FDA on Software That Isn ’t a Medical Device

The 21st Century Cures Act of 2016 (Cures) had many provisions including defining what kinds of software are medical devices, and some specific kinds of software that are not, and which therefore weren’t subject to FDA regulation. Cures then directed the FDA to look into those that are not and report if they presented a public health problem. The FDA has now released  such a report. Curiously the report is based only on information published after the passage of Cures through July 31, 2018 so that what was known before passage or after the given date is not considered. I would not suggest to any student that they follow this bibliographic method if they wanted their work to have any meaning. Another curiosity of the report, which may be related to the limited scope, is that “cybersecurity” is not mentioned, not even once. The five expressly excluded types of software are: (1) administrative support of a health care facility; (2) software promoting a healthy lifestyle and unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition; (3) electronic patient records which do not interpret or analyze such records, (4) transferring, storing, converting formats, or displaying medical data but not interpreting that data; and (5) certain types of clinical decision support (CDS), a type of AI. For each of these 5 areas the report provides a brief overview of potential and reported issues, and a “best practices” for managing the associated ...
Source: Medical Connectivity Consulting - Category: Information Technology Authors: Tags: Standards & Regulatory Source Type: blogs