Digital Health Roundup
A newsletter about digital health, innovation, leadership and productivity (9-5-22)
Hi Everybody,
I am doing my last minute preparations for traveling this week to HRX. I am super excited about the conference. It is hard to believe that it is finally here after almost two years of planning. There are so many great sessions and speakers. The hardest part maybe finding the time to go to all the talks. I will try to take lots of notes and share them with you next week. Please reach out if there is anything specific you want me to cover.
Here is what I have been reading and writing this week. I hope you enjoy them as much as I did.
Thanks again for reading my newsletter!
Science Roundup
Social medial platforms have been able to make us buy more stuff online, watch hours and hours of TV series on Netflix. It makes sense that they should be able to do the same thing in health. Perhaps they are more successful than we think they are. However, the kinds of interventions that “academics” (myself included) think are worthy of JAMA papers are not being widely adopted. This paper nicely lays out the issues in evaluating some of the behavioral solutions. There are a lot of gems in that paper but a couple of major issues in designing behavioral interventions stood out to me:
Methodological issues
It is the difficult to design an adequate control group that is “blinded” to condition in the same way as pill placebo-controlled trials. Most digital behavioral interventions have a variety of features that participants use in different orders and at different times. Behavioral scientists have developed novel testing frameworks such as the N-of-1 studies, Multiphase Optimization Strategy (MOST), factorial or fractional factorial designs, sequential multiple assignment randomized trials (SMART), micro-randomized trials, and control optimization trials for assessing individual components of intervention, change outcomes and mediators of interest.
Engagement
Most people using digital health tools use them for only a few days or weeks at most. This may not be surprising to most clinicians: lack of face-to-face interaction may weaken the capacity to build rapport needed for a continuous behavioral intervention. Engagement for digital interventions is hard to define and it is different based on the intervention. It might be measured via use of any number of features or number of views, likes or comments or posts. But what is the optimal level of engagement needed for an app or wearable device to be considered the optimal intervention dose? Or, to what degree does one need to engage in a social media-delivered intervention to be considered “engaged”? What is optimal level of “effective engagement” that might signal the critical types of interactions with digital forums and materials to produce behavior change.
I am planning to discuss these further with the lead author of the paper, Dr Pagoto, at HRX. Definitely stop by if you are in San Diego this week.
Trends in Remote Patient Monitoring- I would like to see if outcomes were different during the same period …
Regulatory Roundup
I have been thinking about some of the new considerations for the FDA when evaluating efficacy of digital trials. One important question is whether they should require studies to include digital placebo group- version of the same app that is missing the “active ingredient,” is an underutilized approach that may help better identify effective apps- in their clinical trials? This paper discussed an interesting case study.
Novartis acquired the rights to an app for schizophrenia that had completed two successful but uncontrolled pilot studies demonstrating initial efficacy for improving symptoms. However, when Novartis tested a modified version of the app in a larger study that included a digital placebo, they found no differences between the study arms. The problem is that many digital health apps today are complex multimodal interventions and identifying the active ingredient, let alone an appropriate control group remains challenging.
This is an important consideration for the FDA when looking at approving some of these new digital interventions.
5 Digital Health Issues to Watch at FDA in 2022 - Some key issues to keep an eye on ….
1. FDA’s Digital Transformation
2. AI/ML-Based Software Regulation
3. Prescription Drug User Fee Act (most recently reauthorized as PDUFA VI) and the Medical Device User Fee Act (most recently reauthorized as MDUFA IV) Reauthorization in Congress
4. Software-Related Policies in Cures 2.0 and the VALID Act
5. FDA’s Real-World Evidence (RWE) Program
Industry Roundup
Happy Health raised $60M in Series A funding for wearables to track mental and physical health. via FINSMES
Plume, a specialized virtual care provider for transgender individuals, raiseed $24M in Series B funding. via Mobilhealthnews
PsychHub raises $16M Series A to develop a mental health resource library for providers. via Axios
Akili raises $163M in ‘Blank-Check’ Merger via MedTech Dive
Interesting Stuff Roundup
My favorite: Jazz blamed for increase in heat failures.
by the way for those of you still wandering : this is the greatest jazz album of all time
My daughter has been Bullet Journaling for a while and I thought I would give it a try. It is pretty fun and surprising relaxing. This video is a great place to start.
Thank you again for reading my newsletter.
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Talk Soon,
Hamid