When new data sharing regulations go into effect, patients will have the same consumer power they have in other parts of their lives when using smartphone apps to book flights or check their bank accounts, according to top federal health official Donald Rucker, M.D.
On May 1, a regulation spurring healthcare interoperability will officially get published in the Federal Register, and the clock starts ticking for hospitals and vendors to meet the new requirements.
That rule, developed by the Office of the National Coordinator for Health IT (ONC) and mandated by the 21st Century Cures Act, requires that electronic health data be made available to patients at no cost and defines exceptions to data blocking.
"The goal is to give patients electronic control of their medical care, their chart, and their information through modern software. It's the patients’ data for the patients to control as they desire rather than purely controlled by providers and payers," Rucker, the national coordinator for health IT, said Thursday while being interviewed in a virtual "fireside chat" by Hal Wolf, CEO of the Healthcare Information and Management Systems Society.
The current COVID-19 pandemic is a clear example of why the data sharing regulations are so critical, Rucker said.
"Ironically, if we had this rule several years ago, we would be in a far better spot for knowing what’s going on with this pandemic. There are fundamental things about the biology of this virus that we don’t know, such as latency, duration of disease and how immunity is built up. It would be easier if we had richer clinical information streams," he said.
Federal policymakers are relaxing enforcement of the data sharing rules and extending compliance timelines for some requirements due to the COVID-19 pandemic. But various provisions of the regulations will go into effect starting six months from now and through the next two years.
Here's what else Rucker had to say about interoperability and information blocking rules.
ONC's interoperability rule
Rucker said the data sharing regulations are necessary because healthcare is the only market where consumers are not in complete control of their information and their decisions.
"We wouldn’t want someone to tell us what airline to fly, what car to buy, or where to find a house or an apartment. In healthcare we’ve been made subject to the desire of others," he said. "This is being driven by the supercomputer we all have at our side, the smartphone, and we have opportunities to build an entire ecosystem out of that and the rules are a starting point."
Rucker, an emergency medicine physician by training with an extensive background in biomedical informatics, said he has been frustrated in the past, as both a physician and a health IT professional, at how slowly the healthcare industry has moved forward with technology.
The new regulation will spur the flow of patient data which will enable more rapid innovation, he said.
"When I was a graduate student at Stanford, we had the algorithms but we didn’t have the computing power, we didn’t have the networks or any data. And now with electronic health records, we have the data, we have the networks and we have the computing power. I think you’re seeing going to see amazing things in software and hardware in healthcare," he said.
Information blocking and exceptions
The ONC rule seeks to prevent information blocking practices by healthcare providers, vendors, health information exchanges and health information networks. That provision goes into effect in six months.
ONC established eight "exceptions" to the information blocking ban. These exceptions allow clinicians and hospitals "common-sense operational flexibility," including protecting patient privacy and security, he said.
"It has to be a specific reason. You can’t just say 'The world is a dangerous place, we’re not going to share' the information," he said.
One of the eight exceptions address "content and manner," which reflects that exchange technologies such as Fast Healthcare Interoperability Resources application programming interfaces (APIs) are "works in progress."
"The level of standardization available today, the complexity of the data today, the ability of electronic health record (EHR) vendors to supply the data potentially through smartphones, and apps, all those things need to be balanced," Rucker said.
Critics of the interoperability rule say it lacks privacy protections as it opens up data to app developers not covered by HIPAA.
Rucker acknowledged there are real risks to patients' data privacy.
"The privacy issues in healthcare are absolutely paramount. It's also worth noting that technology offers more opportunities to enforce privacy and enforce consent, and I think those things are moving along at a rapid rate," he said.
He added, "In a modern connected world, we are rethinking what privacy is. Every time you move with your smartphone, people know where you are. The main driver here, and it's reflected in the passage of the Cures Act, is consumers' expectations and our knowledge that what we get as a consumer in healthcare is not matching up with what we get as a consumer in the other part of our lives," he said.
The future of healthcare
The interoperability rules from the Department of Health and Human Services lay the pathway for greater exchange and use of healthcare data, Rucker said.
And that opens up innovation for digital health and connected medical devices.
"I think the internet of things is going to mean that the way we look at the body is going to be a much more instrumented way of looking at the body. We’re going to think through and see different information flows. There are some technologies that are in early stages that will really change the nature of healthcare and allow us to catch things far earlier," he said.
He added, "We have a lot of biology that is going to come in with smartphones, the interfaces, the APIs, the network computing and automation. Those are things that drive massive virtualization."
To date, there has been little automation in healthcare, Rucker said, but that will change going forward.
"We are doing early work to start that change at ONC. Virtualization will be very powerful and will lead to things like changing the site of care and service," he said.