Feds propose streamlined strategy for health IT

A new report proposes a "risk based" approach that gives developers latitude to build computer applications for health records and capturing patient data, without the long lead times and trials that accompany FDA approval.

health data

The federal government wants to carve out some areas of health IT that don't require oversight by the Food and Drug Administration, while making sure medical devices and other areas that directly affect patient health and safety remain subject to regulation.

A new report from the FDA, the Federal Communications Commission and the Office of the National Coordinator of Health IT (ONC) proposes a "risk based" approach to health IT that gives developers latitude to build computer applications for health records and capturing patient data without the long lead times and trials that accompany FDA approval. Under the proposed system, the FDA would focus on device functionality, including computer-aided detection systems and alarms that alert caregivers to changes in a patient's condition.

The proposed approach is part of an overall strategy to help provide more regulatory clarity to the growing medical IT industry and to encourage firms to focus on standard-setting, interoperability and best practices in the development of health IT to improve data portability and the more efficient delivery of care.

In particular, the report recommends that industry stakeholders establish some method of testing, validating and certifying the interoperability of health care IT systems and devices. Additionally, the government wants to see some performance verification to rate the quality and safety of health IT products. This function could be split among private sector and government bodies, depending on whether an assessment is "critical to assuring the safety and health of consumers," per the report.

Finally, the agencies advocate the creation of a Health IT Safety Center, a new public-private entity that would serve as a clearinghouse for best practices, governance, and information sharing. While the report isn't binding, the agencies are seeking more input from industry on privacy and security issues arising from creating a new quasi-regulatory body.

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