A proposed rule drafted by three federal agencies would allow patients to receive their test results directly from labs—with no doctor playing middleman.
The Centers for Medicare & Medicaid Service, the Department of Health and Human Services' Office for Civil Rights, and the Centers for Disease Control and Prevention, would amend the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations and HIPAA privacy regulations and is part of a larger effort to strengthen patients' rights to access their own medical records.
The rule was announced Monday at a live HHS event—kicking off a week that's been designated by President Obama as "National Health Information Technology Week."
"Patients have a right to access and use their health information," Farzad Mostashari, MD, the national coordinator for health information technology, said at Monday's first-ever HHS Consumer Health IT Summit. "And we are here today to make it easy for them to exercise that right."
Under the proposed rule, labs would be authorized to release results to patients or their designated representatives upon request after authenticating that the results belong to the patient.
"When it comes to healthcare, information is power. When patients have their lab results, they are more likely to ask the right questions, make better decisions, and receive better care," HHS Secretary Kathleen Sebelius said at the summit. "In the past you often had to wait days or weeks to get the results from your doctor… Under this rule you'll be able to get your results directly and act quickly if there is a cause for concern."
CLIA covers all phases of laboratory testing, including the reporting of test results. Under the current regulations, CLIA limits a laboratory's disclosure of test results to three categories of individuals: the "authorized person," the person responsible for using the test results in the treatment context, and, in the case of reference laboratories, the referring lab.
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.