Why certification of medical software would be useful?
Human drugs and medical devices have to be approved by the health authorities before they can enter the market. For medical software this is not needed. The main argument to resist all attempts to regulate medical software has been that it is impossible to guarantee that software is error-free. This is true of all software. However, in medical software the correctness of medical knowledge is at least as important as the correctness of the code itself. The medical contents of the software could usually be evaluated but the end-users do not have the time or possibilities to do so. The Internet makes it possible to provide commercial services designed by non-professionals. For health care, there are already several commercial services on the net. Since there is no quality assurance or regulation of medical software anyone can sell medical software on the net. Even if physicians were cautious enough not to use untested software, there is a possibility that patients do. In Finland, where over 10% of the population is using the Internet at least weekly, the problem is real. It is impossible to remove poor services from the net and therefore, it is essential to guide the users to use high quality services. The paper discusses different aspects of evaluation of medical software.
Forsström
J
J
Medical Informatics Research Centre, University of Turku, Finland.
D002568:Certification; D003195:Computer Communication Networks; D003661:Decision Support Techniques; D004864:Equipment and Supplies; D005069:Evaluation Studies as Topic; D005387:Finland; D006801:Humans; D008490:Medical Informatics / Q000592:standards* / Q000639:trends; D004364:Pharmaceutical Preparations; D011785:Quality Assurance, Health Care; D012984:Software / Q000592:standards* / Q000639:trends; D014481:United States; D014486:United States Food and Drug Administration
D004364:Pharmaceutical Preparations