Forbes contributor Nicole Fisher, claimed proponent of healthcare human rights, writes long article on EHRs that neglects to mention patient harm

The field of health IT lives a charmed life.

Even self-stated human rights advocates in healthcare won't seem to broach the topic of EHR-related harms and lack of informed consent processes regarding their use in a patient's care, even when authors openly state their concerns for patient and human rights.

This is despite known harms at potentially alarming levels as indicated by organizations including the IOM, FDA, ECRI Institute, AHRQ, Harvard Med Mal insurer CRICO, The Joint Commission, NHS in the UK, and others.

Forbes contributor Nicole Fisher (http://www.forbes.com/sites/nicolefisher/) published an article in Forbes dated 3/18/2014 and entitled "Electronic Health Records - Expensive, Disruptive And Here To Stay" (http://www.forbes.com/sites/nicolefisher/2014/03/18/electronic-health-records-expensive-disruptive-and-here-to-stay/).

You can read the article at the above link.  It focuses on physician distraction and dissatisfaction, poor usability and usefulness, expense, and related issues.  Of course, quotes from HHS figure prominently.

Nowhere, however, is mention of EHR-related harms to patients, such as reported by the aforementioned organizations mentioned - as in this very small sample list of posts, which contain links to source:

Patient Safety & Quality Healthcare: "CRICO Malpractice Claims Analysis Confirms Risks in EHRs"
hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html

Peering Underneath the Iceberg's Water Level: ECRI "Deep Dive" Study of Health IT "Events"
http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html

Internal FDA memorandum on HIT risks
http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html

IOM Report - "Health IT and Patient Safety: Building Safer Systems for Better Care"
http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html

EHRs and Deadly glitches
http://hcrenewal.blogspot.com/search/label/glitch (multiple posts)

Not to forget issues of breach of privacy: 
http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy (multiple posts)

Nor are mentioned the issues of the experimental, unregulated nature of this technology, and the lack of any informed consent process regarding patient's rights to decide whether or not to have these systems used in their care.

The only mention of "unintended consequences" links to "Unintended ICD-10 Consequences: Inadequate Clinical Documentation Can Negatively Impact Physician Profiles."

This is in my view disappointing, and seems to be yet another extraordinary healthcare IT industry accommodation, remarkable for an author with the following bio (emphases mine):

http://www.forbes.com/sites/nicolefisher/

Nicole Fisher is the Founder and Principal at HHR Strategies, a health care and human rights focused advising firm. Additionally, she is a Senior Policy Advisor and health policy expert on health economic analyses mainly focusing on Medicare, Medicaid and health reform, specifically as they impact women and children. Nicole runs a Health Innovation and Policy page at Forbes.com highlighting and advising companies, ideas and people that are changing the health care landscape. She is also currently pursuing her PhD at the University of North Carolina in the Health Policy and Management Department. Her writing has appeared in other publications such as Health Affairs, Wall Street Journal, Washington Post, Centers for Medicare & Medicaid Services Journal, Wright on Health, The Health Care Blog and Health Services Research. Before pursuing her PhD in health policy, Nicole earned her Master’s degree in Public Policy from the University of Chicago and her undergraduate degree from the University of Missouri. Her health care and policy work at those institutions had an emphasis on underserved populations, women's and children’s issues. She presides on several Boards for domestic and international health organizations and frequently speaks on health reform and human rights.

One might conclude the computer has more rights than the patient and the clinician via this Forbes piece.

Finally, although I am a domain specialist (http://www.kaiserhealthnews.org/stories/2013/february/18/scot-silverstein-health-information-technology.aspx), I am getting rather tired of having to point out the obvious to major media outlets and writers, in essence doing their homework for them.  I'm sure other bloggers feel the same way. 

The title of the Forbes piece should have been "Electronic Health Records - Expensive, Disruptive, Deadly."

To the author of the Forbes piece and other HIT writers, here is the face (and gravestone) of someone injured by this "disruptive" technology.   http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html

A few babies too:  http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html

A family man:  http://hcrenewal.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html

I know of others from my legal work supporting the EHR-related injured and deceased that I cannot mention.  And I am but one person.

If health IT were causing rapes** and child abuse, rather then merely causing mundane severe injuries and equally mundane deaths, would the media would pay more attention?

-- SS

** I sadly note that EHR's without proper security measures in force actually did enable rape-like behavior in 2011, as at "EHR as Molestation Candidate Selector: What was this Resident looking for in the EHR before 'examining' female patients?" at http://hcrenewal.blogspot.com/2011/02/what-was-this-medical-resident-looking.html.

Is ONC's definition of "Significant EHR Risk" when body bags start to accumulate on the steps of the Capitol?

In a June 25, 2013 Bloomberg News article "Digital Health Records’ Risks Emerge as Deaths Blamed on Systems" by technology reporter Jordan Robertson (http://go.bloomberg.com/tech-blog/author/jrobertson40/), an EHR-harms case in which I am (unfortunately) intimately involved as substitute plaintiff is mentioned:

When Scot Silverstein’s 84-year-old mother, Betty, starting mixing up her words, he worried she was having a stroke. So he rushed her to Abington Memorial Hospital in Pennsylvania.

After she was admitted, Silverstein, who is a doctor, looked at his mother’s electronic health records, which are designed to make medical care safer by providing more information on patients than paper files do. He saw that Sotalol, which controls rapid heartbeats, was correctly listed as one of her medications.

Days later, when her heart condition flared up, he re-examined her records and was stunned to see that the drug was no longer listed, he said. His mom later suffered clotting, hemorrhaged and required emergency brain surgery. She died in 2011. Silverstein blames her death on problems with the hospital’s electronic medical records.

“I had the indignity of watching them put her in a body bag and put her in a hearse in my driveway,” said Silverstein, who has filed a wrongful-death lawsuit. “If paper records had been in place, unless someone had been using disappearing ink, this would not have happened.”

How can I say that?  Because I trained in this hospital and worked as resident Admitting Officer in that very ED pre-computer.  The many personnel in 2010 who were given the meds history by my mother and myself directed it not to paper for others to see, but to /dev/null.

Why can I say that?  Because the hospital's Motion for Prior Restraint (censorship) against me was denied outright by the presiding judge just days before the Bloomberg article was published (http://en.wikipedia.org/wiki/Prior_restraint):

Prior restraint (also referred to as prior censorship or pre-publication censorship) is censorship imposed, usually by a government, on expression before the expression actually takes place. An alternative to prior restraint is to allow the expression to take place and to take appropriate action afterward, if the expression is found to violate the law, regulations, or other rules.

Prior restraint prevents the censored material from being heard or distributed at all; other measures provide sanctions only after the offending material has been communicated, such as suits for slander or libel. In some countries (e.g., United States, Argentina) prior restraint by the government is forbidden, subject to certain exceptions, by a constitution.

Prior restraint is often considered a particularly oppressive form of censorship in Anglo-American jurisprudence because it prevents the restricted material from being heard or distributed at all. Other forms of restrictions on expression (such as actions for libel or criminal libel, slander, defamation, and contempt of court) implement criminal or civil sanctions only after the offending material has been published. While such sanctions might lead to a chilling effect, legal commentators argue that at least such actions do not directly impoverish the marketplace of ideas. Prior restraint, on the other hand, takes an idea or material completely out of the marketplace. Thus it is often considered to be the most extreme form of censorship.

The First Amendment lives.

(I wonder if it irks the hospital that they cannot perform sham peer review upon me now that the censorship motion is denied.  Sham peer review is a common reaction by hospital executives to "disruptive" physicians, but I have not worked there since 1987 and I no longer practice medicine.)

In the Bloomberg story Mr. Robertson wrote:

... “So far, the evidence we have doesn’t suggest that health information technology is a significant factor in safety events,” said Jodi Daniel (http://www.healthit.gov/newsroom/jodi-daniel-jd-mph), director of ONC’s office of policy and planning. “That said, we’re very interested in understanding where there may be a correlation and how to mitigate risks that do occur.”

In my opinion this statement represents gross negligence by a government official.  Ms. Daniel is unarguably working for a government agency pushing this technology.   She makes the claim that "so far the evidence we have doesn't suggest significant risk" while surely being aware (or having the fiduciary responsibility to be aware) of the impediments to having such evidence.

From my March 2012 post "Doctors and EHRs: Reframing the 'Modernists v. Luddites' Canard to The Accurate 'Ardent Technophiles vs. Pragmatists' Reality" at http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html  (yes, this was more than a year ago):

... The Institute of Medicine of the National Academies noted this in their late 2011 study on EHR safety:

... While some studies suggest improvements in patient safety can be made, others have found no effect. Instances of health IT–associated harm have been reported. However, little published evidence could be found quantifying the magnitude of the risk.

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.[IOM (Institute of Medicine). 2012. Health IT and Patient Safety: Building Safer Systems for Better Care (PDF). Washington, DC: The National Academies Press, pg. S-2.]

Also in the IOM report:

… “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.

More worrisome, some case reports suggest that poorly designed health IT can create new hazards in the already complex delivery of care. Although the magnitude of the risk associated with health IT is not known, some examples illustrate the concerns. Dosing errors, failure to detect life-threatening illnesses, and delaying treatment due to poor human–computer interactions or loss of data have led to serious injury and death.”

I also noted that the 'impediments to generating evidence' effectively rise to the level of legalized censorship, as observed by Koppel and Kreda regarding gag and hold-harmless clauses in their JAMA article "Health Care Information Technology Vendors' Hold Harmless Clause: Implications for Patients and Clinicians", JAMA 2009;301(12):1276-1278. doi: 10.1001/jama.2009.398.

FDA had similar findings about impediments to knowledge of health IT risks, see my Aug. 2010 post "Internal FDA memorandum of Feb. 23, 2010 to Jeffrey Shuren on HIT risks. Smoking gun?" at http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html.

I also note this from amednews.com's coverage of the ECRI Deep Dive Study (http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html):

... In spring 2012, a surgeon tried to electronically access a patient’s radiology study in the operating room but the computer would show only a blue screen. The patient’s time under anesthesia was extended while OR staff struggled to get the display to function properly. That is just one example of 171 health information technology-related problems reported [voluntarily] during a nine-week period [from 36 hospitals] to the ECRI Institute PSO, a patient safety organization in Plymouth Meeting, Pa., that works with health systems and hospital associations in Kentucky, Michigan, Ohio, Tennessee and elsewhere to analyze and prevent adverse events. Eight of the incidents reported involved patient harm, and three may have contributed to patient deaths, said the institute’s 48-page report, first made privately available to the PSO’s members and partners in December 2012. The report, shared with American Medical News in February, highlights how the health IT systems meant to make care safer and more efficient can sometimes expose patients to harm.

One wonders if Ms. Daniels' definition of "significant" is when body bags start to accumulate on the steps of the Capitol.

I also note she is not a clinician but a JD/MPH.

I am increasingly of the opinion that non-clinicians need to be removed from positions of health IT leadership at regional and national levels.

In large part many just don't seem to have the experience, insights and perhaps ethics necessary to understand the implications of their decisions.

At the very least, such people who never made it to medical school or nursing school need to be kept on a very short leash by those who did.

-- SS

Bipartisan Policy Center's Health Innovation Initiative: Health IT Industry Officials Lying to Regulators With Impunity?

On Wednesday, February 13, 2013, The Bipartisan Policy Center's Health Innovation Initiative held a discussion on its new report: An Oversight Framework for Assuring Patient Safety in Health Information Technology.  The announcement is here:  https://bipartisanpolicy.org/news/press-releases/2013/02/bipartisan-policy-center-releases-recommendations-oversight-framework-pa

The report is here (PDF):  "An Oversight Framework for Assuring Patient Safety in Health Information Technology."

The "who's" of the Bipartisan Policy Center's Health Innovation Initiative included these people:

• Senator Tom Daschle, Former U.S. Senate Majority Leader; Co-founder, Bipartisan Policy Center (BPC); and Co-leader BPC Health Project Carolyn M. Clancy, M.D., Director, Agency for Healthcare Research and Quality, Department of Health and Human Services
• Farzad Mostashari, M.D., ScM, National Coordinator for Health Information Technology, Department of Health and Human Services
• Peter Angood, M.D., Chief Executive Officer, American College of Physician Executives
• Russ Branzell, Chief Executive Officer, Colorado Health Medical Group, University of Colorado Health
• John Glaser, Ph.D., Chief Executive Officer, Siemens Health Services
• Douglas E. Henley, M.D., FAAFP, Executive Vice President and Chief Executive Officer, American Academy of Family Physicians
• Jeffrey C. Lerner, Ph.D., President and Chief Executive Officer, ECRI Institute
• Ed Park, Executive Vice President and Chief Operating Officer, athenahealth
• Emad Rizk, M.D., President, McKesson Health Solutions
• Janet Marchibroda, Moderator; Director, BPC Health Innovation Initiative 

Unfortunately, I was unable to attend.  I was at the 2013 Annual Winter Convention of the American Association for Justice (Trial Lawyer's Association) in Florida, as an invited speaker on health IT risk, its use in evidence tampering, and other legal issues.

"United for Justice" - click to enlarge

I found the following statement from the Bipartisan Policy Center's Health Innovation Initiative report remarkable as a "framework for health IT safety":

The Bipartisan Policy Center today proposed an oversight framework for assuring patient safety in health information technology. Among other guiding principles, the framework should be risk-based, flexible and assure patient safety is a shared responsibility, the authors said. “Assuring safety in clinical software in particular is a shared responsibility among developers, implementers, and users across the various stages of the health IT life cycle, which include design and development; implementation and customization; upgrades, maintenance and operations; and risk identification, mitigation and remediation,” the report states. Among other recommendations, the center said clinical software such as electronic health records and software used to inform clinical decision making should be subject to a new oversight framework, rather than traditional regulatory approaches [e.g.,  FDA - ed.] applied to medical devices given its lower risk profile.

I find it remarkable that the health IT industry and its supporters now feel they can lie to our government and regulatory agencies with impunity.  Stating that health IT has a "lower risk profile" is an example.

One cannot know what is acknowledged to be unknown.

From the Institute of Medicine in its 2012 report on health IT safety:

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

... While some studies suggest improvements in patient safety can be made, others have found no effect. Instances of health IT–associated harm have been reported. However, little published evidence could be found quantifying the magnitude of the risk.

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.

... More worrisome, some case reports suggest that poorly designed health IT can create new hazards in the already complex delivery of care. Although the magnitude of the risk associated with health IT is not known, some examples illustrate the concerns. Dosing errors, failure to detect life-threatening illnesses, and delaying treatment due to poor human–computer interactions or loss of data have led to serious injury and death.” 

Even to those with particularly thick skulls, this statement seems easy to comprehend:

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

I repeat once again:

One cannot know what is acknowledged to be unknown.

A statement that health IT has a "lower risk profile" compared to other regulated healthcare sectors such as devices or drugs, in order to seek continued and extraordinary regulatory accommodations, is remarkable.  It is either reckless regarding something that the statement's makers should know, or should have made it their business to know - or a deliberate prevarication with forethought.

The report did attempt to shroud the declarative "lower risk profile" in a sugar coating through misdirection, citing the need to take into account "several factors" including:

"the level of risk of potential patient harm, the degree of direct clinical action on patients, the opportunity for clinician involvement, the nature and pace of its development, and the number of factors beyond the development stage that impact its level of safety in implementation and use." 

These "factors" speak to a higher level of potential risk, not lower, and are a justification for stronger regulatory oversight, not weaker.  I would opine that there is a possibility that health IT. through which almost all transactions of care need to pass (e.g., orders, results reporting, recording and review of observations, finding, diagnoses, prognoses, treatment plans, etc.), could have a higher risk profile than one-off devices or drugs.  Health IT affects every patient, not just those under a specific therapy or using a specific device or drug.

Partial taxonomies developed from limited data themselves speak to the issue of a potentially huge risk profile of health IT, e.g., the FDA Internal Memo on HIT Risks (link), the AHRQ Hazards Manager taxonomy (link), and the sometimes hair-raising voluntary defects reports (largely from one vendor) in the FDA MAUDE database (link).  Further, health IT can and does affect thousands or tens of thousands of patients en masse even due to one simple defect, such as happened in Rhode Island at Lifespan (link), or due to overall design and implementation problems such as at Contra Costa County, CA (link) and San Francisco's Dept. of Public Health (link).

We don't know the true levels of risk and harm - but we need to, and rapidly.  Industry self-policing is not the answer; it didn't work in drugs and devices, and even with regulation there are still significant problems in those sectors.  (Imagine how it would be if those sectors received the special accommodations that health IT receives, and wishes to continue to receive.)

My other issue is with the "shared responsibility" including "users."

The user's responsibility is patient care, not being a beta tester for bug-laden or grossly defective health IT products.  Their responsibility ends at reporting problems without retaliation, and ensuring patient safety.

Their responsibility is to avoid carelessness - as it is when they drive their cars.

In other words, the inclusion of "users" in the statement is superfluous.

It is not a responsibility to be omniscient and be held accountable when bad health IT promotes "use error" (the NIST definition of "use error" I will not repeat again here; search the blog) -- as opposed to and as distinct from "user error" - note the final "r" - i.e., carelessness.

Bad health IT (see here):

Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation. 

One special accommodation that the health IT industry has been afforded for far too long is to be able to "blame the user."

"Blaming the victim" of bad health IT is a more appropriate description.

-- SS

HIMSS Senior Vice President on Medical Ethics: Ignore Health IT Downsides for the Greater Good

The Health Information Management Systems Society (HIMSS) is the large health IT vendor trade group in the U.S.  At a Sept. 21, 2012 HIMSS blog post, John Casillas, Senior Vice President of HIMSS Financial-Centered Systems and HIMSS Medical Banking Project dismisses concerns about health IT with the refrain:

... To argue that the existence of something good for healthcare in many other ways, such as having the right information at the point of care when it’s needed, is actually bad because outliers use it to misrepresent claims activity is deeply flawed.

Through the best use of health IT and management systems, we have the opportunity to improve the quality of care, reduce medical errors and increase patient safety. Don’t let the arguments of some cast a cloud over the critical importance and achievement of digitizing patient health records.

Surely, no one can argue paper records are the path forward. Name one other industry where this is the case. I can’t.

Let’s not let the errors of a few become the enemy of good.

The ethics of these statements from a non-clinician are particularly perverse.

The statement "Don’t let the arguments of some cast a cloud over the critical importance and achievement of digitizing patient health records" is particularly troubling.

When those "some" include organizations such as FDA (see FDA Internal 2010 memo on HIT risks, link) and IOM's Committee on Patient Safety and Health Information Technology (see 2012 report on health IT safety, link) both stating that harms are definite but magnitude unknown due to systematic impediments to collecting the data, and the ECRI Institute having had health IT in its "top ten healthcare technology risks" for several years running, link, the dismissal of "clouds" is unethical on its face.

These reports indicate that nobody knows if today's EHRs improve or worsen outcomes over good paper record systems or not.  The evidence is certainly conflicting (see here).

It also means that the current hyper-enthusiasm to roll out this software nationwide in its present state could very likely be at the expense of the unfortunate patients who find themselves as roadkill on the way to the unregulated health IT utopia.

That's not medicine, that's perverse human subjects experimentation without safeguards or consent.

As a HC Renewal reader noted:

Astounding hubris, although it does seem to be effective.  Such is PC hubris.  Who could ever call for reducing the budget of the NIH that is intended to improve health.  Has health improved?  No.

So why does a group with spotty successes if not outright failure never get cut?  It’s not the results, it’s the mission that deserves the funding.  So it’s not the reality of HIT, it’s the promise, the mission, that gets the support.  Never mind the outcome, it’s bound to improve with the continued support of the mission.

Is this HIMSS VP aware of these reports?  Does he even care?

Does he believe patients harmed or killed as a result of bad health IT (and I know of a number of cases personally through my advocacy work, including, horribly, infants and the elderly) are gladly sacrificing themselves for the greater good of IT progress?

It's difficult to draw any other conclusion from health IT excuses such as proffered, other than he and HIMSS simply don't care about unintended consequences of health IT.

Regarding "Surely, no one can argue paper records are the path forward" - well, yes, I can.  (Not the path 'forward', but the path for now, at least, until health IT is debugged and its adoption and effects better understood).  And I did so argue, at my recent posts "Good Health IT v. Bad Health IT: Paper is Better Than The Latter" and "A Good Reason to Refuse Use of Today's EHR's in Your Health Care, and Demand Paper".  I wrote:

I opine that the elephant in the living room of health IT discussions is that bad health IT is infrequently, if ever, made a major issue in healthcare policy discussions.

I also opine that bad health IT is far worse, in terms of diluting and decreasing the quality and privacy of healthcare, than a very good or even average paper-based record-keeping and ordering system.  

This is a simple concept, but I believe it needs to be stated explicitly. 

A "path forward" that does not take into account these issues is the path forward of the hyper-enthusiastic technophile who either deliberately ignores or is blinded to technology's downsides, ethical issues, and repeated local and mass failures.

If today's health IT is not ready for national rollout, e.g., causes harms of unknown magnitude (e.g., see this query link), results in massive breaches of security as the "Good Reason" post above, and mayhem such as at this link, then:

The best - and most ethical - option is to slow down HIT implementation and allow paper-based organizations and clinicians to continue to resort to paper until these issues are resolved.  Resolution needs to occur in lab or experimental clinical settings without putting patients at risk - and with their informed consent.

Anything else is akin to the medical experimentation abuses of the past that led to current research subjects protections such as the "Ethical Guidelines & Regulations" used by NIH.

-- SS

Ellmers Calls on Sebelius to Address Health IT Safety Concerns: A Responsible Voice in Government on Health IT and HIT Safety

The following press release is very welcome, and speaks for itself.  There is a responsible voice in the government wilderness.  It is perhaps no surprise it comes from a Congresswoman who is also a registered nurse:

Ellmers Calls on Sebelius to Address Health IT Safety Concerns

06/12/12

Safety Risks and Health IT-Related Errors Cited in IOM Recommendations

WASHINGTON – House Small Business Subcommittee on Healthcare and Technology Chairwoman Renee Ellmers (R-NC) today sent a letter to Kathleen Sebelius, Secretary of Health and Human Services (HHS), inquiring about whether the Department has adopted the Institute of Medicine’s (IOM) recommendations for improving the safety of health information technology (IT).

The report, issued in November, recommended several steps to be taken by HHS and called for greater oversight by the public and private sectors. The Secretary was called upon by the IOM to issue a plan within 12 months to minimize patient safety risks associated with health IT and report annually on the progress being made.  The report further recommended that the plan should include a schedule for working with the private sector to assess the impact of health IT on patient safety, and recommended several other steps to help improve the safety of health IT.

Specifically, Chairwoman Ellmers has requested a copy of the Secretary’s plan to minimize patient safety risks, a description of health IT-related errors that have resulted in patient risks, injuries and deaths, and the status of the development of a mechanism for health IT vendors and users to report health IT-related deaths.  She said that because health IT has the promise to improve health care delivery for patients, physicians and other medical professionals, she remains eager to work with the Secretary to ensure that health IT is safe, effective and affordable.

In an August 11, 2011 letter to Secretary Sebelius, Chairwoman Ellmers said that a modern, well-equipped office is critical to the practice of medicine, and asked the Secretary to undertake a study of health IT’s adoption, benefits and cost effectiveness, including medical error rates.

On June 2, 2011, Chairwoman Ellmers’ Subcommittee held a hearing on the barriers to health IT that are encountered by physicians and other health professionals in small and solo practices.   At the hearing, physicians expressed strong concerns about the cost of purchasing and maintaining health IT systems, as well as the staff training and downtime necessary to implement such a system.  Chairwoman Ellmers noted health IT’s great potential to improve health care delivery, decrease medical errors, increase clinical and administrative efficiency and reduce paperwork.

For more than twenty-one years before being elected to Congress, Chairwoman Ellmers served as a registered nurse, focusing on surgical care as Clinical Director of the Trinity Wound Care Center and later helping to manage the family's small medical practice with her husband, Dr. Brent Ellmers, a licensed surgeon. As a registered nurse and the wife of a surgeon, Ellmers understands that a modern, efficient and well-equipped office is critical to the practice of medicine.    

This voice of sanity is quite welcome.  I've spoken with Rep. Ellmers' office, pointing them to my Drexel Univ. writings and materials and recommending Sebelius' reply be gone over with a fine-toothed comb, from the perspective of health IT realities, not merely from the perspective of the Ddulite's good intentions.  (I also introduced her staffer to the concept of the Ddulite, the HIT hyper-enthusiast who ignores all downsides and ethical concerns.)

I also pointed out the ethical lapse in IOM's position of "wait and see" while HIT is pushed nationally under penalty of law, at the cost of hundreds of billions of dollars, when their own report (along with reports from FDA here, JC here and others) admits they don't know the magnitude of benefits, risks and harms:

... While some studies suggest improvements in patient safety can be made, others have found no effect. Instances of health IT–associated harm have been reported. However, little published evidence could be found quantifying the magnitude of the risk.

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.

[IOM (Institute of Medicine). 2012. Health IT and Patient Safety: Building Safer Systems for Better Care (PDF). Washington, DC: The National Academies Press, pg. S-2.]

As I wrote in my Nov. 2011 post "IOM Report - 'Health IT and Patient Safety: Building Safer Systems for Better Care' - Nix the FDA; Create a New Toothless Agency", the IOM's response to their own study was reckless and unethical (at best):

... The panel also recommends that the HHS secretary publicly report on the progress of health IT safety each year, beginning in 2012. If the secretary determines at any time that adequate safety progress has not been made, only then should the FDA take the regulatory lead and be given the resources to do so, the report recommends, adding that the agency should be developing a framework now to be prepared.

In the meantime, during each year of "watching for safety progress", innumerable patients are exposed to HIT's hazards and costs.  Pharma and other medical device industries are afforded no such special accommodation.

-- SS