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."