The U.S. healthcare industry is notoriously slow to change, a fact evident in the country's outdated and clunky IT system. Patients' health data is siloed in various provider and payer databases, making it often extremely difficult to access and control.
Modernizing this system is spearheaded on the the federal side by the Office of the National Coordinator for Health IT, an HHS agency that regulates the nation's health information technology framework. Since April 2017, ONC has been led by longtime medical informatician and emergency physician Don Rucker.
Rucker's tenure has been characterized by efforts to leverage data standards to free up market forces in healthcare, hopefully triggering greater transparency and lower prices for care. The apogee of this work were two HHS regulations released in March prohibiting information blocking and revamping how providers, payers and other health companies exchange data, with the goal of making it easier for patients to control their health information.
The rules, which HHS worked on for more than half a decade, are largely bipartisan, but threaten entrenched business models and have faced industry pushback as a result, along with deadline delays during COVID-19. Proponents agree they've laid the groundwork for a freer IT infrastructure, but there's still room for additional growth.
Shaping that growth is now in the hands of the Biden administration and Rucker's successor, Micky Tripathi. The choice was announced in late January to general approbation from the health IT world — and from Rucker. Tripathi is an expert on interoperability and privacy standards, most recently working as chief strategy officer at a population health management company.
In a conversation with Healthcare Dive, Rucker looked back at the highs and lows of his time at ONC, shared what still needs fixing in health IT and noted what the future could hold, both for him personally and for the country's data infrastructure.
Editor’s note: This interview has been edited for clarity and brevity.
HEALTHCARE DIVE: You've been at ONC since 2017. What are you most proud of accomplishing?
RUCKER: First and foremost, opening up electronic medical records to individuals so patients have agency over their clinical data, increasing opportunities to be in control of their healthcare and direct their data to the app of their choosing. And all the things that implies about transparency. That will I think be transformative in American healthcare. It's hard not to see that as the greatest accomplishment.
Because of the incentives we've had in the payment system to not share data, delivery systems are very inward facing. But from a consumer point of view, not having interoperability is a huge negative. Where consumers are in control, interoperability these days is pretty much a given — in banking, in airlines, in everything. But in healthcare it's something that needs to be fought for. And we did that.
Another big accomplishment that's more of a sleeper thing is bulk FHIR data access, which will allow both providers and payers to use big data techniques, machine learning, neural networks, to analyze clinical data. It puts in place a fundamentally different way for healthcare companies to think about data, and certainly for the federal government to think about getting data. That over time will be transformative in helping drive value in healthcare.
Were there any policies you wanted to enact during your time at ONC that you couldn't get done, for whatever reason? Any big regrets?
RUCKER: Interestingly enough, I don't have big regrets. I was extraordinarily fortunate to have an enabling law, the [21st Century] Cures Act, and a number of folks behind me at ONC and on the Hill. Interoperability is hugely bipartisan, and we had a lot of great support from the White House.
There are obviously things that are still a work in progress. I think COVID exposed some great opportunities in public health reporting. Another huge issue that catches my mind is reducing provider burden. We worked with CMS on burden reduction around electronic medical records and removing some documentation rules, at least on the outpatient side. Hopefully we'll get that removed for the inpatient and emergency settings soon enough. But I think we actually got done the things we needed to.
Your successor, Micky Tripathi, has a long background in health IT. What do you think about his appointment? Being familiar with him and his background, what do you think he'll focus on in the near term?
RUCKER: Micky has spent a lot of solid time in the trenches of implementing EHR. I think that gives him some very solid operational insight. It's not an abstraction to him. He's spent a lot of time in a number of corners of the standards world. So coming into ONC with the knowledge of these things is a big advantage, as standards work has been one of the critical accomplishments of ONC.
The immediacy of his hire, as I understand it, is to do as much around COVID as possible. I can't speak to what his plans are there. But I think he brings a lot to the table that will allow things to move much more rapidly, compared to having, let's say, somebody who maybe understands the clinical world, like installing an EHR, but hasn't been in the operational sphere. It's a very solid choice.
He thanked you on Twitter for your advice during the leadership transition. How was it handing over the reins?
RUCKER: There was a lot to go over. I mean, I benefited from the wisdom of the prior national coordinators, and I think Micky will likewise benefit from their wisdom, individually and collectively. ONC has been a very bipartisan operation, when you think about it and look at the things we've worked on over the last four years.
The Cures Act stuff was signed by President Obama, strengthening health information exchanges was funded by President Obama and Vice President Biden, who is now president — it's a funny kind of thing. But the reality is we worked almost exclusively on things started by the prior administration.
There is a distinction. I'm very focused on using health IT to let market forces work in healthcare. The biggest problem right now is that healthcare's too expensive, right? And interoperability is a tool to solve that. So we were very careful to have our policies be pro-competitive, as opposed to subtly anti-competitive. And I hope this continues.
Getting to your question on what could be next, there are a lot of opportunities in the near-term to make government more efficient. If you look over the totality of federal programs and state programs, we haven't brought modern computing to the beneficiaries of our social welfare programs. I personally believe the state and local health information exchanges are the best way to do that, with local governance and privacy protections.
I think there are also some opportunities — and Micky is very ecumenical here — to figure out, how do we get those things, those issues that aren't fully clinical, plugged into the EHR? You know, I've been an ER doctor for 30 years, and seen thousands of patients from group homes, jails, shelters, patients with mental health issues — how do we make modern computing work for them? We need to go beyond historical thinking about EHRs and take that next step. I believe we've laid the groundwork for that.
That's a good segue to pivot to interoperability. HHS' two rules essentially rewrite how health companies share data, while laying the groundwork for future changes. The regulations are sweeping, but is there more to be done here? Did they go far enough?
RUCKER: I mean, I think a lot of it is frankly done. There will be some more extensions on the rules on information blocking that will be richer. There will be more work on [application programming interfaces]. The ONC rule dealt with read APIs but there's things in the future to look at around clinical decision support and write APIs that will evolve over time.
When it comes to other things, like adding disincentives or penalties for providers found information blocking, I'll defer to the people who are at ONC now working on it. You're going to have to ask them what their plans are and the statuses. But it's a broad issue, and there are a lot of parties involved within HHS on this, ONC, CMS, potentially the Office of Civil Rights. It's a massive, multi-agency project.
Hospital lobbies continue to cite COVID-19 in pushing for an additional extension on compliance dates, while other software stakeholders have re-upped concerns about patient privacy in opposing the rules. Now that you've left ONC, any new thoughts on industry pushback on interoperability?
RUCKER: Obviously, there are folks who are highly interested in transparency, and then there are folks with non-transparent business models. If you've built up your business on essentially arbitrage and non-transparency, you may use the political process to continue that. Speaking as a private citizen, there's no reason why the deadlines should be extended further. The timeframes have balanced.
On privacy and access, my views have not changed. Of course that argument keeps coming up, right? Because it's sort of the central question of modern computing. The reality is, the vast bulk of inferable information about healthcare is totally outside of HIPAA or EHRs. It's in your cell phone, GPS, accelerometer. It's in your credit card spending, your search history. Those things are thousands of times more predictive of a patient's health than anything sitting in a medical record.
Interoperability also ties into the country's spotty public health data sharing infrastructure, which many critics malign as having set back the country's response to COVID-19. In the final days of the Trump administration, ONC said it would disburse $20 million in funds to states to boost data sharing between health information exchanges and immunization registries, to try and better track patients as they're tested, treated and vaccinated for the virus. Is there more the government can do here?
I don't know what the new folks at ONC are going to focus on. I suspect some of those things have already been decided or are in the process of being decided, given the urgency. But I think there are two specific considerations that need to be factored into this.
One is that many of the questions need patient-identified data, which raises a lot of governance issues. But when you look at what has been missing in COVID data, it's identified patients, which allows you to follow patients over time. So you can correlate no matter what provider, no matter what location, no matter what date of service.
How do you track the development of immunity? How do you track the loss of immunity? How do you see patients move from the nursing home to the hospital or vice versa? What are the comorbidities there? All that stuff needs identifiable data. You can't just say, 'Okay, we're going to send a list every day to the CDC of positive tests.' You need to follow individual patients over time. That's a very, very different paradigm than how the public reporting process worked before the pandemic.
That's where the state and local health information exchanges come in, because they actually track over all providers and sites of service, with critical privacy protections. So that tracking is one big critical area that needs to happen, and that plays out with vaccinations too.
With vaccinations there are a few missing links, including needing a population-based assessment of the outcomes of these vaccination programs, beyond just adverse event reporting. For that, to track the downstream things, you need to follow individual patients over time. That would also allow them to track things like what patients got one dose and are coming due for a second. Or who didn't get a vaccine at all.
The other thing is, we have to rethink the entire way we do public health reporting. Public health reporting for the past 150 years has been just reports.
That doesn't sound like a big insight. But we have in the COVID reporting understandably enough relied on a mandate to report positive tests. Right. And then add to that a mandate to report race and ethnicity, well ok. And then moving on to various vaccination things. Those are out of the process — they're extra work. And in many cases there's a lack of understanding that some of these things are being done totally outside of a classic autonomous medical record, and therefore don't get this data. If you're conducting testing in a parking lot, you don't have an EHR with you.
The whole concept of recording is this one-way, one-time unidirectional thing, after the fact, with data reentry from whatever provider of whatever service to various public health agencies. It needs to be rethought so they're using health information exchanges that are already collecting that data and use that with all the privacy protections that are in there so the data's collected once and can be accessed as allowed by law by the other agencies. And you can separate out the identifiability after the fact if need be.
What's next for Don Rucker?
I'm just going to sort out what to do next, look around. I don't want to prejudge. All the work we've discussed — around empowering consumers, modern computing, interoperability, public health, social determinants of health, reducing burden — I think these are all opportunities that have arisen over the last couple years. And I'm optimistic that these things will all continue to blossom.
This is like the most amazing — I mean, I've spent decades doing this stuff with incredibly slow progress. But the last five years, 10 years, whatever — the progress we've made is rapidly accelerating. And it's pretty gratifying.