AI/ML
January 2, 2024
- In early October the FDA announced the formation of a nine-person Digital Health Advisory Committee expected to be operational in 2024.
- Broadly, digital health is defined as AI/ML, augmented reality, virtual reality, digital therapeutics, and remote patient monitoring software and devices.
- The committee will advise the FDA on the ever-changing role of technology in supporting health.
- Jeff Shuren, MD, JD, director of the FDA Center for devices and Radiological Health summed up the initiative best – “DHTs are critical for achieving transformation in care delivery. As DHTs advance, the FDA must capitalize on knowledge from inside and outside of the agency to help ensure we appropriately apply our regulatory authority in a way that protects patient health while continuing to support innovation.”
Link - https://www.pharmacytimes.com/view/fda-to-create-digital-health-advisorycommittee-by-2024
Three reasons why this matters…
- Not only does digital health represent a new frontier of health innovation, it also specifically helps impact health equity. Many of the promises and focus areas of digital health have direct correlation to the pain points that drive gaps in health equity. From expanding and democratizing access to care, to destigmatizing particularly sensitive health care topics, to improving health literacy, to provide a full eco-system of support to disadvantage populations – digital health is not just innovation for innovations sake. It is innovation for good.
- A private public coalition is needed to provide guidance, standards, and set expectations to help digital health scale. Some 20 years ago, Gartner introduced the concept of the Hype Cycle. And having seen the excitement of early digital health pioneers like Pear Therapeutics and Akili Interactive fall short of the hope they once brought, it is clear we need more than breakthrough technology to drive adoption. We need education, dialogue, and clarity
- Digital health is already a part of traditional “analog health” – we just didn’t name it correctly. Pharma manufacturers and marketers have known for some time the concept of “pill plus”. Specifically, that your pill plus a robust patient support program drives more successful outcomes. This new coalition create a forum to formalize those programs impact through AI/ML, real world evidence tracking, and remote patient monitoring.
What to do now…
If you work in digital therapeutics – build your education and behavior change plan with the same user centricity you put into building your product.
Driving awareness, understanding, trial and adoption of a new therapeutic class requires a well customer-centric cross channel coordinated experience – essentially Omnichannel. It is imperative that you build a data-driven understanding of your key stakeholders – from buyers, prescribers, referrers, and payers. For each stakeholder you need to address to their learning style and channel preference. Ask yourself some critical questions. Are you using interactive quizzes to assess learning gaps? Is your content available in different formats? Is it available on demand? How are you leveraging KOLs, peers, and case studies? Are you accounting for regional differences? Are your providing nudges to build an iterative learning experience?
If you work in traditional therapeutics – Look at your patient support initiatives like a digital health product not a program.
Even if you have no intention of ever charging for it, you should be building your digital support components with a eye toward value exchange. What value are you delivering to the patient and caregiver, the HCP, and the payer? Set KPIs based on impact of those value drivers as opposed to traditional engagement metrics. For example – improving patient understanding and confidence; fueling