The key theme of how we will approach health IT is similar to how we want to approach value-based care in general: Government is going to have a role to play here, as a first-mover, sometimes a standard-setter … But fundamentally, we believe the most important progress can be made by providing incentives and encouragement for the private sector to find new ways to innovate, collaborate and communicate.
As Prepared for Delivery
Thank you, Lisa [Simpson], for that introduction, and for having me here today to share a bit about HHS’s vision for fueling the engine of innovation and unleashing the power of data.
And thank you to each and every one of you here today for joining this important gathering — your efforts to improve Americans’ health through better data and better technology are deeply appreciated throughout HHS and the Trump administration.
That appreciation goes straight to the top of our department. Secretary Azar is disappointed he could not be here today, but you should know that your work is absolutely central to the vision he has set out for HHS and for American healthcare.
A key piece of that vision is moving our system from one that pays for procedures and sickness to one that pays for health and outcomes—what many of you may know as the movement from volume to value.
This by itself is not a new idea: Both Secretary Azar and I worked in the George W. Bush administration with then Secretary Mike Leavitt, who identified value-based care as a priority. The Obama administration made it a priority, as well. But, frankly, progress has been disappointing. In fact, the private sector has made more headway toward a value-based system than we at HHS have.
So, in setting out our vision for value-based care, Secretary Azar has worked to identify what we can learn from the past, and how we can ensure that HHS and our federal programs will be driving private-sector innovation, not lagging or impeding it.
One of the key insights we want to apply is about the right way to measure and understand value.
Earlier this year, the Secretary laid out four areas of emphasis for this value-based transformation: maximizing the promise of health IT and promoting interoperability; improving transparency in price and quality; pioneering bold new models in Medicare and Medicaid; and removing government burdens that impede care coordination.
The key theme uniting these four priorities is the recognition that value is not accurately determined by arbitrary authorities or central planners. It is best determined by a market of many players—in the case of healthcare, patients, providers and payers.
Such a market, of course, requires the free flow of information, including information on price and quality, which is where technology can play such a big role.
This insight will not only enable us to make real progress toward a value-based system, it will also represent significant new opportunities for innovators like you.
In picking health IT as one of these key areas for value-based transformation, Secretary Azar and I bring particular past experience at HHS to the table, as well—almost literally bringing it to the table, in fact.
Both Secretary Azar and I spent many, many hours around Mike Leavitt’s conference room table discussing how we could lay the groundwork for a health IT ecosystem.
Secretary Leavitt understood the essential role health IT would play in healthcare in the coming years and he felt that HHS would play a key role in guiding that process.
Above all, he understood how important interoperability is—how much innovation and improvement in care we’d be missing out on if health data is siloed.
The analogy he liked to use is train tracks. The most vivid example is Australia, which struggled mightily throughout the 20th century to develop a national rail network because its railways used multiple different gauges.
If a health IT system was built with multiple different gauges, we worried, communication and exchange of data would be costly and burdensome, preventing innovators, patients and providers from getting the greatest value they could out of the system.
Needless to say, Secretary Leavitt was right, and we’re still struggling today with the fact that there are, in fact, multiple gauges in use.
But there is good news: Today, we don’t live in a world of railroads—we live in the world of ridesharing.
To be clear, in case [Transportation] Secretary [Elaine] Chao gets wind of this, I’m not making particular pronouncements about transportation policy here—I’m an Illinoisan, I have a great love for railroads.
What I mean is that common standards are important, as is the kind of collaboration and cooperation to support them that Secretary Leavitt built in the 2000s.
But today, information technology is at a place where innovators don’t work on train tracks—we have a great deal more freedom than that.
So the key theme of how we will approach health IT is similar to how we want to approach value-based care in general: Government is going to have a role to play here, as a first-mover, sometimes a standard-setter, and the like.
But fundamentally, we believe the most important progress can be made by providing incentives and encouragement for the private sector to find new ways to innovate, collaborate and communicate.
Over the next couple days, you’ll see that theme running through the presentations given by our top HHS leaders.
Our CMS Administrator Seema Verma, for instance, will be discussing how CMS is working to put data in patients’ hands—not just because patients have a right to it, but because value-based care will rely in part on empowering individuals to make informed decisions.
One example of this was updating Medicare’s system of providing claims data, called Blue Button.
The current Blue Button system is of quite limited use for patients: They can download and print a PDF of all of their Medicare claims, and that’s about it.
So we’re replacing it with a system called—get ready for it, we pulled out all the stops on the branding here—Blue Button 2.0.
So sure, the branding is not ambitious. In a move that will really disappoint Silicon Valley, we’re even still capitalizing the words in the name. But more seriously, Blue Button 2.0 is a big step: It will use open APIs to allow patients to connect their data to apps run by private tech developers—in other words, leveraging the private sector to let patients own, use and understand their data.
Blue Button 2.0 is part of a larger government-wide initiative, the White House’s MyHealthEData, which Administrator Verma will share more about later today.
CMS also took some significant steps just this week, laying out new proposals in a draft 2019 Medicare rule that will drive greater transparency and better use of data by providers.
On transparency, for instance, we proposed requiring not just that hospitals make their list of prices available in some format—which, in the past, could have meant just the ability to ask for a paper copy. We’re proposing that they post it on the internet, in a machine-readable format, allowing a greater array of uses for that data.
We’d like to go much further on price transparency, of course. You ought to know how much you’ll owe for a procedure before you get it, and we solicited feedback on how that could work.
We’ve also proposed to focus the Electronic Health Records Incentive Program on promoting interoperability. We have made such strides in meaningful use by providers, it’s time to make sure patients are getting meaningful use of their data through interoperable records, too.
This morning, you’ll be hearing from FDA Commissioner Scott Gottlieb, who is going to be here not just because he is the most prolific user of health IT in the history of HHS—at least, if we’re allowed to count rapid-fire dissemination of public health information via Twitter as health IT.
Really, Dr. Gottlieb is going to be here because FDA has taken a forward-leaning role in regulating devices and technologies that intersect with health IT.
This approach spans the entire life cycle for devices, from pre-market through monitoring and assessing outcomes in the real world.
In 2017, FDA approved more novel medical devices than in any year in its history. But it’s a long way from a world of approving stents and hip replacements to one where we’re looking at Wi-Fi and smartphone-connected devices. Our system has to keep pace.
None of us would hold onto a TV or a smartphone for 50 years, or even five years. Some of you might get sick of them after 5 months. Yet we have a decades-old approach to approving and monitoring medical devices—including even software applications that are, under the Food, Drug, and Cosmetic Act, regulated as devices.
So Commissioner Gottlieb has unveiled a new Medical Device Safety Action Plan, which will not only address many of the challenges of newer medical devices, like cybersecurity, but also lay out a vision for assessing devices from pre-market development through their entire lifecycle.
This approach, which enables the incorporation of real-world evidence, is emblematic of the kind of fundamental changes we aim to make in our work on drug and device approvals.
A similar approach undergirds our work on a Digital Health Innovation Plan, which will enable FDA’s regulatory processes to keep up with the remarkable pace of innovation we are seeing in digital health technologies.
The promise of artificial intelligence and machine learning in healthcare is huge, and FDA is committed not just to ensuring that these technologies are integrated into healthcare safely, but also rapidly enough to deliver real improvement in quality and outcomes.
Tomorrow, you’ll hear from Dr. Don Rucker, our national coordinator for health information technology, about specific measures ONC is taking to advance interoperability by implementing the statutory ban on information blocking and by encouraging the use of open APIs.
Earlier this year, I had the privilege of speaking to the inaugural meeting of the Health Information Technology Advisory Committee, which was established by ONC pursuant to the 21st Century Cures Act. This single committee will convene the perspectives of stakeholders about how to achieve interoperability by empowering individuals, while keeping their data safe.
And just yesterday morning, I was here at this very hotel along with Dr. Rucker and HHS’s Chief Technology Officer Bruce Greenstein to meet with other members of the Global Digital Health Partnership, an international collaboration to share best practices and ideas surrounding health IT.
That discussion included issues ranging from cybersecurity and interoperability to policymaking and consumer engagement. We were glad to be there to represent U.S. and HHS interest in this issue.
This afternoon, you’ll also be hearing from Bruce, our CTO, whom I just mentioned. Bruce and a number of other leaders across our department are passionate evangelists for open data and have made great progress already under this administration.
On many of our healthcare and public health priorities, like the opioid epidemic, better sharing of data across the government, and better sharing of that data with the private sector, is going to be essential.
President Trump, Secretary Azar and I are steadfast supporters of open data, innovation in healthcare, new advances for health IT, and moving to a value-based system for one simple reason: We have seen and heard from so many Americans for whom today’s healthcare system isn’t working.
Healthcare is too expensive, too inaccessible—and we face too many stubborn public health problems, like chronic disease and substance abuse.
I can speak to these challenges personally: I’m from the small town of Mounds, Illinois—at last count, a town of 737 people, or almost precisely half the size of Datapalooza. Opioid abuse has been a presence in places like Mounds for decades, and has affected many members of my family directly.
Part of the challenge of the opioid crisis is extending high-quality treatment into rural areas like Mounds. And this is a challenge for healthcare, more generally: How can we get specialist care to remote and rural areas?
Thankfully, technology can make a huge difference: I’ve personally seen how telehealth can bring access to psychiatric care to rural Alaska Native villages, and we are working now at HHS on how telehealth might be used to expand access to medication-assisted treatment for opioid abuse.
The next steps beyond telehealth are even more remarkable: using AI and remote patient monitoring, for example, to help inform doctors and nurses of how their patients are doing, without patients ever having to leave the comfort of their homes.
But beyond these specific challenges, innovation is going to be necessary nearly everywhere in our healthcare system. Americans are simply not getting the outcomes we need from our system given the amount of money we’re spending.
Fixing this will require a real federal role—indeed, a degree of intervention, at times, that may make existing players uncomfortable.
That is something President Trump and Secretary Azar are unafraid of: If we need disruption to deliver the care Americans deserve, then disruption is on the way.
In laying out his vision for value-based care, Secretary Azar has put it this way: When it comes to American healthcare, change is possible, change is necessary, and change is coming.
We know all of you are unafraid of change. You naturally see it as an opportunity, not a threat.
So we look forward to working with you as you make the most of the opportunity represented by the coming years—and together, reaping the benefits it can bear for the quality of American healthcare and the quality of American life.