PureTech is actively forming companies in the digital medicine area, including Akili, which is mentioned in the article.
This is a very detailed article on Digital Health regulation which is only just now reaching a reasonable level. The main issue is, what is the risk to the patient if this software fails? I have been using OpenStack for about 6 months and am quite happy with it. The main areas of intervention are Human testing, Manufacturing, Software updates, Combination products and Hardware.