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FDA Chief Calls For Stricter Scrutiny Of Electronic Health Records

Food and Drug Administration Commissioner Scott Gottlieb on Wednesday called for tighter scrutiny of electronic health records systems, which have prompted thousands of reports of patient injuries and other safety problems over the past decade.

“What we really need is a much more tailored approach, so that we have appropriate oversight of EHRs when they’re doing things that could create risk for patients,” Gottlieb said in an interview with Kaiser Health News.

Gottlieb was responding to “Botched Operation,” a report published this week by KHN and Fortune magazine. The investigation found that the federal government has spent more than $36 billion over the past 10 years to switch doctors and hospitals from paper to digital records systems. In that time, thousands of reports of deaths, injuries and near misses linked to EHRs have piled up in databases — including at least one run by the FDA.

Gottlieb said Congress would need to enact legislation to define when an electronic health record would require government oversight. He said that the digital records systems, which store a patient’s medical history, don’t fit neatly under the agency’s existing mandate to regulate items such as drugs and medical devices.

Gottlieb said the best approach might be to say that an EHR that has a certain capability becomes a medical device. He called EHRs a “unique tool,” noting that the risks posed by their use aren’t the same as for a traditional medical device implanted in a patient. “You need a much different regulatory scheme,” he said.

The 21st Century Cures Act of 2016 excludes the FDA from having oversight over electronic health records as a medical device.

Gottlieb said that health IT companies could add new functions that would improve EHRs, but they have been reluctant to do so because they didn’t want their products to fall under FDA jurisdiction. He added that he was “not calling” for FDA to take over such a duty, however, and suggested that any new approach could be years away. Proponents have long argued that widespread use of EHRs can make medicine safer by alerting doctors to potential medical errors, though critics counter that software glitches and user errors may cause new varieties of medical mistakes.

How closely the FDA should watch over the digital medical record revolution has been controversial for years. The agency’s interest in the issue perked up after Congress decided in February 2009 to spend billions of dollars on digital medical records as part of an economic stimulus program.

At the time, many industry groups argued that FDA regulation would “stifle innovation” and stall the national drive to bring medicine into the modern era. Federal officials responsible for doling out billions in subsidies to doctors and hospitals generally sympathized with that view and were skeptical of allowing the FDA to play a role.

The debate became public in February 2010, when Jeffrey Shuren, an FDA official, testified at a public hearing that the agency had tied six deaths and more than 200 injuries to health information technology. In all, the FDA said, it had logged 260 reports in the previous two years of “malfunctions with the potential for patient harm.”

The agency said the findings were based largely on reports voluntarily submitted to the FDA and suggested “significant clinical implications and public safety issues.” In one case cited, lab tests done in a hospital emergency room were sent to the wrong patient’s file. Since then, several government and private repositories have associated thousands of injuries, near misses and deaths to EHR technology.

Shuren said in 2010 that the agency recognized that health information technology had great potential to improve patient care, but also needed oversight to “assure patient safety.”

While some safety proponents agree that EHRs offer tremendous benefits, they also see a greater opportunities to improve their safety.

Dean Sittig, a professor of bioinformatics and bioengineering at the University of Texas Health Science Center, said EHRs have improved safety within the health care system, but they have not eliminated errors to the extent that he would have expected. Federal officials were initially pushing for rapid adoption and “there wasn’t a lot of interest in talking about things that could go wrong,” Sittig told KHN and Fortune.

Earlier this month, Gottlieb announced his resignation from the FDA. His last day is scheduled to be April 5.

KHN correspondents Sarah Jane Tribble, Sydney Lupkin and Julie Rovner contributed to this report.

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Podcast: KHN’s ‘What The Health’ Surprise! Fixing Surprise Medical Bills Is Harder Than it Looks

Surprise medical bills — when patients receive an unexpected bill from a health provider not in their insurance network — are among the few problems in health care just about everyone wants to solve. But it turns out that no one in the health industry wants to take responsibility for paying those bills. That could complicate efforts toward a legislative fix, despite bipartisan support.

And the 2020 presidential campaign is already in full swing, with candidates staking out some surprisingly diverse positions on how to expand access to health care.

This week’s panelists are Julie Rovner of Kaiser Health News, Joanne Kenen of Politico, Anna Edney of Bloomberg News and Alice Miranda Ollstein of Politico.

Also, Rovner interviews Scott Gottlieb, the commissioner of the Food and Drug Administration, who is stepping down in early April.

Among the takeaways from this week’s podcast:

  • State and federal lawmakers of both parties and industry groups say they want to find a way to protect patients from getting surprise bills from out-of-network doctors and hospitals after treatment. But they can’t find agreement on a way to fix the system.
  • Efforts to end surprise bills generally fall into two categories: setting rates for out-of-network services (which might be based on some percentage of Medicare rates) or requiring patients and providers to go through an arbitration process (a technique some states are using).
  • Among Democratic candidates for president, the push for switching to a “Medicare-for-all” system appears to be moderating a bit as more centrists call for less sweeping changes in the health care system, hoping to avoid blowback from people who like their current insurance and a united opposition from industry groups.
  • The Trump administration’s budget proposal would put money behind the effort to stop the spread of HIV. But while medical advances have made HIV eradication possible, obstacles remain, including the difficulty of reaching many of the communities that need the support.

Plus, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read too:

Julie Rovner: Fortune’s “Death by a Thousand Clicks: Where Electronic Health Records Went Wrong,” by Erika Fry and KHN’s Fred Schulte

Joanne Kenen: NBC’s “Surprise Medical Bills Lead to Liens on Homes and Crippling Debt,” by Lindsey Bomnin and Stephanie Gosk

Anna Edney: Stat News’ “The Astounding 19-Year Journey to a Sea Change for Heart Patients,” by Matthew Herper

Alice Miranda Ollstein: The New York Times’ “States Seek Financial Relief for Family Caregivers,” by KHN’s Samantha Young

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunesStitcher or Google Play.

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Lengthy Training, Licensing That Health Care Occupations Require Creating Significant Skill Gap For Those Looking For Jobs

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