When it comes to electronic health records mum’s the word.
Earlier this year I wrote a post, Two Dirty Little Secrets About Electronic Health Records [reprinted below], in which I reported that Epic Systems and other EHR companies require hospitals to sign a non-dispargement agreement, or “gag” clause. In fact, I reported, Epic doesn’t even allow its hospitals and physicians to publish screen shots of its software without prior permission.
In response to my post I received a fair amount of pushback. Some readers doubted whether these restrictions actually existed. Now a Politico investigation by Darius Tahir provides important new evidence that these gag orders do in fact exist.
A POLITICO investigation found that some of the biggest firms marketing electronic record systems inserted “gag clauses” in their taxpayer-subsidized contracts, effectively forbidding health care providers from talking about glitches that slow their work and potentially jeopardize patients.
POLITICO obtained 11 contracts through public record requests from hospitals and health systems in New York City, California, and Florida that use six of the biggest vendors of digital record systems. With one exception, each of the contracts contains a clause protecting potentially large swaths of information from public exposure. This is the first time the existence of the gag clauses has been conclusively documented.
“The insiders tell me it’s the confidentiality and intellectual property clauses [that] are the biggest barriers to reporting adverse events,” said David Classen, chief medical information officer of Pascal Metrics. Classen co-authored a landmark 2011 Institute of Medicine report warning that such contracts were a key reason for the lack of knowledge about health IT-related patient safety risks.
Critics say the clauses – which POLITICO documented in contracts with Epic Systems, Cerner, Siemens (now part of Cerner), Allscripts, eClinicalWorks and Meditech – have kept researchers from understanding the scope of the failures.
One particularly sensitive issue has been sharing screenshots. Vendors can forbid their publication, arguing that would give away advantages in design or technology. But without them, it’s impossible to see the confusion that badly constructed software poses to a physician.
“I have … personally asked Judy [Faulkner, Epic’s CEO] for permission to publish screenshots in a student’s master’s thesis and have been told no,” said Dean Sittig, a health IT researcher at University of Texas Health Science Center at Houston.
Others say vendors are arbitrary in their approval process for sharing screenshots.
Bob Wachter, interim chair of the department of medicine at the University of California, San Francisco, cites an example from his recent book, The Digital Doctor.
The book hinges on a case study of a pediatric patient who received a 39-fold overdose of an antibiotic. Epic’s software, Wachter argued, played a contributing role in the overdose, and he wanted to buttress his argument with screenshots from the software.
The approval process was a chore, Wachter said in an interview, and Epic was “quite prescriptive about what I could and couldn’t show.” Nevertheless he eventually received approval.
But when Wachter posted a book excerpt on social media website Medium, he received a “fairly angry email” from Epic executive Carl Dvorak, who demanded he remove the post. Epic had granted permission to publish the screenshots in the book – not in any other form, Dvorak said.
But a lot of problems may go under-reported. That offends Wachter, who says the patient safety world “takes it as religion” that information be shared as widely as possible.
“These are worlds colliding. You can understand why a technology business would put restrictions on screenshots. But we’re not making widgets here, we’re taking care of sick people,” he said.
“At some level, I’d say, ‘How dare they?’”
Here’s what I wrote earlier this year:
Two Dirty Little Secrets About Electronic Health Records
Here are two dirty little secrets about electronic health records (EHR). Just about everyone in the field already knows these secrets, and many are quietly horrified, but few want to discuss them since there are no obvious or easy solutions.
EHRs Are a Threat to Freedom of Speech and Academic Freedom
Epic Systems, a privately-held company, is the largest provider of EHRs. Most of the big medical centers, including all of the top 10 academic medical centers in the US, use Epic. Like many other EHR companies, Epic requires hospitals and physicians to sign a non-dispargement agreement, or “gag” clause. In fact, Epic doesn’t even allow its hospitals and physicians to publish screen shots of its software in use.Think about that for a second: Epic users– including a large percentage of the leading physicians in the country– are legally forbidden to criticize their EHR or even share images of how it works.
Bob Wachter, a leading doctor at UCSF, recently wrote about a case in which a young patient nearly died after receiving a massive overdose of an antibiotic. The incident was caused in large part by the poor design and interface of the Epic system. Wachter needed to obtain permission from the CEO of Epic to reproduce screenshots to tell the story. Wachter, who was recently named Modern Healthcare’s most influential physician in 2015, would not have been able to fully tell this important story without the permission of Epic.
My question: how is it even possible that the top hospitals and medical schools in the country agreed to this severe restriction on academic freedom and freedom of speech? How is it that one company can limit the ability of doctors to write about their cases? Imagine for a moment if a pharmaceutical company insisted that hospitals and doctors could only use its drugs if they agreed not to say bad things about those drugs. I understand that there may be some legitimate issues involving proprietary information, but this limitation goes way beyond any possible legitimate interpretation.
Electronic Health Records Are Not Even Electronic Health Records
Here’s the second secret: EHRs are not really EHRs. That is to say, electronic health records were not designed with the primary goal of helping physicians and other healthcare workers provide the best possible healthcare to their patients. Instead, the primary goal of EHRs is to make sure that healthcare providers receive maximum reimbursement and to provide data to executives to help them “manage” their workers and their systems. EHRs have not been designed by doctors and nurses and patients for the use of doctors and nurses and patients. Instead, these systems have been designed for healthcare executives to manage their enormously and increasingly unwieldy and complex systems.
EHRs and the Future
I don’t want to give the wrong impression: I’m not against EHRs. The future of medicine and our healthcare system depends on their success. Let me just briefly mention two important reasons. One, it is clear that the significant advances promised from “Big Data” or “Precision Medicine” will require an efficient and trustworthy EHR. Two, EHRs are absolutely required if we are going to have randomized registry trials, which may well be the best single way to bring a solid base of evidence to the vast amount of medical care for which no evidence base exists.
But we are not going to be able to achieve those goals if we have proprietary, closed systems, immune from criticism and scrutiny, designed for bureaucrats and not healthcare providers.