Anatomy of Direct
Session 3
April 12, 2011
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
2
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
3
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.
b.wells@direct.aclinic.org
•
•
•
•
h.elthie@direct.ahospital.org
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 e-mail communication.
4
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 e-mail 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
5
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
6
What do you need to enable Direct?
• Direct Addresses
• Security & Trust Services
• Direct Messages
• Message Transport & Delivery
7
Direct Addresses
• Direct Addresses are used to route information
– Look like email addresses
– Used only for health information exchange
b.wells@direct.aclinic.org
Endpoint
Domain
Direct Address
• An individual may have multiple Direct
addresses
8
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.)
9
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 Directformatted address
• Organization-bound certificates are stored under the Health
Domain Name
– If DNS is not supported, an alternate method must be
offered
10
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
11
Direct Messages
• Direct Messages are essentially email 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
12
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
13
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
14
SOAP, IHE and XD* Conversions
• While SMTP is the primary delivery method for Direct,
some healthcare environments have existing SOAPbased 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
15
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
16
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
17
AAFP Physicians Direct
“Direct Plus” secure online messaging for physicians in
partnership with Surescripts
Doctor-to-Doctor Information Sharing
How do doctors predominantly share patient records with other
medical professionals?
17%
Electronic
means
83%
Non-electronic
means
25%
Non-electronic
means
74%
Electronic
means
Electronic = Computer storage devices + electronic networks + email or secure messaging
Non-electronic = Fax + mail or courier + give records to patients Source: Markle Foundation
19
Patient-Doctor Information Sharing
How do doctors predominantly share patient records with patients?
5%
Electronic
means
95%
Non-electronic
means, or do not
share records
52%
Non-electronic
means, or do not
share records
47%
Electronic
means
Electronic = computer storage devices + website + email or secure messaging
Non-electronic = fax/mail or courier + paper copies + don't share records Source: Markle Foundation
20
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
21
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.
22
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)
23
More detail on HISP functionality
• A HISP must be able to assign unique Direct addresses to individuals or
organizations, e.g. johndoe@direct.sunnyfamilypractice.com.
• A HISP must be able to associate X.509 certificates with full Direct
address (e.g., johndoe@direct.sunnyfamilypractice.com) 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
email message with a valid MIME body (RFC2045, RFC2046).
24
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)
25
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)
26
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

27
Opportunity for States and HIEs
to build on and drive adoption
ONC Materials, presented to
HITSC March 29
Incorporation of
HITPC, HITSC,
and ONC policy
guidance
27
First phase
grounded in
real-world
pilot projects
implemented
by early
2011
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 -- 13 (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.
28
ONC Materials, presented to
HITSC March 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
29
ONC Materials, presented to
HITSC March 29
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
30
ONC Materials, presented to
HITSC March 29
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)
31
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.
32
MEDfx Presentation
Using Direct to Enable
Patient Centered Medical Home
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.
34
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.
35
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.)
36
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.
37
Quality of Care
• CenVaNet
– Identified high risk patients who could benefit from ongoing 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.
38
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
39
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?
40
Direct Pilot Components
MedVirginia
HISP
SMTPS
SSL
SMTP
Dominion
HISP
SMTPS
SSL
DOD
NwHIN
Solution 1
Interchang
e
CONNECTfx
Lifescape
Solution 1
Interchange
VA
Lifescape
SSA
HTTPS
MedVirginia
Portal
HTTPS
Dominion
Portal
41
Data Flow – Dominion submits
Referral Request
MedVirginia
HISP
SMTPS
SSL
SMTP
Dominion
HISP
SMTPS
SSL
DOD
NwHIN
Solution 1
Interchang
e
CONNECTfx
Lifescape
Solution 1
Interchange
VA
Lifescape
SSA
HTTPS
MedVirginia
Portal
HTTPS
Dominion
Portal
42
Data Flow – MedVirginia sends back
initial Assessment
MedVirginia
HISP
SMTPS
SSL
SMTP
Dominion
HISP
SMTPS
SSL
DOD
NwHIN
Solution 1
Interchang
e
CONNECTfx
Lifescape
Solution 1
Interchange
VA
Lifescape
SSA
HTTPS
MedVirginia
Portal
HTTPS
Dominion
Portal
43
Demo – Let’s see it work
44
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
45
Direct Project Reference
Implementation
46
Direct Project Reference Materials
• Direct Project Overview
http://wiki.directproject.org/The+Direct+Project+Overview
• Applicability Statement for Secure Health Transport
http://wiki.directproject.org/Applicability+Statement+for+Secure+Health
+Transport
• Direct Project Security Overview
http://wiki.directproject.org/Direct+Project+Security+Overview
• XDR and XDM for Direct Messaging
http://wiki.directproject.org/XDR+and+XDM+for+Direct+Messaging
47
Q&A
Poll
49