Federal officials on March 9 released groundbreaking rules that will let patients download their electronic health records (EHRs) and other health care data onto their smartphones.
"Patients should have control of their records, period. Now that's becoming a reality," said Health and Human Services Secretary Alex Azar. "These rules are the start of a new chapter in how patients experience American health care."
Officials said the rules likely will give patients a greater say in health care decisions and put an end to a long-standing practice in which some doctors and hospitals resist handing complete medical files over to patients upon demand. Many of the provisions are set to take effect in 2022.
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New Rules for Digital Charts
The Department of Health and Human Services issued two rules to give patients greater access to their electronic health records. Among the key provisions:
- Patients must be able to access their medical records on a smartphone at no cost and can share those records as they choose.
- Health systems must be able to exchange information about patients' past medical treatments or conditions.
- "Information blocking" practices (that is, anti-competitive behaviors) by health care providers, developers of EHRs and others are prohibited.
- EHR certification requirements are updated so that health professionals can discuss safety and usability concerns without being bound by gag clauses in software sales contracts.
- Insurers are required to share health claim data with patients on Medicare and Medicaid through a mobile app.
- Insurers must advise patients of their network of health providers through an app.
"The days of patients being kept in the dark are over," said Centers for Medicare & Medicaid Services Administrator Seema Verma. "In today's digital age, our health system's data-sharing capacity shouldn't be mired in the Stone Age."
Yet the new rules also have raised concerns about privacy as technology companies, such as Google, Microsoft, Apple and Amazon, open up new markets for providing medical records through mobile apps. Major EHR vendor Epic, for instance, has warned that freer flow of medical records could spur the unwanted sale of data or other unauthorized uses.
"Family members may be shocked to find that their most personal health data has been mined and sold by data brokers and is now known by others, Epic CEO Judy Faulkner wrote last June in opposing the rules.
Administration officials said they have taken privacy considerations into account and would require developers to attest to plans to protect the security and use of medical data.
Verma took a swipe at Epic in an interview with Kaiser Health News and Fortune.
"We're not afraid to take on special interests to do what's right for patients. Some people disagree because they want to keep the data," she said. "The reality is that patient data belongs to patients. It doesn't belong to EHR companies."
Verma said the nation's health care system remains "hugely expensive and inefficient as repeat tests drive up costs and, perhaps most importantly, doctors are forced to provide care with an incomplete clinical picture, especially at a time when the health care systems could be under stress."
"With the handling of the COVID virus, the urgent need for coordinated integrated care could not be clearer," she said.
Donald Rucker, who coordinates health information technology policy for HHS, said the new rules "will allow patients the ability to manage their health care the same way they manage their finances or the travel or other parts of their life on their smartphone."
Patients will be able to manage their health care the same way they manage their finances, travel or other parts of their life on their smartphone.
While Epic, the maker of the most-used EHR software, led a campaign to derail the rules, its chief competitor, Cerner Corp., argued the rules were long overdue.
"Consumers should have the right to access the health care information their providers have about them and dictate where they want it to go. Although existing laws allow patients to access their data, it doesn't work," Cerner CEO Brent Shafer said in a statement.
The rules also attempt to prevent EHR vendors from silencing critics of their software products. The government wants to encourage doctors and other users of EHR technology to share their experiences about software problems by prohibiting so-called gag clauses in sales contracts. That could free users to criticize EHR systems, including more open discussion of flaws, software glitches and other breakdowns.
"Botched Operation," an investigation published by Kaiser Health News and Fortune last year, found that the federal government has spent more than $36 billion on the EHR initiative. Thousands of reports of deaths, injuries and near misses linked to digital systems have piled up in databases over the past decade—while many patients have reported difficulties getting copies of their complete electronic files, the investigation found.
Consumers have long sought to be more in the loop on health care decisions in a user-friendly form. Many specifics about how that will happen, including how patients would make sense of complex pricing policies for purchasing health care and insurance and assessing quality, remain unclear, however.
To cut down on exorbitant "surprise" medical bills, Verma said, the CMS' new rules would require insurers to let patients know which medical providers are in their networks. One study found that such bills—often not covered by insurance—have struck more than half of American adults.
For well over a decade, federal officials have struggled to set up a digital records network capable of sharing medical data and patient records. In 2004, President George W. Bush said he hoped to have a digital record for most Americans within five years. In early 2009, the Obama administration funneled some $36 billion in economic stimulus money to help doctors and hospitals buy the software needed to replace paper medical files.
Despite the slow progress, federal officials remain optimistic that digital records will save the nation billions of dollars while reducing medical errors, unnecessary medical testing and other waste—and encouraging more Americans to take a bigger role in managing their health care by comparing prices.
John Schultz is a senior correspondent at Kaiser Health News. Erika Fry is a senior writer for Fortune magazine. © 2020 Kaiser Family Foundation. All rights reserved. Reposted with permission.
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