Patients as lab rats for beta software: have sancrosanct patient's rights been trivialized, while poor software of non-trivial risk been sanctified?

I have noted a class action lawsuit vs. Allscripts and Eclipsys, EHR producers, regarding a merger:

UNITED STATES DISTRICT COURT, NORTHERN DISTRICT OF ILLINOIS, EASTERN DIVISION; BRISTOL COUNTY RETIREMENT SYSTEM, Individually and on Behalf of All Others Similarly Situated, Plaintiff, vs. ALLSCRIPTS HEALTHCARE SOLUTIONS, INC., GLEN E. TULLMAN, WILLIAM J. DAVIS AND LEE SHAPIRO, Defendants.

The Lead Plaintiffs' Amended Complaint is available here in PDF:  http://securities.stanford.edu/1048/MDRX00_01/2013515_r02c_12CV03297.pdf.  It is worth reading, if just to understand the inner workings of an unregulated healthcare device industry on which your well-being and that of your family increasingly depends.

Lead Plaintiffs' Amended Complaint, available here in PDF:  http://securities.stanford.edu/1048/MDRX00_01/2013515_r02c_12CV03297.pdf

The lawsuit is primarily about alleged misrepresentations made to investors by Allscripts and Eclipsys in a merger regarding inability to integrate products, leadership chaos, and materially false and misleading statements and omissions made during the Class period by these companies about their progress.

I note that in a chaotic environment such as alleged, product safety is not likely a big concern.

However, even more ominous are the allegations of deliberate use of beta software on patients without informed consent or any knowledge by patients whatsoever of its use, which apparently did not work out well.  Not indicated is if patient harm occurred.  If the allegations are true, considering the ECRI Deep Dive health IT risk study results of nearly 200 health IT "incidents" in 36 hospitals over 9 weeks voluntarily reported, including 8 harm incidents and 3 possible deaths - see http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html it would not be surprising.

From the Complaint, allegations on software beta testing are as follows.  Emphases mine:

41. CW1 [coded person's name - ed.] explained the different interface integration systems as native integration, disparate integration, and High Level 7 “HL7” interface. The goal of native integration was to have the ability to update patient information throughout the Allscripts’ software offerings. This would allow Allscripts’ Sunrise products to seamlessly integrate with Allscripts’ Enterprise, Professional and MyWay products and allow the products to update patient health records without the use of industry standardized codes. Allscripts branded its native software as ADX. [see Complaint footnote 2.] CW1 described disparate integration as allowing Allscripts software to interface with non-Allscripts software which he described as a Health Information Exchange (“HIE”) software that allowed data to be read and
updated from different software vendors.

42. CW1 said ADX 1.0 was designed to pull and update patient electronic health records automatically and was Allscripts’ native integration software. In approximately July 2011, he learned that Allscripts began a complete reworking of ADX 1.0 because customers were complaining about the lack of functionality and integration, and that it did not allow the user to review and approve changes made in other healthcare settings before being accepted by the hospital or physician practice systems. [If the allegations are true, these problems would be creating on its face significant risk of oversights, confusion and medical errors  - ed.] The upgrade was going to be known as ADX 1.5, but the method and interface for data integration changed. In particular, the interface was changed to allow clinicians to approve changes before they were entered into the system. He also learned from other Allscripts employees that ADX 1.0 was being beta tested [see Complaint footnote 3] at Blessing Hospital in Quincy, Illinois and another place he could not recall, but it was suspended in approximately the middle of 2011 because it failed to perform to expectations. [see Complaint footnote 4] [Remarkable - if the allegations are true, experimental software was being beta tested on live patients and was stopped because it did not "perform to expectations" - and what of the unconsenting meatbags a.k.a. patients it was purportedly tested on? - ed.]

Complaint footnotes:

[2] CW1 described the HL7 interface as using industry standardized codes or language to allow users of disparate software systems to update patients electronic health records.

[3] In software development, “beta testing” generally refers to a testing phase in which a subset of the intended user population tries the product out, in order to see how the product works in real-world conditions.  [What sane patient would consent to such testing of medical IT involved in their care, to 'see how it works in real-world conditions'? - ed.]

[4] See also ¶158 (Defendant Davis’ May 8, 2012 statement “our initial release of our integrated capability...was launched in the middle of last year”); ¶189; cf. ¶76 (CW11’s statement that beta testing at Blessing occurred in late 2011 and was halted in Spring 2012);

Again, I find the allegations of great concern - that experimental software was being beta tested on live patients and was stopped because it did not "perform to expectations."  If true, what of the unconsenting meatbags a.k.a. patients?  They would not have counted for much.

More from the Complaint in Count 50:

50. Consistent with CW2, CW3 said the Helios system was never taken to production while he worked at Allscripts. After he left to join Medicity he had heard that Allscripts delivered a Helios type product for beta testing in the fall of 2011 at the New York Presbyterian Hospitals and it did not go well and that the beta testing of the Helios product at the North Shore Long Island Jewish Community Hospital was scratched prior to implementation.

If the allegations are true, New York Presbyterian Hospitals in the fall of 2011 were performing beta testing of software so bad it was deemed unacceptable for LIJ Community Hospital.  Again, if true, what about the risks patients were subjected to, and ... were any harmed?

Still more in Count 76:

76. CW11 said that Blessing Hospital in Quincy, Illinois was beta testing ADX 1.0 sometime in late 2011, but could not recall specifically when it began. CW11 said he was told that the testing was stopped in early 2012 because the product was not working properly and Allscripts deployed a product development team to Blessing Hospital to develop a workflow which lead to ADX 1.5. As far as CW11 knew, no one went live on ADX 1.0. Blessing Hospital began testing ADX 1.5 in late Spring 2012, and was the first to go live using ADX 1.5 in July 2012 which allowed the integration of patient information seamlessly between Sunrise and Enterprise applications. Components of Helios went into ADX 1.5. ADX 1.5 allowed for integration of patient data relating to PAMI (problems, allergies, medications, and immunizations) but some competitor products allow for significantly more types of data to be seamlessly exchanged and Allscripts was working to increase the types of data that could be seamlessly exchanged between acute care and ambulatory applications.

In effect, if the allegations are true, sancrosanct patient's rights have been trivialized, while poor software of non-trivial risk has been sanctified.

This would be, needless to say, deranged.  Software can be debugged in test environments without putting patients at risk - if one is willing to invest the resources to do so.

The Class Action lawsuit Plaintiffs should perhaps seek to discover if there were patient harms or deaths as a result of the alleged software beta testing - assuming that information was not thoroughly "cleansed" by now.

I also note that even small NIH SBIR/STTR grant proposals involving use of new or modified IT on patients, on whose study sections I am an invited reviewer in the domain of Medical Informatics, are subject to human subjects protection evaluation:

http://grants.nih.gov/grants/peer/critiques/sbir-sttr.htm

... Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46 [see http://www.research.uci.edu/ora/forms/hrpp/categories_of_exempt_human_subjects_research.pdf - ed.], the [grant review] committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

In health IT tests in hospital settings, which is most certainly experimentation, there are simply no human subjects protections whatsoever.  Hospital IT deserves no special accommodation regarding Protections for Human Subjects.  There are no justifiable reasons I can think of. 

-- SS

Addendum:  Perhaps I'm wrong about people's generosity and altruism.  I would like to hear from people who would gladly submit, say, their newborns as test subjects for the beta testing of experimental health IT software.

Bad Science (and Perhaps Conflict of Interest) At ONC / HHS

This article recently appeared, quoting Jacob Reider, M.D., chief medical officer at ONC on an upcoming Health IT Safety Plan:

Health Data Management

http://www.healthdatamanagement.com/news/HIMSS13-ONC-HIT-safety-plan-45809-1.html 

ONC Sets Early Summer for Release of HIT Safety Plan

The Office of the National Coordinator for Health Information Technology anticipates releasing a final health information technology safety plan by early summer, officials announced on March 5 at HIMSS13 in New Orleans.

ONC released a draft plan in December and accepted public comment until February 4. The draft followed an Institute of Medicine report that ONC commissioned that highlighted the need for better understanding of the HIT impacts on safety, as well as shared responsibilities among all stakeholders to improve safety, Jodi Daniel, director of the ONC office of policy and planning, said during an educational session.

There is little doubt that use of I.T. results in fewer medical errors, particularly medication-related because of electronic prescriptions and clinical decision support, noted Jacob Reider, M.D., chief medical officer at ONC. “It’s obvious that in many areas there will be fewer errors, but at the same time, in other areas there will be more errors.” Consequently, a priority of the plan will be implementing a framework to help the industry better understand what the trouble areas will be as I.T. use increases.

Less than 1 percent of patient safety events are related to HIT, Reider contended, but the industry needs more data to better understand the level of harm from such events and how to improve the technology. HIT-related errors, he reminded the audience, are not always the fault of vendors; providers can introduce risk when customizing their systems.

The upcoming safety plan release is fine and good, but I, for one, wonder if it can be trusted.

The level of bias and lack of knowledge of the domain, evidence of incomplete research, and/or poor scientific judgement inherent in the statements I bolded above are disturbing.  They are also  reminiscent of the problems in the ONC-authored paper discussed at this link.

First:

• There is little doubt that use of I.T. results in fewer medical errors

On the contrary, there is significant well-researched doubt in that the evidence is quite contradictory.  Let's cite the IOM's 2012 report on health IT risk:

… “For example, the number of patients who receive the correct medication in hospitals increases when these hospitals implement well-planned, robust computerized prescribing mechanisms and use barcoding systems. But even in these instances, the ability to generalize the results across the health care system may be limited. For other products— including electronic health records, which are being employed with more and more frequency— some studies find improvements in patient safety, while other studies find no effect.   

IOM (Institute of Medicine) 2012. Health IT and Patient Safety: Building Safer Systems for Better Care (PDF). Washington, DC: The National Academies Press.

Let's quote one of the IOM study panel members, an international authority on safety, Dr. Richard Cook:

... HIT's cornucopia has been promised repeatedly since the 1960's. Nothing like the promises has materialized.  Indeed, the IOM committee that was commissioned to evaluate the best evidence on this subject found no persuasive evidence that HIT improved patient safety. I know because I was there. 

The body of literature here also contains relevant studies contradicting Dr. Reider's quoted, dispositive statement.

Next:

• It’s obvious that in many areas there will be fewer errors

This statement requires no response, but I'll respond anyway.  

In science, stating something is "obvious" (i.e., what is referred to at the site "36 Humorous Methods of Proof" as "Proof by obviousness") is, on its face, bad science.

Next:

• Less than 1 percent of patient safety events are related to HIT

The aforementioned IOM report was quite clear on the following:

... Several reasons health IT–related safety data are lacking include the absence of measures and a central repository (or linkages among decentralized repositories) to collect, analyze, and act on information related to safety of this technology. Another impediment to gathering safety data is contractual barriers (e.g., nondisclosure, confidentiality clauses) that can prevent users from sharing information about health IT–related adverse events. These barriers limit users’ abilities to share knowledge of risk-prone user interfaces, for instance through screenshots and descriptions of potentially unsafe processes. In addition, some vendors include language in their sales contracts and escape responsibility for errors or defects in their software (i.e., “hold harmless clauses”). The committee believes these types of contractual restrictions limit transparency, which significantly contributes to the gaps in knowledge of health IT–related patient safety risks. These barriers to generating evidence pose unacceptable risks to safety.

... The magnitude of the risk associated with health IT is not known.

Likewise, FDA has concluded that what they know on HIT-related patient safety events is likely "the tip of the iceberg"  due to systematic impediments to knowing, as has the ECRI Institute who has only now begun to study the issue with any degree of rigor.  (The results are of great concern to anyone who should know, or should have made it their business to know, as at this link.)

Perhaps Dr. Reider needs a lesson on basic epistemology:  "We simply don't know what we don't know."

Finally:

• HIT-related errors, he reminded the audience, are not always the fault of vendors; providers can introduce risk when customizing their systems.

I find it remarkable that a government official uses a public/industry platform HIMSS to defend an industry, while at the same time stating more study is needed to understand the causative factors of harm from the industry's products.

This raises the question of conflict of interest, and the possibility this official is not impartial or trying to be "fair" but aiming towards protecting an industry he once worked for - and to where he's likely to return at some point.  (See Roy Poses' posts on "revolving doors" for examples of that.)

From his government biography here:

Dr. Jacob Reider
Director, Office of the Chief Medical Officer

Jacob Reider, MD is a family physician with 20 years of experience in health information technology and special interest in clinical innovation, user experience, and clinical decision support. His background includes leadership roles in nearly all facets of the health IT domain – from small start-up companies to academic facilities, primary care medical groups, and large health IT development organizations. Dr. Reider has served as a member of the Board of Trustees of the American Medical Students Association, the Society of Teachers of Family Medicine, and has served in directorial positions on boards of several innovative health IT companies.

  
I note I do not find evidence of formal medical informatics education, which selfsame ONC recommends for leadership roles in health IT (see my Dec. 2009 post "ONC Defines a Taxonomy of Robust Healthcare IT Leadership"), but I do find roles such as:

Chief Medical Informatics Officer
Allscripts
June 2009 – January 2011 (1 year 8 months)

Medical Director
Allscripts
March 2007 – June 2009 (2 years 4 months)

Chief Medical Officer
MedRemote (Now Nuance)
November 1999 – December 2002 (3 years 2 months)

One might reasonably wonder what personal gains might accrue to Dr. Reider from the promotion of health IT - which includes downplaying its current risks - from an influential government perch.  (I for example held many Merck stock options after my late 2003 departure.  They remained underwater until expiration, but even a a $10 or $20 increase in stock price could have bought me, say, a new sports car or even house.)

I also note that the former CEO of Allscripts, Glen Tullman was, in fact, a close confidant of our current President and advisor on health IT during his first campaign:

A tireless advocate of technology in medicine, Tullman has been featured in virtually every major news outlet. An early supporter of fellow Chicagoan Barack Obama, Tullman introduced him to the Electronic Health Record (EHR) and served on his finance and healthcare committees during the 2008 presidential campaign.

Is it any wonder, then, that my expectation is that the forthcoming ONC HIT safety plan will be biased towards industry, reflect poor science and incomplete/selective research, and overall be a whitewash?

I'll be presenting on issues such as this to the Plaintiff's Bar.  They seem to be the last protectors of people's/patient's rights where clinical IT is concerned - a role they seem most familiar with in other sectors.

I emailed Dr. Reider a link to this post with a request that if he has robust evidence to support his assertions that is not publicly available, to please release it.

-- SS

Mar. 16, 2012 Addendum: 

A correspondent asked me the following that I thought deserved mention beyond the comments section:

"How would he know, exactly, when we know, that they never tallied the thousands of e-Rx errors from a national Siemens defect that was disclosed only at the Brown Medical Center Hospitals (Lifespan) but was a systemwide defect; nor from the Cerner convert to e-Rx defect that was evident at the Trinity Health System; and millions of other errors from when the e-Rx system was unavailable. Or, do they simply do not count those?"

My response?  No, they probably consider those "anecdotal." 

-- SS
 

Medscape re: Class Action suit: "Doctors Who Sued EHR Company Win First Round"

Interesting article about a Class-Action lawsuit against a health IT seller, Allscripts, see Medscape link below (the story is copyrighted so I cannot repost it here).

Relevant excerpts:

On Monday, March 4, a group of doctors who are suing their electronic health record (EHR) manufacturer for selling them a "buggy" product and then discontinuing it learned that the defendant's motion to block the lawsuit and compel them to accept binding arbitration was overruled by a judge in Miami, the first step in getting a court date in what is believed to be a first-of-its-kind case.

... In December 2012, 4 physician practices -- 2 pain clinics in Florida, 1 in Missouri, and a family medicine practice in Alabama -- became plaintiffs in a class-action suit filed against Allscripts, "an action arising from an expensive, but defective electronic health records software product," according to the complaint. The bottom line: The EHR was "buggy."

Says one of the doctors plaintiffs:

Anesthesiologist Robert J. Joseph, MD, of the Pain Clinic of Northwest Florida in Panama City, a plaintiff in the suit, makes no bones about it. "Our EHR is a piece of crap," he states.

-----

Link to full article:
http://www.medscape.com/viewarticle/779721

(It seems to come up fulltext without Medscape login, but I cannot guarantee this will persist.)

-- SS

Allscripts shares plunge on weak outlook, board changes, unhappy customers - but mostly unhappy customers, I surmise

Glen Tullman is CEO of the health IT seller Allscripts-Misys Healthcare.  He was an advisor to the Obama campaign on health information technology issues.

My organization had to sue his company for non-working products a few years ago (link to PDF of civil complaint) .

Apparently other customers were unhappy as well.  This from Reuters:

Allscripts shares plunge on weak outlook, board changes

Fri Apr 27, 2012 9:24am EDT

(Reuters) - Allscripts Healthcare Solutions Inc's shares plunged 42 percent in premarket trade on Friday, after the company forecast weak full-year earnings, hurt by software development costs and weaker bookings.

On Thursday, the healthcare information technology provider reported a lower-than-expected quarterly profit and also announced the resignation of its CFO, three directors and board Chairman Phil Pead.

Citigroup analyst George Hill said the results were strongly disappointing and downgraded the company's stock to "neutral" from "buy."

Hill said he was most troubled by the loss of long tenured CFO Bill Davis, who had been the public face of Allscripts to investors for many years.

"We suspect CEO Glen Tullman won a power struggle at the 11th hour leading to the board departures," Hill said.

"Too few customers are buying its products, due to lack of confidence or satisfaction," Barclays Capital analyst Lawrence Marsh wrote in a note.

Allscripts shares were trading at $9.27 in premarket trade. They had closed at $16.02 Thursday on the Nasdaq.

(Reporting by Shailesh Kuber in Bangalore; Editing by Joyjeet Das)

The statement 'too few customers are buying its products, due to lack of confidence or satisfaction', speaks volumes about the state of health IT in general in 2012.

That state includes eventual regulation after an IOM report on dubious safety, mission hostile user interfaces as identified by NIST and others that will require expensive remediation (due to the industry arrogantly ignoring this crucial issue for decades), 'glitches' due to poor or non-existent validation and quality control that will increasingly result in expensive litigation when patients are harmed, likely government investigations and clawbacks due to EHR-promoted upcoding, and an increasing awareness that many of the so-called miracle 'revolutionary' gains (as opposed to facilitation of medical practice) are largely illusory industry-promoted memes not based on robust, scientifically-generated evidence.

I'd pull out of this market - if I had any money invested in it.  I have none, and never have, because I have great lack of confidence in the industry that began when I was first exposed to it and its leaders - that being in 1992.

I note that the HITECH component of ARRA, containing incentives and penalties related to health care information technology designed to accelerate the adoption of EHR systems, was advanced largely via advice to the President on the wonders of health IT.  (I thought HITECH was a reckless, premature move destined to waste billions of dollars as did the erstwhile NPfIT in the NHS, and I still stand by that prediction.)

-- SS

4/27/12 Addendum:

EHR glitches like this and this never seem to affect patients...

-- SS