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HIPAA Privacy Rule Adversely Affecting Cancer Research

HIPAA Privacy Rule Adversely Affecting Cancer Research

The federal patient privacy rule that went into effect in April is "wreaking havoc on crucial aspects of cancer research" and "is severely derailing 'the progress of knowledge,'" according to a report prepared by an ad hoc subcommittee of the National Cancer Advisory Board. The full board pledged to pursue the issue with the Department of Health and Human Services (HHS), which enforces the rule. The subcommittee reached its conclusion about the impact of the National Privacy Rule, a federal regulation mandated by Congress as part of 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 medical research. HHS wrote the rule and began implementing it on April 14. "HIPAA needs to be clarified to eliminate the current paralyzing uncertainty resulting from the varying interpretations emanating from institutional legal departments," the subcommittee said. "Uncertainty about the requirements of the rule, and excessive fear of sanctions potentially resulting from noncompliance, are having wide-ranging repercussions." According to the report, respondents "generally felt the rule 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 identifiable data opens the door for greater errors in diagnosis and treatment)." Moreover, the respondents "were most outspoken on the many new obstacles to research generated by the privacy rule."

 
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