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Summary recommendations for responsible monitoring and regulation of clinical software systems

Article Abstract:

A consortium of health-information related organizations has developed recommendations for effectively supervising and regulating clinical software systems. The systems would be ranked according to the health risks posed by software malfunction or misuse and how easily inappropriate guidance can be recognized and overruled by qualified users. It is advised that only those with the highest clinical risks be regulated by the Food and Drug Administration. Most of the systems could be supervised at a local level, and it is advocated that the developers of such systems adopt a code of good business practices.

Author: Gardner, Reed M., Miller, Randolph A.
Publisher: American College of Physicians
Publication Name: Annals of Internal Medicine
Subject: Health
ISSN: 0003-4819
Year: 1997
Laws, regulations and rules, Computer-aided medical diagnosis, Computer aided medical diagnosis, Medical informatics

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Predictive models for primary caregivers: risky business?

Article Abstract:

A decision support tool that predicts which patients may benefit from thrombolytic therapy illustrates the danger of relying exclusively on such tools. Thrombolytic therapy is used to break up blood clots that cause most heart attacks. The tool was developed after an evaluation of 4,911 heart attack patients and was published in 1997. However, there are other causes of heart attacks, including aortic dissection, coronary vasculitis and infectious endocarditis. Patients with these conditions may be harmed by thrombolytic therapy. Physicians still need to use judgment when using decision support tools.

Author: Miller, Randolph A.
Publisher: American College of Physicians
Publication Name: Annals of Internal Medicine
Subject: Health
ISSN: 0003-4819
Year: 1997
Editorial, Analysis, Planning, Decision support systems, Thrombolytic therapy

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Empirical Derivation of an Electronic Clinically Useful Problem Statement System

Article Abstract:

The authors explain how they developed a vocabulary for computerized use of problem list statements to assist in patient management by inter-connecting diagnoses with therapy, prognoses, and psychosocial issues. Such a list can aid in cost-containment and quality control, and in tested, their program was able to identify 23,503 problem relationships as well as 22,690 modifier words for further categorization.

Author: Brown, Steven H., Miller, Randolph A., Camp, Henry N., Guise, Dario A., Walker, H. Kenneth
Publisher: American College of Physicians
Publication Name: Annals of Internal Medicine
Subject: Health
ISSN: 0003-4819
Year: 1999
Statistical Data Included, Methods, Software, Design and construction, Database management systems, DBMS software

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