Why Is Google’s Clinical Depression Tool Not a FDA-Regulated Medical Device?
[Posted on: Thursday, August 31, 2017]
Do online diagnostic tests qualify as FDA-approved diagnostics, it seems not. Last week Google partnered with a mental health group to offer an online tool for diagnosis of clinical depression; every time someone searches on Google for clinical depression, he/she will be suggested to try out the online tool to find out if he/she suffers from clinical depression. The tool is based on a clinically validated screening questionnaire for clinical depression, PHQ-9. The test is based on scoring the answers to a series of questions related to one’s feelings to evaluate if one suffers from clinical depression. The goal of the self-assessment test is for one to talk their doctor to get treatment for depression. Only about 50% of individuals with depression, get properly diagnosed, and treatment. By offering the screening test widely, Google plans to change that. In the past FDA would have likely required that Google pursue formal approval as a 510k diagnostic. In fact, FDA has till recently required 510k even for software for viewing medical images on tablets or internet, and in the early days required 510k approval of a calendar reminder for medications. But last month FDA announced a hands-off approach for most software. It should be noted that PHQ-9 was already available at other websites, so all Google did was create a mobile app for it. This could be a beginning of several such diagnostics to become available online and we could see practically all such validated self-diagnostic tests on mobile apps. Tests for quality of life measures, pain, dementia, and most mental health diagnostics could be put online for self-diagnosis. It could mean that patients will increasingly self-diagnose mental health diseases and pursue treatment. By taking FDA approval out of simple diagnostics, FDA may be paving the way for automated diagnosis using validated questionnaires running on mobile apps. These could in turn be very valuable to pharmaceutical companies developing therapies for such diseases to find potential patient pools. Offering free diagnosis could be a good way to find future patient consumers. Google has not announced how the data it collects will be used but the business opportunity is obvious.