This article by Wes Fisher found on the KevinMD.com news captured my interest because what I think the author is saying is that we should have Research Ethics Boards (REB) or Institutional Review Boards (IRB in the United States) to review implementations of Electronic Medical Record systems. It is interesting because I am a research ethics professional and I have a graduate degree in eHealth. He compares developing and use of EMRs to human experimentation, and as we know today, no human research experimentation can be done without clearance by an REB or IRB. He uses quotes from the Belmont Report, which is one of cornerstone research ethics policies, to make comparisons for the need for human participant protection from possible harms from EMRs. In the United States there is a technology push for EMRs and a lot of money mandated for development of EMRs. This could and probably does lead to the development of systems that are not going to be successful, and possible pose harm for patients. The ethics discussed in the article is also more about economic ethics, or the ethics of pushing a technology in advance of knowing net benefits, user acceptability, user satisfaction.
I have recently been thinking that EMR systems should not only have Privacy by Design principles built into their conception, development, and implementation, but also Evaluation By Design. We know that IT systems are notorious for high failure rates - up to 70% of them. It is no different in Health IT. In Canada, Health Infoway does have a certification system for EMRs, which costs about $100,000 and several companies have obtained that certification. This is not same as having an REB review the system. As well, Health Canada can define some EMRs as class II Medical Devices, which require a certification. Class I medical devices only display or transport data. Class II devices manipulate the data for decision support purposes, and thus, act more like humans - prone to making error. This Health IT failure website has great case studies.
From what I have studied, a lot of private companies are developing innovative healthcare applications to help people with chronic conditions. Often these applications are tested with patients without having gone through an REB review, unless the companies are working directly with university or hospital researchers who have requirements for REB review. At minimum, the clinical efficacy of these systems needs to be proven in such things as controlled clinical trials, before governments and businesses decide to spend vast sums for patient healthcare. As Dr. Norm Archer in the McMaster School of Business says, the return on investment (ROI) in Healthcare has to be improvement in quality of life.
I have been doing some research lately on information system success models, such as the DeLone and McLean model. This model for IS success has been well tested and measure in information systems studies, but I don't know how it has been applied to healthcare. I have seen the Technology Acceptance Model (TAM) used, but I am told this model is overused and many journals don't accept articles anymore using it. I am going to look into how the Delone and McLean model is used in Healthcare, because it could be one of the cornerstones for an Evaluation by Design model for EMR systems. I also want to think more along the lines of this article by Dr. Fisher, and think about how the Canadian policy for research ethics, the Tri-Council Policy Statement, could apply to the review of EMRs.
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