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Bioethics in practice - a quarterly column about medical ethics: ethics of chart review research.

Patients presume their medical records are private. They think their records are not seen by anyone other than their physicians and that this privacy is guaranteed under the Health Insurance Portability and Accountability Act, commonly known as the HIPAA law. Patients are surprised that many other people have access to their medical records and their private health information (PHI). In addition to people in the extended physician team (nurses, medical assistants, registration, billing, coding, and health information management), insurers, regulators, and accreditation personnel might also see a patient's chart in the course of performing their duties. Quality improvement activities in an institution may involve staff members who have no clinical connection with patients seeing the details of medical records as they look for quality problems with the care given at the institution. 
 
Chart review research is also done by people with no involvement in the healthcare operations described above. The use of medical records for research is common and in many cases important to society. For example, a surgical resident may review the last 100 cases of a procedure performed with 2 different techniques and then run a statistical analysis to determine if 1 technique results in better outcomes than the other. In the process, the resident sees a great deal of PHI about 100 people. Chart review research can also be computerized. An example is data mining 20,000 diabetic records using algorithms to evaluate which drug combinations have the best impact on hemoglobin A1c values. Data mining research often distances the details of a specific patient's PHI from the researcher. 
 
Is it okay for chart review researchers to routinely see a patient's PHI without the patient's specific authorization, permission, or consent? Is it legal? Is it ethical?