Giving patients access to their health data on their smartphones will open up new business models of healthcare, the head of the Trump administration's health IT policy arm said this week.
On March 9, the Department of Health and Human Services issued two rules, one each by the Office of the National Coordinator for Health IT (ONC) and the Centers for Medicare & Medicaid Services (CMS), that implement interoperability and patient access provisions of the bipartisan 21st Century Cures Act.
The ONC's information blocking rule (PDF) requires that electronic health data be made available to patients at no cost and defines exceptions to data blocking.
Speaking about recently released interoperability regulations, Donald Rucker, M.D., the national coordinator for health IT, said the rules will "materially change the state of patient care and patient control over their health data" and will create a healthcare app economy.
The rules have faced some blowback with critics citing a lack of privacy protections and too much burden on providers. Electronic health record (EHR) vendor Epic and many hospitals came out against the interoperability rules citing concerns about data privacy.
Just last week, payer and provider organizations said the timelines to implement interoperability regulations are "troubling" and not realistic given the current evolving coronavirus pandemic.
Getting the rules out has been a major undertaking for ONC and CMS, and Rucker, for one, is optimistic about the future impact. In an interview with FierceHealthcare, he shares his views on why the ONC rule is "pro-consumer" and responds to criticism about privacy risks and timelines for implementing the requirements.
This interview has been edited for length and clarity.
FierceHealthcare: How will these interoperability provisions improve patient care?
Donald Rucker, M.D.: The movement to an app economy is ultimately going to be transformative. It will take a couple of years for this to happen. There are going to be two phases. The first stage is really a transparency stage as patients get their records, and the first group of apps and tools will allow things like getting a better understanding of their medical care and looking at the drugs that are being used. Combined with the CMS rule, you’ll see start to see more transparency on prices and costs.
The second stage, I think, is rethinking how to deliver care, especially chronic care. These APIs (application programming interfaces) will allow the smartphone to essentially be the nexus of computing and for care. We’re going to see all kinds of devices and interactions for chronic care, which today is ultimately based on intermittent office visits. That will move to something that is more continuous with tools that monitor diabetes with digital glucometers and then also providing online guidance. You’re going to see a world that’s very different, and we’ll also see different business models.
FH: Industry groups have voiced concerns about the implementation timelines, especially in light of the coronavirus pandemic. Is there a possibility that the timelines will change?
DR: The administration is obviously looking at many things. I think that is to be determined.
It’s worth noting that we would be in a vastly better position to fight the virus and do home-based care through technology today if we had these APIs up and running. This points out the need to move quickly on getting this implemented. As a nationwide rollout, this is what gives us a lot of capability for the next virus. And it’s wise to assume there will be more of these as time goes on. There’s an argument to be made that it is a cause for delay. I could equally well argue that the virus and the lack of data flow and the lack of ability to allow people to change the site of care are impediments to care in this era of a viral pandemic.
FH: Critics of the interoperability rule say it lacks privacy protections as it opens up data to app developers not covered by HIPAA. What is your response to those concerns?
DR: If you look at the folks who have made that point, there seems to a high correlation between those with nontransparent business models and folks trying to protect patient privacy, which raises the obvious questions about what is actually being protected here. Look, there are privacy and security issues in the modern world, everyone knows that.
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What we’re saying and what Congress said with the 21st Century Cures Act is that patients should be the ones making these decisions. The decisions should not be made by providers or EHR vendors. People are smart, and they can balance the risks. We let adults buy homes, we let adults buy cars and we let adults decide where to bank. In this modern consumer world, healthcare is the one area where adult patients don’t have a choice on what to do.
FH: How does the ONC rule frame privacy protections for patients when using apps?
DR: We're saying the provider should require the app to provide a plain-language privacy policy. And we’re building in consent that we believe is enforceable by the Federal Trade Commission (FTC), under deceptive business practices. What that does is binds the companies to a contractual obligation to honor the privacy policy. That’s enforceable in several different ways, such as the FTC and 20 states that have causes of action.
We are trying to encourage the privacy protections to be handled by app developers under the fair information process rather than trying to encumber folks with HIPAA business associate agreements (BAAs). We want to engender competition, and covered entities are not going to sign BAAs with competitors. It’s easy for folks to forget that when we think about privacy, a lot of the deals done under HIPAA business associate agreements if that were extended to the app economy, it would be profoundly anti-consumer.
FH: As a clinician and a technologist, what excites you most about the impact of these rules?
DR: Two things: One, to get healthcare to be something that’s controlled by the American consumer. I think our healthcare could be more economical, more efficient and more satisfying if we have consumers in the catbird seat. Healthcare needs to be reformed, and one way to do that is by taking the values that we treasure in a consumer economy and providing people choice, competition and information. That is exciting, coming from the public policy person in me.
And two, the technology/science/clinician side of me is excited about new possibilities in computing. The American entrepreneurial and scientific community has the ability to be creative and innovative, and I’m looking forward to unleashing that.