Nowadays, information of healthcare institutions, providers, and patients are usually communicated via mail or fax. However, this method of communication of information is slow, less secure, and costly. These drawbacks are solved by the Direct Project, a set of standards and services aimed at improving the transport of health information, for a faster, more secure, and less expensive way of exchange of information between healthcare-giving entities.
The Direct Project emphasizes on technical standards and services (and not the actual content exchanged) to facilitate easy and reliable method of communication with an aim for more advanced levels of interoperability than simple means of communication, such as paper. These technical standards and services are implemented to securely send information. In short, as stated by the Direct Project Organization (2011), “the Direct Project specifies a simple, secure, scalable, standards-based way for participants to send authenticated, encrypted health information directly to known, trusted recipients over the internet.”
Since the Direct Project allows communication of health data among health care participants, it assumes that the sender is responsible for minimum requirements before sending data. These requirements may not necessarily be handled electronically. It is even possible to share information by paper, e-mail or fax (“out of band” verification). Direct Project’s standards and services are based on the following assumptions:
- Nationwide Health Information Network Workgroup of the HIT Policy Committee shall provide the policy guidance for Direct Project Exchange. It is under the discretion of the organizations to choose the policies and practices that support their respective environments.
- Federal and State laws regarding security and privacy of protected health information must be followed by any Direct Project exchange.
- The patient’s privacy preferences must be honored at all times by the Sender and receiver, to conform to laws and policies regarding a patient’s consent.
- Both the Sender and the Receiver are fully aware of the clinical and legal requirements of sending information via out-of-band means.
- The Sender has verified of the Receiver’s address.
- Purpose of the exchange of information has are known both by the Sender and the Receiver.
- Both the Sender and the Receiver do not need any common or pre-negotiated patient identifiers, thus, there should be no expectation that a received message will automatically be matched to a patient or filed in an EHR.
Specifications of the Direct Project provide a way to communicate in a secure and encrypted way, validating the identity of the sender and ensuring authenticity and integrity of the content sent, along the way. However, these specifications do not assert that the sender or receiver has met the assumptions stated.
It should be noted that the Direct Project does not target complex scenarios, as it does not embody a model of obtaining information. Instead, the Direct Project focuses on the transport of health information. However, it does not produce inoperability when alone, as interoperability requires three perquisite predefined components:
- Transport, or the manner of sending and receiving of information;
- Content, or the structure and format of the information being exchanged; and
- Vocabulary, or the terms used within the information.
Any health-related organization or person seeking to implement simple direct electronic communications can adopt the Direct Project standards and services, sometimes to satisfy the objectives of Stage 1 Meaningful Use. Aside from health-related entities, businesses may also adopt the Direct Project for improving processes (as practice). The Direct Project can also support efficient exchange of health information for the benefit of patients and families.
The Direct project can range from certified comprehensive electronic health records (EHRs) and personal health records (PHRs), to other technology that that can communicate health information securely (e-mail client/web browser). Human interactions with data may or may not be involved on both ends of the communications, and direct messages can carry patient-specific or non-patient specific content.
There are three scenarios (or “user” stories) that can be enabled using the Direct Project’s standards and services. Priority One are stories that support the Stage 1 Meaningful Use; Priority Two are stories prioritized for early implementation but may have complex policy considerations; and Priority Three are other high priority cases. Analysis of these stories shows common patterns that are required to satisfy these stories:
- Identity of the Sender;
- Identity of the Receiver;
- The reason to deliver health information from the Sender;
- A means to separate the routing of health information from clinical content; and
- Security that establishes and verifies trust and protects the content being transferred.
An Abstract Model of the Direct Project forms the basis of its technical specification. It also provides a common ground for stakeholders to investigate the standards and services in the context of the “user stories.” This abstract model (Figure 1) introduces the concept of a Health Information Service Provider (HSIP).
The HISP is not necessarily a separate entity, but it is a logical concept that covers certain services for Direct Project exchange that may be performed by another party. As such, the model is abstract in a sense as there are other ways to implement each concept.
Technical implementation of the Direct Project involves the packaging of the message content, its security, and its means of transportation. Content is packaged by Multipurpose Internet Mail Extensions (MIME), secured by Secure MIME (S/MIME), authenticated by X.509 digital certificates, and routed through Simple Mail Transport Protocol (SMTP).
The Direct Project relates itself with other health information exchange methods in that they have an integral component of a broader national strategy to have an interconnected system. Known as the Nationwide Health Information Network, this interconnected health system is being developed for a secure, nationwide, interoperable health information infrastructure to cater providers, consumers, and other entities involved in healthcare. The Direct Project’s main goal is actually to align itself with health information exchange services based on existing Nationwide Health Information Network standards and services. Moreover, the Direct Project provides an option to change messages between senders and receivers who support different protocols.
A Health Information Organization (HIO) is not required to support the Direct Project services specifications, but it can provide capabilities which may be used by HIOs to complement existing approaches such as to implement cases that require a complementing model for their current model, and to replace or augment current communication mechanisms with the subset of Direct Project specifications.
Direct Project is an open government initiative to promote transparency, participation, and collaboration in the government, as mandated by Obama’s administration. It was started by the Office of the National Coordinator for Health Information Technology of the Department of Health and Human Services. This project provides multiple avenues for development of standards and services by organization into multiple workgroups with dedicated set of timelines and goals. The Direct Project currently has more than 200 participants from over 50 organizations, including EHR and PHR vendors, medical organizations, and HIT consultants, among others.
REFERENCES
Blue Button Plus Implementation Guide (2013). Transmitting Data Using the Direct Protocol. Accessed thru: http://bluebuttonplus.org/transmit-using-direct.html
Health Information Technology (n.d.). What is the Direct Project? Accessed thru: http://www.healthit.gov/providers-professionals/faqs/what-direct-project
The Direct Project Organization. (2011). The Direct Project Overview. Accessed thru: http://wiki.directproject.org/file/view/DirectProjectOverview.pdf.
The Direct Project Organization. (n.d). The Direct Project. Website of the Direct Project Organization: http://directproject.org/
The Office of the National Coordinator for Health Information Technology (n.d.) The Direct Project. Accessed thru: http://www.tn.gov/ehealth/forms/DirectProject.pdf
