Direct is the First Meaningful Step toward Full Interoperability
By
Jeff Cunningham, Chief Technology Officer, ICA
Why Direct?
The Direct Project was launched in early 2010 as an open forum sponsored by the federal government
and guided by the Office of the National Coordinator for Health IT (ONC). The ONC convened numerous
public and private stakeholders to develop a simple, scalable and cost-effective solution to transport
patient health information securely to “trusted” recipients over the internet using industry-standard
technology.
At its most basic level Direct is an option to give providers a mechanism to exchange information in a
secure manner. Direct was designed to be a solution for the ongoing problem of a lack of
communication across the spectrum of care for the individual patient. Communication is the key to any
business relationship. In healthcare, communication is doubly important because it is a business built
on sensitive relationships. As patients continue to see a growing universe of providers within their
lifetimes, communication will increasingly become the essential element of effective care delivery. The
impact on the patient of poor communication is both physical and financial because it often results in
redundancies and inadequate outcomes. This primary function of Direct is a reality today and is gaining
momentum as it has become clear that healthcare reform is here to stay and that the tenets of
Meaningful Use (MU) will, in fact, become part of the daily fabric of providers nationally.
While the basic capabilities of Direct are not the final answer to pervasive clinical interoperability, they
do provide some foundational benefits:
1) An easy-to-implement technology standard that can work across a wide variety of systems and
can truly scale on a nationwide basis relatively inexpensively
2) A ubiquitous pipe to get data in and out of clinical systems, particularly those that have been
historically difficult
3) An immediate use-case to help spur adoption.
For Direct to have meaningful impact to clinical workflow across a wider range of use-cases, capabilities
that automate both ends of the pipe are critical. It is in this arena that we expect to see the next wave of
development around Direct capabilities.
The Direct Platform Now -- and in the Future
The comprehensive Direct platform of the future will consist of Direct’s foundational components –
Direct-enabled Healthcare Internet Service Provider (HISP) capabilities, Certificate Authority and
Registration Authority services, and Provider Directory capabilities, along with additional value-added
adaptors and workflow automation capabilities needed to automate one or both endpoints in a Direct
exchange.
The following diagram provides a high-level depiction of a comprehensive Direct platform of the future:
The most basic components of a Direct platform are its HISP and Provider Directory. The HISP is
responsible for encrypting and decrypting messages sent between authorized participants. These
messages may consist of free form text along with attached content. Encryption and decryption are
handled via X.509 certificates specific to each authorized organization. Additionally, HISPs need to make
the certificates available to other HISPs using standard Domain Name Systems (DNS) and Lightweight
Directory Access Protocol (LDAP) protocols. This function allows secure messaging to occur within and
across Direct providers. Also, HISPs need to be able to support “whitelisting” and “blacklisting” services
to communicate or block system abusers as well as to publish certificate revocation lists to inform other
HISPs of invalid certificates. Once all of the encryption functions are complete, the HISP transports the
message via standard secure, simple mail transport protocol (sSMTP) to the designated endpoint
address. To support the HISP, certificate authority and registration authority services are needed to
manage who is authorized to use Direct, and create or revoke the corresponding certificates.
Organizations such as Directtrust.org have developed protocols for the RA/CA functions and
corresponding certification standards. This exchange can occur within the workflow of the provider if
their electronic health record (EHR) has Direct internal messaging system functionality. If an authorized
provider does not have an EHR or their EHR is not Direct-enabled, communication can still occur through
a secure portal or an external email client respectively.
The second key component, the Provider Directory, should support the Healthcare Provider Directory
(HPD)+ protocol as defined by the EHR/health information exchange (HIE) Interoperability Workgroup,
www.interopwg.org. This standard combines Integrating the Healthcare Enterprise’s (IHE) HPD standard
protocol with the addressing needs required for Direct. It provides a common directory structure based
on LDAP and standard interoperability services such as white pages and yellow pages services. These
services are comprised of message adaptors which allow for a wider variety of connection options
(Representational State Transfer [RESTful] messaging and simple access object protocol [SOAP]) and
automation services which can create messages, validate and process payload content, and orchestrate
workflow scenarios.
The Broader Strategic Power of Direct
But Direct, coupled with innovation and ingenuity, can provide the strategic underpinning of a broad
and powerful interoperability technology. Fully integrating a Direct HISP deployment within a
strategically developed interoperability platform gives healthcare entities the opportunity to add
intelligence to the production and consumption ends of the Direct process and incorporates Direct as a
ubiquitous payload transport system to meet the complex workflow requirements of the extended
healthcare enterprise. Because many organizations are implementing a standalone version of Direct in
order to solve their immediate tactical issues, they are not reaping its full value. Only by integrating
Direct into an overall interoperability strategy will its full impact be felt.
Expanding the Core Direct Services with Edge Adaptor Services is integral for Direct to play a
transformative role in improving coordinated care. These services are comprised of message adaptors
that allow for a wider variety of connection options. In addition to the standard sSMTP protocol,
message processing protocols should include IHE’s XDR/XDM profiles, RESTful web services and
SOAP/HL7v3 web services. Additionally, alternative RESTful web services should also be available for
provider directory access in addition to the HPD+ protocols. Paired with these additional connection
options, processes that automate the creation and distribution of messages along with capabilities that
validate and process message payloads are critical to supporting automation scenarios on both ends of
the connection. For example, admission and discharge notifications could be automated by monitoring
HL7v2 admission and discharge messages and pairing it with the Direct automation service that would
identify the appropriate provider address, create a Direct message with the appropriate clinical content
attached and send the message to the appropriate providers.
Finally, it is important that Direct connections can be used to support more advanced query-response
interoperability use-cases. A cross enterprise document sharing (XDS.b) Patient Registry Bridge service
accomplishes this by allowing participants to use Direct messaging to share data with an HIE. This
service receives the Direct message, strips off the Continuity of Care Document (CCD) payload, registers
the patient or document in the Patient Registry and stores the CCD in the IHE Document Registry.
How is the Interoperable Application of Direct Being Used
Direct is rapidly becoming the go-to clinical messaging protocol nationally. Direct is all about enhancing
communications to improve care coordination and transitions. The Kansas Health Information Network
(KHIN), for example, uses Direct in a variety of critical ways. KHIN is a statewide HIE linking over 4,000
providers, numerous hospitals and clinics, and covering a broad geographical area of over 85,000 square
miles. Direct enables KHIN providers to communicate emergency department discharge information to
primary care physicians, as well as admission and discharge summaries to post-acute-care settings. It is
also being used to help coordinate chronic disease therapies by creating a communications channel for
disease management. KHIN uses Direct to coordinate acute disease therapies as well, for example to
shorten oncology diagnostic time by creating a communication channel for diagnostic evaluation where
pathologic images can be transported and auditable transactions of care can be tracked. KHIN also uses
Direct to reduce administrative burden and costs, with the goal, for example, of eliminating fax
machines across the entire enterprise. Prior to using Direct, KHIN was faxing approximately 10,000
pages of medical information a day, with an estimated 20 per cent of those faxes not reaching their
destination. Since using the Direct protocol, a return on investment was achieved in a matter of weeks
and core tenets of Meaningful Use 2 were met. Risks to HIPAA violations were also minimized.1
KHIN is also the first HIE in the country to use Direct to begin populating the Center for Disease Control’s
BioSense program sharing significant amounts of aggregated patient data to track health problems as
they arise in the state of Kansas in order to provide public health officials with the data, information and
tools they need to better prepare for and coordinate responses. The secure Direct transport standard is
assisting providers in transmitting data from EHRs and other healthcare information systems using the
Health Level 7 Clinical Document Architecture (CDA) standard for automated entry into the agency’s
safety surveillance system.2 This is part of a larger effort by the CDC to enable organizations to submit
data to the National Healthcare Safety Network to put a national public health program into place.
Central Illinois Health Information Exchange (CIHIE) is currently using Direct to improve care transitions
with the goal of reducing re-admissions and emergency department returns. Direct is improving
discharge summaries to PCPs and other post-acute care-givers; improving PCP to specialist referral
coordination and follow up; ensuring that emergency depart summaries are forwarded to follow-up
physician & PCPs and even coroners use it for timely access to cause of death.
The Iowa Health Information Network (IHIN) is using Direct to manage and improve public health with
the goal of reducing reporting burdens. They can send attachments with immunization reports using
Direct; they report on Medicaid outcomes through CCDs; and can fulfill provider requests through portal
queries. The states goal is to reduce or eliminate the manual processes associated with populating state
health reporting requirements.
1
KHIN Newsletter, various
2
“CDC will use Direct protocol for health safety network”; August 31, 2012, Mary Mosquera; Government HealthIT
And MedAllies, an HIE in the Hudson Valley area of New York, is using Direct in a pilot designed to
improve transitions of care after discharge and patient referrals to specialists. In the closed-loop referral
process, a primary care doctor sends an "order" for a consult to a specialist and receives a "result" back
from the specialist after the patient is seen--all via Direct messages. Similarly, a hospital can push a
Direct e-mail to a primary-care physician about a patient's discharge. Because two-thirds of the
physicians who belong to MedAllies have electronic health record systems, the HIE has adopted an EHRbased workflow for Direct messaging. For instance, CCDs can be sent from the Siemens EHR at Albany
Medical Center to a practice that uses Allscripts. 3
Toward a New Interoperability
Full interoperability is one of the ultimate goals in healthcare technology. Devising technologies that
interoperate with other technologies, whether those technologies are already in place or are ready to be
installed, is what will bring us what we seek: the smooth, secure, unimpeded flow of clinical information
across all care settings, organizations, geographies. Direct is NOT that final solution, but is an important
step along the way. Direct enables the transmission of secure clinical messaging regardless of where
clinicians are or what technologies they may have in place. And Direct gives us the possibility, through
the integration of more robust solutions, of becoming the core piece of a comprehensive and strategic
interoperability platform that is capable of tying large organizations and communities together. The
ONC’s bolstering and promoting of Direct is a giant step toward finally mandating a simple form of crosscultural clinical communications. The rapid uptake of this technology will only bring us closer to our goal
of giving physicians and patients the information they need, when and where they need it.
About ICA
Originating from clinical informatics solutions developed within Vanderbilt Medical Center, ICA’s stateof-the-art CareAlign® interoperability and informatics platform addresses and solves data and
communication challenges for many healthcare entities, including hospitals, IPAs, IDNs, HIEs, payers and
others. CareAlign delivers a flexible architecture to connect, collect, consume and intelligently distribute
data through Direct, IHE, HL7, and custom methods for use in EHRs, third party applications, and ICA’s
applications. CareAlign unites a wide range of information supporting analytics associated with
population health management, transitions of care communication, re-admissions reduction,
meaningful use requirements and PCMH/ACO operations. Visit www.icainformatics.com, and follow us
on Twitter, ICA HITme Blog, Facebook, LinkedIn and YouTube.
3
“HIEs discover new ways to use 'Direct Project' messaging protocol”; February 21, 2012, Ken Terry, FierceHealthIT