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Rucker talks ONC rules in Boston: What they mean and why they matter for innovators

A panel of innovators joined Rucker to examine the news and to invite comments in the last few days.
By Jonah Comstock
04:24 pm

Dave Schoolcraft, partner at Ogden Murphy Wallace, chats with Dr. Don Rucker, the National Coordinator for Health IT.

Even as a number of IT organizations pressed the ONC to extend the comment period, and delay the implementation, of its new data sharing and information blocking rules, a group of entrepreneurs gathered in Boston to hear National Coordinator for Health IT Don Rucker discuss those rules and their implications for the innovation community.

At the 2.5-hour event, which also included a panel of innovator perspectives, the new rules weren’t hailed as a panacea; indeed plenty of criticisms were leveled and even acknowledged by Rucker. But the assembled innovators were overwhelmingly opposed to a delay, framing the rules as a strong starting point and a crucial catalyst for much-needed changes in how the health system operates.

“I understand the health systems’ desire to delay, given the challenges,” Stead Burwell, CEO of healthcare cloud company MultiScale, said during the panel. “… As an innovator, we clearly want to drive this faster because the adoption curve is so hard and slow that we don’t want these delays.”

“The resources won’t be there unless there’s a forcing function,” added Dr. Laura Esserman, who directs the UCSF Breast Cancer Center in addition to leading the Athena Breast Health Network. “It’s going to be painful whenever the change is. So why not get it over with? This is the beginning, not the end.”

Rucker urges participation

Even with only a handful of days left to comment, Rucker implored innovators to express their opinions, alluding to the pushback from EHR vendors in the process.

“If for your business model, having a standards-based API is valuable, you should comment,” he said. “I assure you we have gotten comments from people who come up with 50 reasons they don’t want to open up their APIs. So if that is important to you, this would be the perfect and most opportune time for you to comment on that or anything else.”

Rucker acknowledged that the comment process can sometimes favor larger organizations with the resources to make extensive comments, but it’s important to have a multiplicity of voices represented.

“The stakeholder process is a problematic process, because the stakeholders we meet are the people who are in DC, people who can lobby up,” he said. “How do you keep the public in mind, the 50,000 people a month who are going bankrupt from medical costs, the people who can’t get their medical records?”

And while interoperability and information blocking can seem like daunting topics for patients, they affect them tremendously, a theme that came up repeatedly during the panel.

“Seventy-five to 80% of medical images in the US are moved on CDs today,” Life Image CEO Matthew Michela said during the panel. “Nineteen-eighties technology. And it’s not because we don’t have the technology. The technology is there.

“We need the rules, we need the influence to change practice patterns and let folks know ‘Stop doing things like producing film and CDs that cause duplicative errors, that cause poor patient care.’ Because that’s the true cost to the system of unintentional data blocking. It’s about quality care and cost. Patients are affected. They can’t get the treatment. World-renowned clinical leaders can’t make the most informed decision because they only have 80% of the information. That’s the true cost here.”

Rucker also explained that the ONC doesn’t just look at longer comments or necessarily give them more weight.

“To file a comment, you can just say one sentence,” he said. “‘I agree with this’, or ‘Do this’. You don’t have to make this a 750-page exercise. You can just say what you believe and what you want.”

What’s in these rules anyway?

The rule in question is the beginning of ONC’s implementation of some of the duties assigned in the 21st Century Cures Act, a landmark bipartisan legislation signed into law by President Obama in December 2016, shortly before he left office. But the rules also have the support of the Trump administration, Rucker said.

For entrepreneurs and innovators, there are two important upshots, he said. One is the prohibition on information blocking, a somewhat contentiously defined term that essentially says stakeholders, including hospitals and EHR vendors, can’t refuse to give each other electronic health information or make doing so unreasonably onerous.

“In Cures, information blocking is now illegal,” Rucker said. “It’s the law of the land. It’s not really been enforceable because there’s a provision that ONC needs to come up with allowable exceptions. But as we speak that is the law of the land. It was signed into law December 2016 by President Obama. The White House, president Trump, are all onboard for this.”

The second major upshot is a requirement for healthcare vendors to include standards-based APIs.

“When you look at your smartphone, the bulk of the apps on your smartphone exist because of Restful and JSON [APIs] which add a huge layer of simplicity. And you could argue that that’s what makes the smartphone app economy. If you got here with Uber or Lyft, think about all the APIs in those applications. They need a credit card API, they need a map API, they need a traffic API,” Rucker said. “APIs have transformed industry after industry. Think about all the facets of entertainment, transportation, banking, finance that have been transformed to get them on the smartphone. Congress said ‘What do we need to do, what can we do to get healthcare on a smartphone?’ and that’s what Cures is all about.”

Information blocking

Whether information blocking is happening in a premeditated or intentional way, because of perverse monetary incentives, was a point of some contention during the panel.

“I don’t believe information blocking exists,” Dr. John Halamka, executive director of the Beth Israel Lahey Health Technology Exploration Center in Boston, said. “What I mean is that, as IT professionals, we have about a billion priorities. If someone comes to me and says ‘I’m a two-doctor practice in Texas and I want to do interoperability with you, I’ll say ‘that’s great. I will put you 1001st on my list. It’s not that I don’t like you; it’s that I don’t have the bandwidth.”

But the ONC’s 2015 report on information blocking, which informs the new rules, states that “[a]vailable evidence and ONC’s experience suggest that certain business, technical, and organizational practices are inherently likely to interfere with the exchange of electronic health information in ways that raise these serious information blocking concerns.”

In his talk, Rucker mentioned one example, also involving APIs, which the Cures Act stipulate must be made available “without special effort”.

“One issue where entrepreneurs have come to us repeatedly is the vendors are charging them,” he said. “First they didn’t have an API or they refused, then they would ask for 30% of your company or your source code or your first-born child to provide a quote-unquote ‘open’ API. It’s gotten somewhat better. But we’re still hearing it’s a million dollars a pop to get access to an API and that is not ‘without special effort’. When the cost of goods there is essentially negligible.”

That sort of thing is the reason the rules have taken so long already, Rucker contends.

“Everybody has a voice and then you have to put it all together and there’s just a lot of complexity,” he said. “So how do you draw the line on what are allowable costs? We allow costs reasonably incurred and for the licensing of interoperability we allow costs that are reasonable and non-discriminatory. To try to make this practical but open to everybody.”

Whether information blocking is happening intentionally or not, UCSF’s Esserman said, enforceable rules — with penalties attached — can put an end to it.

“While I do have sympathy for the priorities people have and it’s hard, that is precisely the reason why we need these regulations,” she said. “Because if there’s no carrot and no stick, there’s going to be no change. If there’s one enforcement and someone pays a penalty, all of a sudden it’s going to be a priority.”

“I would argue we need a bigger stick and it needs to be heavier,” Michela added.

Making APIs available

The API requirement connects to the reason Rucker thinks these rules will be successful, when many years of rules aimed at interoperability have not been.

“If you’ve been in the field for 30 years or more you can’t help but have a certain skepticism and a sense of reality and observe some model of what’s been missing,” Rucker said. “So I think there’s a couple of things that have been missing and some things we now have. We have EMRs, so we have the data, which we didn’t have before. We now have adequate bandwidth, in general — though I know there are pockets that don’t, but we pretty much have the bandwidth. And I think the part that is most recent is we now have everybody with computers on their person and smartphones.”

But many in the developer community wish the API rule would go further. As written, it will stipulate that only read APIs — not those that write information back into the EHR — be made available.

Rucker defended the decision because of the additional complexity that write APIs would add.

“Figuring out the whole set of function calls to insert into an EMR or an enterprise EMR — there are literally thousands of function calls over decades,” he said. “Some of them are documented, some of them aren’t. It’s an absolute blackbox. So making a general rule, that is not technically possible.”

But the rules do start to lay the groundwork for write APIs in areas, including clinical decision support, prior authorization, and price transparency, Rucker said.

Halamka said that the EMR companies are embracing APIs — to a certain extent.

“What’s starting to happen with the CEOs is they’re recognizing unless they have an app store they’re not going to grow,” he said. “So we have More Disruption Please from Athena and Orchard form Epic and various Smart on FHIR things from Cerner, and the Greenfield from Meditech. They’re all starting to see this. Because in a sense, we’re kind of a saturated market, everyone who needs an EHR has an EHR, so the next logical place to go is apps.”

But while the EHR vendors are doing well on technical aspects, including participating in FHIR and the Argonaut project, their business models — which can make launching an app very expensive — can undermine the effectiveness of their stores.

Why the rules matter

Data-sharing can seem like an esoteric topic, but getting it right can have huge positive ramifications, panelists say.

“These rules are really important,” Burwell said. “If you care about the space you should read them. Because the way they have been written they clearly understand the challenges of interoperability [for clinicians]. And then from the patient side they’re clearly written to stimulate flow of data from the healthcare systems to the patients. So it’s landmark legislation and the rules as they’re written clearly understand the deep gaps that innovators face to benefit clinicians and ultimately patients.”

Halamka and Esserman both emphasized that current data blockages prevent the health system from learning from itself and put a stopper on the idea of evidence-based medicine. Esserman said she sees that most clearly when trying to integrate her two worlds of research and practice.

“We have a system of research and a system of clinical care and the problem is they’re completely different,” she said. “Anyone who is a practicing physician knows that we gather data many times and probably use it once. The truth is what we should be doing in clinical practice is practicing to improve, not just practicing. Which essentially is what we do in clinical research. These rules are an essential first step.”

But more immediately pressing is the waste data blockages create; for instance, the fact that patients are having to repeat expensive and even dangerous diagnostic tests because one health system can’t get results or images from another.

“Really bad things happen when data doesn’t flow, but when it does all of a sudden you create all sorts of really good things,” Michela said. “These rules are the beginning of that. … These regulations are fundamental if we’re going to solve the problems of the 21st Century. But it won’t just be the rules, it’ll be how they’re executed, how they’re defined.”

Rucker also brought it back, at the end of the day, to the patients.

“That is frankly why I do this job, why I put up with it,” he said. “When I talk about stakeholders, you need them because they all have a voice, but the biggest stakeholder is the American public.”

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