Digital Health Roundup 8-29-22
A newsletter about digital health, innovation, leadership, productivity and wisdom (8-29-22)
Hi Everyone,
I know it has been a long minute since the last time I sent out this newsletter, so if you are still reading this I want to say thank you. I am planning to start writing these on a regular basis again. The focus will be on digital health science, regulation and innovation. I will continue to share other interesting things I have come across along the way. Please reach out to me with feedback on ways I can improve this publication.
Science Roundup
Behavioral change is the holy grail of digital health. Digital technologies are very useful in promoting behavior change especially when it means watching more cat videos or endlessly watching ticktocks. It is not surprising that most tech optimists believe that you can “nudge” patients into “healthier” behaviors. Of course tech companies are not completely self less, there is a huge market for apps that cost $10 to make and then sell them to health plans for $899. The problem is that these interventions need to stand the rigor of evidence based medicine and lucky for us there are lots of smart physicians who can test these interventions. The ChooseWell 365 Randomized Clinical trial was an automated behavioral intervention to prevent wight gain and improve diet using employee.
For 12 months, participants in the intervention group received 2 emails per week with feedback on previous cafeteria purchases and personalized health and lifestyle tips and 1 letter per month with peer comparisons and financial incentives for healthier purchases. Control group participants received 1 letter per month with general healthy lifestyle information. The email included a colored summary graphic, as well as a list of daily items, calories, and remaining calories for each day (daily calorie goal minus total purchased calories) to provide a benchmark to guide future food choices. The second email, sent on Thursdays, provided 2 personalized tips about healthy eating, physical activity, or disease prevention, as well as a simple and healthy recipe.
They showed that although patients made better choices everyday (more green light, less red) they did not lose a significant amount of weight from their baseline. I guess the moral of this trials is that making good choices at the cafeteria does not stop you from getting a big mac after work, or before work, or stress eating at night waiting for your teenage daughter to come home (completely random and not personal at all).
I am chairing a session at HRX in a couple of weeks with Dr Ann Thorndike who was the PI of this study and looking forward to getting her thoughts on how to stop stress eating at night as well talk about how we can do promote effective healthy behaviors using digital technologies. The main lesson here is that digital interventions need to be applied in the context of the patient’s life and not just at work if you want to achieve meaningful clinical success.
Regulatory Roundup
FDA Green Lights iRhythm-Verily Zio® Watch and ZEUS System
I was fortunate enough to work with this amazing team as the PI of their clinical study. This is a medical grade device that can be used along with a service to help detect atrial fibrillation while reducing the burden of diagnosis on clinicians. There is so much more work ahead of us but I believe this will be the future of atrial fibrillation care.
Regulatory considerations to keep pace with innovation in digital health products
I have been trying to get my head around the software as as a medical device program at the FDA. It is very confusing and that has lead to lots of digital health products being produced with varying degrees of regulatory scrutiny. This is what I learned from this paper:
Software as a Medical Device is “software intended to be used for one or more medical purposes that perform these purposes (diagnosis, mitigation and prevention of disease) without being part of a hardware medical device”
SaMD products are primarily regulated through the traditional approaches used to approve lower-risk medical devices, including the de novo and 510(k) pathways.
If sponsors can show substantial equivalence to one or more already marketed devices (i.e., a “predicate device”), they can submit a 510(k) application, which does not require additional safety or efficacy data.
The de novo process is typically used for novel low-risk medical devices (e.g., Class I and II) and requires “reasonable assurance of safety and effectiveness for the intended use.” Given the novelty of may of these interventions, this is the route for many of new SaMDs.
The agency may also exercise “enforcement discretion” for certain devices deemed to pose a low risk to patients or designed to help patients manage their disease without providing specific treatment or treatment. These can be available without FDA oversight
Other products are not regulated by the FDA, such as the vast majority of consumer medical apps, as these products are intended to help individuals maintain general fitness, health, or wellness, and do not meet the definition of a medical device.
Industry Roundup
Alma which promises to provide high quality affordable mental health care raised $130 million in Series D funding led by Thoma Bravo, with participation from Cigna Ventures, Insight Partners, Optum Ventures, Tusk Venture Partners, Primary Venture Partners and Sound Ventures. Alma has now raised more than $220 million. via Mobilehealthnews
Brightline, a telehealth company that provides pediatric mental health care, received a $10 million investment from Northwell Health with a strategic partnership patients receive in-network care on its platform. via Medcitynews
Fair Square Medicare, an insurance navigator raised $15 million in Series A funding led by Define Ventures, with participation from Slow Ventures, YCombinator and angel investors. Fair square has now raised close to $19 million. via Mobilehealthnews
Trial Library raised $5 million in seed funding led by Deena Shakir, partner at Lux Capital, with participation from Julian Eison, managing partner at NEXT VENTŪRES and Unseen Capital and other angel investors. via Mobilehealthnews
Cleerly, the company creating a new standard of care for heart disease, announced that it has closed a Series C financing round of $192M. The round was led by funds and accounts advised by T. Rowe Price Associates, Inc. and T. Rowe Price Investment Management, Inc., and Fidelity Management and Research Company, brings the total raised by the fast-growing health care company to $248M. via HITconsultants
Interesting Stuff Roundup
One of the best mindset shifts in productivity is to focus on managing energy not time. Mastering your energy begins with your calendar. Ms Excel suggests that we label “left brain” tasks as those that require hustle, focus, and an iced coffee (or several). “Right brain” tasks are more laid back—they call for introspection, creativity, and idea generation. That way you can start with tasks with the most energy and then organize your days that way. She suggest following these steps
Step 1: Brain dump your upcoming tasks for the week.
Step 2: Separate the left brain and right brain tasks.
Step 3: Time block by task type.
Step 4: Stick to your calendar.
This is another great video on how to organize your day based on your energy level.
A little reminder about to spend more time with the ones you love while you still can
103 bits of advice I wish I had known- Kevin Kelly is probably the most interesting man on the world. This has some many gems in there. Some examples:
Don’t ever work for someone you don’t want to become.
No one is as impressed with your possessions as you are.
Cultivate 12 people who love you, because they are worth more than 12 million people who like you.
Don’t keep making the same mistakes; try to make new mistakes.
If you stop to listen to a musician or street performer for more than a minute, you owe them a dollar.
Anything you say before the word “but” does not count.
Efficiency is highly overrated; Goofing off is highly underrated. Regularly scheduled sabbaths, sabbaticals, vacations, breaks, aimless walks and time off are essential for top performance of any kind. The best work ethic requires a good rest ethic.
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Talk Soon,
Hamid
Hy Hamid, i loved your newsletter, its really helpful. I am also a fellow creator just like you. Could we do a written article of things your grab wisdom from internet. My audience will love to see you, just let me know about it.