* In Rhode Island, some physicians who use EHRs can automatically upload a finished record to currentcare, the state's health information exchange, with the same keystrokes that saved it to the practice's database.
* In Tennessee, the VA Mountain Home Medical Center outsources its mammograms to local health systems. While almost all Veterans Affairs hospitals outsource their mammograms, Mountain Home is the only one sending its referrals and receiving reports back electronically.
* In New York, Albany Medical Center (AMC) has successfully tested a way to securely exchange electronic referrals and discharge summaries among primary care physicians, specialists, and the hospital, with data that flows seamlessly among systems from four different vendors. "It almost feels like they're all using the same EHR," says Albany's CIO George Hickman. The medical center is now exploring how to put the enhanced communications capability into daily use.
All of these information swaps, and several others now in pilot phases, are propelled by the Direct Project: secure electronic mail designed specifically for health care. The idea-simple to describe, less simple to execute, and potentially transformative-is to make HIPAA-compliant, one-to-one Internet-based communication as easy for providers, and as ubiquitous, as regular e-mail.
Using Direct Project protocols, providers could send clinical messages to one another, regardless of their location or institutional affiliation, without relying on fax machines and sneakernet (i.e., courier service). The information contained in the messages could, when appropriate and correctly formatted, slide directly into an electronic health record, a database, or any other digital receptacle without scanning or transcription.
"We've been toying with this for awhile, but we've been so busy getting EHRs to be something that's clinically usable," Hickman says. "For this to be meaningful, you have to have a critical mass of EHR users in a community. We have that critical mass and [Direct messaging] will be the next thing."
In Hickman's mind, the Albany pilot shows how seamlessly and inexpensively Direct messaging should work if it's executed correctly. "The vendors are the ones who have made the notable investment, because they had to make software changes," he says. "The investment we've made is one we had planned to make already, and it wasn't substantial. It's been mostly just smart people getting together, and doctors showing us what's clinically meaningful to them."
Four EHR vendors are participating-Allscripts, Epic, Greenway, and Siemens (AMC's vendor). They've built a capability into their software so that a primary care physician can click a "referral" button in an EHR.
The system automatically gathers the information needed for the type of specialist the referral is going to and creates a "package" that is routed using Direct-compliant protocols to MedAllies, which maintains a master directory of Direct addresses for all the physicians in the pilot.
It finds the receiving physician and sends the package to the workflow area of the doctor's EHR.
At that point, the specialist's office staff can open it, schedule the referral visit, and incorporate the patient's data into its EHR.
Once the specialist sees the patient, the system compiles the specialist's report, orders and recommendations and sends that package back through MedAllies to the referring physician, who can add the new information into the patient's record.
"This one set of transactions could markedly improve the quality of care and address a remarkable inefficiency that physicians have tolerated day in and day out, even if they have an EHR," Hickman says, referring to the current reliance on phone, fax, and traditional mail service. "Our physicians get really pumped about it."
To quote the project's own overview, "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."
Strongly encouraged by the federal government (which requires secure communications in connection with several EHR "meaningful use" criteria), the Direct Project launched March 1, 2010, as a collaboration among a coalition of providers, vendors, and state and federal agencies. The idea is to build standardized secure messaging capability into all the pieces of the health care information infrastructure.
"There are lots of ways to do secure exchanges now, but they're not very standardized and they require lots of custom work at each end," says Kevin Larsen, M.D., chief medical information officer for Hennepin County Medical Center. "The idea of the Direct Project is, let's do it one way as a country so we don't have to do that work."
The Direct Project, which began releasing final specifications in March, is an offshoot of the National Health Information Network development. It specifies widely used Internet standards: SMTP, MIME, S/MIME, and x.509 digital signatures. It also utilizes health-care-specific standards such as SOAP that are supported by Integrating the Healthcare Enterprise (IHE), the force behind the Interoperability Showcase featured at annual HIMSS meetings. "That's important because all EHR vendors have been moving to [IHE] standards over the last few years," says Leroy Jones, CIO of MedAllies, Fishkill, N.Y., which is handling the data exchange for the Albany Medical Center Direct Project pilot.
"The connection should be straightforward for a good programmer," says Pat Pope, provider relations coordinator at CareSpark, the Kingsport, Tenn.-based health information exchange that's handling the messages for the VA mammogram referral pilot mentioned earlier.
Because many aspects of Internet messaging have more than one standard in use, it was vital to narrow things down, says Doug Fridsma, M.D., director of the office of standards and interoperability for ONC. "We've heard from the industry that when we put out a standard that says you can do this or that, vendors have to be sure they can do both this and that," he says. The government doesn't want to go too far in specifying how things are done, he adds, but the Direct Project's purpose was to arrive at a consensus that the government can endorse and providers and vendors can embrace with confidence.
Though it's still early, there are promising signs. The American Academy of Family Physicians has introduced a $15/month Direct-compliant messaging service, Physicians Direct, in collaboration with Surescripts, which operates the national electronic prescribing network. David Kibbe M.D., senior advisor to the AAFP and also a participant in several Direct Project work groups, says interest among family physicians is intense. "They have EHRs, but they can't communicate with each other or anyone else." Other specialties also yearn for better methods. Kibbe's brother is a hospitalist, and communicates with outside physicians exclusively by phone and fax.
Most major EHR vendors have representatives on the various Direct Project workgroups, and at this writing 22 EHR vendors had publicly expressed some level of support.
Using Direct Project standards can eliminate the need to create custom interfaces among systems from multiple vendors, says Laura Adams, president of the Rhode Island Quality Institute, the parent of currentcare. "We wanted to build one standard for Rhode Island and get the vendors interested in embedding it into their products," she says. "It's so lightweight, cheap and easy and we can't believe it works, but it does. Now we know how we're going to get data out of EHRs and into the exchange."
Other Direct Project pilots are in progress in Texas, Connecticut, Missouri, and California.
While the Direct Project specifies how messages get from A to B, there are several aspects that still need to be worked out either locally or nationally. They include:
* Addressing. The Direct Project specifies that e-mail addresses used for Direct messages should have the same format as regular e-mail addresses. The question is whether to give users a separate address just for sending and receiving Direct messages. The New York pilot managed by MedAllies uses a dedicated addressing system, and the California test managed by HISP Redwood Mednet is considering doing the same, says project manager Will Ross.
The pilot in Texas, which is testing referral communications and lab reports, won't use a separate address. Or at least not until the participants can figure out how to incorporate them into physicians' workflow, says Hank Fanberg, director of technology advocacy at Christus Health, one of the participating providers. "We want to have the least amount of disruption possible, and any time you require more clicks to do something, it slows things down," he says. "A lot of it should be running behind the scenes."
* Trust issues. How do providers know that the address they're sending to actually belongs to the recipient? And how does the recipient know that the sender is who it appears to be? They can swap contact information "out of band"-that is, independent of the electronic communication, via phone, personal meeting, paper mail, fax, carrier pigeon-or they can use a digital certificate, as secure Web sites do. MedAllies, the HISP for the New York pilot, selected a certificate authority for all the participants to use, but CIO Leroy Jones says it's still an open question nationally.
* Workflow integration. Ideally, the provider shouldn't have to worry about, or even notice, the inner workings of secure messaging, says Will Ross of Redwood Mednet. "If a Direct message is more cumbersome to receive than a fax, that's going to be an incentive not to use it," he says. "We want to go electronic from end to end. If we can take a care plan and ship it direct [to the EHR] so they don't have to type it in, then bingo, we've hit it."
Some observers think vendors will fight attempts to standardize a hitherto proprietary function. The AAFP's Kibbe says they will adopt the Direct protocols begrudgingly. "They'd rather not, because if you and I can talk to each other as easily as we can on a telephone, regardless of who we're buying service from, then its cost has to go down."
But Rich Elmore, vice president of strategic initiatives at Allscripts, says standardization can spark innovation. He also leads the Direct Project's communication workgroup. Allscripts operates its own proprietary network, but Elmore says it's not enough. "We want to make sure we can connect with others as well," he says. "When we have control of both ends of the communication, we can do a better, deeper workflow."
Elmore says there will still be plenty of opportunities to innovate. "Any number of things are possible once you have a core transport mechanism," he says. "The Direct Project is very much like the phone system-it provides the spec for the jack, and you can plug in any gadget you want."
The ONC's Fridsma looks forward to the day when providers can send secure messages so routinely that they don't even think about it anymore.
"Most of the things in my office are successful when people stop talking about them."
Direct Project Models a New Kind of Standard Development
The development process for the Direct Project is an unusual combination of government pressure (but very little money) and industry consensus-building-the Internet itself was one such combination. It began in the 1960s as a DoD contract to develop a computer network that couldn't be easily disrupted by an enemy. As it grew, the process of coordinating the adoption of standards was taken over in the mid-1980s by the Internet Engineering Task Force. Originally a government-funded activity, it morphed into a loose confederation of volunteers who meet three times a year and otherwise communicate virtually.
The Direct Project skipped the government contract and went directly to the volunteer stage. Aside from project coordinator Arien Malec, who draws his salary from the ONC, and some support for meetings and administrative staff, the government's role has been what Malec calls an "impatient convener," pushing the vendor and user community to agree on standards. Dozens of companies and organizations donated staff time.
Malec says the Direct Project experience has already set the tone for developing other aspects of the national HIT infrastructure. "This is the right model whenever there's a national consensus on the mission and it cuts across multiple standards development organizations," he says. "Government procurement won't work, because the government is not the customer-the nation is.
"Will Ross, project manager for Redwood MedNet, Ukiah, Calif., a HISP and a Direct Project pilot site, has been donating between two and six hours a week to the project. "It's a massive breakthrough," he says.
You Might Find This Useful
If you're interested in learning more about the Direct Project, visit www.directproject.org. But allow yourself plenty of time, especially if you venture into the wiki (wiki.directproject.org), where the collaborative development effort is elaborately documented and discussed.
Delving into the "Reference Implementation Workgroup" section will eventually bring you to software available for download (either Java or C-Sharp). Some in-house time and programmer know-how is needed to make it work, says Will Ross, project manager for Redwood MedNet, Ukiah, Calif., a HISP and a Direct Project pilot site. "It's the equivalent of buying parts at Home Depot and taking them home and building something."
Another interesting page is Who's Fueling Direct? (http://directproject.org/content.php?key=getstarted⊂=vendorsupport), a list of vendors, HIEs, and various other parties supporting Direct-compliant messaging. Many of the largest EHR vendors are on the list.
The National E-health Collaborative presented a course on the Direct Project in March. Details are here: http://www.nationalehealth.org/NHIN301.aspx.
Covering new developments in health information technology involves continual dÃ©jÃ vu. Look, X is happening! It happened 10 years ago in (banking, retail, manufacturing-pick one). If it's frustrating for us as reporters, we can only imagine how HIT pros feel.
The nice thing is that when history repeats itself the way it's always doing in HIT, it's easy to predict what will happen next. Everyone knows secure messaging is an essential component of HIT infrastructure. Various vendors and health information exchanges offer it, and some forward-thinking providers have bought it, or developed their own systems. They can send messages to providers on the same system.
Prediction #1: The Direct Project (or something like it-standards-based, open-source, consensus-driven, and cheap to implement) will displace proprietary secure messaging systems the way the Internet displaced Compuserve and Prodigy (remember them?). The Internet was such an obvious improvement that life has never been the same and no sane person has ever made an argument for returning to the Old Way.
Prediction #2: Fax machines will go away when Prediction #1 comes to pass, and not before. It wasn't until the Internet replaced proprietary online services that e-mail made serious inroads on fax. It took awhile because standard e-mail is not secure and secure e-mail is a lot of trouble. Over time, most of the world has learned to live with less-than-secure e-mail because the speed and convenience so dramatically outstrip the risk. (Really, do you care if bandits learn the call-in number for your Monday meeting or obtain copies of the cute cat pictures your cousin sent you?)
Fax still dominates in health care because providers are appropriately risk-averse about personal health information. They can't afford the time and hassle to figure out secure e-mail on their own, and even if they could, there's no point unless other providers are figuring it out, too. Fax is not iron-clad against breaches-you never know who's standing at the other end-but its speed/security trade-off is the current standard. Secure, simple, inexpensive and widely available electronic messaging will change that standard, and 10 years after that, it will be hard to remember that it was ever done any other way.
What's a HISP?
The Direct Project has spawned a new acronym: HISP, or health information service provider. A HISP is a switchboard for Direct messages. The switchboard made the telephone a winner for one-to-one communication, while walkie-talkies remain a niche technology, and HISPs may play a similar key role in pushing messages among multiple providers, especially small ones that can't afford the I.T. know-how to maintain their own servers for Direct messaging.
HISPs are often health information exchanges, though they don't have to be. However, Albany Medical Center CIO George Hickman points out that secure messaging is the biggest reliable revenue-generator for HIEs, and he expects most of them to adopt Direct protocols to insure their futures. Ultimately, though, the future may be less localized. "For the sake of the health care dollar, we'd like to see this evolve, and HISPs are scalable to a large geography," he says, observing that e-prescribing is handled almost entirely through a national network, Surescripts.
Check the growing list of HISPs at www.directproject.org to see if any of your current business partners are listed in the HIE/HIO category, because they could potentially be your HISP. "You may have a HISP and not know it," says Kevin Larsen, M.D., chief medical information officer for Hennepin County (Minn.) Medical Center, which for its Direct Project pilot is contracting for HISP services from Ability (formerly VisionShare), the same company it uses for direct payments to Medicare.
What's the Story?
Though the Direct Project's objective is for anyone to be able to send any kind of message securely to anyone else, it has to start somewhere.
The Direct Project's starting points (many of them currently in pilot tests) are the specific communications listed below, which participants variously call "user stories" or "use cases."
They were selected because they're required capabilities under federal EHR meaningful use criteria and can't be easily met using existing solutions. The top dozen are:
* Primary care provider refers patient to specialist including summary care record
* Primary care provider refers patient to hospital including summary care record
* Specialist sends summary care information back to referring provider
* Hospital sends discharge information to referring provider
* Laboratory sends lab results to ordering provider
* Transaction sender receives delivery receipt
* Provider sends patient health information to the patient
* Hospital sends patient health information to the patient
* Provider sends a clinical summary of an office visit to the patient
* Hospital sends a clinical summary at discharge to the patient
* Provider sends reminder for preventive or follow-up care to the patient
* Primary care provider sends patient immunization data to public health
Various types of public health and quality reporting make up much of the second and third tier of use cases.