With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
In November, Mount Sinai Health System released RxUniverse allowing doctors to easily prescribe approved mHealth apps, personalized educational materials, patient satisfaction surveys, and other documents for their patients.
When I first read about the platform, I was impressed: Physicians and tech leaders at Mount Sinai worked for months to create a list of apps they believe will be most useful for their population, helping care providers and consumers parse through an oversaturated landscape of thousands of digital health apps. With this platform, they’ve finally provided a way for care providers to prescribe digital therapeutics. Right now, RxUniverse is only being used at Mount Sinai, but there are plans to offer the platform for use in other care organizations in 2017.
RxUniverse has been a topic of discussion in the digital health world since its launch because it hopes to solve a big problem: We need a one-stop-shop in digital health. When you’re prescribed a pill-based medication, you probably go to your local pharmacy to pick it up. But if you’re looking for a digital solution for a health problem, where do you go? The app store? Your doctor’s office?
Plus, how do you sort through the thousands of apps on the market right now, to understand what works and what doesn’t? RxUniverse hopes to function like a digital version of the drugstore we’re used to, with “shelves” of validated apps that care providers can easily prescribe.
The big question, though, is whether this digital health application pharmacy is living in the right place. Should that kind of platform live with hospitals, as it does in RxUniverse? Or should it live with retail companies? With payers? Somewhere else entirely? Who should regulate this process?
If RxUniverse is distributed to many hospital systems, which is the plan, each system will have its own database of curated applications, all of which have been approved for use by a team of leaders at that specific hospital. The perk of this system, in which digital application prescriptions and decisions live with each individual provider system, is that it allows care providers and experts to make decisions about the best tools for their specific population.
The problem here, though, is that each system is then likely to have a different list. These “certified” apps will be inconsistent across hospitals, and the burden of sifting through thousands of applications will be large and redundant.
Based on this, some folks have suggested that this process should be given over to a retail pharmacy for management. However, retail pharmacies are distribution centers, not certification boards. Plus, retail pharmacies don’t currently approve pill-based therapies, so why should they manage the validation of digital therapies?
In my mind, a third party management system for digital therapeutic approval seems like the strongest answer to this problem. Right now, the FDA manages drug approval processes and oversees clinical trial proceedings. They provide the first-level of approval, safety, and regulation to the validation of pill-based therapies. Then, with this information in mind, providers look at the research and stats and decide which drugs to administer to their patients. This system, which we’ve already built, should ideally carry over to digital therapies as well.
We need a governing body for digital health solutions and have needed this for a long time. Once we have this third party regulatory board, we’ll be in a place to use a large, overarching system like RxUniverse, but different – a system that is not many versions of curated lists, but one list based on one rulebook.
Ideally, in a best case scenario, the FDA would likely manage about 80 percent of the digital therapeutics validation process for major, common disease, with the final 20 percent of decision making falling upon hospitals for rare diseases and specific population needs. Retailers, then, would handle distribution.
RxUniverse is a good idea. It fills a huge gap in digital health, and that is not to be discounted. However, RxUniverse alone cannot fix the validation gap that currently exists in digital health.
The way in which we validate and distribute digital therapies still requires significant refining. In fact, I can’t help but wonder why digital therapies are separated from pill-based therapies at all in a distribution system like this.
If my patient is diagnosed with a disease, I should be able to see all the treatments available on one platform, choosing from both pill-based and digital treatments, and even combining the two, to give my patient the best care possible. To get to this point, the first step is certainly setting up a third party regulator, potentially FDA, to supply new standards for digital health app validation and success, and leveraging the medical research and publication processes to provide a better understanding of a digital solution’s efficacy.
Photo: Bigstock
