FDA pondering new software regulations
FDA pondering new software regulations
The U.S. Food and Drug Administration is considering expanding its regulatory powers beyond traditional medical devices to include patient information software.
That could mean that the computerized patient record (CPR) you’re developing or are interested in buying could go through the same type of extensive approval system that new drugs and patient care devices face.
The move could affect all software that is not part of a medical device but runs systems that contain patient-related data. The standards also could extend to claims processing programs and applications that enable physicians to prescribe, order, or implement services that affect treatment and outcomes.
"It would present a terrible barrier to the development of computer-based patient records," says Linda Kloss, RRA, executive vice president of the American Health Information Management Association in Chicago. A coalition of interested health care organizations was quickly formed to counteract the move and is urging the FDA now to include CPR-type software in any new regulations.
Hospitals using software not in compliance with any new regulations could have to alter their existing programs to comply or replace them with federally approved commercial software even if a provider’s existing system is similar or identical. Providers also might have to submit to regular quality-assurance audits and periodic reviews conducted by the FDA.
The additional regulation should be of special concern to anyone involved in hospital reimbursement because of the increasing reliance by finance departments on computerized claims processing systems.
The regulations also could pose special problems for large hospitals that deal with several software companies and consultants at the same time. In trying to comply with regulations, administrators may have a difficult time, especially if some vendors have gone out of business.
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