The change in demography, multiple chronic conditions, increasing infectious disease threats, and small healthcare budgets put healthcare systems under serious challenge. In addition, there is an increasing need to generate more knowledge to improve patient treatments. Reuse of patient health data is promoted as a means to generate evidence on the effectiveness, benefits, and harms of different treatments. Patient data are also reused for quality assurance, public health and commercial applications.
The wide deployment of electronic health records has created a potential for timely access to enormous amount of data to answer a given research question. However, reuse of patient data has ethical and legal concerns. These concerns have led to several national and international laws and regulations. For example, in the United States, the health insurance portability and accountability act (HIPPA)  establishes minimum federal standard for protecting patient´s data privacy. The privacy rule allows the reuse of patient identifiable data if consented by patient and ethical board approval. Data anonymized or de-identified according to specific standards is not subjected to the privacy rule and can be reused without patient consent. Many other privacy rules also allow the use of de-identified data without consent.
Retrospective observational studies are typically conducted only at patients´ data backward in time with no interaction with the patients. Such kinds of studies involve large number of patients and it is not practical to collect consent and consent can also introduce bias. Thus, many research reuse de-identified patient data that are already collected for patient treatments. The outcomes of the researches may lead to improvements in medical care. However, research projects are conducted without patient consent, using information private to those patients. As a result, the outcomes of research override the rights of the patients. This essay discusses the ethical issues associated with de-identified patient data reuse without consent.
Discussions about the moral concerns of research on humans have been looked at from three broad area of concerns: (1) address the scientific validity of research, which is related to consequentialist theory that states an action is justified by its outcome; (2) moral duty to do the best for the patients (research participants), which is related to deontological theory that states the duty to do the right thing; and (3) take into consideration the patients autonomy, which is related to another kind of deontological theory that states the moral rule to respect patients and don’t use them as a means .
The main aim of the essay is to discuss the ethical issues of using de-identified patient data for research without consent. It can be argued that this falls under the third area of concern, that is, respect for the autonomy of patients whose data is used. I believe the issues are...