HIPAA Privacy Rule Adversely Affecting Cancer Research

December 1, 2003

The federal patient privacy rule that went into effect in April is"wreaking havoc on crucial aspects of cancer research" and "isseverely derailing 'the progress of knowledge,' " according to areport prepared by an ad hoc subcommittee of the National Cancer AdvisoryBoard. The full board pledged to pursue the issue with the Departmentof Health and Human Services (HHS), which enforces the rule.

The federal patient privacy rule that went into effect in April is"wreaking havoc on crucial aspects of cancer research" and "isseverely derailing 'the progress of knowledge,'" according to areport prepared by an ad hoc subcommittee of the National Cancer AdvisoryBoard. The full board pledged to pursue the issue with the Departmentof Health and Human Services (HHS), which enforces the rule.The subcommittee reached its conclusion about the impact of theNational Privacy Rule, a federal regulation mandated by Congress as partof the Health Insurance Portability and Accountability Act of 1996 (HIPAA).The rule applies to the release of patient information by providers, insurers,and medical clearinghouses, and contains restrictions governing medicalresearch. HHS wrote the rule and began implementing it on April 14."HIPAA needs to be clarified to eliminate the current paralyzinguncertainty resulting from the varying interpretations emanating frominstitutional legal departments," the subcommittee said. "Uncertaintyabout the requirements of the rule, and excessive fear of sanctionspotentially resulting from noncompliance, are having wide-rangingrepercussions." According to the report, respondents "generally felt therule fails to improve over previously developed privacy requirements(eg, the Common Rule) and, in some cases, erodes existing protections(eg, patients' health may be at greater risk because removing identifiabledata opens the door for greater errors in diagnosis and treatment)."Moreover, the respondents "were most outspoken on the many newobstacles to research generated by the privacy rule."