The Healthcare Information and Management Systems Society has submitted comments (pdf) on HHS' proposed rule on the Clinical Laboratory Improvement Amendments Program of 1988 and the HIPAA Privacy Rule.
The proposed rule would amend CLIA to provide patients direct access to lab test reports and amend the HIPAA Privacy Rule to remove the exceptions that relate to CLIA and restrict patients' direct access to their lab test reports.
HIMSS' comments focus on the following three points:
1. Potential laboratory workflow process and cost impacts. HIMSS recommends consideration of costs for laboratory readiness and customer service, laboratory fees, appropriate staffing and laboratory interface capabilities.
2. Patient identification and authentication requirements. HIMSS suggests the government specify the standards for verifying patient identification.
3. Alignment between emerging HIPAA requirements for labs and those proposed in this rule. HIMSS notes that the HITECH Act requirements for labs to electronically provide information will go into effect after the current proposed rules, which may place more burden on labs that have to first meet the proposed rule changes and then the changes under HITECH and potential changes for meaningful use Stage 2.
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The proposed rule would amend CLIA to provide patients direct access to lab test reports and amend the HIPAA Privacy Rule to remove the exceptions that relate to CLIA and restrict patients' direct access to their lab test reports.
HIMSS' comments focus on the following three points:
1. Potential laboratory workflow process and cost impacts. HIMSS recommends consideration of costs for laboratory readiness and customer service, laboratory fees, appropriate staffing and laboratory interface capabilities.
2. Patient identification and authentication requirements. HIMSS suggests the government specify the standards for verifying patient identification.
3. Alignment between emerging HIPAA requirements for labs and those proposed in this rule. HIMSS notes that the HITECH Act requirements for labs to electronically provide information will go into effect after the current proposed rules, which may place more burden on labs that have to first meet the proposed rule changes and then the changes under HITECH and potential changes for meaningful use Stage 2.
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