Confusing “Consent” Terminology Emerges

In its August 19th letter to the Office of the National Coordinator, the HIT Policy Committee creates the term “meaningful consent” related to the coming choices patients will be asked to make about the sharing and use of their clinical data. In the recommendations, the committee clearly states that the recommendations apply to exchange of identifiable health information in order to meet Stage 1 meaningful use requirements. So now is the perfect time to ensure that the difference between the two types of consent remain distinct in the mind of the patient population. » Continue reading “Confusing “Consent” Terminology Emerges”

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Technology Muddies Informed Consent Part 2

My previous post “Technology Muddies Informed Consent” is an excerpt from a slightly longer piece that examines the dehumanizing effect of information technology as it applies to healthcare, the coming role of personal health records and their potential role in helping manage informed consent, and the bifurcation of the meaning of informed consent itself thanks to the increasingly complicated world of managing data use derived from healthcare encounters. The entire piece is available: Download the pdf here. This will be one of many challenges we face as clinical data, privacy issues and patient control converge. Your comments are welcomed of course!

-Rod Piechowski

Copyright © 2010, Rod Piechowski, Inc., Consulting

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Technology Muddies Informed Consent

The concept of “consent” in healthcare is getting more complex and likely to create confusion not only to patients but also to clinicians and policy makers. Specifically, the term consent can be used in a variety of ways. First, it can refer to the process of determining whether or not a patient understands the clinical procedures and their inherent risks, and whether or not that patient has the capacity to understand and give their consent.

Secondly, EHRs and PHRs play a role in modifying this landscape. The HITECH provisions of the American Recovery and Reinvestment Act, passed February 17, 2009, include substantial financial incentives for the “meaningful use” of certified EHR systems. One of the qualifying requirements of meaningful use, by law, is the exchange of clinical data among physicians and hospitals using EHR systems.

All of these connected systems will eventually feed data across the country through the Nationwide Health Information Network (NHIN), which is still under development. Initially, the meaningful use connectivity requirement will be accomplished through many local and regional Health Information Exchanges (HIE), each of which will likely create very different rules for the exchange of clinical data along the network. The rules will vary by state and organization, since there are no standardized business or legal models for HIE structure.

In this scenario, patients will be asked for their consent to move their clinical data along these networks, as well as to use their information in a variety of ways ranging from mundane billing to clinical research. Consent for this purpose will not be standardized, nor will it be easy to comprehend, since some HIE models will allow patients to opt in while others require an opt out. To further obfuscate the situation, patients will be empowered to allow the movement of some of their data while restricting or withholding other data either under certain conditions or altogether.

We have an obligation to see that the value of information technology plays an appropriate and supportive role, and that we clearly articulate the difference between information consent and clinical consent.

We must make a distinction between information consent and clinical consent. Ethicists, clinicians and technologists make an effort to ensure that the use of information technology does not dehumanize the physician-patient relationship. We must recognize that it plays a role in expanding that relationship. We must take extra care to ensure that technology does not further complicate the process of making treatment decisions under difficult circumstances. If we do these things now, the transition to EHR can be a smoother one for all.

– Rod Piechowski

(See updated piece September 10, 2010)

Copyright © 2010, Rod Piechowski, Inc., Consulting

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