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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 we wait for final rules that will enable consumers to freely access their health data, electronic health record (EHR) giant Epic is saying breaking down the silos where this information lives will create a privacy hazard for patients.

While privacy concerns over health data sharing are always legitimate, they can’t stem the tide of the inevitable: Patients and consumers are demanding access to their data, and new proposed government rules supporting a consumer-directed, seamless flow of medical information will likely go into effect as soon as this month.

When they do, it will accelerate the race among technology companies to offer consumers the end-to-end healthcare experience and outcomes we’ve all been missing. At the same time, they will force the government to move quickly to establish a new privacy framework that will replace HIPAA’s limited reach and work to benefit all stakeholders.

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

We could be in for a wild ride. But when the dust settles, we will have what we should have had all along: a healthcare system where consumers sit at the center and are empowered by ownership of their own health data.

A snapshot of health IT’s bumpy history

In 2004, the Office of the National Coordinator for Health IT released a framework for strategic action, the decade of health information technology: delivering consumer-centric and information-rich care (PDF).

I worked for David Brailer at the time, who was appointed by President George W. Bush to be the country’s first information “czar” for healthcare. Dr. Brailer is still an advocate for information-sharing, recently calling on healthcare CEOs to lean into, not away from, the opportunity to engage the patient in a more meaningful way. If healthcare CEOs fall short, tech companies will fill the void (more on that later). 

We envisioned a system where important health data would follow the individual by building interoperability into EHRs from the start—a vision that tragically has yet to be realized. 

ELATED: Epic’s Judy Faulkner: ONC data blocking rule undermines privacy, intellectual property protections

We imagined health data would function as a powerful currency for consumers, but to date, this valuable asset has stayed in the hands of EHR companies who keep it under lock and key. 

Consumers will soon hold this currency in their hands for the first time. If they seek to understand and apply their health data like they have with their genetic information—consider the explosion of tech companies like 23andMe and others—we’ll see dramatic shifts in the health tech landscape.

Consumers are most likely to share their health information with companies that have proven they can offer a powerful, secure and user-friendly experience: companies like Amazon, Apple, Google and a host of established and emerging technology players.

We must now endeavor to build the necessary security and privacy frameworks that ensure the consumer will always be protected and in control of their personal health information.

Where to go from here

We’re entering a new era, one where healthcare providers, payers, solutions providers and technology companies will create a superior healthcare experience and deliver improved patient outcomes.

The days of medical information being walled off and guarded by EHR vendors are coming to an end.

We can expect three things to occur once the rules are finalized:

  •  EHR companies will see their business models disrupted: As consumers control their health data, the silos created by EHR companies will gradually erode. This will change these companies’ business models permanently. No longer the central gatekeepers of the country’s medical information, EHR companies will scramble to build new capabilities and services in a bid to remain important players in healthcare.
  • Technology companies that build trust will earn their moment in the sun: Consumers have shown a willingness to share sensitive information with technology companies in exchange for insights about their health. With new rules in place that turn loose volumes of health data, incumbent tech giants and newcomers will compete to create compelling new healthcare experiences and superior outcomes. Consumers will decide the winners by preferentially sharing their data with companies whose products and services are both transparent and secure.
  • New privacy laws must take shape: As tech companies compete to win the trust of consumers, the government will develop updated rules of the road for our new, consumer-centric health system. This effort is already underway thanks to multi-stakeholder groups like the CARIN Alliance and the work that the Robert Wood Johnson Foundation is doing with Manatt. We can expect these efforts to ramp up quickly.

HIPAA doesn’t cover many of the new digital products and services that can benefit consumers, but that doesn’t mean consumers and technology companies cannot hold this data. It means we need to modernize HIPAA.

When these trends come to pass, it will be the consumer—newly empowered with their health data—who will drive our country toward value-based care. Top-down decisions by healthcare providers, insurers and government agencies haven’t accomplished this vision—consumers can and will.

As a consumer, a health tech entrepreneur, a mother and a former federal and state official, I am eager to bear witness as consumers take the driver’s seat, which was the intention all along.

Lori Evans Bernstein is a co-founder and the president and chief operating officer of HealthReveal. She was a senior advisor to the first National Coordinator for Health IT in the U.S. Department of Health and Human Services and served as deputy commissioner of the New York State Department of Health’s Office of Health IT Transformation. 

Federal lawmakers are taking a hard look at how the VA protects patient data shared with VA-approved health apps.

As more health data is shared with technology companies and mobile apps, it raises concerns about potential privacy and security risks for veterans, according to federal lawmakers charged with oversight of the Department of Veterans Affairs’ IT modernization efforts.

The VA’s App Store includes close to 50 smartphone apps designed to help veterans manage their healthcare.

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

Many of these apps required “significant elevated permissions” and request access to a user’s contacts, calendars, photos, and other files, and that raises questions around privacy, said Susie Lee, D-Nevada, chairwoman of House Veterans’ Affairs Subcommittee on Technology Modernization during an oversight hearing Wednesday.

Lee said she’s concerned that smartphone apps could access users’ sensitive health information, such as a post-traumatic stress disorder (PTSD) diagnosis, that could be shared or sold by third-party companies and lead to workforce discrimination or other negative consequences for veterans.

Ranking Member Phil Roe, R-Tenn., said one VA-recommended app designed to provide support to veterans with PTSD requests permission to access the smartphone user’s contacts and microphone. “That’s disturbing to me. You might inadvertently hit that,” he said.

He added, “I look at a risk-benefit ratio. Is this information shared? Is it accessible? Is it sold?”

Paul Cunningham, the VA’s deputy assistant secretary and chief information security officer (CISO), testified that the department has to make “risk-based decisions” over the value of the app while balancing security and privacy.

“We’re trying to solve this problem around access to data. If we go strictly by compliance and zero tolerance, we miss out on opportunities that technology brings if we’re not able to share information with third parties that are trusted,” he said.

Health systems are grappling with the same issues around app privacy, as the Department of Health and Human Services (HHS) will soon finalize a regulation that will allow patients to download their health data using third-party apps.

The VA is the process of implementing a multi-billion dollar IT modernization project, including a new electronic health record (EHR) system from health IT vendor Cerner. 

The Mission Act also is expanding the number of VA patients seeking treatment from community care providers which requires more data sharing. The VA needs to ensure that privacy and security policies keep pace with new technology, Lee said.

“As we assess the data landscape at the VA and the larger health IT space, we need to look at where protections exist or don’t exist and whether we need more guardrails,” Lee said. 

Cunningham said the VA has policies and practices to ensure that access to veterans’ information is strictly controlled. Apps that connect to an application programming interface (API) from the VA and are part of VA’s App Store must sign a “comprehensive and strict’ user agreement that sets limits to how health data can be used, he said.

The VA’s acceptable use agreement includes a commitment not to sell patient data.

Cunningham told lawmakers that VA does not “police” the networks of third parties, but the department would take “swift action’ to investigate if a breach was discovered.

Like many in the healthcare industry, Cunningham acknowledged that he has concerns about how third-party companies not regulated by the Health Insurance Portability and Accountability Act (HIPAA) use health data and the potential privacy risks for veterans.

“It’s difficult to make sure that people really understand when they accept an app that they understand the full access they are granting and how that information will be used downstream,” he said.

Privacy policies used by apps can be thousands of words long and many consumers do not read them, Lee noted.

Key lawmakers are considering whether federal laws like HIPAA need to be updated to better protect veterans’ sensitive health information.

Rep. Jim Banks, R-Indiana, ranking member of the committee, wants to see the HIPAA privacy rule updated to prevent health data from being monetized. 

“Today some of the HIPAA-permitted purposes to asses patient records when applied in a new context, could become loopholes,” he said. “The health technology landscape is evolving quickly. Mobile apps already have taken over the software marketplace. In a few years, most health records will be stored in the cloud. Privacy safeguards have to evolve as well.”

Women and family health startup Maven landed $45 million in series C funding with some high-profile backers.

The funding round was led by Icon Ventures with participation from existing investors Sequoia, Oak HC/FT, Spring Mountain Capital, Female Founders Fund and Harmony Partners.

Individual strategic investors include Reese Witherspoon, Natalie Portman, Mindy Kaling and 23andMe CEO Anne Wojcicki.

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

Over the last 12 months, Maven has expanded rapidly, driven by the adoption of its family benefits platform among individuals, employers and health plans seeking better solutions for women’s health, family planning and diversity in the workforce, the company said.

The latest round of funding will be used to support Maven’s growth, deepen investment in its core digital programs across fertility, maternity, return-to-work and pediatrics and expand into adjacent areas.

Ten women’s health digital startups brought in $177 million in funding through the third quarter of 2019, and funding for women’s health companies has risen 812% from 2014 to 2018, according to Rock Health. But only a few women’s health startups have made it to a series C round.

Founded in 2014 by Katherine Ryder, Maven has raised $88 million to date.

The company was initially started as an app but grew into a business that helped employers offer benefits to support their workers with maternity and fertility costs. The product was designed to offer women “end-to-end” support in areas including preconception, egg freezing, IVF/IUI, adoption, surrogacy, pregnancy, postpartum, early pediatrics, return-to-work and breast milk shipping.

Maven was among FierceHealthcare’s 2020 class of Fierce 15 winners.

Ryder told FierceHealthcare in December that she started the company because she saw major gaps when it came to offerings for women, who make up the dominant customer base in healthcare. And that was particularly the case when it came to the biggest healthcare decision of their lives: starting a family.

The company recently launched Maven Wallet, a new feature designed to help members better manage receipts and expenses associated with fertility, egg freezing, adoption and surrogacy reimbursement.

“We believe that women’s and family health is not just a vertical, but the core of a functional healthcare system. With this latest round of funding, Maven will continue to double down and invest in the long term to drive meaningful, sustained change,” Ryder said.

“Maven is addressing critical gaps in care by offering the largest digital health network of women’s and family health providers,” Tom Mawhinney, lead investor from Icon Ventures, said. “With its virtual care and services, Maven is changing how global employers support working families by focusing on improving maternal outcomes, reducing medical costs, retaining more women in the workplace, and ultimately supporting every pathway to parenthood.”

Mawhinney will join the Maven board of directors.

Last year, the company tripled in size to offer care to 5 million women and families. Maven’s women’s and family telehealth network has expanded to include 1,700 providers across more than 20 specialties.

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.