Tuesday, March 6, 2012

AMA News Article Offers Incomplete (and Thus Misleading) Advice on the Legal Risks of EHRs and other Clinical IT

An article was published in the AMA News by Alicia Gallegos, AMA Medical News staff, entitled "Legal risks of Going Paperless." While it is not clear if these are the official views of the AMA leadership, the article is interesting nonetheless.

It should perhaps have been entitled "Some of the Legal Risks of Going Paperless, excluding the ones that make the health IT industry look bad:"

Legal Risks of Going Paperless
AMA News
March 5, 2012

Electronic medical records are meant to save time and money, but they also can create liability issues for doctors.

By Alicia Gallegos, amednews staff.

Defense attorney Catherine J. Flynn knows how electronic medical records can overwhelm — and often change — the course of a medical liability lawsuit.

In one of her cases, a New Jersey doctor being sued for medical negligence has been accused by a plaintiff’s attorney of modifying a patient’s electronic history. A printing glitch caused the problem, Flynn said, but the accusation has meant extra time and defense costs. Computer screen shots were reviewed, more evidence was gathered and additional arguments were made.

“This has taken a life of its own, and we’ve done virtually no discovery on the medical aspects of the case,” she said. “The cost of the e-discovery alone is in excess of $50,000.”


This is a variation on the theme of plaintiff's lawyers being the cause of EHR problems as I wrote at "Plaintiff's Trial Lawyers Are to Blame for EHRs That 'Tattle' on Doctors - And Harm Patients."

System breaches. Modification allegations. E-discovery demands. These issues are becoming common courtroom themes as physicians transition from paper to EMRs, legal experts say. Not only are EMRs becoming part of medical negligence lawsuits, they are creating additional liability.

Missing is the problem that is most important of all: health IT system defects, poor user interfaces, unreliability, data loss, etc. causing or contributing to medical malpractice that results in patient harm or death. (An example that I personally observed and reported to the FDA MAUDE database is here; there are numerous others in this blog.)

Data breaches are among the most common reasons that electronically stored information lands doctors in court, said Lisa Gallagher, senior director for privacy and security at the Health Information and Management Systems Society, which advocates health information technology

Most common perhaps (a big problem unto itself), but not the most clinically significant problem. Yet the AMA article goes on about this issue for many paragraphs; it's the prime focus of the article.

A 2011 ruling in New York highlights how e-discovery creates a burden for doctors.

During a lawsuit against St. Luke’s Hospital Roosevelt Center, a debate arose about whether the plaintiff should be allowed access to screen shots from a doctor’s computer. Joan Bowman, who sued the hospital for wrongful death on behalf of her husband, wanted to see a computer template used to aid physicians in diagnoses. The hospital said the request was overly broad and oppressive.

But the Supreme Court of the State of New York ordered the release of the screen shots.

“Defendant doctors testified that they utilized these materials in coming to their diagnosis,” Judge Alice Schlesinger wrote. “It is not a stretch to allow counsel to see and understand these materials.”

At this article’s deadline, the hospital’s attorney had not returned messages seeking comment.

The case sets a precedent, said Susan Dennehy, Bowman’s attorney.

“If others want to see screen shots from records, I think they’ll rely on this case,” she said. “It was important to see where the template led you if you put in an inaccurate chief complaint.”


Note the "spin" about the "burden for doctors" of eDiscovery. To the pundits and voluntary adopters: you have gotten what you asked for. To the non-pundit clinicians forced to use health IT: I hate to say this, but you've gotten screwed.

The article then offers a laundry list of how to avoid EHR-related liability:

... As the number of electronic medical records increases, so do certain legal risks, medical liability experts say. Common mistakes doctors make with EMRs and how attorneys recommend that physicians reduce their liability risks:

Mistake: EMRs allow users to move quickly through patient records, but cutting and pasting information makes it easy to paste incorrect information.
Recommendation: Refrain from copying and pasting EMR data, and be cautious when moving from one patient’s record to the next.

Mistake: Computer programs can help doctors make a differential diagnosis, but the templates don’t often include every possible symptom and corresponding medical condition.
Recommendation: Doctors should not become overly dependent on electronic diagnosis aids. Electronic systems are no substitute for hands-on diagnosis.

Mistake: Because EMRs allow physicians to move through patient charts much more quickly than paper charts, attorneys are noticing that some doctors are not being thorough when writing notes electronically.
Recommendation: Physicians should keep meticulous electronic notes on each patient and take time to document each chart.

Mistake: Some practices can fail to safeguard electronic patient data.
Recommendation: Practices should encrypt all information on computer devices and have policy that discourages employees from taking portable devices out of the office.

Mistake: A system may not clearly indicate changes to records.
Recommendation: Physicians should install systems that show transparency when modifications are made and/or have a program lockout period where no more modifications can be made to a record.

Mistake: Doctors may fail to follow notification requirements in the event of a data breach.
Recommendation: Be clear on what your state law requires when a data breach occurs, and make sure employees follow the rules immediately.

Mistake: Doctors may destroy or delete electronic records when a lawsuit is possible.
Recommendation: If doctors suspect they are being sued, they must preserve all electronic data related to the patient in question, including emails, phone messages and computer records.


Missing is this, as is well-covered by almost 8 years of posts on this blog, and elsewhere:

Big mistake: Doctors and hospitals buy and implement experimental technology approved by nobody, of uncertain quality to the point of losing or corrupting data, often with glass-tube black-and-white TV user interface modernity. Such technology is "errorgenic", i.e., it promotes "use error", can mislead, and can promote medical errors.
Recommendation: Hold off until the industry has gotten its act together.

Also missing from the AMA News article is the fact that physicians and hospitals use health IT at their own risk, even if the IT is "certified."

This article is clearly pregnant with omissions and spin that reveal a pro-health IT bias.

-- SS

Another Health IT Mythbuster: Doctors order more X-rays, not fewer, with computer access

This piece is in the Washington Post about a just-released piece in Health Affairs (at this link) by Danny McCormick, David H. Bor, Stephanie Woolhandler and David U. Himmelstein of Harvard Medical School.

(Woolhandler and Himmelstein have written on such topics before, such as in the Nov. 2009 article “Hospital Computing and the Costs and Quality of Care: A National Study”, Amer J Med 123:1; 40-46.)

In the abstract of the new article, the researchers note:

Giving Office-Based Physicians Electronic Access To Patients’ Prior Imaging And Lab Results Did Not Deter Ordering Of Tests

Health Aff March 2012 vol. 31 no. 3 488-496

Abstract
Policy-based incentives for health care providers to adopt health information technology are predicated on the assumption that, among other things, electronic access to patient test results and medical records will reduce diagnostic testing and save money.
To test the generalizability of findings that support this assumption, we analyzed the records of 28,741 patient visits to a nationally representative sample of 1,187 office-based physicians in 2008. Physicians’ access to computerized imaging results (sometimes, but not necessarily, through an electronic health record) was associated with a 40–70 percent greater likelihood of an imaging test being ordered. The electronic availability of lab test results was also associated with ordering of additional blood tests.
The availability of an electronic health record in itself had no apparent impact on ordering; the electronic access to test results appears to have been the key. These findings raise the possibility that, as currently implemented, electronic access does not decrease test ordering in the office setting and may even increase it, possibly because of system features that are enticements to ordering. We conclude that use of these health information technologies, whatever their other benefits, remains unproven as an effective cost-control strategy with respect to reducing the ordering of unnecessary tests.

The WaPo offered these observations in their article:

Doctors order more X-rays, not fewer, with computer access

By , Published: March 5

In the debate over the high cost of health care, federal policymakers have always claimed that one way to cut costs is for doctors to use electronic medical records and other information technology. Doing so, they say, avoids duplication and saves money.
But new research suggests that may not be the case.
Doctors who have easy computer access to results of X-rays, CT scans and MRIs are 40 to 70 percent more likely to order those kinds of tests than doctors without electronic access, according to a study to be published in the March issue of the journal Health Affairs.

This is not surprising to me. Click a button, order an test, click a button, get the results. What could be easier?
What the pundits failed (and continually fail) to take into account is the social context of health IT. It is not used on a robotic assembly line. There are incentives, both proper and perverse (e.g., "defensive medicine", profits, patient demands) that figure into how any IT will "play out" in healthcare.
Making the blanket statement that "IT in healthcare will save money" without solid, sustained evidence (as opposed to the anecdotal evidence that now exists), while simultaneously ignoring contrary evidence is simply promoting an industry-created meme, a.k.a. wishful thinking.

“On average, this is comparing doctors who had electronic medical records and those who didn’t,” said lead author Danny McCormick, a physician and assistant professor of medicine at Harvard Medical School.
Researchers say the findings challenge a key premise of the nation’s multibillion-dollar effort to promote the widespread adoption of health information technology.
“This should give pause to those making the argument,” McCormick said. Instead of saving money, that effort could drive costs higher, he said.
For the study, researchers at the Cambridge Health Alliance, a health system in Cambridge, Mass., and the City University of New York analyzed data from a 2008 federal government survey. The data included information collected from 28,741 patient visits to 1,187 office-based doctors. The information included the type of doctor, their office computerization and the tests ordered at each visit. About half of the doctors’ offices surveyed had computerized access to results of X-rays and other imaging tests.
Researchers found that doctors who did not have computerized access ordered imaging tests in 12.9 percent of visits, while doctors with electronic access ordered imaging in 18 percent of visits, a 40 percent greater likelihood. Doctors with computerized access were even more likely — about 70 percent more likely — to order advanced imaging tests, such as PET scans, which experts said are most commonly used to detect cancer, heart problems, brain disorders and other central nervous system disorders.
The study found the results hold true even after taking into account other factors, such as patient demographics, doctor specialty and physician self-referral.

Unfortunately, nothing up to and including HIT-related patient deaths will give pause to health IT pundits pushing national rollout. They have too much skin in the game in the health IT bubble, psychologically (link) and financially.

The pundits need to be opposed by medical and legal professionals in an organized, systematic fashion until such time as this industry follows the National Academies' direct recommendations on getting health IT "right."

... Researchers were not able to determine why physicians ordered the imaging tests, or whether in those cases, physicians had looked at patients’ prior chest X-rays. Nor were they able to assess whether the increased imaging helped or harmed patients.

That needs to be followed up upon, obviously. Will it? Probably not.

At some flagship hospitals with customized health information technology systems, for example, doctors get specific feedback about diagnostic tests that can result in ordering fewer tests.

Note the word "can." (After decades there is no rigorous, unopposed proof, yet we are embarking on a national rollout with penalties for non-adopters?) This rationalization is both the "it will be better in version 2.0" and wishful thinking combined.

Michael Furukawa, a health economist in the Office of the National Coordinator for Health Information Technology, the administration’s health IT czar, said the researchers’ focus was not deep enough to support the study’s conclusions.
“The data are sound, the methods are appropriate, but the focus is limited,” he said. “They only looked at one piece of health IT.”

"But the focus is limited?"

So what?

That was all they intended to look at, and the result was concerning. Moving the goalposts is not a valid refutation of research.

On the other hand, coming from a political office that clearly does not understand how to conduct qualitative research and creates political promotion pieces masquerading as "research", such a statement is not surprising. See "ONC: "The Benefits Of Health Information Technology: A Review Of The Recent Literature Shows Predominantly Positive Results" at this link, where essential research methodologies were thrown under the bus for publication in Health Affairs.

At least the deviations from rigorous research methodologies were admitted:

“... Our findings must be qualified by two important limitations: the question of publication bias [e.g., bias in evidence selection - ed.], and the fact that we implicitly gave equal weight to all studies regardless of study design or sample size.”

Unfortunately, the media, politicians, financial decisionmakers and others are likely not to really comprehend, in-depth, the full significance of that sentence.

I can only imagine the reaction to such an excuse made by pharma for the mainstreaming of a risk-prone drug.

I personally take with the greatest of skepticism anything coming from ONC, an increasingly politicized government office in my observation.

You should, too, in my opinion.

-- SS