The Future Pathways for e-Health in NSW

Prof. Patrick has now added a new section to his report on health IT in NSW Australia, entitled "The Future Pathways for e-Health in NSW." It is available at this link (PDF).

It inoculates against most of the 'Ten Plagues' that bedevil health IT projects (such as the IT-clinical leadership inversion, lack of transparency, suppression of defects reporting, magical thinking about the technology, and lack of accountability of the bureaucrats).

Emphases mine:

In Short Term ( 0-3 months)

1. Halt further rollouts of Firstnet or other CIS systems. The current roll-out programs use significant efforts in training staff for a system that is counterproductive to patient well being.
2. Complete a full and thorough risk assessment analysis and usability of the software. The CIS report indicates there are a number of risks in the current software that are not likely to have been assessed in the past.
3. Address the current problems before doing anything else. There are a number of problems that appear solvable in the short term that would improve the situation for current users, such as providing needed reports.
4. Create the NSW IT Improvement Panel composed of ED Directors, IT-savvy clinical and quality improvement staff responsible for advising on the preparedness and process of the rollout.
5. Create an effective error and bug reporting mechanism that is viewable by all ED directors and with the display of the priority of each entry and expected completion time.
6. Initiate a high profile campaign to encourage staff to lodge fault records on anything they discover wrong, problematic or inefficient in using the system.

In the longer term (3-12 months)

1. Review the Health Support Services and make it clinically accountable by appointing a clinical head with an IT education.
2. Create a culture change in the HSS. The current operation of the HSS seems to be devoid of influence from the clinical community.
3. All NSW CIS system procurement should be guided by an IT Advisory Board of IT experienced clinical, academic and medical software industry experts.
4. Create pathways for hospitals that wish to be early adopters and take a lead role in the development of new methods for using and deploying IT systems.
5. Support innovation within the Australian medical software communities that contribute to a culture of innovation and continuous quality improvement.
6. Adopt transparency rules in all new healthcare information acquisitions. Secrecy has bedevilled the efforts of staff and management to get improvements in the CIS systems and hold service agents accountable for their failure to comply to service level agreements. All agreements about a signed contract should be available to the ED Directors.
7. Replace the State Based Build policy with a policy of providing a technology to match the technology experience of the individual departments so that leaders are not dragged backwards with inappropriate technology installation

The de facto "National Program for IT in the HHS" here in the United States needs a similar inoculation.

I can only add that our own ONC office (Office of the National Coordinator for Health IT of the Dept. of HHS) had more granular recommendations about expertise levels required for leadership roles in such undertakings. I wrote about them at my Dec. 2009 post "ONC Defines a Taxonomy of Robust Healthcare IT Leadership."

--SS

The Future Pathways for e-Health in NSW

Prof. Patrick has now added a new section to his report on health IT in NSW Australia, entitled "The Future Pathways for e-Health in NSW." It is available at this link (PDF).

It inoculates against most of the 'Ten Plagues' that bedevil health IT projects (such as the IT-clinical leadership inversion, lack of transparency, suppression of defects reporting, magical thinking about the technology, and lack of accountability of the bureaucrats).

Emphases mine:

In Short Term ( 0-3 months)

1. Halt further rollouts of Firstnet or other CIS systems. The current roll-out programs use significant efforts in training staff for a system that is counterproductive to patient well being.
2. Complete a full and thorough risk assessment analysis and usability of the software. The CIS report indicates there are a number of risks in the current software that are not likely to have been assessed in the past.
3. Address the current problems before doing anything else. There are a number of problems that appear solvable in the short term that would improve the situation for current users, such as providing needed reports.
4. Create the NSW IT Improvement Panel composed of ED Directors, IT-savvy clinical and quality improvement staff responsible for advising on the preparedness and process of the rollout.
5. Create an effective error and bug reporting mechanism that is viewable by all ED directors and with the display of the priority of each entry and expected completion time.
6. Initiate a high profile campaign to encourage staff to lodge fault records on anything they discover wrong, problematic or inefficient in using the system.

In the longer term (3-12 months)

1. Review the Health Support Services and make it clinically accountable by appointing a clinical head with an IT education.
2. Create a culture change in the HSS. The current operation of the HSS seems to be devoid of influence from the clinical community.
3. All NSW CIS system procurement should be guided by an IT Advisory Board of IT experienced clinical, academic and medical software industry experts.
4. Create pathways for hospitals that wish to be early adopters and take a lead role in the development of new methods for using and deploying IT systems.
5. Support innovation within the Australian medical software communities that contribute to a culture of innovation and continuous quality improvement.
6. Adopt transparency rules in all new healthcare information acquisitions. Secrecy has bedevilled the efforts of staff and management to get improvements in the CIS systems and hold service agents accountable for their failure to comply to service level agreements. All agreements about a signed contract should be available to the ED Directors.
7. Replace the State Based Build policy with a policy of providing a technology to match the technology experience of the individual departments so that leaders are not dragged backwards with inappropriate technology installation

The de facto "National Program for IT in the HHS" here in the United States needs a similar inoculation.

I can only add that our own ONC office (Office of the National Coordinator for Health IT of the Dept. of HHS) had more granular recommendations about expertise levels required for leadership roles in such undertakings. I wrote about them at my Dec. 2009 post "ONC Defines a Taxonomy of Robust Healthcare IT Leadership."

--SS

Dr. Scott Monteith on "The Best Compromise" on Physicians and Use of Troublesome Health IT

I have posted two guest posts by Dr. Scott Monteith, a psychiatrist/informaticist, at the Jan. 2011 post "Interesting HIT Testimony to HHS Standards Committee, Jan. 11, 2011, by Dr. Monteith" and the Dec. 2010 post "Meaningful Use and the Devil in the Details: A Reader's View".

Here is another, with his permission. He is responding to a talking point from a health IT commentary website that was distributed among the AMIA evaluations special interest group readership.

Dr. Monteith asks some very probing questions. He writes:

I would like to respond to what I see as being one of the most important and challenging “real-life” issues confronting clinicians, and is captured in this excerpt [below, from the multi-vendor sponsored site HISTalk - ed.]:

HisTALK: ... Somewhere between “we vendors are doing the best we can given a fiercely competitive market, economic realities, and slow and often illogical provide procurement processes that don’t reflect what those providers claim they really want” and “we armchair quarterbacks critics think vendors are evil and the answer is free, open source applications written by non-experts willing to work for free under the direct supervision of the FDA” is the best compromise.

That is, this excerpt performs the helpful task of framing “the best compromise” somewhere between two extreme viewpoints.

It would be helpful (at least for me) if this group could discuss what “the best compromise” actually ‘looks like’ in practice. How does one actually understand and live within “the best compromise”?

Let’s start with a relatively simple scenario:

What should clinicians do when they are working with EHRs that have known “problems” that are putting patients at risk, and the problems are not being immediately addressed, either directly or indirectly through, for example, an acceptable “work around,” or other adjustments to the EHR or local business processes?

Should the clinician continue to use the EHR and…

• assume that others (e.g., vendor, IT department, administration, etc.) will fix the problem(s)?

• report the problem(s)? Once? Twice? Three or more times? (How many?) To whom?

• inform the patient of the known problem(s) (if the problem(s) apply to the patient)?

• inform the patient that we do not have a good understanding of how to balance or even understand the risks posed by the EHR, given the dearth of peer-reviewed literature and algorithms? (What is “acceptable risk” for a given EHR problem? Does the EHR-related problem’s risk/benefit analysis change if the patient is in the hospital for a simple, nonlife-threatening problem vs. a complex, life-threatening problem)?

• give the patient the option to NOT use the EHR? (Note that we almost always give patients the choice to refuse other “risky ventures” such as diagnostic procedures and treatments.)

• inform their medical malpractice insurance company of the EHR-related problems?

• submit the problem(s) to the organization’s ethics committee, if there is one?

• report the problem(s) to the organization’s risk management staff?

• report the problem(s) in writing or verbally?

• stop using the EHR?

Etc. (including some combination of things).

Can providers (especially physicians) legitimately rationalize, given our ethical (to patients and our colleagues) and legal obligations (to patients and the state where we are licensed), the use of tools that are posing risks to patients and providers, when those risks are not spelled-out, not well understood, not peer-reviewed, etc.?

(Obviously everything we do has risks, but we are obligated to revel and discuss those risks as noted above. Further, the risks/benefits of a given diagnostic or treatment intervention are the product of peer-reviewed algorithms. Are patient’s aware of the risks associated with their doctor’s or hospital’s EHR?)

Again, the above excerpt suggests that there is a “ best compromise.” But what is/are “the best compromise(s)”?

I joke with friends that I am a “radical moderate” – that is, I usually find myself committed to the “middle ground” in most complex and thoughtful discussions. But when it comes to EHRs, I am finding it difficult to define or understand what a “moderate” or an acceptable “best compromise” looks like.

Given the current EHR exuberance driven by ONC’s incentive dollars and vendor profits (or hoped-for profits), we all know that the “politically correct” approach is to “go along” and be an “early adopter” (without too many protests). But is the politically correct approach really the “best compromise,” especially in light of our ethical and legal obligations?

I am anxious to hear what other people think about this matter. I am sincerely seeking help in better understanding a sensible, real-life “best compromise” for those of us in the trenches.

Note that if we cannot define “the best compromise,” then what does that say about us? How can we justify “getting on board” with patient care tools (e.g., EHRs, eRx’ing, etc.) that are posing risks (known and unknown), with no clear processes for informing patients, not giving patients their choice to use these e-tools, no clear evidence-based risk/benefit analyses, etc.?

My own pithy, initial responses are as follows:

Re: Given the current EHR exuberance driven by ONC’s incentive dollars and vendor profits (or hoped-for profits), we all know that the “politically correct” approach is to “go along” and be an “early adopter” (without too many protests). But is the politically correct approach [i.e, "go along to get along" - ed.] really the “best compromise,” especially in light of our ethical and legal obligations?

No, for the reasons after your comma. [i.e., in light of our ethical & legal obligation - ed.]

One should look to the past for lessons in what the "compromises" might be.

How about the Flexner Report of 1910 as a start?

The treatises on human research protections penned largely after the Tuskegee experiments and the horrors of WW2, such as these as listed on an NIH web page "Office of Human Subjects Research, Regulations and Ethical Guidelines" might also shed some light:

• 45 CFR 46 Protection Of Human Subjects

• Guidelines for Conduct of Research Involving Human Subjects at NIH (Gray Booklet) (pdf file)

• The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research

• Nuremberg Code Directives for Human Experimentation

• World Medical Association Declaration Of Helsinki

I further opine:

Re: How can we justify “getting on board” with patient care tools (e.g., EHRs, eRx’ing, etc.) that are posing risks (known and unknown), with no clear processes for informing patients, not giving patients their choice to use these e-tools, no clear evidence-based risk/benefit analyses, etc.?

Perhaps with the line that "I never make mistakes ... everything I do is an experiment."

The technology is experimental. Perhaps the best way forward is to treat it as such.

In medicine I think there's a rich history of how to conduct proper (and improper) experimental research.

Again, Dr. Monteith raises some critical questions that need to be answered.

Or, more correctly, needed to be answered a long time ago, and long before planned national rollouts of healthcare information technology.

-- SS

Dr. Scott Monteith on "The Best Compromise" on Physicians and Use of Troublesome Health IT

I have posted two guest posts by Dr. Scott Monteith, a psychiatrist/informaticist, at the Jan. 2011 post "Interesting HIT Testimony to HHS Standards Committee, Jan. 11, 2011, by Dr. Monteith" and the Dec. 2010 post "Meaningful Use and the Devil in the Details: A Reader's View".

Here is another, with his permission. He is responding to a talking point from a health IT commentary website that was distributed among the AMIA evaluations special interest group readership.

Dr. Monteith asks some very probing questions. He writes:

I would like to respond to what I see as being one of the most important and challenging “real-life” issues confronting clinicians, and is captured in this excerpt [below, from the multi-vendor sponsored site HISTalk - ed.]:

HisTALK: ... Somewhere between “we vendors are doing the best we can given a fiercely competitive market, economic realities, and slow and often illogical provide procurement processes that don’t reflect what those providers claim they really want” and “we armchair quarterbacks critics think vendors are evil and the answer is free, open source applications written by non-experts willing to work for free under the direct supervision of the FDA” is the best compromise.

That is, this excerpt performs the helpful task of framing “the best compromise” somewhere between two extreme viewpoints.

It would be helpful (at least for me) if this group could discuss what “the best compromise” actually ‘looks like’ in practice. How does one actually understand and live within “the best compromise”?

Let’s start with a relatively simple scenario:

What should clinicians do when they are working with EHRs that have known “problems” that are putting patients at risk, and the problems are not being immediately addressed, either directly or indirectly through, for example, an acceptable “work around,” or other adjustments to the EHR or local business processes?

Should the clinician continue to use the EHR and…

• assume that others (e.g., vendor, IT department, administration, etc.) will fix the problem(s)?

• report the problem(s)? Once? Twice? Three or more times? (How many?) To whom?

• inform the patient of the known problem(s) (if the problem(s) apply to the patient)?

• inform the patient that we do not have a good understanding of how to balance or even understand the risks posed by the EHR, given the dearth of peer-reviewed literature and algorithms? (What is “acceptable risk” for a given EHR problem? Does the EHR-related problem’s risk/benefit analysis change if the patient is in the hospital for a simple, nonlife-threatening problem vs. a complex, life-threatening problem)?

• give the patient the option to NOT use the EHR? (Note that we almost always give patients the choice to refuse other “risky ventures” such as diagnostic procedures and treatments.)

• inform their medical malpractice insurance company of the EHR-related problems?

• submit the problem(s) to the organization’s ethics committee, if there is one?

• report the problem(s) to the organization’s risk management staff?

• report the problem(s) in writing or verbally?

• stop using the EHR?

Etc. (including some combination of things).

Can providers (especially physicians) legitimately rationalize, given our ethical (to patients and our colleagues) and legal obligations (to patients and the state where we are licensed), the use of tools that are posing risks to patients and providers, when those risks are not spelled-out, not well understood, not peer-reviewed, etc.?

(Obviously everything we do has risks, but we are obligated to revel and discuss those risks as noted above. Further, the risks/benefits of a given diagnostic or treatment intervention are the product of peer-reviewed algorithms. Are patient’s aware of the risks associated with their doctor’s or hospital’s EHR?)

Again, the above excerpt suggests that there is a “ best compromise.” But what is/are “the best compromise(s)”?

I joke with friends that I am a “radical moderate” – that is, I usually find myself committed to the “middle ground” in most complex and thoughtful discussions. But when it comes to EHRs, I am finding it difficult to define or understand what a “moderate” or an acceptable “best compromise” looks like.

Given the current EHR exuberance driven by ONC’s incentive dollars and vendor profits (or hoped-for profits), we all know that the “politically correct” approach is to “go along” and be an “early adopter” (without too many protests). But is the politically correct approach really the “best compromise,” especially in light of our ethical and legal obligations?

I am anxious to hear what other people think about this matter. I am sincerely seeking help in better understanding a sensible, real-life “best compromise” for those of us in the trenches.

Note that if we cannot define “the best compromise,” then what does that say about us? How can we justify “getting on board” with patient care tools (e.g., EHRs, eRx’ing, etc.) that are posing risks (known and unknown), with no clear processes for informing patients, not giving patients their choice to use these e-tools, no clear evidence-based risk/benefit analyses, etc.?

My own pithy, initial responses are as follows:

Re: Given the current EHR exuberance driven by ONC’s incentive dollars and vendor profits (or hoped-for profits), we all know that the “politically correct” approach is to “go along” and be an “early adopter” (without too many protests). But is the politically correct approach [i.e, "go along to get along" - ed.] really the “best compromise,” especially in light of our ethical and legal obligations?

No, for the reasons after your comma. [i.e., in light of our ethical & legal obligation - ed.]

One should look to the past for lessons in what the "compromises" might be.

How about the Flexner Report of 1910 as a start?

The treatises on human research protections penned largely after the Tuskegee experiments and the horrors of WW2, such as these as listed on an NIH web page "Office of Human Subjects Research, Regulations and Ethical Guidelines" might also shed some light:

• 45 CFR 46 Protection Of Human Subjects

• Guidelines for Conduct of Research Involving Human Subjects at NIH (Gray Booklet) (pdf file)

• The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research

• Nuremberg Code Directives for Human Experimentation

• World Medical Association Declaration Of Helsinki

I further opine:

Re: How can we justify “getting on board” with patient care tools (e.g., EHRs, eRx’ing, etc.) that are posing risks (known and unknown), with no clear processes for informing patients, not giving patients their choice to use these e-tools, no clear evidence-based risk/benefit analyses, etc.?

Perhaps with the line that "I never make mistakes ... everything I do is an experiment."

The technology is experimental. Perhaps the best way forward is to treat it as such.

In medicine I think there's a rich history of how to conduct proper (and improper) experimental research.

Again, Dr. Monteith raises some critical questions that need to be answered.

Or, more correctly, needed to be answered a long time ago, and long before planned national rollouts of healthcare information technology.

-- SS

An Updated Reading List on Health IT

“It is only the ignorant who despise education.” - Publilius Syrus, Latin Poet, 43-85 AD

In a March 2009 post "A Primer On Why We Have Busywork Generators Masquerading as EMR's: Health IT Reality vs. the Bernard Madoff Version", I posted a "reading list" of articles about health IT that I consider essential in understanding the issues surrounding the experimental nature of this technology.

I wrote:

Anyone contemplating policy work in health IT should be intimately familiar with these works, as they illustrate the true HIT environment in 2009, not the Bernard Madoff "unlimited returns no matter what" version.

What these articles do not illustrate is the common atmosphere of irrational exuberance and complacency now prevalent about HIT, with healthcare organizations and physicians now being pushed forcefully to adopt these technologies or suffer payment penalties they can ill afford:

I've updated the list.

Updated reading list (not meant to be at all comprehensive; this is just a set I've collected over recent years writing on health IT):

[1] Electronic Health Records and Clinical Decision Support Systems: Impact on National Ambulatory Care Quality. Max J. Romano, BA; Randall S. Stafford, MD, PhD, Arch Intern Med. Published online Jan. 24, 2011. doi:10.1001/archinternmed.2010.527

[2] Electronic Health Record Use and the Quality of Ambulatory Care in the United States. Linder, Ma, Bates et al. Arch Intern Med. 2007;167:1400-1405

[3] The Impact of eHealth on the Quality and Safety of Health Care: A Systematic Overview. Black AD, Car J, Pagliari C, Anandan C, Cresswell K, et al. PLoS Medicine 8(1): e1000387 (Jan. 18, 2011). doi:10.1371/journal.pmed.1000387.

[4] Electronic Health Records’ Limited Successes Suggest More Targeted Uses. DesRoches, Jha et al., Health Affairs, April 2010 vol. 29 no. 4 639-646, doi:10.1377/hlthaff.2009.1086

[5] Health information technology: fallacies and sober realities. Karsh et al. (Oct. 2010). JAMIA 2010 17: 617-623.

[6] Challenges in ethics, safety, best practices, and oversight regarding HIT vendors, their customers, and patients: a report of an AMIA special task force. Goodman et al. JAMIA doi:10.1136/jamia.2010.008946. Nov. 2010.

[7] The Top Ten Health Technology Threats to Patient Safety for 2011. ECRI Institute, Plymouth Meeting, PA, Dec. 7, 2010.

[8] Current Approaches to U.S. Healthcare Information Technology are Insufficient. Computational Technology for Effective Health Care: Immediate Steps and Strategic Directions. National Research Council of the U.S. National Academies, Jan. 2009.

[9] Evaluating the Impact of the Electronic Health Record on Patient Flow in a Pediatric Emergency Department. Mathison, Chamberlain, Children's National Medical Center – Division of Emergency Medicine, Washington, DC. Applied Clinical Informatics, Vol. 2, Issue 1, 2011, 10.4338/ACI-2010-08-RA-0046

[10] A Critical Essay on the Deployment of an ED Clinical Information System ‐ Systemic Failure or Bad Luck?, Professor Jon Patrick, Health Information Technology Research Laboratory, School of Information Technologies, University of Sydney, Australia, Jan. 2010.

[11] E-Health Hazards: Provider Liability and Electronic Health Record Systems. Sharona Hoffman and Andy Podgurski. Berkeley Technology Law Journal (2010). Followup paper on EHR medical and legal risks. This article is a first of its kind, a comprehensive analysis of the liability risks associated with use of clinical IT. The authors point out that the potential benefits of computerization could be substantial, but EHR systems also give rise to new liability risks for health care providers that have received little attention in the legal literature.

[12] Meaningful Use and Certification of Health Information Technology: What About Safety? Sharona Hoffman and Andy Podgurski. Case Research Paper Series in Legal Studies Working Paper 2010-34, October 2010.

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

[14] Emerging Trends in Electronic Health Record Liability. Chad P. Brouillard. For the Defense, July 2010 (Defense Research Institute).

[15] Electronic Health Records: Recognizing and Managing the Risks. ClaimsRx: Clinical and Risk Management Perspectives. NORCAL Mutual Insurance Company, Oct. 2009.

[16] Litigation in the Decade of Electronic Health Records. Joel B. Korin and Madelyn S. Quattrone. New Jersey Law Journal, June 11, 2007.

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

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

[19] 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.

[20] 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

[21] Hospital Computing and the Costs and Quality of Care: A National Study. Himmelstein. Wright, Woolhandler. The American Journal of Medicine, Volume 123, Issue 1 , Pages 40-46, January 2010.

[22] Unintended errors with EHR-based result management: a case series. Yackel and Embi; JAMIA 2010 17: 104-107; doi: 10.1197/jamia.M3294, Oct. 2009.

[23] Information Technology: Not a Cure for the High Cost of Health Care: Knowledge@Wharton, Wharton School of Business, University of Pennsylvania, June 10, 2009. (PDF version available at this link).

[24] Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties. Teaching website, Scot Silverstein, MD, Drexel University, College of Information Science and Technology, Philadelphia, PA. Site initiated in 1999.

[25] Healthcare Renewal blog. I write on healthcare IT issues at this multi-author website sponsored by the Foundation for Integrity and Responsibility in Medicine (FIRM), a 501(c)(3) advocacy group. FIRM researches problems with leadership and governance in healthcare that threaten healthcare's core values.

[26] 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.

[27] Joint Commission: Sentinel Events Alert on HIT, Dec. 2008.

[28] Internal FDA memorandum on HIT risks to Jeffrey Shuren MD JD (Director, Center for Devices and Radiological Health). "Not Intended for Public Use." Feb. 23, 2010. (Description/summary of memorandum is at this link).

[29] FDA's Manufacturer and User Facility Device Experience database (MAUDE) and HIT risks. Healthcare Renewal Blog, Scot M. Silverstein MD, Drexel University, Philadelphia, PA, Jan. 2011

[30] Health IT's Mission Hostile User Experience (eight-part essay), Healthcare Renewal Blog, Scot M. Silverstein MD, Drexel University, Philadelphia, PA, Feb. - Mar. 2009.

[31] The National Programme for IT in the NHS: Progress since 2006. Summary points, conclusions & recommendations. UK Parliament House of Commons, Public Accounts Committee, January 2009. (Full report at this link.)

[32] The future of the NPfIT. Program slated for major downsizing and decentralization after poor progress and expenditures exceeding £13 billion. UK Dept. of Health, Sept. 2010.

[33] "Don't Repeat the UK's Electronic Health Records Failure". Stephen B. Soumerai, Professor of Population Medicine at Harvard Medical School, Anthony Avery, Professor of Primary Care at the University of Nottingham Medical School, UK. Huffington Post, Dec. 5, 2010.

[34] Health informatics — Guidance on the management of clinical risk relating to the deployment and use of health software. UK National Health Service, DSCN18 (2009), formerly ISO/TR 29322:2008(E).

[35] Health Informatics — Application of clinical risk management to the manufacture of health software. UK National Health Service, DSCN14 (2009), formerly ISO/TS 29321:2008(E).

[36] The Impact of eHealth on the Quality & Safety of Healthcare, A Report for the NHS Connecting for Health Evaluation Programme. (Note: 7 MB in length). Car et al., Imperial College, London, March 2008.

[37] Medical Project Agency's Working Group on Medical Information Systems: Project summary. Proposal for guidelines regarding classification of software based information systems used in health care. Läkemedelsverket - Swedish Medical Products Agency (MPA), June 2009, revised Jan. 2010.

[38] Tensions and Paradoxes in Electronic Patient Record Research: A Systematic Literature Review Using the Meta-narrative Method. Greenhalgh, Potts, Wong, Bark and Swinglehurst, University College London. Milbank Quarterly, Dec. 2009.

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

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

[41] Software hiccups cause drug, treatment errors at VA”, Associated Press, January 14, 2009

[42] Electronic Records System Unreliable, Difficult to Use, Service Officials Tell Congress, Sandra Basu, U.S. Medicine - the Voice of Federal Medicine, May 2009

[43] 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 (doi:10.1542/peds.2005-1287).

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

[45] Physician testimony to HHS Standards Committee Implementation Workgroup of the ONC, Jan. 11, 2011. Reproduced with permission at Healthcare Renewal blog.

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

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

[48] "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

[49] 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 to healthcare. It also references sources of information on information security, and related media reports.

[50] The Machinery Behind Health-Care Reform: How an Industry Lobby Scored a Swift, Unexpected Victory by Channeling Billions to Electronic Records - Robert O'Harrow Jr., Washington Post, May 16, 2009

[51] American Association of Physicians and Surgeons Survey on Health IT, June 2008

[52] 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

I await invective that these sources are "cherry picked" and "anecdotal."

-- SS

An Updated Reading List on Health IT

“It is only the ignorant who despise education.” - Publilius Syrus, Latin Poet, 43-85 AD

In a March 2009 post "A Primer On Why We Have Busywork Generators Masquerading as EMR's: Health IT Reality vs. the Bernard Madoff Version", I posted a "reading list" of articles about health IT that I consider essential in understanding the issues surrounding the experimental nature of this technology.

I wrote:

Anyone contemplating policy work in health IT should be intimately familiar with these works, as they illustrate the true HIT environment in 2009, not the Bernard Madoff "unlimited returns no matter what" version.

What these articles do not illustrate is the common atmosphere of irrational exuberance and complacency now prevalent about HIT, with healthcare organizations and physicians now being pushed forcefully to adopt these technologies or suffer payment penalties they can ill afford:

I've updated the list.

Updated reading list (not meant to be at all comprehensive; this is just a set I've collected over recent years writing on health IT):

[1] Electronic Health Records and Clinical Decision Support Systems: Impact on National Ambulatory Care Quality. Max J. Romano, BA; Randall S. Stafford, MD, PhD, Arch Intern Med. Published online Jan. 24, 2011. doi:10.1001/archinternmed.2010.527

[2] Electronic Health Record Use and the Quality of Ambulatory Care in the United States. Linder, Ma, Bates et al. Arch Intern Med. 2007;167:1400-1405

[3] The Impact of eHealth on the Quality and Safety of Health Care: A Systematic Overview. Black AD, Car J, Pagliari C, Anandan C, Cresswell K, et al. PLoS Medicine 8(1): e1000387 (Jan. 18, 2011). doi:10.1371/journal.pmed.1000387.

[4] Electronic Health Records’ Limited Successes Suggest More Targeted Uses. DesRoches, Jha et al., Health Affairs, April 2010 vol. 29 no. 4 639-646, doi:10.1377/hlthaff.2009.1086

[5] Health information technology: fallacies and sober realities. Karsh et al. (Oct. 2010). JAMIA 2010 17: 617-623.

[6] Challenges in ethics, safety, best practices, and oversight regarding HIT vendors, their customers, and patients: a report of an AMIA special task force. Goodman et al. JAMIA doi:10.1136/jamia.2010.008946. Nov. 2010.

[7] The Top Ten Health Technology Threats to Patient Safety for 2011. ECRI Institute, Plymouth Meeting, PA, Dec. 7, 2010.

[8] Current Approaches to U.S. Healthcare Information Technology are Insufficient. Computational Technology for Effective Health Care: Immediate Steps and Strategic Directions. National Research Council of the U.S. National Academies, Jan. 2009.

[9] Evaluating the Impact of the Electronic Health Record on Patient Flow in a Pediatric Emergency Department. Mathison, Chamberlain, Children's National Medical Center – Division of Emergency Medicine, Washington, DC. Applied Clinical Informatics, Vol. 2, Issue 1, 2011, 10.4338/ACI-2010-08-RA-0046

[10] A Critical Essay on the Deployment of an ED Clinical Information System ‐ Systemic Failure or Bad Luck?, Professor Jon Patrick, Health Information Technology Research Laboratory, School of Information Technologies, University of Sydney, Australia, Jan. 2010.

[11] E-Health Hazards: Provider Liability and Electronic Health Record Systems. Sharona Hoffman and Andy Podgurski. Berkeley Technology Law Journal (2010). Followup paper on EHR medical and legal risks. This article is a first of its kind, a comprehensive analysis of the liability risks associated with use of clinical IT. The authors point out that the potential benefits of computerization could be substantial, but EHR systems also give rise to new liability risks for health care providers that have received little attention in the legal literature.

[12] Meaningful Use and Certification of Health Information Technology: What About Safety? Sharona Hoffman and Andy Podgurski. Case Research Paper Series in Legal Studies Working Paper 2010-34, October 2010.

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

[14] Emerging Trends in Electronic Health Record Liability. Chad P. Brouillard. For the Defense, July 2010 (Defense Research Institute).

[15] Electronic Health Records: Recognizing and Managing the Risks. ClaimsRx: Clinical and Risk Management Perspectives. NORCAL Mutual Insurance Company, Oct. 2009.

[16] Litigation in the Decade of Electronic Health Records. Joel B. Korin and Madelyn S. Quattrone. New Jersey Law Journal, June 11, 2007.

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

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

[19] 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.

[20] 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

[21] Hospital Computing and the Costs and Quality of Care: A National Study. Himmelstein. Wright, Woolhandler. The American Journal of Medicine, Volume 123, Issue 1 , Pages 40-46, January 2010.

[22] Unintended errors with EHR-based result management: a case series. Yackel and Embi; JAMIA 2010 17: 104-107; doi: 10.1197/jamia.M3294, Oct. 2009.

[23] Information Technology: Not a Cure for the High Cost of Health Care: Knowledge@Wharton, Wharton School of Business, University of Pennsylvania, June 10, 2009. (PDF version available at this link).

[24] Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties. Teaching website, Scot Silverstein, MD, Drexel University, College of Information Science and Technology, Philadelphia, PA. Site initiated in 1999.

[25] Healthcare Renewal blog. I write on healthcare IT issues at this multi-author website sponsored by the Foundation for Integrity and Responsibility in Medicine (FIRM), a 501(c)(3) advocacy group. FIRM researches problems with leadership and governance in healthcare that threaten healthcare's core values.

[26] 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.

[27] Joint Commission: Sentinel Events Alert on HIT, Dec. 2008.

[28] Internal FDA memorandum on HIT risks to Jeffrey Shuren MD JD (Director, Center for Devices and Radiological Health). "Not Intended for Public Use." Feb. 23, 2010. (Description/summary of memorandum is at this link).

[29] FDA's Manufacturer and User Facility Device Experience database (MAUDE) and HIT risks. Healthcare Renewal Blog, Scot M. Silverstein MD, Drexel University, Philadelphia, PA, Jan. 2011

[30] Health IT's Mission Hostile User Experience (eight-part essay), Healthcare Renewal Blog, Scot M. Silverstein MD, Drexel University, Philadelphia, PA, Feb. - Mar. 2009.

[31] The National Programme for IT in the NHS: Progress since 2006. Summary points, conclusions & recommendations. UK Parliament House of Commons, Public Accounts Committee, January 2009. (Full report at this link.)

[32] The future of the NPfIT. Program slated for major downsizing and decentralization after poor progress and expenditures exceeding £13 billion. UK Dept. of Health, Sept. 2010.

[33] "Don't Repeat the UK's Electronic Health Records Failure". Stephen B. Soumerai, Professor of Population Medicine at Harvard Medical School, Anthony Avery, Professor of Primary Care at the University of Nottingham Medical School, UK. Huffington Post, Dec. 5, 2010.

[34] Health informatics — Guidance on the management of clinical risk relating to the deployment and use of health software. UK National Health Service, DSCN18 (2009), formerly ISO/TR 29322:2008(E).

[35] Health Informatics — Application of clinical risk management to the manufacture of health software. UK National Health Service, DSCN14 (2009), formerly ISO/TS 29321:2008(E).

[36] The Impact of eHealth on the Quality & Safety of Healthcare, A Report for the NHS Connecting for Health Evaluation Programme. (Note: 7 MB in length). Car et al., Imperial College, London, March 2008.

[37] Medical Project Agency's Working Group on Medical Information Systems: Project summary. Proposal for guidelines regarding classification of software based information systems used in health care. Läkemedelsverket - Swedish Medical Products Agency (MPA), June 2009, revised Jan. 2010.

[38] Tensions and Paradoxes in Electronic Patient Record Research: A Systematic Literature Review Using the Meta-narrative Method. Greenhalgh, Potts, Wong, Bark and Swinglehurst, University College London. Milbank Quarterly, Dec. 2009.

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

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

[41] Software hiccups cause drug, treatment errors at VA”, Associated Press, January 14, 2009

[42] Electronic Records System Unreliable, Difficult to Use, Service Officials Tell Congress, Sandra Basu, U.S. Medicine - the Voice of Federal Medicine, May 2009

[43] 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 (doi:10.1542/peds.2005-1287).

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

[45] Physician testimony to HHS Standards Committee Implementation Workgroup of the ONC, Jan. 11, 2011. Reproduced with permission at Healthcare Renewal blog.

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

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

[48] "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

[49] 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 to healthcare. It also references sources of information on information security, and related media reports.

[50] The Machinery Behind Health-Care Reform: How an Industry Lobby Scored a Swift, Unexpected Victory by Channeling Billions to Electronic Records - Robert O'Harrow Jr., Washington Post, May 16, 2009

[51] American Association of Physicians and Surgeons Survey on Health IT, June 2008

[52] 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

I await invective that these sources are "cherry picked" and "anecdotal."

-- SS

BLOGSCAN - By Feb. all ER physicians at DePaul Health Center (MO) will be using scribes

At my Sept. 2010 post "The Ultimate Workaround To Mission Hostile Health IT: Humans (a.k.a. Scribes)" I had written that:

The EMR is a technology that was supposed to improve clinical medicine (revolutionize it, some say). It was supposed to facilitate clinical medicine. It was not supposed to slow physicians and others down to the point of impairing their ability to practice medicine. However, the rosy predictions are not proving to be the case. Instead, we have the ultimate workaround to the health IT mission hostile user experience: [the medical scribe].

On the HisTALK blog today, apparently one medical center agrees:

By February, all ER physicians at DePaul Health Center (MO) will be using scribes for electronic medical documentation. Administrators hope to improve staff productivity as well as patient satisfaction. Apparently patients were “annoyed” that doctors were sharing their attention with a computer.

In the cited article "Scribes are finding their place in emergency rooms" by Michele Munz, St. Louis Post-dispatch.com, Jan. 25, 2011:

"[With a scribe] I can just completely focus on and deal with the patient," [ED physician] Lebo said.

The emergency department at DePaul Health Center in Bridgeton, which sees about 60,000 patients a year, is the first to use scribes in the St. Louis area. By February, all the hospital's emergency physicians will have a scribe tapping away at a laptop or tablet computer while they work. Across the nation, about 200 hospital emergency departments have started using scribes, most within the last two years, according to the three major companies providing scribes.

Several points worthy of note:

• The cost of scribes will be an issue affecting the supposed ROI of EHR's, and are necessitated by the fact that the EHR and its mission hostile nature get in the way of physicians. (See Dr. Doug Perednia's analysis at this link.)
  

• Scribes are a workaround to the mission hostile user experience.

• You should not have to work around something that is not in the way.

• That a technology touted as of extreme benefit now is seen to need an "isolation layer" between enduser and subject of the system's benefits is another example of how health IT remains an experiment.

-- SS

BLOGSCAN - By Feb. all ER physicians at DePaul Health Center (MO) will be using scribes

At my Sept. 2010 post "The Ultimate Workaround To Mission Hostile Health IT: Humans (a.k.a. Scribes)" I had written that:

The EMR is a technology that was supposed to improve clinical medicine (revolutionize it, some say). It was supposed to facilitate clinical medicine. It was not supposed to slow physicians and others down to the point of impairing their ability to practice medicine. However, the rosy predictions are not proving to be the case. Instead, we have the ultimate workaround to the health IT mission hostile user experience: [the medical scribe].

On the HisTALK blog today, apparently one medical center agrees:

By February, all ER physicians at DePaul Health Center (MO) will be using scribes for electronic medical documentation. Administrators hope to improve staff productivity as well as patient satisfaction. Apparently patients were “annoyed” that doctors were sharing their attention with a computer.

In the cited article "Scribes are finding their place in emergency rooms" by Michele Munz, St. Louis Post-dispatch.com, Jan. 25, 2011:

"[With a scribe] I can just completely focus on and deal with the patient," [ED physician] Lebo said.

The emergency department at DePaul Health Center in Bridgeton, which sees about 60,000 patients a year, is the first to use scribes in the St. Louis area. By February, all the hospital's emergency physicians will have a scribe tapping away at a laptop or tablet computer while they work. Across the nation, about 200 hospital emergency departments have started using scribes, most within the last two years, according to the three major companies providing scribes.

Several points worthy of note:

• The cost of scribes will be an issue affecting the supposed ROI of EHR's, and are necessitated by the fact that the EHR and its mission hostile nature get in the way of physicians. (See Dr. Doug Perednia's analysis at this link.)
  

• Scribes are a workaround to the mission hostile user experience.

• You should not have to work around something that is not in the way.

• That a technology touted as of extreme benefit now is seen to need an "isolation layer" between enduser and subject of the system's benefits is another example of how health IT remains an experiment.

-- SS