In 2018, interoperability remained just beyond the horizon

Another year, another set of draft frameworks and rules, app releases and APIs, and the healthcare IT industry still hasn't solved interoperability. And yet leaders spent so much time talking about it over the course of 2018, a year punctuated by moments in data exchange that felt big but failed to deliver the holy grail of industrywide interoperability.

Interoperability nevertheless remained top of mind in 2018, with players big and small, entrenched and untraditional, joining the cacophonous call for a health system in which patient data can move between providers and, sometimes, even move via the patients themselves.

Over the year, the promise and potential of interoperability stretched from patient to provider, from consumers' step-counting to providers' electronic health record software. The industry struggled to connect the two, held up by questions of privacy and standards as well as by vendors and providers that still see a business case in not sharing patient data.

“We've all been waiting for some way to connect medical records,” said OptumLabs CEO Paul Bleicher. “Morally, ethically, that should have happened a long time ago.”

As the industry shifts, in theory, toward value-based payment models, information-sharing becomes paramount. “The premise in a lot of these arrangements is that a clinician is going to be held accountable for quality and total cost of care,” said Anders Gilberg, senior vice president of government affairs for the Medical Group Management Association. “They can't control the outcomes of these patients if they don't have the data.”

The trickle rather than torrent of data has slowed the uptake of value-based models, Gilberg said. In turn, a closed-off system of data sharing seems less and less sustainable. And the industry knows it—as do those outside of the industry.

The year started out strong with both insiders and outsiders from both government and private industry making announcements about how to boost interoperability. The Office of the National Coordinator for Health Information Technology kicked things off with the draft Trusted Exchange Framework and Common Agreement, a plan for pushing interoperability among health information exchanges, with a to-be-determined private-sector organization leading the charge.

The ONC released the draft in hopes of getting useful comments from the industry about how to improve it. It was not, in other words, a rule.

“This year has been marked by an unprecedented amount of requests for information,” Gilberg said. “If 2018 was the year of information gathering, then 2019 almost has to be a year of implementation, or this stuff isn't going to happen.”

What's more, the release of the draft, to be followed by the release of another draft, left the industry uncertain about what the provisions laid out actually mean. “It's really done a disservice, because it's caused a lot of confusion in the market,” said Micky Tripathi, CEO of the Massachusetts eHealth Collaborative.

Another source of confusion is the CMS' MyHealthEData, an initiative to give patients more control over their health data. After announcing the initiative at HIMSS, CMS Administrator Seema Verma still hasn't provided details about how it will work.

Meanwhile, consumer companies forged ahead, driving toward interoperability where those in the industry fell short. Notably, Apple announced it would allow people to download their health data from participating organizations (now more than 100) to their iPhones via the Health app, thanks to the FHIR standard. It later expanded the capability to let people share the information they'd collected with third-party apps.

Apple's work can't end with these two capabilities of the Health app, though, Tripathi said. “If it ends up being an endpoint, this is nothing,” he said. “It's about being the gateway to a rich and thriving app ecosystem.”

Other companies unveiled apps too, with Epic pushing its App Orchard and Cerner its Open Developer Experience for developers to build using their open APIs.

The promise of interoperability also brought organizations and companies together in 2018. Google, Amazon, Microsoft, IBM, Oracle, and Salesforce joined together to push for increased information exchange for cloud- and AI-based tools. Lyft and Uber formed partnerships with providers dependent on the flow of information. And, notably, the Veterans Affairs Department and Cerner finally signed a contract for Cerner to replace the VA's homegrown EHR, VistA.

The replacement is expected to take 10 years, the two organizations said. And it would take $10 billion—a number that grew, by year's end, to over $16 billion. The contract process was drawn out by disputes over the system's potential interoperability with the Defense Department's EHR (also made by Cerner) and with community providers.

“It could really be a positive force for interoperability and standardization, assuming the VA doesn't force Cerner into all sorts of dark nooks and crannies of customization,” Tripathi said.

Alongside partnerships were mergers and acquisitions of the sort hitting the rest of the industry. American Well acquired Avizia, and Allscripts acquired HealthGrid for $60 million, to name a couple. And after months of drama, Athenahealth sold itself to Veritas Capital and Evergreen Coast Capital for $5.7 billion.

As these companies grow, so do their datasets. Whether the data will be useful depends in part on standardization and the degree of interoperability. “You do have to ask yourself: Is it interoperability that is the most important thing, or is it the ability to combine data into a single format?” Bleicher said. “What's particularly complex about medical data is the longitudinal nature of it.”

But that doesn't mean that at least some of the data aren't ready for analytics and AI. The industry has been rife with companies promising the latest and greatest in AI-based tools. Some work as promised, others don't. One that does is IDx-DR, a retinopathy-detecting software made by IDx, which received the first FDA marketing approval for an autonomous AI-powered medical device—meaning it can make a diagnosis without a physician's interpretation. These kind of applications will proliferate, Bleicher said.

The FDA sped the product through the regulatory process, using the de novo premarket review pathway for low- and moderate-risk devices. The agency is working on a new regulatory framework for AI-based devices, which sometimes complicate current regulatory processes because the devices can change over time, learning as they're fed more data.

As more data move around and multiply, there are more opportunities for hackers to get their hands on them. “2018 was not a good year for breaches in the U.S.,” said David Finn, executive vice president of strategic innovation for CynergisTek.

Between Jan. 1, and Nov. 30, 2018, there were 333 data breaches reported to the Office for Civil Rights, which tracks breaches. These attacks can be expensive, costing each affected organization $4 million on average, according to the Ponemon Institute.

The year was marked by both data breaches and settlements. In June, HHS announced that the University of Texas MD Anderson Cancer Center must pay a $4.3 million fine to the agency for several data breaches. And in October, the OCR announced Anthem would have to pay $16 million for a 2015 data breach that exposed information on 79 million people—the largest breach ever reported to the OCR.

More and more, hackers are getting in through phishing emails, Finn said. No technology alone can stop this kind of attack, he said. “We're not yet training people well enough.”

And as the industry inches closer to greater interoperability, with data flowing between providers, patients and payers, that kind of training will become all the more important.

As the year drew to a close, the industry got antsier and antsier about the ONC's information-blocking rule, which spent weeks held up at the White House Office of Management and Budget. The rule is meant to define information-blocking and set out exceptions to it.

RELATED YEAR IN REVIEW STORIES:

• Healthcare organizations turned to unexpected partners in 2018
• Dealmaking stayed hot in 2018, with a focus on physician practices
• Greater flexibility, new alliances define insurance industry in 2018
• Medicaid expansion battle shifted in 2018 to the executive branch and the states
• Bookended by Obamacare, 2018 was the year of policy change
• Absence of government action on public health issues pushed industry to act in 2018
• CMS amps up value-based payments in 2018 as other quality issues fall by the wayside

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