EHR Promises Threats

8/14/2019 EHR Promises Threats

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Health IT Promises and Threats:A Dose of Reality about Cybernetic Miracles

Oct. 1, 2009

Scot M. Silverstein, MDCollege of Information Science & Technology

Drexel University, Philadelphia, PA



You will hear about:

• A cross occupational invasion of healthcare by the IT sector – thishurts you – along with an “irrational exuberance” about computersthat the health IT sector and its pundits generate and nurture.

• Promises of the Informatics pioneers

• Utopian promises

– Where did these promises originate?

• Real world reports and experiences

• Threats to patient safety and privacy, medical practice, medicalautonomy

• Action items



First principles (1)

• Health IT can achieve many of the promises made about it, but:

only if done well.

• Behind the simple words “done well” lies massive complexity.

• Computerizing healthcare may be more of a “wicked problem”

than a tractable one.

– Wicked problem: problem that is difficult or impossible to solve because of

incomplete, contradictory, and changing requirements that are often difficult to

recognize. Because of complex interdependencies, the effort to solve one aspect of a

wicked problem may reveal or create other problems.

http://en.wikipedia.org/wiki/Wicked_problem

http://en.wikipedia.org/wiki/Wicked_problem



• Critical thinking always, or your patient’s

dead. - Victor P. Satinsky, MD, Hahnemann Medical College.

First principles (2)



(Modest) Promises of the Pioneers

Practitioners of medicine need the help of computer techniques:

• (1) for the storage and retrieval of the facts of care of their individualpatients;

• (2) in order to place these facts immediately in the spectrum of similar studies or observations on other patients in the same hospitalor region; and

• (3) in order to keep contact with the ever-growing mass of newmedical knowledge (Lindberg DAB. The Computer and Medical Care.Springfield, IL.: Charles C. Thomas, 1968.)

When I began in medical informatics, 1992:

• Computer tools can help facilitate the clinician in delivering better quality medical care through quicker access to data, and throughautomated decision support based on the patient’s condition andknown medical science. (And maybe improve costs of the caresomewhat.)



Irrationally exuberant promises?

• “We will revolutionize healthcare!” - CEOs of HBOC,

Cerner, etc. leading a CIO panel at Microsoft Healthcare User’s Group, ca.

1997.

– I ask “who in this room has ever studied medicine or cared

for patients?”

• “Bellicose grandiosity” surprised me.



Irrationally exuberant promises? (cont.)

• President Bush, Address to Nation,1/24/2004:

– “… we can control health care costs and improve care by moving Americanmedicine into the information age … [my budget] would encourage thereplacement of handwritten charts and scattered medical files with a unifiedsystem of computerized records. By taking this action, we would improvecare, and help prevent dangerous medical errors, saving both lives and

money."

• President Obama:

– Computers “will cut waste, eliminate red tape, and reduce the need torepeat expensive medical tests," he said, adding that the switch alsowould save lives by reducing the number of errors in medicine.”

– Let’s invest tens of billions now … or else …

• A perfected technology … right?

– Bernard Madoff: “Continuous returns, no matter what!”



Where did these promises originate? A Wash. Post article lands a bulls eye

• The Machinery Behind Health-Care Reform: How an IndustryLobby Scored a Swift, Unexpected Victory by ChannelingBillions to Electronic Records - Robert O'Harrow Jr., May 16,2009 (link)

– When President Obama won approval for his $787 billion stimulus packagein February, large sections of the 407-page bill focused on a push for newtechnology that would not stimulate the economy for years. The inclusion of as much as $36.5 billion in spending to create a nationwide network of electronic health records … was more than a political victory for the newadministration. It also represented a triumph for an influential trade

group whose members now stand to gain billions in taxpayer dollars.

http://www.washingtonpost.com/wp-dyn/content/article/2009/05/15/AR2009051503667.html?hpid=topnews

http://www.washingtonpost.com/wp-dyn/content/article/2009/05/15/AR2009051503667.html?hpid=topnews



The Health IT Lobby (cont.)• Washington Post review found that the trade group, the Healthcare

Information and Management Systems Society (HIMSS), had workedclosely with technology vendors, researchers and other allies in asophisticated, decade-long [lobbying] campaign to shape public opinionand win over Washington's political machinery

• Started a half-century ago, it represents 350 companies and about 20,000members.

• Corporate members include government contractors such as LockheedMartin and Northrop Grumman, health-care technology giants such asMcKesson, Ingenix and GE Healthcare, and drug industry leaders,including the Pharmaceutical Research and Manufacturers of America.

• With financial backing from the industry, they started advocacy groups,generated research to show the potential for massive savings** andmet routinely with lawmakers and other government officials.

** Any conflicts of interest here?



Inescapable Consequences of New Information Technologies:

(Does your CIO and vendor know about these? Or care?)

• IT is not value neutral: its use creates winners and losers.

• IT use leads to multiple, and often paradoxical, effects.

• IT use has moral, and ethical aspects and these have social

consequences.

• IT is configurable – it is actually collections of distinct

components (and mis-configurable as well)…

• IT follows trajectories and these trajectories often favor the

status quo

• IT co-evolves during design/development/use (functionally, or dysfunctionally)…

(from Kling, Rosenbaum & Sawyer, “ Understanding And Communicating Social

Informatics”, Information Today, 2005 (Amazon link here )

http://www.amazon.com/Understanding-Communicating-Social-Informatics-Communication/dp/1573872288/ref=sr_1_1/102-9749119-8288920?ie=UTF8&s=books&qid=1174318804&sr=8-1

http://www.amazon.com/Understanding-Communicating-Social-Informatics-Communication/dp/1573872288/ref=sr_1_1/102-9749119-8288920?ie=UTF8&s=books&qid=1174318804&sr=8-1



•Some successes: – Veterans Administration

(VistA-CPRS)

– Unique environment, uniqueapproaches, not emulated in

the HIT industry:

• Medical Informatics 20/20:Quality and Electronic HealthRecords through Collaboration,Open Solutions, and Innovation.

Goldstein, Groen, MPA, Ponkshe,Wine, 2007 (link).

HIT In The Real World, 2009

http://www.amazon.com/Medical-Informatics-Electronic-Collaboration-Innovation/dp/0763739251

http://www.amazon.com/Medical-Informatics-Electronic-Collaboration-Innovation/dp/0763739251



However…even here…“Software hiccups cause drug, treatment errors at VA”

Associated Press

Posted: January 14, 2009 - 5:59 am EDT

http://www.modernhealthcare.com/apps/pbcs.dll/article?AID=/20090114/REG/301149994/1153&nocache=1

Patients at Veterans Affairs health centers around the country were given incorrect doses of drugs, hadneeded treatments delayed and may have been exposed to other medical errors because of softwareglitches that showed faulty displays of their electronic health records.

Glitches began in August 2008 and lingered until Dec. 2008. Not disclosed by the Veterans Affairs

Department to patients even though they sometimes involved prolonged infusions of drugs such as heparin,according to internal documents obtained by the AP under the Freedom of Information Act.

… The glitches involved medical data—vital signs, laboratory results and active medications—that sometimespopped up under another patient's name on the computer screen.

Records also failed to clearly display a doctor's stop order , leading to reported cases of unnecessarydoses of intravenous drugs such as blood-thinning heparin … there were nine reported cases where patientsat the VA medical centers were given incorrect doses—six of them involving heparin drips that were given for

up to 11 hours longer than necessary.

Luck prevailed … this time.





AHLTA, on the other hand…• “Electronic Records System Unreliable, Difficult to Use, Service

Officials Tell Congress”: U.S. Medicine - the Voice of FederalMedicine, May 2009 - Sandra Basu

– AHLTA, the DOD’s $4 billion EMR, continues to be difficult for militaryphysicians to use, according to top military health leaders who spoke at aHouse Armed Services subcommittee hearing at the end of March.

– At a Congressional hearing titled “AHLTA is ‘Intolerable,’ Where do we gofrom here?” top leaders said “medical personnel are hampered by anelectronic medical record system that, among other issues, is slow,difficult to use, unreliable and frequently crashes.”

– … we faced a near mutiny of our healthcare providers, our doctors, our

nurse practitioners, physician assistants and others last summer.” ArmySurgeon General Lt. Gen. Eric Schoomaker, MC, USA at a joint MilitaryPersonnel Subcommittee and Terrorism, Unconventional Threats andCapabilities Subcommittee hearing.



AHLTA, cont.• Military doctors and nurses who use AHLTA: it is unreliable, difficult

to use and has decreased the number of patients they can seeeach day. Medical professionals leave the military because of their frustration.”

• … medical personnel, particularly specialists, often “spend as muchor more time working around the system as they do with thesystem.”

• Air Force primary care physicians spend about 40 percent of their time working with AHLTA versus 60 percent of their time withpatients.

• Specialists “working around the system trying to find newsolutions,” since the system does not address the needs unique totheir practices … the problems have resulted in “low productivity andprovider morale.”



• Kaiser Permanente (“Kaiser’s Long Road”, Health Data Management, Aug. 1,2009, link):

• So far, Kaiser's hospitals and clinics have reaped a “wide range of large and small benefitsfrom the EHR effort”:

– Ambulatory visits dropped 8% in the 18 months after each EHR implementation. That eases the needto hire more staff as HMO enrollment grows

– Patients using the portal are making far fewer phone calls, relying on more efficient e-mails instead – Eliminated a large volume of mailings of routine lab results. – Able to shut off a number of information systems that have become obsolete thanks to the clinical

automation effort, "savings tens of millions of dollars.” – Early successes in improving outcomes .. study of 14,000 patients treated after MI, the death rate

decreased substantially compared with before automation.

• At what cost?

– Nov. 2006: Justen Deal, a 25-year-old employee of HMO giant Kaiser Permanente, placed onadministrative leave after criticizing the company's $3 billion information technology investment and

some of its providers, including Epic Systems, in an e-mail he sent to all Kaiser employees andlater to the company's board of directors. Projected a $7 billion loss for the company over thenext two years if expenses aren't better controlled.

– Deal: “We're spending recklessly, to the tune of over $1.5 billion in waste every year, primarily onHealthConnect, but also on other inefficient and ineffective information technology projects.

– His entire letter can be read here. Many themes familiar to medical informatics specialists. Trueor not?

HIT In The Real World, 2009 (cont. )

http://www.healthdatamanagement.com/issues/2009_69/-38718-1.html?zkPrintable=true

http://hcrenewal.blogspot.com/2006/11/kaiser-healthcare-it-meltdown.html

http://hcrenewal.blogspot.com/2006/11/kaiser-healthcare-it-meltdown.html

http://www.healthdatamanagement.com/issues/2009_69/-38718-1.html?zkPrintable=true



Information on HIT problems remarkably scarce: why?



Scarcity of information easing.

2009 has been a remarkableyear…



National Academies study - at the best HIT centers:

• National Academies, National Research Council, Jan. 2009: “CURRENT

APPROACHES TO U.S. HEALTH CARE INFORMATION TECHNOLOGY AREINSUFFICIENT” (link):

– Current efforts aimed at the nationwide deployment of health care information technology (IT)will not be sufficient to achieve medical leaders' vision of health care in the 21st century andmay even set back the cause.

– Difficulties with data sharing and integration, deployment of new IT capabilities, and large-scale

data management.

– Current health care IT systems offer little cognitive support; clinicians spend a great deal of time sifting through large amounts of raw data (such as lab and other test results) andintegrating it with their medical knowledge to form a whole picture of the patient.

– Data entered mainly to comply with regulations or to defend against lawsuits, rather than toimprove care. As a result, valuable time and energy is spent managing data as opposed tounderstanding the patient.

So, let’s all rush right in!

http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572




• Safely implementing health information and converging technologies -Dec. 2008 (link)

– As health information technology (HIT) … is increasingly adopted by health careorganizations, users must be mindful of the safety risks and preventable adverseevents that these implementations can create or perpetuate.

–Any form of technology may adversely affect the quality and safety of care if it isdesigned or implemented improperly or is misinterpreted.

– There is a dearth of data on the incidence of adverse events directly caused by HIToverall.

– Technology-related adverse events … happen when health care providers andleaders do not carefully consider the impact technology can have on care processes,

workflow and safety.

Joint Commission:

Sentinel Events Alert


http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_42.htm




• … IT implementation projects are often not successful. Across industry sectors, at least 40% of suchgeneric IT projects either are abandoned or fail to meet business requirements, while fewer than 40% of large systems purchased from vendors meet their goals. Some sources report 70% failure rates. Other studies show that as few as one in eight information technology projects is considered truly successful,with more than half overshooting budgets and timetables and still not delivering what was promised.

• Failure in health care IT: ”significant budget and timeline overruns, under-delivery of value, and theoutright termination of a project before completion are all forms of failure.

• Hospitals are among those organizations where delays and cancellations of software projects are endemic.For years, problems have plagued the implementation of health IT applications, whether for ancillaryservices, for whole institutions, for regional or national systems, or for consumers. Heeks 2006: "bestestimate that most HIS [health information systems] fail in some way."

• Severe problems repeatedly have beset a variety of efforts: hospital information systems and electronic

records; ambulance services; community, regional, and national Health Information Networks; publichealth systems; patient education; and physician order entry.

• The situation is even more disturbing when high-profile failures, partial successes, and unsustainable ITundertakings are coupled with accumulating evidence of negative unintended consequences, increasederror rates accompanying IT use, and the need for workarounds.

American Medical Informatics Association

Health IT Success and Failure: Recommendations from Literature and an AMIA

Workshop. Kaplan and Harris-Salamone, Journal of the American Medical Informatics

Association 2009;16(3):291-299 (evolutionary history of this paper is here).

http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=workshop

http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=workshop



• Progress in the UK National Programme for IT in the NHS:Progress since 2006 - Public Accounts Committee, House of Commons,14 Jan 2009 (link)

– Recent progress has been very disappointing, just six deployments in total during thefirst five months of 2008-09. The completion date of 2014-15, four years later than

originally planned, was forecast before the termination of Fujitsu's contract and

must now be in doubt. The arrangements for the South have still not been resolved.

– By end of 2008 the “Lorenzo” care records software had still not gone live

throughout a single Acute Trust. Continuing delays, history of missed deadlinesgrounds for serious concern as to whether Lorenzo can be deployed in areasonable timescale in a form that brings demonstrable benefits to users andpatients.

– Of the four original Local Service Providers (contractors), two have left theProgramme, and just two remain, both carrying large commitments … it is vitallyimportant that the Department assesses BT's and CSC's capacity and capability to

continue to meet their substantial commitments.

UK National Programme for IT in the NHS

http://www.publications.parliament.uk/pa/cm200809/cmselect/cmpubacc/153/15304.htm




UK The National Programme for IT in the NHS

(cont.)

– Termination of Fujitsu's contract has caused uncertainty among Trusts in the South

and new deployments have stopped. One option: have a choice of either Lorenzo or

[Cerner] Millennium. There are, however, considerable problems with existing

deployments of [Cerner] Millennium and serious concerns about the prospects for

future deployments of Lorenzo.

– Programme not providing value for money at present because there have been few

successful deployments of the [Cerner] Millennium system and none of Lorenzo

in any Acute Trust. Trusts cannot be expected to take on the burden of deploying

care records systems that do not work effectively … the Department should assess

the financial case for allowing Trusts to put forward applications for central funding for

alternative systems compatible with the objectives of the Programme.

– This in a medical system far less complex than in the USA



• Appx. £13 billion spent so far.

• 2007: The former head of the NHS IT programme Richard Granger has said hewas “ashamed of the quality of some of the systems put into the NHS byConnecting for Health suppliers”, singling Cerner out for criticism (link).

• Going further than he before in acknowledging the extent of failings of systemsprovided to some parts of the NHS - such as Milton Keynes – the Connecting for Health boss, said "Sometimes we put in stuff that I'm just ashamed of . Someof the stuff that Cerner has put in recently is appalling."

UK National Programme for IT in the NHS

(cont.)


http://www.e-health-insider.com/news/item.cfm?ID=2854

http://www.e-health-insider.com/news/item.cfm?ID=2854



Busting other myths…



Health IT in Ambulatory care

• Electronic Health Record Use and the Quality of Ambulatory Carein the United States. Arch Intern Med. 2007;167:1400-1405 (link toabstract here)

– The authors examined EHR use throughout the U.S. andassociation with 17 basic quality indicators.

– Concluded that “as implemented, EHRs were not associated withbetter quality ambulatory care.”

– – To medical informaticists, the key phrase that explains these

findings is “as implemented”, to which I would also add “asdesigned”, i.e., badly.


http://archinte.ama-assn.org/cgi/content/short/167/13/1400




On the cost savings forecasts• “Electronic Medical Records and Health Care Transformation”,

Walker JM (Geisinger), Health Affairs, Sept/Oct 2005:

– “Expectations get set too high in the process [of health IT sales, implementationand promotion], making non-clinicians forget that EMR supported healthcaretransformation is 'too immature for credible estimates of cost or benefits’…

– We need to know more about the total cost of EMR’s and the ways in which theywill interact with existing healthcare systems to make compelling predictionsabout their clinical benefits or the savings they can enable.”

• Peter Orszag, CBO director:

– “Use of EHRs, without a major change in health care delivery, would notsignificantly reduce overall health care costs” - CBO 2007 report on long-term health care spending.

– “The ROI for EHRs "is not going to be as substantial as people think."




“Failure and de-installation abound”

• Oct. 2007: Modern Healthcare reports on a survey of healthcare IT use conducted by the Boston-basedMedical Records Institute

• Nearly 19% of respondents have experienced EMR de-

installation (12%) or are now going through a de-installation (7%)

• 8% of those surveyed indicated they'd ripped out EMRs& gone back to paper, with 6% indicating the uprooting

occurred in the past, while another 2% responded thatthey were now experiencing the reversion to paper.

http://www.modernhealthcare.com/apps/pbcs.dll/article?AID=/20071030/FREE/310300002/0/FRONTPAGE

http://www.modernhealthcare.com/apps/pbcs.dll/article?AID=/20071030/FREE/310300002/0/FRONTPAGE



Examples of what my “in the trenches” studentscandidly and regularly report:

• “… In our organization we implemented an electronic clinical documentation system for the ED, a

completely different system than for inpatient. A dilemma has been created ...when patients receive

care in our ED, are admitted and held in the ED due to lack of bed capacity in the hospital, the staff

have to double document pertinent information in both systems because the systems do not

"talk" to each other . We are in the process of building an interface, but it has taken a lot of time,

effort and money.”

• “Last year we implemented barcoding medication administration, where the patient's medications andbracelet is scanned at the bedside ... it has added 15-30 minutes on to our nurses workflow at every

med administration pass, which occur at least 4-5 times per shift.”

• Hi all, I saw a really interesting presentation by [name redacted] of [name redacted] Health System

today. He is a practicing GI doctor in a [~20]-doctor practice. His practice is planning to replace the

EMR they installed only 5 years ago. The reason he gave was that the vendor was "under capitalized"

and therefore unable to keep up with other companies technologically. (An interesting thing that they

did not take into account in the initial evaluation.)



They also report known EMR defects:• The EMR we use has thousands of reported defects. We have lists of them

awaiting remediation.

– There are currently __ defects known at as reported by its staff. Of these defects, __% fallinto the category of affecting revenue, __% fall into the category of affecting clinician workefficiency, and __ % fall into the category of affecting patient safety and outcomes.

__ % fall into Class 1, "likely to cause patient harm in short term if uncorrected", __%fall into Class 2, "may cause in patient harm in medium or long term", and __% fall intoClass 3, "not likely to cause patient harm, but may affect operations."

• Note: Patients do not undergo informed consent regarding use of thesevirtual medical devices in their care …

– (See my partially tongue in cheek essay “Patient Rights Statement and Informed Consent on Use of Clinical IT Devices” at http://hcrenewal.blogspot.com/2009/03/draft-patient-rights-statement-and.html)

• They tell me of “Close Calls” – order transpositions, ghost orders and lostorders, EMAR problems, wrong unit conversions, etc. Have to come upwith workarounds introducing still more chances for errors.

• Are vendors in a hurry to fix these defects? If not, why not?

http://hcrenewal.blogspot.com/2009/03/draft-patient-rights-statement-and.html

http://hcrenewal.blogspot.com/2009/03/draft-patient-rights-statement-and.html



No: Vendors Held Harmless,

users gagged on divulging defects

• Health care information technology (HIT) vendors enjoy acontractual and legal structure that renders them virtually liabilityfree—"hold harmless" is the term of art—even when their

proprietary products may be implicated in adverse eventsinvolving patients.

• This contractual and legal device shifts liability and remedialburdens to physicians, nurses, hospitals, and clinics, evenwhen these HIT users are strictly following vendor instructions.

• HIT vendors are not responsible for errors their systemsintroduce in patient treatment, because physicians, nurses,pharmacists, and health care technicians should be able toidentify—and correct—any errors generated by software faults.

Health Care Information Technology Vendors' "Hold Harmless“ Clause:

Implications for Patients and Clinicians, Ross Koppel, PhD; David Kreda, BA[Univ. of Pennsylvania], JAMA. 2009;301(12):1276-1278 (link)

http://jama.ama-assn.org/cgi/content/extract/301/12/1276




Doctors are liable for IT screw-up's?

• Hey, you’re omniscient, right?

• (Hospital execs signing such contracts violateJC safety standards and their fiduciary dutiesas well)

– “Health Care Information Technology, Hospital Responsibilities, andJoint Commission Standards”, Silverstein S., JAMA. 2009;302(4):382 (link).





• Thank god for sociologists

• (Medicine needs sociologists to pointout to us that health IT has major

problems?)



CPOE – user friendly panacea, right? • Role of Computerized Physician Order Entry Systems in

Facilitating Medication Errors, Ross Koppel, PhD et. al.,JAMA. 2005;293:1197-1203 (link).

– Found that a widely used CPOE system facilitated 22 types of medicationerror risks from misdesign, e.g.:

• fragmented CPOE displays that prevent a coherent view of patients’ medications• pharmacy inventory displays mistaken for dosage guidelines, ignored antibiotic

renewal notices placed on paper charts rather than in the CPOE system• separation of functions that facilitate double dosing and incompatible orders• inflexible ordering formats generating wrong orders.• Three quarters of the house staff reported observing each of these error risks,

indicating that they occur weekly or more often.

– Versioning problem, or not? (I noted similar problems w/same vendor product: in 1992!)

http://jama.ama-assn.org/cgi/content/abstract/293/10/1197




Barcoding – anther slam dunk, right?

• Workarounds to Barcode Medication Administration Systems: Their Occurrences, Causes,and Threats to Patient Safety, Koppel et al, Journal of the American Medical Informatics

Association 2008;15(4):408-423 (link)

– Found that shortcomings in barcoded medication administration (BCMA)‘s design, implementation, andworkflow integration encourage workarounds.

– Identified 15 types of workarounds, for example: affixing patient identification barcodes to computer carts,scanners, doorjambs, or nurses' belt rings; or carrying several patients' prescanned medications on carts.

– Identified 31 types of causes of workarounds, e.g.,

• unreadable medication barcodes (crinkled, smudged, torn, missing, covered by another label);• malfunctioning scanners;• unreadable or missing patient identification wristbands (chewed, soaked, missing);• Non-barcoded medications;• failing batteries;• uncertain wireless connectivity;• emergencies.

– Possible consequences of the workarounds include wrong administration of medications, wrong doses, wrongtimes, and wrong formulations.

– Integrating BCMAs within real-world clinical workflows requires attention to in situ use to ensure safety features'correct use. (Perhaps even more so for health IT used for cognitive support rather than process support!)

http://www.jamia.org/cgi/content/short/M2616v1

http://www.jamia.org/cgi/content/short/M2616v1



So, the time is ripe, let’s all rush right in!



Regulation of Health IT:

In some fields, non-regulationinvites chaos and charlatans.But not computers … right?



In EU countries, regulation of HIT is becoming uncontroversial.

• Sweden's Medical Products Agency’s** “Working Group on Medical

Information Systems: Project summary" http://www.lakemedelsverket.se/upload/foretag/medicinteknik/en/Medical-Information-Systems-Repor

– ... It is becoming more common that electronic patient record systems and other systems are

interconnected, for instance imaging systems or laboratory systems. It is obvious that such systems

should not be regarded as “purely administrative”; instead they have the characteristic features that

are typical for medical devices. They sort, compile and present information on patients’ treatments

and should therefore be regarded as medical devices in accordance to the definition.

– Patient record systems have crucial impact on patient safety, and this has been proven to be

the case after a series of incidents that has been reported to the Swedish National Board of Health

and Welfare.

– A general opinion of the health care providers represented in this Working group is that from a

patient safety point of view, it is desirable that stand alone software and systems intended to, directly

or indirectly, affect diagnosis, health care and treatment of an individual patient shall be regulated

under a Product Safety Regulation.

** The FDA and Sweden's Medical Products Agency have agreements on information sharing andare not strangers.

http://www.lakemedelsverket.se/upload/foretag/medicinteknik/en/Medical-Information-Systems-Report_2009-06-18.pdf

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108646.htm

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108646.htm

http://www.lakemedelsverket.se/upload/foretag/medicinteknik/en/Medical-Information-Systems-Report_2009-06-18.pdf



The good, the Bad and the Ugly



What are the threats from this Experimental “Wild West” Technology?

The “good” (very relative term): (Predictable, known, preventable)

• Incur high costs that can threaten financial viability of your practice.

• Cause large, wasteful transfers of wealth from the healthcare sector to the IT sector, especially whenproblems occur. $100 million for an EHR?

• Benefits to payers far outweigh benefits to clinicians.

• Unauthorized disclosure of personally identifiable medical information - computers insecure as a rule.

• System failure and malfunctions, yielding wrong results, wrong orders, lost orders, and other datadiscrepancies.

• Billing errors that you have to “eat”

• Information overload ---> mistakes

• Wasted time that could be used for other purposes, especially if IT presents a mission hostile userexperience

• Distraction from patient interaction

• Legal issues - eDiscovery (outputs may differ from what you saw on screens at time of care), liability for

outcomes affected by system errors, alerts that are ignored, etc.• Effects on medical education - cut & paste instead of doing careful H&P

• Over-reliance on others’ data and tests

• Documentation errors that would not occur on paper (e.g., cut and paste of old data), entry into wrongpatient record etc.



The bad (and why the “good” is unlikely to disappear soon).

• An unlikely HIT leadership, and attitudes of the facilitators: hospital and vendor IT personnel. Are these MIS “data processing” cultural relics clinicians’ friends,or their enemies?

Hollerith programmable tabulator, 1932

– "I think that physicians bring a certain aspect to the job, but I don’t think they necessarily know how a hospitalworks. I think they know how their practice works and how they interact with the hospital, but I don’t think they

absolutely know what nursing does, or any of the ancillary departments, and what they do." - CIO, FloridaHospital

– I’d like to think that I could run any of the departments in this hospital … A very good friend of mine in another hospital — he’s the CIO there — runs the pharmacy down there. Another friend of mine who’s a CIO runs thehome care division (CIO, N. Carolina)

– I don't think a degree gets you anything," (healthcare IT recruiter). "There's nothing like the school of hard

knocks." (another recruiter). Clinical experience does not yield hospital IT people who have broad enoughperspective. Physicians in particular make poor choices for CIOs. They don't think of the business issues athand because they're consumed with patient care issues.” (another recruiter).

– Doctors who don’t like the clinical systems we install are just having a “pissing contest” with us. (health ITworker, anonymous location).



The bad (cont.): IT territorial nonsense

???



The ugly

• Control of physicians and healthcare – He who controls the data controls the playing field.

• Erroneous metrics creating perverse incentives

– Comparative effectiveness research based on uncontrolled EHR data. (“Syndromeof Inappropriate Overconfidence in Computing: An Invasion of Medicine by the

Information Technology Industry?”, Journal of American Physicians and Surgeons,June 2009, link). Where are the CER studies on this type of CER compared toclinical trials?

– "Beginning in 2015, payment [under Medicare] would be reduced by five percent if an aggregation of the physician's resource use is at or above the 90th percentile of

national utilization." Thus, in any year in which a particular doctor's average per-patient Medicare costs are in the top 10 percent in the nation, the feds will cut thedoctor's payments by 5 percent."

http://www.jpands.org/vol14no2/silverstein.pdf

http://www.jpands.org/vol14no2/silverstein.pdf



Recommendations (1)• Let’s get our heads out of the sand (and other places) and fully apply the

rigor and appropriate skepticism of medical science itself to health IT. Theabsence is a major failing in the health IT field. (Would you prescribe drugswith such an equivocal track record?)

• End the syndrome of irrational exuberance and inappropriate overconfidence incomputers. There are no cybernetic miracles.

• If must adopt health IT, use utmost rigor and skepticism, as if buying a usedcar.

• Get professional help, especially from those with healthcare informaticseducation.

• Support and push for formal regulation of health IT quality and efficacy,

scientific evaluation of dangers.

• Report all adverse events associated with health IT to the FDA via their adverse events website (as you would with a drug AE) or via a letter to theCommissioner. Also consider reporting to your elected representatives.



• (Most of) you are not medical residents anymore. Don’tpassively accept abuses from The Chief, from the CIO, or ITpersonnel who patronize you, know “better than you” what youneed to practice medicine, or act like they are the enablers -rather than the facilitators - of care delivery.

• HIT should not be coerced. Voice your opinion to Congress,Health Departments, Joint Commission, and others. SLOWDOWN!

• Consider delaying adoption, up to the point of incurringpenalties after 2014 as best of bad situation, until the

government and technologists are ready to become true clinicalpartners, not “overlords.” Let the industry learn how to “do HITwell” at their own expense.

Recommendations (2)



Final thoughts• Electronic health records systems can facilitate (not revolutionize!) medicine

when DONE WELL, especially when led by competent experts cross-trainedto a meaningful extent (i.e., graduate level or beyond) in clinical medicine,information science and IT. (When done poorly, results will match.)

• Even these professionals must often expend much effort in "managing themismanagement" by hospital and IT leadership and vendors. Help them!

• Be part of the solution. Learn more about Healthcare Informatics.

• My Drexel U. site “Contemporary Issues in Medical Informatics:Common Examples of Healthcare IT Failure” is atwww.tinyurl.com/hit-misadventure .

• I write on health IT at the “Healthcare Renewal” weblog of the Foundation for Integrity and Responsibility in Medicine (FIRM) athttp://hcrenewal.blogspot.com as well.

“Short” Reading List

http://www.tinyurl.com/hit-misadventure

http://hcrenewal.blogspot.com/


http://www.tinyurl.com/hit-misadventure



Healthcare Renewal blog: http://hcrenewal.blogspot.com

Health IT Project Success and Failure: Recommendations from Literature and an AMIA Workshop. Journal of the American Medical Informatics Association. Bonnie Kaplan and Kimberly D.Harris-Salamone.Joint Commission: Sentinel Events Alert on HIT, Dec. 2008.

National Research Council report. Current Approaches to U.S. Healthcare Information Technology are Insufficient. Computational Technology for Effective Health Care: Immediate Steps and

Strategic Directions, Jan. 2009

The National Programme for IT in the NHS: Progress since 2006, Public Accounts Committee, January 2009. Summary points here.

Common Examples of Healthcare IT Failure (website). S. Silverstein, MD, Drexel University College of Information Science and Technology.

Health Care Information Technology Vendors' "Hold Harmless" Clause - Implications for Patients and Clinicians, Ross Koppel and David Kreda, Journal of the American Medical Association,2009; 301(12):1276-1278

Finding a Cure: The Case for Regulation And Oversight of Electronic Health Records Systems, Hoffman and Podgurski, Harvard Journal of Law & Technology 2008 vol. 22, No. 1

Failure to Provide Clinicians Useful IT Systems: Opportunities to Leapfrog Current Technologies, Ball et al., Methods Inf Med 2008; 47: 4–7,

IT Vulnerabilities Highlighted by Errors, Malfunctions at Veterans’ Medical Centers, JAMA Mar. 4, 2009, p. 919-920.

Unexpected Increased Mortality After Implementation of a Commercially Sold Computerized Physician Order Entry System, Han et al., Pediatrics Vol. 116 No. 6 December 2005, pp. 1506-1512

Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors. Ross Koppel, PhD, et al, Journal of thae American Medical Association, 2005;293:1197-1203

Hiding in Plain SIght: What Koppel et al. tell us about healthcare IT. Christopher Nemeth, Richard Cook. Journal of Biomedical Informatics. 38 (4): 262-3.

Workarounds to Barcode Medication Administration Systems: Their Occurrences, Causes and Threats to Patient Safety, Koppel, Wetterneck, Telles & Karsh, JAMIA 2008;15:408-423

The Computer Will See You Now, New York Times, Armstrong-Coben, March 5, 2009,

Bad Health Informatics Can Kill. Working Group for Assessment of Health Information Systems of the European Federation for Medical Informatics (EFMI).

Electronic Health Record Use and the Quality of Ambulatory Care in the United States. Arch Intern Med. 2007;167:1400-1405

"Dutch nationwide EHR postponed: Are they in good company?", ICMCC.org, Jan. 24, 2009

"The failure rates of EMR implementations are also consistently high at close to 50%" , from Proceedings of the 11th International Symposium on Health Information Management Research –iSHIMR 2006

Adverse Effects of Information Technology in Healthcare. This knowledge center presents a collection of information on the adverse effects of information technology in its application tohealthcare. It also references sources of information on information security, and related media reports.

Pessimism, Computer Failure, and Information Systems Development in the Public Sector . Shaun Goldfinch, University of Otago, New Zealand, Public Administration Review 67;5:917-929,Sept/Oct. 2007

Short Reading List


http://hcrenewal.blogspot.com/2009/03/health-it-project-success-and-failure.html





http://www.ischool.drexel.edu/faculty/ssilverstein/medinfo.htm


http://www.ischool.drexel.edu/faculty/ssilverstein/regulation_and_oversight_hoffman.pdf

http://www.ncbi.nlm.nih.gov/pubmed/18213422


http://pediatrics.aappublications.org/cgi/content/abstract/116/6/1506


http://www.ctlab.org/documents/Hiding%20in%20plain%20sight.pdf

http://www.jamia.org/cgi/content/short/15/4/408

http://www.nytimes.com/2009/03/06/opinion/06coben.html

http://iig.umit.at/efmi/badinformatics.htm


http://articles.icmcc.org/2009/01/23/dutch-ehr-postponed-are-they-in-good-company/

http://www.infoclin.ca/assets/emr%20success%20methodologies%20framework%20development%20ishimr%202006%20v2.pdf

http://www.taxonomer.com/PublishTxgd001/index.htm

http://www.ischool.drexel.edu/faculty/ssilverstein/Goldfinch_pessimism_PAR.pdf

http://www.ischool.drexel.edu/faculty/ssilverstein/Goldfinch_pessimism_PAR.pdf

http://www.taxonomer.com/PublishTxgd001/index.htm

http://www.infoclin.ca/assets/emr%20success%20methodologies%20framework%20development%20ishimr%202006%20v2.pdf

http://articles.icmcc.org/2009/01/23/dutch-ehr-postponed-are-they-in-good-company/


http://iig.umit.at/efmi/badinformatics.htm

http://www.nytimes.com/2009/03/06/opinion/06coben.html

http://www.jamia.org/cgi/content/short/15/4/408

http://www.ctlab.org/documents/Hiding%20in%20plain%20sight.pdf


http://pediatrics.aappublications.org/cgi/content/abstract/116/6/1506


http://www.ncbi.nlm.nih.gov/pubmed/18213422

http://www.ischool.drexel.edu/faculty/ssilverstein/regulation_and_oversight_hoffman.pdf


http://www.ischool.drexel.edu/faculty/ssilverstein/medinfo.htm




http://hcrenewal.blogspot.com/2009/03/health-it-project-success-and-failure.html


EHR Promises Threats

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