Proposed CLIA Rules Amendment Skirts Doctors

Gienna Shaw, for HealthLeaders Media , September 13, 2011

An "authorized person" is defined as the individual authorized under state law to order and/or receive test results. In states that do not provide for an individual's access to his or her results patients have no option but to receive their results through the provider who ordered them.

"We believe that the advent of certain health reform concepts (for example, individualized medicine and an individual's active involvement in his or her own health care) would be best served by revisiting the CLIA limitations on the disclosure of laboratory test results," the proposed rule states.

The proposal notes that some stakeholders—including providers, labs, health exchange organizations, and others—contend that the current rules impose barriers to the exchange of health information, impede individuals' access to their health records, and prevent patients from taking a more active role in their personal health care decisions.

There were two other announcements at the HIT summit:

Secretary Sebelius announced the appointment of Leon Rodriguez as the Director of the Office for Civil Rights. He will be charged with ensuring consumers' health information is kept private and secure.

"Consumers need to know that private and secure access to their health information is a given," OCR Director Rodriguez said in a statement. "The privacy and security of health data will be a top priority for OCR during my tenure."

Sebelius also unveiled a voluntary Personal Health Record (PHR) Model Privacy Notice—touted as an easy-to-read, standardized template that will allow consumers to compare and choose PHR products based on privacy and security policies and data practices. The new template is similar to the Nutrition Facts Labels, Sebelius said, in that it presents complex information in a simple way to improve transparency and consumer understanding about data practices.

Mostashari said the label was created with input from consumers, and added that the FTC has agreed to enforce its use for entities under its jurisdiction. A handful of vendors and providers who offer PHRs have already pledged to post the noticed on their websites.




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