Innovative State

by Aneesh Chopra

  Among those tasks: downloading your own health data from a provider. That was the topic at a gathering of Internet thought leaders hosted by the Markle Foundation in New York in January 2010.33 Participants included Todd Park, then the HHS CTO; Dr. Peter Levin, the CTO of Veterans Affairs, and a former entrepreneur in the biotech and semiconductor sectors; former Google Health leader Adam Bosworth; and Professor Clay Shirky, an author and Internet scholar.

  During brainstorming, the meeting’s participants decided to use a simple text format called ASCII that, if sensibly organized, machines and people could read with equal ease. Park and Levin agreed that Veterans Affairs would serve as the test case, with Medicare to follow shortly thereafter. The VA had a head start as it had the largest consolidated network of hospitals, the largest electronics records system, and nearly a million users on its personal health records platform. “There was certainly no technical challenge to doing this,” Levin said.

  President Obama took on some of the marketing challenge himself. With everything proceeding smoothly in production, he shared the news with the Disabled Veterans of America on August 2, 2010: “Today, I can announce that for the first time ever, veterans will be able to go to the VA website, click on a simple ‘blue button,’ and download or print your personal health records so that you have them when you need them and you can share them with your doctors outside of the VA. That’s happening this fall.”

  But how many of the roughly 1.5 million veterans would use it? When asked by Eric Shinseki, the VA Secretary, Levin pulled a figure out of the air: 25,000 in the first year. “But I had no idea whether they would really want this,” Levin said. “I figured the worst case scenario is, I’m out on Pennsylvania Avenue with a clipboard, getting people to sign up.”

  No clipboard required. By October 2012, Blue Button would serve more than 1 million downloads across all of its federal agency partners—the VA, the Department of Defense (serving active duty military), and the Medicare program—under the basic premise that any American should be able to download information the government keeps on them in machine-readable form. Its popularity in the public sector inspired adoption in the private sector, and Dr. Levin would fill a role there, too, spearheading the development of the service to convening a volunteer network of private sector developers. A coalition of health insurance companies, led by UnitedHealthcare and Aetna, would offer Blue Button services for their own members as well. In September 2013, the Office of the National Coordinator (ONC) for Health IT touted another milestone: 500 partner organizations had pledged consumer access through Blue Button in order to reach 100 million Americans, nearly one-third of the population.34 Further, new privacy regulations, updating those originally mandated by the Health Insurance Portability and Accountability Act of 1996 (HIPAA), required any medical providers with electronic records on patients to offer them back to those patients in electronic form at a nominal fee.35 All of this means that the country is getting closer to honoring President Bush’s long-ago promise of providing personalized health records to everyone.

  Those measures, while important to transform the health care system, are not sufficient. So in a parallel effort, beginning in 2010, ONC would apply the “light federal approach” to how patients and caregivers could safely and securely share health information over the Internet.

  That effort began in response to Dr. Floyd “Tripp” Bradd’s testimony to the HITSC about a patient who was moving to Arizona and wanted his records forwarded electronically. After receiving that consent, Dr. Bradd was able to e-mail the records in a format that the other provider—using the same software package—could import and read. But conventional e-mail isn’t that secure. The data isn’t encrypted, and there is no way to prove the identity of the sender or receiver. Dr. Bradd challenged us to develop a safer, more secure version of e-mail.

  Two public servants teamed up to provide it. Doug Fridsma was already working inside the administration, leading standards work at the ONC. Arien Malec was taking a leave of absence from his executive position at RelayHealth to join the government on a temporary basis.

  “If there are existing standards, we say, ‘our job is done, we don’t have to do anything else,’” Fridsma said. “If people say, ‘We’ve got a big hole; this is a problem because everybody is doing it in a whole bunch of different ways,’ then we can use our convening authority to say, ‘Success is filling this gap in the standards in such a way that it works with these other things that people care about, and meets all of our policy objectives as well, but you guys have to tell us whether it solves the problem or not.’ At the end of the day, the government’s role is to convene.”

  Together, Fridsma and Malec led a new initiative called the Direct Project, aimed at developing a safe, secure, and cost-­effective method to “push” health information between providers, patients, and other stakeholders. By standardizing interfaces, the duo hoped to achieve a 90 percent reduction in the cost of exchanging laboratory results, to name just one example.

  They recognized that the road to interoperability required an incremental, thoughtful approach, with Fridsma noting that, just as people use more than one means of personal communication, cell phones, landlines, and social media, to name the most popular, “We shouldn’t expect that within health care, which is far more complicated, we should have a single way of communicating either.” Further, they recognized the critical need for all sorts of outside input. Rather than call upon contractors to construct a monolithic system that the community would accept, reject, or ignore, as had been done in the United Kingdom a few years earlier, it was more constructive to work with the community toward the standardization of the fundamental building blocks—meaning, structure, transport, security, and services—for electronic health record communications. “We turned the whole project inside out,” Fridsma said. “We created government as a platform, if you will, a way to engage the public and let them tell us what was important and then support them in accelerating their consensus to a common solution.”

  This engagement approach—consistent with what Tim O’Reilly had described as Government 2.0—also squared perfectly with lessons Malec had learned in the private sector, particularly in startup companies, “that participation drives innovation and, that in the open source software, the more you share, the more you get from the community.” Malec also believed that, since most health care is provided by the private sector and it would be writing the integrated software that pulls everything together, it needed to be part of the process. That way, the private sector would be more likely to own the responsibility for creating the solution.

  “Instead of having an approach of telling people what to do, it just seemed like the right thing would be to set a challenge, set a vision, and ask people to get involved,” Malec said. “We set a vision, a view of the world as it would look past the innovation, but that outcome would describe what happens and not how it happens. Then we got people together, gave them this big inspiring vision, and said we want you to be the ones to figure out how and to own how.”

  Malec had anticipated that perhaps a handful of hypermotivated organizations would participate in the Direct Project. That was, until he attended the annual Healthcare Information Management Systems Society meeting and got a chance to introduce the idea to tens of thousands of health IT stakeholders. “The response was overwhelming,” he said. Within a month, 90 organizations wanted to participate—and thanks to modern collaboration technologies, they could do so with just an Internet connection and the occasional conference call.

  The Direct team set up a series of wiki sites without restrictions on participation or observation. Then it elevated some participants, those with special interest in the implementation of a solution, to the status of Committed Members. Before and throughout the process, the government promoted some basic discussion guidelines (discouraging members from conducting side e-mail conversations) and even some policy parameter
s (“guard rails,” in Fridsma’s parlance) that were meant to keep the community moving forward toward solutions that, at the least, sufficiently conformed with technological and security realities to have a shot. The government was vocal, but not tyrannical. “Ultimately, we have just a single vote at the table,” Fridsma said.

  Still, the government’s steering role was significant. Even when conversations became contentious, Malec kept all parties at the table. As Sean Nolan of Microsoft noted, “Arien’s personality was key. He maintained the respect of a bunch of people that generally don’t respect each other.”

  In Malec’s view, plenty was accomplished.

  “In one year, we had progressed from nothing to ‘running code,’ real-world testing, and commitment,” Malec said, noting that 70 organizations implemented the work of the Direct Project in their products. “We had a model for every provider in the country sending secure information to every other provider in the country and every patient in the country; we had a path, a real path, to make that happen. We had enabling software that any software developer could incorporate into their products to smooth the path. And we had the process for process. We had a template for how to do this in the federal government—this new style of interaction between the federal government and private sector.”

  They had accomplished all of this at a very low marginal cost, and their work led to products that were relatively inexpensive, with a growing competitive marketplace offering unlimited Direct messaging services for less than $20 a month.

  Malec returned to RelayHealth in the summer of 2011, nine months after he had planned, and not due to any disillusionment. Rather, his time in government had reinforced his belief in its unique position to see problems from coast to coast and its capability, through a handshake with—and handoff to—the private sector, to effect positive change. A little push, a lot of support. “That’s a trick that I think government can replicate,” Malec said. “The risk of doing the wrong thing, of trying too much and getting unintended consequences, is so small—and the risk of doing the right thing and creating the right outcome is so huge—that it’s a really useful thing that government can do. And the second big idea is that when the relationship is participatory, when the relationship is open, it really does foster a sense that the government isn’t a thing, it’s what we do together.”

  The work went on after Malec’s departure. In August 2012, the ONC announced that the Direct standards would be required for the next stage of the health IT incentive program taking effect in 2014. In response, members of the Direct community took the ball, launching an independent, self-regulatory nonprofit called DirectTrust to ensure the agreed-upon standards are deployed in health IT. Essentially, the private sector was picking up where the government left off.

  As of this writing, the open government approach utilized for Direct and other health IT standards has attracted more than 500 people representing over 300 organizations, working on one or more of 10 active programs.36 This will give a head start to new startups seeking to compete in the health IT industry.

  Will the interoperability standards adopted for 2014 deliver on their promise? Will future health IT regulations result in the ultimate objective: a true “plug and play” health IT ecosystem where innovative new products and services could be distributed as easily as apps on the iPhone app store, perhaps through an API standard?

  Too soon to say. But, in May 2013, milestones were met—more than 50 percent of America’s doctors and more than 80 percent of hospitals were participating in the meaningful use incentive program.37 That represented a doubling and quadrupling, respectively, from previous participation. It appears the industry has reached a tipping point that will position the care delivery system for its most difficult chapter: achieving more with less.

  “We have done more the past two years than in the previous twenty,” Halamka said.

  Which merely means that more can be done.

  “Standards aren’t standards because we say so,” Fridsma said. “Standards are standards because people use them. The only standard you don’t have to maintain over time is the standard you never use. Standards, good ones anyway, will continue to grow and change to accommodate new use cases and new innovations that are out there.”

  Sometimes, successful innovations come at the intersection of ongoing and evolving initiatives. In this case, some combination of Blue Button and the Direct Project could eliminate extra steps for patients, and make them more likely to participate. Rather than be required to download their information onto the computer after every medical development, and then determine which parts to share with which caretakers, what if patients could simply set preferences at various points of care (whether the emergency room or the pharmacy) that would automatically route medical information to other places it should go? For instance, it is useful for a primary care physician to know not only that a patient was admitted to a hospital the previous night, but also every test that was run, every diagnosis that was made, and every medication that was prescribed while the patient was there. It is also useful for the physician to know whether the patient ever picked up a prescription. This sort of knowledge is especially valuable to address one of the health care system’s most troubling inefficiencies: nearly one in five Medicare patients discharged from a hospital is readmitted within one month, at a cost of nearly $17 billion to the government, and often due to inadequate patient follow-through, especially when it comes to taking the proper medication.

  As was the case with energy data and Green Button, all this progress in the field of health information records could not occur without that initial enabling piece—the development of a standardized method for health IT applications to send and receive Blue Button files on behalf of patients to everyone in the health care ecosystem, with security and privacy built in. That Auto Blue Button Initiative effort, again largely driven by private sector entities, would eventually be launched as Blue Button + in February of 2013.38 It would enable consumers to do everything from printing a physical copy of their records to sharing it with a third party application.

  “All of this data more or less exists in the market,” Levin said. “But getting all of it in one place, making sure your prescriptions are in the same place as your immunizations, in the same place as your radiologist images, in the same place as the last time you took antibiotics because you had a sore throat, and with all of those things now able to flow without friction between places of trust, that’s what the Auto Blue Button Initiative is all about.”

  Technical standards aren’t a sufficiently sexy topic to sneak their way into the daily senior staff briefings held in the West Wing, nor common in cocktail party conversation. Yet, someday, they might be. Look at how they were applied after President Obama announced the official end of combat operations in Iraq on August 5, 2011.

  Service members, who had spent months or years in an unforgiving conflict, would be coming home. They would need jobs. The President, citing the shockingly high unemployment rate among young veterans, called upon the private sector to provide those opportunities. Corporate executives enthusiastically raised their hands, eager to assist. But this was about more than good will or gracious gestures. The veterans would need direction in order to navigate their way through all that might be available via the competitive and expansive online job listings industry. They needed to have some idea of which listings had been set aside for them.

  There were essentially two options to assist them. We could create a single website, through government funding, which would provide places for every willing employer to post listings. That would have been the default. That, however, also would be redundant and burdensome for employers, most of which already had preferred methods for online job postings. Alternatively, we could engage the job listings industry in designing and deploying a standardized method to “tag” job listings associated with a veteran hiring commitment, regardless of the we
bsite they chose for those postings.

  We chose the latter and started our 90-day sprint for a Veterans Day launch by calling upon the experts at Schema.org, a voluntary collaboration between Google, Microsoft, and Yahoo, that tagged web pages in a way that helped users find the most relevant and specific information.39 Take recipes. Schema.org includes a recipe standard that reflects a consensus among many in the online recipes industry on the sort of information that is most useful to a cook, including cuisine type, calorie count, ingredients, and instructions.40 Any website is free to add the schema to its page, enhancing its search results on the participating search engines and inspiring customers to click through and learn more.

  This sounded like something we could simply and seamlessly apply to our project. I engaged the private sector online job listings industry to help design the schema. Figuring that veterans would need to know more about job descriptions, locations, and compensation, among other topics, we engaged a variety of stakeholders for further input before publishing the agreed-upon standard at schema.org by October 2011. That would give us a month to encourage the job listings industry to begin tagging relevant job listings with the standard before a Presidential announcement on Veterans Day.