,

Agenda 1.Schedule and objectives 2.Scope of workgroup effort 3.Review of standards 4.Review options as explored in other initiatives 2

Schedule -- Original 3 DateObjective(s) Wednesday, May 2 nd, 2012, 10 AM (Week 1) Identify the needs of other S&I initiatives, the community at large, and esMD Wednesday, May 9 th, 2012, 10 AM (Week 2) Conduct a survey of options applicable to the identified needs from Week 1 Wednesday, May 16 th, 2012, 10 AM (Week 3) Identify implications and obstacles associated with the adoption of various approaches to digital authentication technologies

Schedule – Amended and Proposed 4 DateObjective(s) Wednesday, May 2 nd, 2012, 10 AM (Week 1) Identify the needs of other S&I initiatives, the community at large, and esMD Wednesday, May 9 th, 2012, 10 AM (Week 2) Conduct a survey of details, options and approaches to meeting the specific needs from Week 1 Wednesday, May 16 th, 2012, 10 AM (Week 3) Continue with effort from Week 2 and start to identify operational, technical and cost issues associated with various solutions Wednesday, May 23 rd, 2012, 10 AM (Week 4) – new, stakeholder decision Finish Week 3 effort and discuss priorities

Scope of workgroup effort 1.Identity proofing 2.Digital identity management 3.Encryption 4.Digital signatures 5.Delegation of Rights 6.Author of Record 5

Initiative Requirement Summary InitiativeIdentify Proofing Digital Identity Management Signing (Exchange Artifact) Encryption Delegation of Rights Author of Record DS4POrg/IndividualYes Direct ProjectAddress/ServerYes esMDOrg/IndividualYes Healthcare Directories Org/IndividualYes Audit? LCCOrg/IndividualYes Query HealthOrg/IndividualYes Transitions of Care Org/IndividualYes 6 Mandatory Optional with consequences Optional Future Uses

Review of Standards and Solutions 7 1.Applicable Standards (overview) 2.Option and approaches for –Identify proofing –Digital identity management –Encryption –Digital signatures –Delegation of rights –Author of Record Approach: Examples and then group input

Relevant Standards NIST SP , Electronic Authentication Guideline Version 1.0.1, September 2004 NIST SP , DRAFT An Ontology of Identity Credentials, Part I: Background and Formulation, Oct 6, 2066 ASTM E , Standard Guide for Privilege Management Infrastructure, 2007 ISO/IEC 27001:2005, Information technology-Security techniques-Information security management systems-Requirements, 2005 ISO/IEC Information technology -- Security techniques -- Code of practice for information security ISO/TS 21091:2005, Health Informatics-Directory services for security, communications and identification ISO "Health Informatics - Trusted End-to-End Information Flows" NIST FIPS PUB 201-1, Personal Identity Verification (PIV) of Federal Employees and Contractors, Mar 2006 OASIS, Security Assertion Markup Language (SAML) v2.0, March :2008 Health informatics -- Public key infrastructure -- Part 3: Policy management of certification authority

Additional IHE and HITSP Standards Identity Management IHE PWP IETF: RFC ‐ 2181, ‐ 2219, ‐ 2782 (DNS services) IHE PWP IETF: RFC ‐ 2251, ‐ 2252, ‐ 2253 (LDAP) Non-repudiation IHE XDM IETF Cryptographic Message Syntax, RFC ‐ 2630, ‐ 3852 IHE DSG ISO/TS ‐ 17090, Health Informatics, Public Key Infrastructure HITSP C26 ETSI Technical Specification TS : XML Advanced Electronic Signatures (XadES) HITSP C26 ASTM Standard Guide for Electronic Authentication of Health Care Information: # E1762 ‐ 95(2003) Secure Transmission IHE ATNA FIPS 197, Advanced Encryption Standard IHE ATNA FIPS PUB 180 ‐ 2 with change notice to include SHA ‐ 224. IHE ATNA IETF Transport Layer Security (TLS) Protocol: RFC 2246, RFC 3546 IHE BPPC IHE ITI ‐ TF Cross Enterprise Document Reliable Interchange (XDR) 9

Summary Documents Federal Identity, Credential, and Access Management (FICAM) Roadmap and Implementation Guidance (ID: CSD5885) 3/5/

Requirements Area Level 1Level 2Level 3Level 4 Level Major Characteristics Little or no confidence in the asserted identity’s validity Some confidence in the asserted identity’s validity High confidence in the asserted identity’s validity Provides highest practical remote network authentication assurance Authentication Token NoneSingle-factorMulti-factorMulti-factor; requires hard cryptographic token Components for identity proofing Confirmation of address, telephone number, or address of applicant Confirmation of address or telephone number in records with voice recording In-person presentation of two identifying documents with confirmation; fingerprint or photo taken Background: NIST E-Authentication Guidelines SP Note: Other security frameworks have been developed and have been used in the private sector 11

National Health Information Network Exchange Authentication performed at the Gateway (machine) level, using certificates issued at the Exchange level Gateways generally correspond to Participants (signatories to the DURSA) which may be Federal providers or agencies, IDNs, State or Regional HIOs, etc. Behind the Gateway, Participants implement authentication and express the result of authentication in SAML assertions Requirements for authentication defined at a high level in the DURSA, not otherwise standardized See background section for relevant excerpts from the DURSA 12

DEA Level 3 – Factors from Draft Knowledge Tokens –Memorized Secret Token (password) –Pre-registered Knowledge Token (favorite ice cream flavor) –Look-up Secret Token (card with number in cells) –Out of Band Token (text message to cell phone) Hard Tokens –Single Factor (SF) One Time Password (OTP) Device (SecureID fob) –Multi Factor (MF) OTP Device (OTP w/biometric unlock mechanism) –SF Cryptographic Device (FIPS verified crypto software) –MF Software Cryptographic Token (crypto software activated by password or biometric) –MF Cryptographic Device (crypto device activated by password or biometric) Stringent identity proofing requirements –e.g., requires use of federally approved credential service providers (CSPs) or certification authorities (CAs) The computer being used is not by itself a factor A biometric adds to the factor count when activating a device but not when used directly 13

Identity Proofing and Authentication: The Process 14

Identity Proofing (Stakeholder) 1.Identity proofing compatible with requirements of the federal bridge (i.e. certification authorities cross-certified with the federal bridge) 2.Numerous certificate issuers have a variety of processes for ID proofing which needs to be further explored (i.e. notaries, raised seals, stamps, Lexis Nexis) 3.Identity proofing for organizations 1.Establish a responsible party within the organization taking responsibility for the information (person with authority to bind the organization, may include physical visits to verify identify) 2.Mix between individual and organization level authorization with IHEs in various states such as Oregon and Arizona 15

Identity Management (Stakeholder) 1.Digital certificates (X509, *assertion) 2.Work-level identity management 1.Individual level: single level/one-factor (password) 2.Within the context of an organization, an individual may be certified with a lesser approach than a digital certificate 3.General Applicability of tokens/certificates 1.One or multiple certificates/tokens per organization based on specific Use Case(s)? 2.DS4P: Requirement to be able to identify the organization and departments within an organization; therefore, multiple certificates may be needed for each organization for each department 1.Individual level may be needed depending on the Use Case 16 * Indicates an item added during the meeting on 5/16

Encryption (Stakeholder) 1.Who –Author –Sending System –Third party –*Authority at source 2.What –Message (i.e.- HL7 2.x transported on MLLP) –*Routing/Header –*Transport –Metadata –Payload (if content neutral message) 3.Why –Protect from inappropriate use –Avoid tampering –*Non-repudiation 4.How –Secure transmission vehicles (VPNs) –Secure transmission protocols –*TLS (AES Encryption) –*Message and Transport Mechanisms 17 * Indicates an item added during the meeting on 5/16

Signing (Stakeholder) 1.Who –Author –Sending System –Third party –*Authority at the source 2.What –Message –Metadata –Payload (if content neutral message) –*Assertions (i.e.- SAML holder of key, piece of metadata that goes along with a message) Legal/Compliance vs. Technical 3.Why –Authenticity of a message (e.g. encrypt hash) –Authenticity of individual –As proof of identity 4.How –Operationally –Signature Artifact (characteristics) –*IHE Digital Signature Profile –*SMIME and detached signatures 18 * Indicates an item added during the meeting on 5/16

Delegation of Rights (Stakeholder) 1.Who is delegating rights 2.What rights are they delegating 3.What is the process for delegation 1.*Proxy accounts for EHRs and HIEs 4.How is the delegation used and proved to a third party –e.g. Signature/Assignment Artifact (characteristics) 5.*Considerations 1.Transcriber/Nurses’ Agent vs. Author 2.Credentials of parent and proxy 3.Patient and healthcare proxy 4.Distinction between electronic and cryptographic signatures 19 * Indicates an item added during the meeting on 5/16

Author of Record (Stakeholder) 1.Who is the Author –Contributor –Responsible party –Legal owner 2.What are they “signing” –Specific contribution –Final “document” –Assembled set of “documents” 3.Why –Verify authenticity of the content –Verify credentials of “author” –Legal proof of “author” 4.How –Operationally –Signature Artifact (characteristics) 20

Summary (Stakeholder) 21

Next Steps Do we want an additional call next week 5/23 10am EDT to continue the pre-discovery process Focus on issues and challenges Consideration for technical, cost, regulatory, implementation and operational issues 22