HHS wants to expand its oversight of electronic health record vendors.
The proposal released on Tuesday (PDF) would allow the agency to review how certified health IT products interact with other products. The efforts aims to prevent data blocking.
“Today's proposed rule will help us ensure that health IT products and the health IT marketplace are continuing to meet the needs of the healthcare system,” Dr. Karen DeSalvo, national coordinator for health information technology, said in a statement.
In April 2015, HHS' Office of the National Coordinator for Health Information Technology released a report indicating widespread business practices by providers and health information vendors that intentionally prevent the easy flow of data among EHRs. Practices include charging exorbitant fees to access medical records and simply preventing one company from accessing lines of codes needed to talk to another system.
The proposed rule would give the ONC broad discretion to review certified health IT products. However, it anticipates that such reviews would be relatively infrequent and would focus on situations that pose a risk to public health or safety, it said.
In addition to data blocking, the ONC could initiate a direct review whenever it becomes aware of information that indicates that certified health IT products may be leading to medical errors or breaches in the security of a patient's health information.
The proposed rule would enable the ONC to require corrective action for these nonconformities and, when necessary, suspend or terminate a certification issued to a complete EHR or health IT module.
The potential costs of this proposed rule for health IT developers, the ONC, and healthcare providers may be as much as $650 million, with an annual cost of $6.5 million.
The rule comes one day after 17 vendors who provide EHR and other IT systems to 90% of U.S. hospitals pledged to help patients more easily access their electronic health information and transfer it to any other provider or data user.
Last week, President Barack Obama said he was concerned that EHR companies could be a barrier to the success of his precision medicine initiative. A central component of the effort is a database that will have information voluntarily submitted by 1 million or more Americans. The genetic information is expected to enable clinical trials of targeted therapies.
The database will also use information from mobile health devices to correlate activity, physiologic measures and environmental exposures with health outcomes.
Obama said he was worried that EHR vendors may not be commercially motivated to create a mechanism that will allow patients to upload their data.
The comment period for the ONC rule ends on May 2.
