Story snapshot: The FDA has launched a Digital Health Center of Excellence with the goal to connect and build partnerships to accelerate digital health advancements, provide efficiency and less burdensome regulatory approaches. 

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Why is it notable? 

• The Center's programs include very pertinent areas: Software Precertification Pilot Program, Cybersecurity, Wireless Medical Devices, Artificial Intelligence and Machine Learning in Software as a Medical Device.
• This is indicative of forward-looking and cumulative moves by the FDA to support digital health innovation - starting with the Pre Certification Program last year. 

Industry Implications 

• Cannot expect good practices and guidelines off the bat: This Center is very much a work in progress and is yet to convene digital health experts to initiate the exploration. 
• We should expect an aligned regulatory approach to harmonize international regulatory expectations and industry standards, which is a huge need at this time. 
• Whether this body will be approved in Congress is yet to be seen - maybe we should not put the cart before the horse!

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Story snapshot: A recent report has outlined the need for digital/tech innovation to help older adults tackle loneliness and to help their caregivers better care for them. These are areas we touched on 4 years ago in our own opinion piece on Independent Living Through New Care Models. 

Why is it notable? 

• While progress has been made, and a lot of interesting and necessary work is currently underway in the space, there still clearly remains a host of unmet needs when compared with our report from 4 years ago. 
• Despite cultural stereotypes about baby boomers, many actually do utilize technology in their day-to-day lives, with almost 80% using technology to access medical information. 
• Social isolation and loneliness negatively impact mental health. There is a big opportunity for tech to support social connections. While AI can enable companionship at scale, hybrid models, facilitating in-person connection are likely to be most successful.

Industry Implications

• CMS taking note: Over the past two years, CMS introduced two new types of supplemental benefits that opened the door to improved at-home coverage for those on Medicare Advantage plans.
• Let us not just copy-paste innovations: According to a JAMA study, 38% of the 13 million seniors in the U.S. are not ready for virtual visits, mainly because of inexperience with technology. In line with this, emerging technologies from start-up companies are not always designed to deliver value to an older audience. Considering our ageing population, the current trends of design and distribution channels will have to be carefully reconsidered to deliver on population needs into the future.

Story snapshot: Boehringer Ingelheim has signed a $500 million contract with Click Therapeutics to co-develop and market a digital treatment for patients with schizophrenia. The deal is based around a digital therapeutic (DTx) app, called CT-155, which will be prescribed either as a standalone treatment or in combination with pharmaceuticals.

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Why is it notable? 

• This announcement coincides with the recent trial progress that BI has made -  BI 425809 has been seen to have improved cognition in stable adults with schizophrenia in a Phase II clinical trial. Named Study 1346.9, the randomised, double-blind, parallel group Phase II trial was performed in schizophrenia patients on stable treatment in 11 countries.
• Click has other deals with pharma companies. CT-152, its major depressive disorder app, is licensed to Otsuka under a deal worth $10m in an upfront fee, development funding and regulatory milestones; a further $272m is tied to commercial milestones. 

Industry Implications 

• CT-155/ DTx assets will have to go into their own pivotal study, to demonstrate its efficacy both alone and in combination with drug therapy. So, much like the case with all other partnerships, the onus lies with the DTx company to prove clinical efficacy.
• It is not clear yet how CT-155 works or what the intended outcome is from it to the patient, but there have been attempts in the past to work on schizophrenia patient cohorts via tech that have struggled to scale up. What is Click Therapeutics doing differently to ensure success? 

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