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ASM provided written comments to Centers for Medicare & Medicaid Services, Centers for Disease Control and Prevention, and the Office of Civil Rights on the proposed rule "CLIA Program and HIPAA Privacy Rule; Patients' Access to Test Reports."
ASM supports the Department of Health and Human Services's proposed federal regulatory changes that will allow patients the right to obtain laboratory data from CLIA-certified diagnostic laboratories as part of their health care information. ASM recommends that, since reports of complex laboratory tests will require interpretation to be useful to patients, language be included in the proposed CLIA changes that require direct patient communication, preferably by a board-certified laboratory director. ASM stakeholders have also expressed concern over the assumptions regarding impact and costs presented in the proposal. Laboratories not now engaged in issuing reports directly to patients will have to expend significant resources to be compliant with this process. For access to the full document, go to http://www.asm.org/index.php/policy/hipaa-11-15-11.html.
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