October 15, 2007

Powerful. Dependable. The Future?
By David Yeager
For The Record
Vol. 19 No. 21 P. 22

PDF Healthcare has the potential to make health information exchange more functional and convenient for physicians and patients.

Suppose you could exchange health information using a well-known, easily understood, and widely available format. Well, you can—sort of. If the PDF Healthcare working group, consisting of more than 20 companies from the healthcare and IT industries, is successful in its bid to ballot the PDF with the American Society for Testing and Materials (ASTM) International and the Association for Information and Image Management (AIIM), healthcare providers and consumers may soon be exchanging lab results, clinical histories, and even medical images in PDF, which has many in the healthcare field excited.

“There is a consensus in this industry that there has to be some form of standardization,” says Sam Bhat, cofounder and vice president of sales for eClinicalWorks. “The initiatives of CCR [continuity of care record] and some of the other organizations have generated momentum but have not been really that successful for different reasons. We feel that the organizations which have come together right now are committed to taking it to the next level and making it happen, and I think every vendor and every user in the industry understands that we need to have some type of standardization.”

The working group, which is cochaired by Intel and Adobe, decided to submit PDF Healthcare to the ASTM and the AIIM for balloting to demonstrate that it’s compatible with existing standards such as ASTM’s CCR and Health Level Seven’s Clinical Document Architecture (CDA). It is being published as a joint effort of AIIM and ASTM International. PDF Healthcare is not a new standard, however; it’s a best practices guide.

Best Practices in Health Data Exchange
“This Best Practices Guide is a reference tool that explains to anybody in the healthcare field what features and functions PDF has that are applicable for health data exchange,” says Deborah Kohn of Dak Systems Consulting. “Therefore, because PDF is a file format, it can be used as the container of the healthcare information that gets sent or received during health information exchange.”

The PDF Healthcare Best Practices Guide and a supplemental Implementation Guide are intended to explain the PDF features relevant to healthcare. “Basically, it explains that if you have images—let’s say diagnostic images—from one provider that need to be forwarded to a different provider, this is how the PDF reader and writer works today, in their most current versions, to facilitate that data exchange,” says Kohn. “In other words, this is what you should do if you have diagnostic images and you want to ‘stick those images’ in the container for sending and receiving purposes. True, a savvy healthcare computer user could pick up a copy of the most current version of PDF and figure out most of this. However, the wording in this Best Practices Guide is specifically tailored to the healthcare industry.”

“It talks about fonts. It talks about metadata. It talks about security. It really talks about the current way that PDF is used in healthcare today but providing the best practices around that,” says Steven E. Waldren, MD, director of the American Academy of Family Physicians’ (AAFP) Center for Health Information Technology. “I think that will be used quite a bit, but it won’t really change a lot of workflows or anything else. I think it will clean things up a lot and make sure that everything’s done in a standard way.”

One important aspect of health data exchange that the Best Practices Guide addresses “is exchanging data back and forth between the multiple physician organizations,” says Bhat. “[Currently,] there’s no standardization on how the information is provided, either to the patient or any other physician’s office. PDF is a format that has fared very well in the standardization process.”

Another important consideration is data security. The Best Practices Guide provides details about preventing unauthorized data exchange. “You have the ability to set up a password on the document. You also have the ability to set up permissions,” says Waldren. “You can view it, but you have to have a password to edit it, so you can lock it down in that regard. It also has the ability to embed digital signatures, and you can have an audit log that’s inside the PDF, so if you do allow a change, anybody that changes it must have a digital signature, and those changes are applied with that digital signature. We can see who edited what and [the document’s] history. So there are some robust security features within the PDF specification.”

For now, the working group is focusing on password protection and setting up document permissions, but there are other features available. “There are whole things with policy servers, PTI [permit to install] servers you could implement,” says Waldren. He also expects the working group to eventually provide detailed implementation guidance for additional, more complex security features.

How Does It Work?
One of the advantages of the PDF platform is that nearly everyone is familiar with it. “PDF is a widely used format already and a well-known format for all document management,” says Bhat. “I think that is probably one of the factors why we feel that it is going to be a successful initiative.” PDF also uses existing extensible markup language (XML) standards. “The XML standard is very well-defined in the Web industry, and I think having the XML and PDF together makes it even more powerful,” says Bhat.

According to Waldren, a data-enabled PDF utilizing XML forms architecture, which is an open specification like PDF, offers dynamic possibilities for the data container. “What it allows for is the incorporation of XML data that allows you to put a standardized data set inside a PDF,” he says, “and then it’s linked to the actual display of that data.

“What we’ve been doing—and [the reason] ASTM International and the AAFP have been really involved—is developing the ability to embed the CCR XML inside a PDF and allow the display of that,” says Waldren. “It allows you to take advantage of all those other things that we’ve kind of just started to talk about with password protection and fonts and embedding pictures and things like that.” The PDF is “able to retain the XML so that if you’re moving that around—say I put a CCR in a PDF to send to a patient—now they have the ability to open up any free reader to see that CCR document rendered as a document, and they can see their medications and their allergies,” he adds.

“Now if they take that to another physician who doesn’t have an EMR [electronic medical record], they can print it off on paper,” Waldren continues. “But if they go to a doctor who has an EMR, that EMR can suck the XML data—the CCR—out of that PDF and use that to populate their EMR. They can actually pull out [the patient’s] medication list or their problem list and add that to their record at that office. So that interoperability, the embedding of that standardized data set, is what I think is really going to be exciting about PDF Healthcare.”

Consumer-friendly
The working group envisions PDF Healthcare as a critical step in moving health information exchange to the digital world. “The intent is really to look at ways to bridge the gap as we move from paper-based to electronic healthcare,” says Rick Ratliff, chief operating officer at SureScripts. “Paper will still be needed; however, a standard approach to building the paper document where there is actually some intelligence in the document (eg, a bar code) may have some application. PDF may play a role in healthcare applications and, in particular, e-prescribing as a means of transitioning from paper to 100% electronic care.”

But e-prescribing is only part of the picture. One of the working group’s goals is to put the healthcare provider and the consumer at the center of the process. To that end, PDF Healthcare has the potential to make EMRs and personal health records (PHRs) more functional and convenient. “Instead of my hospital, with some or all of its medical record in a digital format, having to print the documents to hard copy and then postal mail the hard copies to me for my PHR, I’m going to ask the hospital if they plan on using the PDF Healthcare Best Practices Guide so I can just receive the documents electronically,” says Kohn. “That way, I don’t have to worry about security or storing the paper. I can keep the documents on my computer, and if I want to then send them off to another provider, I will do this electronically, too.”

“Not a lot of recipients of a CCR realize, when we use the CCR, the underpinnings behind what you see on the screen is XML,” says Stasia Kahn, MD, the regional health information organization developer of the Northern Illinois Physicians for Connectivity. “A benefit of sending a PDF based on the CCR is that the XML is interoperable with both EHRs [electronic health records] and PHRs, especially since now I might be sending it to patients as well as other providers.

“I’m currently using the CCR as a referral to other consultants that my patient might be seeing,” says Kahn. “They can receive it electronically, and it’s secure and private. They can, if they would like, just print a copy of it. They could view it on the computer screen, or if they really wanted to, they could import it into their electronic medical record. The advantage that PDF Healthcare adds to the CCR, from my standpoint, is that it allows me to attach images to that record. For example, if I’m sending a patient to the cardiologist and the EKG [electrocardiogram] is really important, it allows me to attach that EKG.”

Additionally, Kahn believes it can increase the depth of physician/patient communications. “If I’m sending it to a patient, which is what I see as another really advanced capability that I would like to start doing with this new format,” she says, “I could actually make a CCR for my own patient, add to it those documents that I think that patient should carry around with them, and then allow the patient access to it. And so PDF Healthcare allows me to add another layer to the CCR.”

Challenges
Despite PDF Healthcare’s rosy outlook, hurdles remain. “I think the resistance that we get is people’s limited understanding of PDF, thinking that it’s just a display format for a document and not understanding the functionality that’s provided by the specification and the things that you can do,” says Waldren. “And also with [all the] harmonization stuff that’s going on currently in healthcare, how does this harmonize with all of the other different standards that are out there?

“And then I think there are also some issues around, ‘Well, what about healthcare? Isn’t it special? Aren’t there some special things about healthcare that we couldn’t leverage something outside of healthcare and really not need to define our own?’”

While there may be concerns about harmonization or healthcare’s special status, PDF Healthcare is moving forward. The working group is addressing the negative comments that have been put forward during the balloting process and believes the final outcome will be a better product. “We’re in the process now of talking to the negative balloters, and some of their comments have been very constructive,” says Kohn. “It’s a third pair of eyes, which is always good.”

Once the balloting process is concluded, the Best Practices Guide and supplemental Implementation Guide will be published.

What’s Next?
Although the members of the working group believe the balloting process is nearly complete, no one can say for sure when it will end. According to Waldren, the working group has spoken to more than one half of the negative balloters, and he reports that nearly all their issues have been addressed. “We’ll have to see what happens in the next set of those negative balloters, see what their issues are, and if they’re solvable by clarifications of the Best Practices Guide,” he says. “If so, then we’re good to go. If not, then we’ll need to send those changes back out to ballot. So we suspect we’ll be [finished], hopefully, in the next couple of months.”

In many ways, some of the large hurdles have already been cleared. “I think we probably encountered some of the challenges in the earlier standardizations because of different oppositions, and we did not have bigger players in the picture,” says Bhat. “I think some of those issues are not coming up since we partnered with [some] well-known organizations, including Harvard University and some of the well-known institutions [joining] this initiative.” Bhat believes that once the Best Practices Guide is published, PDF Healthcare will gain a wider acceptance within 12 to 18 months.

Kahn, who is currently working on a PDF Healthcare pilot program in Illinois, does not intend to wait that long. “There are always drawbacks to being the first, and trying to work out all the details and all the kinks and things like that,” she says. “But then, I think that’s always exciting, too, to be on the forefront of something. I think it’s a great addition to what physicians have to communicate electronically with providers and patients. I’m ready to embrace it and hopefully start sending them out and show that it can be done.”

— David Yeager is an editorial assistant at For The Record.

Resources
Association for Information and Image Management (AIIM) — PDF Healthcare

AIIM — PDF Healthcare FAQ

Northern Illinois Physicians for Connectivity — PDF Healthcare Overview