U.S. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius proposed new rules designed to expand the rights of patients to access their health information through the use of health information technology (IT). Specifically, the new rules would empower patients and allow them to gain access to test results reports directly from labs. They would ensure that labs covered by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) provide such information, upon request, directly to patients or their personal representatives.
The announcement came at the kick-off of the first-ever HHS Consumer Health IT Summit, which brought consumers, providers, and the public and private sectors together to discuss how best to empower consumers to be partners in their health and care through health IT.
The Notice of Proposed Rulemaking (NPRM), jointly drafted by the Centers for Medicare & Medicaid Services, the HHS Office for Civil Rights (OCR), and the Centers for Disease Control and Prevention, proposes to amend the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations and HIPAA privacy regulations to strengthen patients’ rights to access their own laboratory test result reports. The NPRM will be published in the Federal Register on September 14, 2011; public comments on the proposal will be accepted for 60 days after publication in the Federal Register.
Secretary Sebelius also unveiled an innovative voluntary Personal Health Record (PHR) Model Privacy Notice, which creates an easy-to-read, standardized template allowing consumers to compare and make informed decisions based on their privacy and security policies and data practices about PHR products. The new template is similar to the Nutrition Facts Labels in that it presents certain complex information in a simple way to improve transparency and consumer understanding about data practices. By making this Model Privacy Notice available, PHR companies can help build greater trust in PHRs.
For more information about the proposed amendments to the CLIA and HIPAA Privacy regulations, please visit https://www.cms.gov/apps/media/fact_sheets.asp.
Source: HHS News Release