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Monitoring and Regulating Clinical Software
The Editors welcome submissions for possible publication in the Letters section. Authors of letters should:
•Include no more than 300 words of text, three authors, and five references
•Type with double-spacing
•Send three copies of the letter, an authors' form signed by all authors, and a cover letter describing any conflicts of interest related to the contents of the letter.
Letters commenting on an Annals article will be considered if they are received within 6 weeks of the time the article was published. Only some of the letters received can be published. Published letters are edited and may be shortened; tables and figures are included only selectively. Authors will be notified that the letter has been received. If the letter is selected for publication, the author will be notified about 3 weeks before the publication date. Unpublished letters cannot be returned.
Annals welcomes electronically submitted letters.
TO THE EDITOR:
Drs. Miller and Gardner and the organizations they represent are to be commended for developing guidelines for monitoring the performance of medical software [1]. Using the concepts of risk to the patient and the opportunity for competent clinician intervention to determine the stringency of the regulation and monitoring is a reasonable way to frame the recommendations. However, in allowing less strict regulation of systems in which a competent clinician has the opportunity to override the system, the authors assume that clinicians will routinely review the system output and will accurately recognize when to ignore the software's suggestions. Such vigilance is more likely when the software's performance is known to be mediocre and require frequent overrides than when the software is consistently accurate in its recommendations. Ironically, as the software improves, fewer errors may occur, but these errors may be less likely to be detected. Because “closed-loop” systems do not allow human intervention, mechanisms are usually built in to assure fail-safe operation. As developers of other types of software systems continue to improve their products, they may need to give more attention to similar internal measures to compensate for failures of human intervention.
Eta S. Berner, EdD
University of Alabama at Birmingham; Birmingham, AL 35294
The Editors welcome submissions for possible publication in the Letters section. Authors of letters should:
•Include no more than 300 words of text, three authors, and five references
•Type with double-spacing
•Send three copies of the letter, an authors' form signed by all authors, and a cover letter describing any conflicts of interest related to the contents of the letter.
Letters commenting on an Annals article will be considered if they are received within 6 weeks of the time the article was published. Only some of the letters received can be published. Published letters are edited and may be shortened; tables and figures are included only selectively. Authors will be notified that the letter has been received. If the letter is selected for publication, the author will be notified about 3 weeks before the publication date. Unpublished letters cannot be returned.
Annals welcomes electronically submitted letters.
- Copyright ©2004 by the American College of Physicians
