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

Leave a Comment

You must be logged in to post a comment.