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Article by Katherine Gustafson

Digital health tools are an increasingly prominent part of medical care in the U.S and around the world, with the global digital health market projected to grow almost six-fold by 2025. (Although the Coronavirus pandemic will have profound effects on global business and may well reduce those pre-virus projections.)

With innovation proceeding at a rapid clip, regulatory oversight is evolving rapidly and practitioners are scrambling to keep up with the latest best practices and recommendations. It’s telling that the American Medical Association’s vice president for digital health strategy referred to physicians’ use of technology in medicine as the “Wild, Wild West.”

Medical providers and administrators should seek a solid understanding of the field of digital health when choosing tools in this fast-changing corner of medicine.

What is digital health?

Digital health refers to products and services that collect and exchange data to inform care. The scope of digital health is constantly increasing, moving from Web fora and communities, to mobile apps that provide information and conduct surveys, to current cutting-edge developments in telemedicine, wearables, and biosensors.

The rising popularity of fitness tracking tools confuses the definition of digital health. Such tools collect biologic information, but unless they contribute to medical care, they are typically not regulated as medical devices.

“It’s difficult to judge because there aren’t a ton of data to support clinical effectiveness of most digital products,” says Adam Cohen, a neurologist at Johns Hopkins University hospital, who leads the Health Technologies program at JHU’s Applied Physics Lab. “Many products are not FDA approved; they’re direct-to-consumer, so patients are left to fend for themselves.”

It’s best to look for FDA-cleared devices; such products can be relied upon to live up to established standards of care, just like traditional pharmaceuticals.

FDA clearance for digital health products

Digital health products must get FDA clearance if they collect patient health data that is used to inform diagnosis and treatment. A digital device that does not inform treatment is not of concern to the FDA.

“It’s not the idea that they are a wearable, it’s the idea of what are you doing with the data that comes out,” says Shahid Shah, an advisor to NODE Health, a nonprofit network focused on evidence-based digital medicine. “If you have a wearable like an Apple Watch and it’s telling you your steps, but you’re not making a medical decision off of that, then the FDA doesn’t care. If you use that same watch to tell you if you’re having a heart attack or to tell you if you should go to the hospital, the FDA cares.”

Applying for FDA approval requires submitting a “Premarket Notification 510(k),” a packet of information that lays out your product’s intended use, development process, and manufacturing process so you can demonstrate that you know the risks and are prepared to handle them.

The FDA prefers proper clinical trials, but device manufacturers may be able to satisfy this requirement using computer simulations. Once you’ve gained approval, the FDA will check every year or two that your operations accord with your own plan.

“It’s an evolving situation,” says Cohen. “Regulatory bodies like the FDA will learn from their current program and change to a new program. I think they will become stricter and have more specific guidance for approval process for digital health technologies.”

Tips for practitioners on digital devices

New digital products can be seductive; it’s easy to assume they’ll benefit patients and providers. But it’s essential to look at whether each tool will improve care in quantifiable ways.

“You need to have an outcome you’re trying to drive towards,” says Shah. “That’s probably the trickiest part.”

Digital devices may appear to contribute to better outcomes when they are really highlighting patient compliance. For example, a diabetic patient who is by nature vigilant about managing blood sugar will demonstrate good health outcomes using an app. That means that the app is quantifying and reporting pre-existing compliance rather than creating that outcome.

For wearables specifically, consider three factors in vetting products, recommends Pete Celano, Director of Consumer Health Initiatives for MedStar Institute for Innovation.

1. Form factor: The device ideally can attach to the body and collect data automatically, since difficult or unwieldy standalone devices often see low usage (adherence) rates.

2. Data surveillance: A practitioner must monitor the information the device generates in order to alert patients when something is amiss and needs attention.

3. Virtual care: Digital devices that enable virtual visits are more effective in easily and affordably translating monitoring into outcomes.

“The FDA and other regulatory agencies are increasingly considering usability,” says Celano. “Form factor matters, they want providers, often with an AI_assist, to review the data, and they are contemplating the accompanying care aspect of diagnostic and screening devices alike.”

The goal—for the FDA, providers, payers and employers—is for medical devices such as wearables to make monitoring and treating patients ever more convenient, lower cost, and more effective.

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