A fistful of topical events

November 16, 2017 | by

The London Health Technology Forum has just announced the details of its Christmas evening meeting on 13th December. Star turn will be the seasonally-appropriate Andrew Nowell, CEO of Pitpatpet who has a brilliant story to tell of how an activity tracker can unlock so many revenue sources. Attendees will also unlock mince pies, courtesy of longstanding host Baker Botts, and a roundup of key digital health changes in 2017 from this editor.

NICE Health App Briefings: NICE has finally published the end result of its review of three health apps on their Guidance & Advice list. Given that digital health is so much faster moving than pharma, it is disappointing that these apps appear to be being judged to a very high level of evidence requirement.

For example Sleepio, whose evidence for  effectiveness “is based on 5 well-designed and well-reported randomised controlled trials and 1 large prospective unpublished audit” is still judged, in terms of clinical effectiveness, as “has potential to have a positive impact for adults with poor sleep compared with standard care. There is good quality evidence that Sleepio improves sleep but the effect size varies between studies, and none of the studies compared Sleepio with face-to-face cognitive behavioural therapy for insomnia (CBT‑I).”

This editor is unaware of any other app that has five good RCTs under its belt so (more…)

FDA, new technology approval and the Ossification Tango (US)

September 22, 2015 | by

When it comes to new technologies–and drugs for that matter–the worst thing that can happen to your invention is to receive a letter from FDA that you have been classified into Class III. Based on regulations passed by Congress in 1976, there are three FDA classes primarily based on device risk. Exception: Class III. Anything not ‘substantially equivalent’ to an existing device is automatically put into Class III, regardless of risk level. Author and health tech legal advocate Bradley Merrill Thompson of Epstein Becker Green takes a comprehensive review at this flawed and outdated system that puts groundbreaking health tech at an extreme disadvantage in his latest article on regulation in Mobihealthnews. (more…)