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As the world becomes ever more reliant on digital technology, there is enormous potential for it to be used to prevent, diagnose, and manage diseases.
With large amounts of investment flowing into companies producing digital therapeutics and health apps, there is a proliferation of potential new digital tools that patients could use to improve their health. The challenge now is to get these into the clinic.
There are, for example, some 300,000 health apps that have been developed – getting them into clinical practice will be a considerable task.
Health apps making progress
Thankfully, there has already been considerable progress about developing and regulating the apps, as noted in a recent article in Nature Digital Medicine.
The FDA has already put processes in place to regulate apps, including the ability to have them prescribed as a digital therapy should they have sufficient clinical evidence behind them.
For other health apps where this approach may not be feasible, several strategies are being pursued to regulate the market. These include using existing regulations from organizations such as the Federal Trade Commission to ensure minimum standards and to prevent issues such as misleading claims.
Nature’s authors concluded that over time more apps will overcome regulatory hurdles – with the outstanding task being to communicate with doctors and healthcare professionals to outline their value and benefits.
Specialized education courses for doctors can be used where the FDA has regulated an app and approved it for a specific indication. While the investment in this process is considerable, it does have the advantage of ensuring that a treatment has credibility and medical evidence to back its safety and efficacy.
In the future, it’s envisaged that doctors may require formal digital health training in the same way that they are required to keep up to speed with pharmacology. Training could be led by hospitals or vendors, who could keep registries of certified providers to streamline the process. App providers could also create demand for products with direct-to-consumer marketing that could direct them to online app stores.
This is a double-edged sword – although apps could be reviewed using these stores, this information may not always correlate with the patient experience. The fact that apps may help treat mental health issues, involving patients making difficult lifestyle decisions, could further complicate matters.
Digital health formularies
Another solution to deciding which treatments could be prescribed or used could be digital formularies, which could provide an important mechanism to disseminate health apps and digital therapies and ensure their regular use.
It’s an idea that has already been piloted by Express Scripts, the large US pharmacy benefits manager, and its rival CVS Health has announced a similar system allowing customers to manage third-party health products.
In the UK, the National Health Service’s Apps Library acts similarly, allowing patients and providers to search for apps that have been reviewed and approved while also providing price information.
There are also technical hurdles to consider as apps must be integrated into electronic patient records for them to be of use.
Other issues include integrating them into decision support tools if used, along with functionality allowing doctors to note the indication an app has been prescribed for.
Information should also reflect how long a patient has been using an app, as they may have been designed for use only over a certain period.
Winning patient uptake
The authors also look at how to win patients over and envisage using incentives, such as reducing co-payments, using the app, suggesting use could also be encouraged by packaging them with drugs or medical devices.
It’s a theme explored in a recent editorial by Jennifer Geetter, a partner at McDermott Will & Emery, on the website MedTech Intelligence.
She argues that while governments can make a difference to digital medicine uptake, there must also be buy-in from providers in the wider healthcare system.
There’s been a tremendous amount of goodwill built up during the COVID-19 pandemic, with technology such as telehealth allowing many services to continue that otherwise would have been halted or severely cut back.
Once the pandemic recedes, the task will be to convert the “crisis response” into a “sustained new normal” way of working.
Digital care must be integrated into in-person care, and Geetter envisages a joined-up digital health system that provides continuous care for patients, rather than the current arrangements based on episodic interventions.
Only by creating a “continuum of digital care delivery” will the benefits of the technology be realized, but this will also require a shift in how payers are thinking about funding healthcare.
This will require a new way of thinking based on a broader focus on the patient experience, backed with innovative reimbursement schemes based on outcomes and value, Geetter argued.
Although there is much work to be done, the groundwork is already there to create a joined-up healthcare system in the next decade, enabled by digital technology.
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