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WASHINGTON, D.C.—Federal health IT leader Donald Rucker, M.D., said an upcoming interoperability rule will include “solid” privacy protections for patients as they share their medical data. 

Speaking at Health Datapalooza on Tuesday, Rucker—who is the head of the Office of the National Coordinator for Health IT (ONC)—acknowledged that privacy in a digital world is a challenging issue. But he reiterated his perspective that patients should be able to easily access and share medical data.

“It is our human right as patients to have access to our data,” he said.

Case Study

Across-the-Board Impact of an OB-GYN Hospitalist Program

A Denver facility saw across-the-board improvements in patient satisfaction, maternal quality metrics, decreased subsidy and increased service volume, thanks to the rollout of the first OB-GYN hospitalist program in the state.

See how

Rucker was pushing back on health IT vendor Epic’s lobbying efforts against the proposed rules, including an email Epic CEO Judy Faulkner sent to customers encouraging them to sign an opposition letter. The letter cited risks to patient privacy and intellectual property if the rules are finalized now.

According to reporting from CNBC’s Chrissy Farr, about 60 health systems signed the letter.

“Most of their customers did not sign on to that letter,” Rucker said. “If you parse out the big academic medical centers, only three out of 100 AMCs signed on.”

He also called out hospitals that signed the opposition letter due to their claims about data privacy concerns but then disregard patient privacy when filing lawsuits for unpaid medical bills.

“One of the signers of the letter is known for taking thousands of patients to court. If you take someone to court, that information becomes public discovery. Their medical care is now public. It’s part of the court record,” he said. “Looking at protecting privacy, we need to walk the walk here as we look at who is saying what and letter-writing campaigns.”

Almost a year ago, ONC issued a proposed interoperability and information-blocking rule that defines the demands on healthcare providers and electronic health record (EHR) vendors for data sharing. The rule also outlines exceptions to the prohibition against information blocking and provides standardized criteria for application programming interface (API) development. 

Department of Health and Human Services (HHS) leaders have not offered a timeline for when the rule will be published, but many have speculated it will be released during the Healthcare Information and Management Systems Society conference in March.

While Epic and many hospitals have come out against the interoperability rules, many technology vendors, including Apple and Microsoft, along with health plans and consumer advocacy groups have urged HHS to move forward with publishing the rule.

Four healthcare leaders recently penned an op-ed in Health Affairs calling for ONC to publish the rule immediately. Omada Health’s Lucia Savage and University of California, San Francisco’s Aaron Neinstein, Julie Adler-Milstein and Mark Savage said the ONC rule will not make the current consumer privacy protections worse.

“All health care stakeholders who are concerned about that issue should raise it with Congress and state legislatures, which have authority to act, rather than request to delay the ONC’s rule, delaying critical improvements to interoperability, access, innovation, and ending information blocking,” the authors wrote.

APIs are the technology used to link IT systems, such as EHRs, with apps and will help bring healthcare into the modern app economy, according to Rucker.

ONC’s vision is for patients to choose what apps to use, he said

“We’ve often looked at interoperability in a narrow view, which is just as a replacement for moving the patient’s chart. Modern computing and APIs offer a vastly richer and more empowering global computing environment. Well-built APIs can do almost anything that your creativity allows,” he said.

Before Rucker took the stage at Health Datapalooza, HHS Secretary Alex Azar also addressed the upcoming interoperability rules and the Trump administration’s commitment to putting “patients in charge of their data” and called out industry stakeholders who are “defending the status quo.” They are protecting a health records system that is “segmented and Balkanized,” he said. 

“We have a serious problem—and scare tactics are not going to stop the reforms we need,” Azar said.

As the industry waits for a landmark rule aimed at opening up access to patient data, Donald Rucker, M.D. said Wednesday that regulators are challenged with balancing data privacy and transparency.

The proposed interoperability rule will be coming out “relatively soon,” Rucker, who is head of the Office of the National Coordinator for Health IT (ONC), said during a Health IT Advisory Committee meeting Wednesday.

Many have speculated that the rule will be released during the Healthcare Information and Management Systems Society conference in March.

Case Study

Across-the-Board Impact of an OB-GYN Hospitalist Program

A Denver facility saw across-the-board improvements in patient satisfaction, maternal quality metrics, decreased subsidy and increased service volume, thanks to the rollout of the first OB-GYN hospitalist program in the state.

See how

A year ago, ONC, which is part of the Department of Health and Human Services (HHS), proposed an interoperability and information-blocking rule that defines the demands on healthcare providers and electronic health record (EHR) vendors for data sharing. The rule also outlines exceptions to the prohibition against information blocking and provides standardized criteria for application programming interface (API) development. 

HHS officials say the rule, which promotes the use of application programming interfaces (APIs), will help bring healthcare into the modern app economy.

The proposed rule has created an industry rift—EHR vendor Epic, many health systems, and some privacy groups have voiced strong opposition to the rule. About 60 health systems signed an opposition letter circulated by Epic CEO Judy Faulkner that was sent to Azar. The letter cited risks to patient privacy and intellectual property if the rules are finalized now.

Meanwhile, newer technology entrants to healthcare such as Apple and Microsoft, some EHR companies like Cerner and consumer advocates are backing the rule. Google Health’s David Feinberg, M.D. has met with HHS officials about the rule, Politico reported.

Rucker was asked by members of the Health IT Advisory Committee about the status of the rule.

“There are complicated issues balancing the various interests of the American public to get a good deal in healthcare, to have transparency, to do this in a way that doesn’t prevent innovation and allows vendors to be able to build products in a practical way and draws the right balance on protecting privacy, yet addressing what is ultimately the biggest issue, which is simply the vast amount of healthcare costs that are out there and lack of patients having agency.”

As the lobbying battle over the rule goes on, Politico reported Tuesday that ONC’s rules gained a rare endorsement from a hospital system: the University of California, San Francisco. The “nation needs ONC’s proposed regulations,” the leaders of UCSF and its health system wrote to HHS Secretary Alex Azar, according to Politico.

All the lobbying efforts and public debates could have some positive results, Rucker said.

“Maybe it’s had the unintended benefit of getting people to focus on how this all will play out and part of a broader dialogue about what we want to do with technology in our lives,” he said.

Federal regulators have listened to physicians’ complaints about health IT burdens and they have some solutions.

The Department of Health and Human Services (HHS) released Friday a final version of an overarching strategy to reduce clinician burden revolving around entering information into the electronic health records (EHRs), meeting regulatory requirements and improving EHR ease of use.

The new report (PDF), which includes 43 recommendations around clinical documentation and health IT usability, is a follow-up to a draft strategy released in November 2018.

Case Study

Across-the-Board Impact of an OB-GYN Hospitalist Program

A Denver facility saw across-the-board improvements in patient satisfaction, maternal quality metrics, decreased subsidy and increased service volume, thanks to the rollout of the first OB-GYN hospitalist program in the state.

See how

The overall goal is to improve patient care by enabling physicians to spend more time focused on them instead of their keyboards, HHS officials said.

“Physicians and other healthcare providers have long identified regulatory and administrative burdens as a key contributor to the many challenges they face. They also note these burdens weigh down the overall healthcare delivery system as well. Clinicians have pointed to an ever-increasing and poorly coordinated set of requirements they must meet to deliver and receive payment for patient care,” senior officials with the Office of the National Coordinator for Health IT (ONC) wrote in a blog post Friday.

The clinical community frequently links the increased burden of meeting these requirements with the tasks and use of health IT, such as EHRs, Andrew Gettinger, chief clinical officer for ONC, and Thomas Mason, ONC’s chief medical officer, wrote.

The report targets burdens tied to regulatory and administrative requirements that the federal government can directly impact through the rule-making process.

When looking at the steps HHS could take to mitigate EHR-related burden for healthcare providers, ONC and the Centers for Medicare & Medicaid Services (CMS) focused on strategies that are achievable within the near to medium term, roughly a three- to five-year window, according to the report.

And HHS is looking at strategies it can implement through existing or easily expanded authority.

EHR burdens have been a near-constant complaint from physicians that see the technology as an impediment to their relationship with patients. Numerous studies have documented the time suck of the technology.

The finalized strategy, required under the 21st Century Cures Act, reflects feedback from industry stakeholders and healthcare groups, including 200 comments submitted to the draft strategy, HHS said.

In several recommendations, the agency vowed to continue its work stripping down regulations and working with the industry to find solutions to growing problems. 

CMS already has taken some steps to reduce administrative burden such as changes to the more-than-two-decades-old E/M documentation and coding framework that clinicians use to bill Medicare for common office visits. 

HHS also wants to see health IT vendors doing more to improve technology usability. EHR vendors need to work with clinicians when designing systems or new features and should consult with experts in user-centered design during development, HHS officials said.

Specifically, EHR vendors should take the lead in developing health IT-specific user interface best practices and should collaborate to develop a shared repository of EHR usability practices.

This collaboration would help provide better consistency with user interface best practices while still enabling EHRs to compete with each other, HHS said in the report.

HHS also wants an EHR vendor’s user-centered design process to be highlighted on the ONC Certified Health IT Product List so potential EHR customers can see the efforts that went into the products they are considering acquiring.

“A shift from check-box interface elements to intelligent features that extract needed data from routine clinical workflows would provide a substantial reduction in usability-related clinician burdens,” HHS officials wrote in the report.

HHS’ recommendations represent the “best next steps” to address the growing problem of clinician burden related to their use of health IT and EHRs, ONC chief Donald Rucker, M.D., said in the report.

As part of its ongoing strategy, ONC plans to work to enable further automation in healthcare, with a focus on prior authorization and quality reporting.

“Through this HHS strategy, we look forward to advancing the premise of how to accurately model and support the clinical cognitive process in the EHR—a shift away from a strictly linear, logic-based model to a more sophisticated design that supports the complex pattern recognition inherent in the diagnostic and treatment process,” Rucker said in the report.

“We envision a time when clinicians will use the medical record not as an encounter-based document to support billing, but rather as a tool to fulfill its original intention: supporting the best possible care for the patient.”