1. Anatomy of Direct Session 3
April 12, 2011

2. Agenda Overview of Direct How does Direct work?
Direct in the Real World
Panelists:
David C. Kibbe, MD MBA, Senior Advisor, American Academy of Family Physicians; Chair, ASTM International  E31Technical Committee on Healthcare Informatics; Principal, The Kibbe Group LLC 
Cris Ross, Executive Vice President and General Manager, Clinical Interoperability, Surescripts
Mark Bamberg, VP Research & Development, MEDfx
Q&A
Poll

3. What is Direct?
A project to create the set of standards and services that, with a policy framework, enable simple, directed, routed, scalable transport over the Internet to be used for secure and meaningful exchange between known participants in support of meaningful use

4. Secure Internet-based Direct Communications
Direct Project specifies a simple, secure, scalable, standards-based way for participants to send encrypted health information directly to known, trusted recipients over the Internet.
Simple. Connects healthcare stakeholders through universal addressing using simple push of information.
Secure. Users can easily verify messages are complete and not tampered with in travel.
Scalable. Enables Internet scale with no need for central network authority.
Standards-based. Built on common Internet standards for secure communication.

5. When current methods of health information exchange are inadequate:
Why Direct?
When current methods of health information exchange are inadequate:
Communication of health information among providers and patients still mainly relies on mail or fax
Slow, inconvenient, expensive
Health information and history is lost or hard to find in paper charts
Current forms of electronic communication may not be secure
Encryption features of off-the-shelf clients not often used in healthcare communications today
Physicians need to transport and share clinical content electronically in order to satisfy Stage 1 Meaningful Use requirements.
Need to meet physicians where they are now
Direct will be one of the communication methods in the Nationwide Health Information Network

6. Who is Direct? (as of November 2010)
The Direct Project represents over 50 organizations and over 200 participants.
Members participate in the Implementation Group and one or more of 6 workgroups.
Implementation Group
(50+ organizations, 200+ participants)
Security and Trust
Best Practices
Implementation Geographies
Communications
Documentation
and Testing
Reference Implementation

7. What do you need to enable Direct?
Direct Addresses
Security & Trust Services
Direct Messages
Message Transport & Delivery
Need a way to route information to the right party. That’s where Direct addresses come in.
Need a way to protect that information when you send it – Security & Trust Services.
Need to be able to build a Direct Message that contains the health information you want to send.
Finally, need a way to move that message.

8. Direct Addresses Direct Addresses are used to route information
Look like addresses
Used only for health information exchange
An individual may have multiple Direct addresses
Endpoint
Domain
Direct Address

9. Security & Trust: Certificates
Each Direct Address must have at least one digital certificate associated with it in order to securely transmit and receive health information
Certificate may be tied to either the specific Direct Address or the Domain that is part of that address
X.509v3 digital certificate standards
By using certificates to securely transmit and receive information…
The Sender has a strong mathematical certainty that only the Receiver or explicitly authorized delegates can view the message
The Receiver has a strong mathematical certainty that only the Sender sent the message
Both Sender and Receiver have confidence that nothing happened to the message in transit (e.g., tampering, disclosure, etc.)

10. Security & Trust: Certificate Discovery
Certificate discovery must occur prior to a Direct message being sent in order to fulfill the encryption functions of the S/MIME format
Discovery based on existing Internet protocols
Existing specifications exist for discovery via DNS
Address-bound certificates must be associated with a Direct-formatted address
Organization-bound certificates are stored under the Health Domain Name
If DNS is not supported, an alternate method must be offered

11. Security & Trust: Trust Anchors
Certificates are issued by Trust Anchors
Trust Anchors are Certificate Authorities (CAs)
Certificates are issued to parties that agree to abide by policies set and/or enforced by the Trust Anchor

12. Direct Messages
Direct Messages are essentially messages (RFC 5322)
Headers
Contents – text plus attachments
Security information – signatures, certificate information as applicable
Contents can be (and often are) structured, but can be unstructured
HL7 lab results
CCD, CCR
PDF, TIFF
Text and other human-readable representations
IHE XDM specifications

13. Message Transport & Delivery
Direct specifies Simple Mail Transport Protocol (SMTP) as its primary mechanism for delivering healthcare content from a sender to a receiver
This choice supports environments that have minimal capabilities in terms of using Web Services and generating detailed metadata and allows for more advanced interoperability

14. Direct Project Compliance
Compliance is defined in the Applicability Statement for Secure Health Transport
Core set of requirements for using SMTP, S/MIME, and X509 certificates in an interoperable way
However, it’s recognized that communities may use other standards or proprietary mechanisms internally
Will generally have Direct-compliant gateways that implement the Applicability specification while harmonizing local standards/mechanisms to Direct-equivalents
XDR and XDM for Direct Messaging specifies such a solution when using IHE XDR for local transport

15. SOAP, IHE and XD* Conversions
While SMTP is the primary delivery method for Direct, some healthcare environments have existing SOAP-based Web Services that provide detailed metadata and have adopted a family of IHE profiles
SOAP – format for exchanging structured information, based on XML for message format
XDR and XDM for Direct Messaging
XDR – supports a direct push model using Web Services transport
XDM – supports a direct push model with SMTP as a transport option, among several
XD* Conversion
Enables interoperability between Direct participants who may be using SOAP+XDR, SMTP+XDM, or SMTP+MIME

16. XD* Conversion Processes
XD* Conversion involves both transport and metadata
Always occurs when moving between transport mechanisms
Metadata may be created or transformed
Three cases each for Senders and Receivers:
SMTP+nonXDM (RFC5322+MIME)
SMTP+XDM (RFC5322+XDM)
SOAP+XDR

17. Direct in the Real World
AAFP Physicians Direct
David C. Kibbe, MD MBA, Senior Advisor, American Academy of Family Physicians; Chair, ASTM International E31Technical Committee on Healthcare Informatics; Principal, The Kibbe Group LLC
Cris Ross, Executive Vice President and General Manager, Clinical Interoperability, Surescripts
MEDfx
Mark Bamberg, VP Research & Development, MEDfx

18. AAFP Physicians Direct
“Direct Plus” secure online messaging for physicians in partnership with Surescripts

19. Doctor-to-Doctor Information Sharing
How do doctors predominantly share patient records with other medical professionals?
17% Electronic means
25% Non-electronic means
Q1a. How do you predominantly share patient records with other medical professionals who provide care for your patients outside your office/hospital?
Currently
Use electronic means 17%
Use non-electronic means 83%
Electronic = Computer storage devices + electronic networks + or secure messaging
Non-electronic = Fax + U.S. mail or courier + give records to patients (4%)
Q1b. How would you prefer to share patient medical records with other medical professionals who provide care for your patients outside your office/hospital?
Prefer
Use electronic means 74%
Use non-electronic means 25%
Non-electronic = Fax + U.S. mail or courier + give records to patients (2%)
74% Electronic means
83% Non-electronic means
Electronic = Computer storage devices + electronic networks + or secure messaging
Non-electronic = Fax + mail or courier + give records to patients Source: Markle Foundation

20. Patient-Doctor Information Sharing
How do doctors predominantly share patient records with patients?
5% Electronic means
52% Non-electronic means, or do not share records
47% Electronic means
95% Non-electronic means, or do not share records
Q1c. How do you predominantly share patient records with patients?
Currently
Use electronic means 5%
Use non-electronic means 95%
Electronic = Computer storage devices + website + or secure messaging
Non-electronic = Fax/U.S. mail or courier + paper copies + don't share records (8%)
Q1d. How would you prefer to predominantly share patient records with patients?
Prefer
Use electronic means 47%
Use non-electronic means 52%
Electronic = Computer storage devices + website + or secure messaging
Non-electronic = Fax/U.S. mail or courier + paper copies + don't share records (7%)
Electronic = computer storage devices + website + or secure messaging
Non-electronic = fax/mail or courier + paper copies + don't share records Source: Markle Foundation

21. Agenda A brief overview of Direct-compliant implementations
What does having a Direct address mean? What can you do with it? What basic service or infrastructure must a Direct addressee have available to her to do Direct-compliant clinical messaging?
What is a HISP? What does the Direct Project specify that a HISP must do in order to offer Direct-compliant clinical messaging functionality to its users, members, or subscribers?
AAFP Physicians Direct via the Surescripts CI Network
Why did the AAFP choose to partner with Surescripts to bring its members a national, secure, and affordable clinical messaging service?
What are the differences between Direct-compliance and what we are calling a “Direct-plus” clinical messaging solution

22. means you can can send authenticated and encrypted health information
What will having a Direct address mean for me?
Therefore, one answer to this question is that having a Direct address
means you can can send authenticated and encrypted health information
directly to a known and trusted recipient over the Internet.

23. What’s a HISP?
In brief, the essence of a HISP’s duties are to:
Package message content using MIME and, optionally, XDM.
Secure the confidentiality and integrity of the content by handling it through S/MIME encryption and signatures.
Ensure the authenticity of the sender and receiver via X.509 certificates.
Route messages through at minimum SMTP (other protocols allowed by
mutual consent between HISPs)

24. More detail on HISP functionality
A HISP must be able to assign unique Direct addresses to individuals or organizations, e.g.
A HISP must be able to associate X.509 certificates with full Direct address (e.g., or Health Domain Names (e.g., direct.sunnyfamilypractice.com). The HISP may issue the certificates itself as a Certificate Authority (CA) or obtain the certificates from a trusted third-party CA.
A HISP must provide an “edge” or “on-ramp” protocol or application/protocol combination to the user, for sending and receiving messages and attachments. The protocol must comply with a minimum set of privacy and security requirements for protection of PHI. (What are these?)
A HISP must be able to format the “payload” as an RFC5322-compliant message with a valid MIME body (RFC2045, RFC2046).

25. More detail on HISPs, continued
A HISP must be able to sign, encrypt, decrypt, and verify the payload using S/MIME.
A HISP must have a method for discovering the certificates of message recipients prior to sending a message, in order to fulfill the encryption functions of S/MIME. (TBD)
A HISP must be able to judge the trustworthiness of certificates issued by Certificate Authorities that are presented to it in the course of sending and receiving messages. ((TBD)
A HISP must be able to judge the trustworthiness of leaf certificates used as trust anchors. (TBD)

26. More detail on HISPs, continued
In addition to these requirements, it is optional that a HISP
Support certificate publication in a directory that is available to other HISPs. (TBD)
Utilize DNS servers to store both the users’ Direct addresses and the certificates associated with them (public key only). (TBD)

27. Context - governance
Direct standards and specifications are developed by a group of public-private stakeholders, using an open and transparent collaborative process.
Direct Project Output:
Standards and Service Definitions
Implementation Guides
Reference Implementation
Pilot project testing and real-world implementation
Vendors incorporate reference implementation into HIT products
Wide-scale adoption of Direct standards by late 2012
Opportunity for States and HIEs to build on and drive adoption
First phase grounded in real-world pilot projects implemented by early 2011
Incorporation of HITPC, HITSC, and ONC policy guidance
ONC Materials, presented to HITSC March 29 27

28. Context - NwHIN Nationwide Health Information Network Exchange (NwHIN)
10 Current Exchange Participants
DoD Kaiser Permanente
VA Regenstrief Institute
SSA HealthBridge
CDC Inland Northwest Health Services
MedVA NCHICA
Active Onboarding applicants
Qualification -- 9 (Beacon Community, State HIEs and CMS and their partners)
Validation (7 SSA Awardees, 3 Beacon Community and 3 State HIEs)
Activation -- 5 (5 SSA Awardees)
Inquiries received: 14 (combination of State HIEs, Beacon Community awardees and others)
HITECH obligates ONC to establish a governance mechanism for the nationwide health information network. ONC is initiating rulemaking process, with notice of proposed rulemaking expected in fourth quarter of 2011.
ONC Materials, presented to HITSC March 29

29. Context - Connect Ongoing Release cycles and development
CONNECT 2.5 released February 2011
CONNECT 3.2 to be released in June 2011
Additional Updates
Building an automated test environment for organizations to better test their CONNECT installations to be able to share data securely with other organizations using Nationwide Health Information Network standards
Expecting to award new development contract within next month
ONC remains committed to establishing modular implementation specifications and robust testing to assure interoperability
ONC Materials, presented to HITSC March 29

30. Context – look ahead to Stage 2/3 MU
Need to explore “low regret” standards for future information exchange needs to support innovation and a learning healthcare system
Candidates include:
Synchronous secure transport (e.g., SOAP + TLS + WS-Security and HTTP + TLS + OAuth2)
Subset of current NWHIN specifications for exchange
Metadata for a universal exchange language derived from existing exchange standards
Distributed queries to support risk adjustment, quality reporting, public health
ONC Materials, presented to HITSC March 29

31. Implementation example: Surescripts
Surescripts extending network beyond e-prescribing to doctor-to-doctor exchange of messages
Will connect to EHR vendors using interfaces similar to e-prescribing
Directories, certification, security and privacy, vendor and user support
Internet portal and “send to anyone”, including HISPs
Will leverage Direct protocols (e.g. hospital lab to public health connection, connect to HISPs)
Will leverage Exchange, Connect and standards as developed
Provide interoperability regardless of technology platform or protocol
“Direct Plus”
Direct and connection to other protocols
Direct augmented with additional services (directory, certification, support)

32. Physicians Direct Description
AAFP Physicians Direct is an information service, offered in partnership with Surescripts, which will provide users and their colleagues secure, affordable, and easy-to-use electronic clinical messaging. Use of the service to exchange health data among physicians will improve continuity of care, support achievement of Meaningful Use, and advance the patient-centered medical home. AAFP Physicians Direct will provide a web-based portal for subscribers to securely send and receive messages and attachments, and the portal will be branded as an AAFP service. Colleagues (consultants) will be urged to subscribe to the portal, and to use AAFP Physicians Direct to send and receive messages from users. Integration with EHRs will also be part of the offering in time, and the plan is to have at least 6 EHR vendors onboard at the launch of the project. A key attribute of AAFP Physicians Direct is that users will be able to securely message to any provider, including non-subscribers. However, for ease of use it is likely that these one-time sessions will induce the receiving consultants to subscribe and become part of the network.

33. Patient Centered Medical Home
MEDfx Presentation
Using Direct to Enable
Patient Centered Medical Home

34. Background Dominion Medical Associates
Is an independent, minority physician practice located in Richmond, Virginia.
Has traditionally been a paper-based practice
Is in the process of moving toward use of an EMR
MedVirginia
CenVaNet and MedVirginia are working with the practice to help in its achievement of recognition as a Level 3 NCQA Patient Centered Medical Home
Objectives
Utilize the Direct Project standards and transactions to facilitate the referral process
Improving care management and coordination services for identified high risk chronic disease populations, including diabetes.

35. Patient Centered Medical Home
Is a model of care that puts the needs of the patient first.
Is the base from which health care services are coordinated to provide the most effective and efficient care to the patient.
This includes
Use of health information technology
Coordination of specialty and inpatient care
Providing preventive services through
through health promotion
disease management and prevention
health maintenance
behavioral health services
patient education
diagnosis and treatment of acute and chronic illnesses.

36. Dominion Medical Associates Goal
Achieve Level 3 PCMH status as defined by NCQA.
Care coordination and chronic disease management are integral to meeting the requirements
CenVaNet is providing Dominion Medical Associates with RN care managers to support the needs of the high-risk patients with chronic diseases
Care managers provide
Direct services to targeted patients
Coordinate additional support (community resources, referral coordination, etc.)
Dominion Medical Associates’ goal is to achieve Level 3 PCMH status as defined by NCQA.
Care coordination and chronic disease management are integral to meeting the requirements
CenVaNet is providing Dominion Medical Associates with RN care managers to support the needs of the high-risk patients with chronic diseases
Care managers provide
Direct services to targeted patients
Coordinate additional support (community resources, referral coordination, etc.)

37. Quality of Care Today Physicians at Dominion Medical Associates
Attend to the needs of approximately 6000 patients
Have two office locations in Richmond, Virginia
Employ certified medical assistants
Care is episodic and acute
Usually provided in response to an event as opposed to being proactive in nature.
Patients are seen when they are sick, with instructions for follow-up or on-going personal management.

38. Quality of Care CenVaNet
Identified high risk patients who could benefit from on-going care management support.
Information about these patients is documented on the referral form and uploaded into Lifescape by a Dominion staff member at the practice.
This is transmitted to the CenVaNet care manager who retrieves the document and begins the assessment process.
Using MedVirginia Solution the care management nurse has access to any CCD information on these patients to aid in their assessment and intervention.

39. With Direct A referral letter is generated electronically
Replaces manual process of
Printing
Creating fax coversheet
Faxing to MedVirginia
Transmitted to MedVirginia using Lifescape Portal via Direct
Stored in Clinical Data Repository
Used by CenVaNet nurse to create an Initial Assessment

40. What makes it work? What are the components?
How do the component interact?
When Dominion submits a referral request
When MedVirginia sends an Initial Assessment
What were the challenges?

41. Direct Pilot Components
MedVirginia
HISP
SMTP
Dominion
HISP
SMTPS
SSL
SMTPS
SSL
DOD
Solution 1
Interchange
Solution 1
Interchange VA
NwHIN
CONNECTfx
Lifescape
Lifescape
SSA
HTTPS
HTTPS
MedVirginia
Portal
Dominion
Portal

42. Data Flow – Dominion submits Referral Request
MedVirginia
HISP
SMTP
Dominion
HISP
SMTPS
SSL
SMTPS
SSL
DOD
Solution 1
Interchange
Solution 1
Interchange VA
NwHIN
CONNECTfx
Lifescape
Lifescape
SSA
HTTPS
HTTPS
MedVirginia
Portal
Dominion
Portal

43. Data Flow – MedVirginia sends back initial Assessment
HISP
SMTP
Dominion
HISP
SMTPS
SSL
SMTPS
SSL
DOD
Solution 1
Interchange
Solution 1
Interchange VA
NwHIN
CONNECTfx
Lifescape
Lifescape
SSA
HTTPS
HTTPS
MedVirginia
Portal
Dominion
Portal

44. Demo – Let’s see it work

45. What were the challenges?
Certificate Generation
SMTPS configuration
Identifying and locking down the HISP
Permission to open port 25 on the public internet
Configuring the HISP through an SSL tunnel
Managing external communications

46. Direct Project Reference Implementation

47. Direct Project Reference Materials
Direct Project Overview
Applicability Statement for Secure Health Transport
Direct Project Security Overview
XDR and XDM for Direct Messaging

48. Q&A

49. Poll