Wednesday May 16, 2012

Electronic Submission of Medical Documentation (esMD)

Digital Signature and Author of Record Pre-Discovery

Wednesday May 16, 2012

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Agenda1. Schedule and objectives2. Scope of workgroup effort3. Review of standards4. Review options as explored in other initiatives

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Schedule -- Original

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Date Objective(s)

Wednesday, May 2nd, 2012, 10 AM (Week 1)

Identify the needs of other S&I initiatives, the community at large, and esMD

Wednesday, May 9th, 2012, 10 AM(Week 2)

Conduct a survey of options applicable to the identified needs from Week 1


Identify implications and obstacles associated with the adoption of various approaches to digital authentication technologies

Schedule – Amended and Proposed

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Date Objective(s)

Wednesday, May 2nd, 2012, 10 AM (Week 1)

Identify the needs of other S&I initiatives, the community at large, and esMD


Conduct a survey of details, options and approaches to meeting the specific needs from Week 1


Continue with effort from Week 2 and start to identify operational, technical and cost issues associated with various solutions

Wednesday, May 23rd, 2012, 10 AM(Week 4) – new, stakeholder decision

Finish Week 3 effort and discuss priorities

Scope of workgroup effort1. Identity proofing2. Digital identity management 3. Encryption4. Digital signatures5. Delegation of Rights6. Author of Record

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Initiative Requirement SummaryInitiative Identify Proofing Digital Identity

ManagementSigning

(Exchange Artifact) Encryption Delegation of Rights

Author of

RecordDS4P Org/Individual Yes Yes Yes Yes Yes

Direct Project Address/Server Yes Yes YesesMD Org/Individual Yes Yes Yes Yes Yes

Healthcare Directories Org/Individual Yes Yes Yes Yes Audit?

LCC Org/Individual Yes Yes Yes Yes YesQuery Health Org/Individual Yes Yes YesTransitions of

Care Org/Individual Yes Yes Yes Yes

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Mandatory

Optional with consequences

Optional

Future Uses

Review of Standards and Solutions

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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 800-63, Electronic Authentication Guideline Version 1.0.1, September 2004• NIST SP 800-103, DRAFT An Ontology of Identity Credentials, Part I: Background and Formulation, Oct

6, 2066• ASTM E2595-07, Standard Guide for Privilege Management Infrastructure, 2007• ISO/IEC 27001:2005, Information technology-Security techniques-Information security management

systems-Requirements, 2005• ISO/IEC 27002 Information technology -- Security techniques -- Code of practice for information

security• ISO/TS 21091:2005, Health Informatics-Directory services for security, communications and

identification• ISO 21089 "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 2005• 17090-3:2008 Health informatics -- Public key infrastructure -- Part 3: Policy management of

certification authority

Additional IHE and HITSP StandardsIdentity Management

IHE PWP IETF: RFC‐2181, ‐2219, ‐2782 (DNS services)IHE PWP IETF: RFC‐2251, ‐2252, ‐2253 (LDAP)

Non-repudiationIHE XDM IETF Cryptographic Message Syntax, RFC‐2630, ‐3852 IHE DSG ISO/TS‐17090, Health Informatics, Public Key InfrastructureHITSP C26 ETSI Technical Specification TS 101 903: XML Advanced Electronic Signatures (XadES)HITSP C26 ASTM Standard Guide for Electronic Authentication of Health Care Information: # E1762‐95(2003)

Secure TransmissionIHE ATNA FIPS 197, Advanced Encryption StandardIHE 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)

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Summary DocumentsFederal Identity, Credential, and Access

Management (FICAM) Roadmap and Implementation Guidance (ID: CSD5885)

3/5/2012

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Requirements Area

Level 1 Level 2 Level 3 Level 4

Level MajorCharacteristics

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

None Single-factor Multi-factor Multi-factor; requires hard cryptographic token

Components for identity proofing

Confirmation of address, telephone number, or email 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 800-63

Note: Other security frameworks have been developed and have been used in the private sector

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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

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DEA Level 3 – Factors from 800-63 DraftKnowledge 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 factorA biometric adds to the factor count when activating a device but not when used directly

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Identity Proofing and Authentication: The Process

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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 organizations1. 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

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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 certificate3. 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 department1. 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


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


Delegation of Rights (Stakeholder)1. Who is delegating rights2. What rights are they delegating3. 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. Author2. Credentials of parent and proxy3. Patient and healthcare proxy4. Distinction between electronic and cryptographic signatures


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)

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Summary (Stakeholder)

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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

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