Showing posts with label Healthcare IT failure. Show all posts

Sharona Hoffman, Professor of Law and Bioethics and Co-Director of the Law-Medicine Center, Case Western Reserve University School of Law, and Andy Podgurski, Professor of Electrical Engineering and Computer Science at Case Western, had written an important article on HIT that I highlighted in my March 2009 post "Let's Deregulate Pharmaceutical Information Technology."

In that article, entitled "Finding a Cure: The Case for Regulation And Oversight of Electronic Health Records Systems", Harvard Journal of Law & Technology 2008 vol. 22, No. 1, they called for premarketing and postmarketing surveillance of healthcare IT, adverse events reporting, and tight regulation as in the medical device and pharmaceutical industries. summarized and amplified their views in the short piece , Bioethics Forum, March 20, 2009.In a remarkable new followup article entitled E-Health Hazards: Provider Liability and Electronic Health Record Systems, they expand their case in a highly organized and extremely well documented piece. The abstract is as follows:In the foreseeable future, electronic health record (EHR) systems are likely to become a fixture in medical settings. 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. This Article features a first of its kind, comprehensive analysis of the liability risks associated with use of this complex and important technology. In addition, it develops recommendations to address these liability concerns. Appropriate measures include federal regulations designed to ensure the quality and safety of EHR systems along with agency guidance and well crafted clinical practice guidelines for EHR system users. In formulating its recommendations, the Article proposes a novel, uniform process for developing authoritative clinical practice guidelines and explores how EHR technology itself can enable experts to gather evidence of best practices. The authors argue that without thoughtful interventions and sound guidance from government and medical organizations, this promising technology may encumber rather than support clinicians and may hinder rather than promote health outcome improvements. EHR systems can facilitate access to patients’ medical records, improve the quality of care and the accuracy of treatment decisions, achieve cost savings, and promote clinical research. Without discounting any of these potential benefits, this article focuses on the risks of EHR systems and on liability concerns associated with their use ...The liability risks of EHR systems have received little attention in the legal literature. This new technology may bring with it novel responsibilities, burdens, and complexities for medical practices at the same time that it can potentially enhance health outcomes.The liability risks are not just to hospitals, but to EHR users of all stripes. They find current efforts at HIT "certification" severely lacking in usefulness, and strongly support federal regulation of health IT due to the risks and dangers involved. The authors are opposed to vendor "hold harmless" and "defects nondisclosure" clauses, and have included in their article many well thought out solutions to the double-edged sword that HIT represents.

In summary, though, they believe that:It is only with appropriate interventions that they will become a much-hoped for blessing rather than a curse for health care professionals and patients. I am in strong agreement with their positions. The unregulated free-for-all that has been the health IT marketplace, with dangerous and even outrageous practices I noted starting a decade ago, must come to an end as the market matures and as diffusion of this technology massively increases per the government mandates now in effect.

The rationalizations for problems, the excuses for defects and the starry eyed utopian exuberance about this technology (not to mention the conflict-of-interest and/or HIT lobby-driven irrational exuberance) must come to an end.

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A somewhat remarkable new book will be released in Nov. 2009 by the American Health Information Management Association , of which I am an associate editor. It is aimed at the non-medical- informatics IT and healthcare management professional. I express thanks to AHIMA for their forward thinking in accepting and publishing this material.

Books such as this were difficult to get into print just a few years ago, likely due to resistance to their publication by the powerful trade organizations of the health IT vendors:

H.I.T. or Miss: Lessons Learned from Health Information Technology Implementations

In H.I.T. or Miss: Lessons Learned from Health Information Technology Implementations, the editors—all of whom have led successful electronic health record (EHR) and Health Information Technology (HIT) projects—have collected case studies of HIT implementations that didn't go as planned, offering expert insight into key obstacles that must be overcome to leverage IT and modernize and transform healthcare.

... the adoption of effective HIT—now a national priority with the passing of President Obama's American Recovery and Reinvestment Act of 2009 (ARRA)—remains at a fairly primitive stage compared with IT adoption in every other major industry. In fact, healthcare is the only trillion dollar industry that remains primarily in the paper stage, even though most healthcare data are available electronically.

By studying HIT implementations that failed, the editors are able to document, catalogue, and share key lessons that all project managers of HIT, health system leaders in informatics and technology, hospital executives, policy makers, and service and technology providers must learn in order to succeed with HIT.

H.I.T. or Miss presents a model to discuss HIT failures in a safe and protected manner, providing an opportunity to focus on the lessons offered by a failed initiative as opposed to worrying about potential retribution for exposing a project as having failed.

Authors

The editor and associate editors all served on the 2007 leadership board of the Clinical Information Systems Working Group of the American Medical informatics Association (AMIA).

Editor: Jonathan Leviss, MD

Associate Editors:

Brian Gugerty, DNS, MS, RN
Bonnie Kaplan, PhD
Gail Keenan, PhD, RN
Jonathan Leviss, MD
Larry Ozeran, MD
Eric Rose, MD
Scot Silverstein, MD

This book follows the anonymized case study approach I used in my website on HIT difficulties, started in 1999, itself based loosely on the style of the introduction of the 1994 book (ed. 1) by sociotechnical issues pioneers informaticists Nancy Lorenzi and Robert Riley.

One can talk about "healthcare transformation" via HIT all one wants, but until the current inadequate approaches to HIT are themselves transformed, doing so is largely wide-eyed utopianism.

I am quite pleased to see this new book appear. (Note: I will not receive any royalties for sales).

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I have written numerous times on this blog about the blind-man ignorance displayed by many healthcare IT and biomedical companies regarding Medical Informatics expertise.

As a graduate and postdoctoral-level Medical Informatics educator with considerable applied expertise, as well as talent management experience, I teach students of a variety of healthcare backgrounds that the only way to overcome the sociotechnical complexities (i.e., issues at the intersection of people and their interaction with technology) of HIT is via education and considerable experience.

Once students become aware of the nuances and complexities of HIT in real-world clinical settings (if not already enmeshed in such environments), they find the lessons learned from substantial and rigorous immersion into a wide corpus of literature, overseen by someone with expertise, profoundly important towards advising their own organizations in avoiding pitfalls and achieving success.

I note that I used to admire German engineering rigor, but after seeing ill conceived, misguided position ads like the following from Siemens Healthcare, I am having sincere doubts about that country's current prowess in that domain.

I refer to a recent ad (here at the moment) for a Physician Consultant:

Job Description

Siemens Medical Solutions is the industry leader in Healthcare IT technology and Clinical workflow solutions. We are seeking to hire an experienced Physician for our Professional Consulting Services Organization. In this highly visibly position, you will support the implementation of Siemens products (such as Soarian ) in hospitals nationwide. To be considered for this position, qualified candidates must have the following credentials and experience:

• U.S. based Medical degree with at least five years of post-residency experience in large multi-specialty practice or hospital-based facility in the United States.
• Currently practicing medicine, or must have practiced at least 1 week per month within the last 3 years
• Leadership experience with at least one CPOE implementation in a large, multi-facility health system, Integrated Delivery Network (IDN) setting
• Extensive public-speaking and executive presentation experience
• Medical informatics credentials or advanced degree preferred, but not required [Medical Informatics not required? - ed.]
• Prefer some experience in public-health related projects

Here are the obvious major problems:

One CPOE implementation or even several does not by any means qualify a person to counsel other medical organizations and clinicians as a representative of a company citing itself as "the industry leader in Healthcare IT technology."

Further, the criteria "Medical informatics credentials or advanced degree preferred, but not required" suggests the crafters knows little about Medical Informatics, or hold it at a low level of esteem, considering it an optional "gift" that might add slight extra value to the incumbent's ability to travel the country and give good advice and support in clinical IT implementation. What might substitute for such knowledge and expertise?

This J.D. might better be described as "glorified salesperson." It might be a good exit route for a "techie doc" (usually, someone who knows just enough about HIT to be destructive) who hates the current practice environment. It might also be good for managers who don't want knowledgeable experts pointing out their bad decisions and mismanagement, but I think a global company like Siemens should be setting its sights higher in such a crucial area as electronic medical records and clinical IT consultants.

I would not want such a physician advising or supporting complex HIT projects at my organization.

I spent time at Siemens Healthcare headquarters in Erlangen in 2000, and was offered gracious hospitality and a position overseeing the Soarian cardiology suite. The people I met in Erlangen then seemed extremely competent and informatics-savvy, but I turned the offer down through no fault of Siemens. I'd received a near-simultaneous offer (FAXed to my hotel in Erlangen, in fact) from pharma that involved a much stronger management role.

I understand through conversations over the past few years with current and ex-Siemens personnel that most of the Siemens personnel I'd met in Germany in 2000 are no longer with the company. I was told they'd performed suboptimally after the acquisition/merger with Shared Medical Systems (SMS) in Malvern, PA. (I do not find that credible, and would find it far easier to accept that the problems were on the American side, but that is a personal opinion.)

Questions raised by these observations:

• What manner of ideology about education and expertise does this job description represent?

• Is there nobody left in Germany with a realistic sense of the education and expertise required to advise on and support HIT implementations in a competent manner, I ask?

Allow me to answer question #1. It represents the IT designer-centric, data processing and tabulator punch card culture-based (and antithetical to medicine and science) view that with enough generalists and sufficient "process", any problem can be solved. By this logic, Bach and Beethoven would have had symphonies written for them by low level musicians in the name of "efficiency" and cost savings.



Shareholders, take note. I emailed this post to the Siemens Healthcare CEO Hermann Requardt, who I note (almost predictably) lacks a biomedical background other than having been a research assistant for aviation medicine once, and having worked on MRI:

Education

• Secondary school (baccalaureate)
• Studied physics at the Technical University of Darmstadt and University of Frankfurt (Dr. phil. nat., Dipl.-Phys.)

A lack of response is therefore not surprising.

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