Dive Brief:

• Physicians at Johns Hopkins have called for the development of a Digital Health Scorecard to support the transparent validation of new products.

• The proposal grew out of recognition that physicians, payers and other healthcare players need a better way to find quality products in the crowded, hype-driven digital health market.

• Following the models of product evaluation organizations such as UL and Consumer Reports, the physicians want to see providers and regulators work together to transparently define standards and evaluate products against those standards.

Dive Insight:

The explosion of digital health products has created problems for people who provide, pay for and use healthcare services. Although digital health products such as apps and wearables may improve care, the size of the marketplace and pace of development make it hard for people to identify the devices they need. The challenge is exacerbated by the failure of many companies to rigorously validate the clinical effectiveness of their devices.   

Writing in Nature's digital medicine journal, physicians at Johns Hopkins outlined a potential answer to this problem. Their proposal seeks to improve on the patchwork of standards and validation initiatives underway at groups including Xcertia and NODE.Health by using a transparent process to identify effective products that integrate into particular healthcare scenarios.

The proposed Digital Health Scorecard would evaluate digital health products across four domains: technical, clinical, usability and cost. In doing so, the physicians foresee the scorecard could show how a new product compares to the current gold standard, assess its effect on clinical outcomes and elucidate the time and resources providers will need to spend to buy and adopt the device.

But the physicians acknowledge there are multiple challenges to realizing the goal. The questions prioritized by the scorecard may differ from those that other stakeholders want answered, and someone will need to pay for the initiative, even if it starts small.

"A Digital Health Scorecard would likely fail in the current landscape if applied universally. Initially, a pragmatic approach could be applied to select products, such as those relevant to high burden or high-cost conditions, already popular with patients or providers, or with peer-reviewed studies to demonstrate validation, efficacy or both," the authors wrote.

The physicians see two potentially complementary ways the scorecard could get off the ground. One option is for regulators to move it forward in collaboration with clinical partners. The other option is for a hospital system or healthcare provider to develop and adopt a scorecard.

But the physicians say the ideal outcome is a combination of these two options. Such an outcome would include major hospital systems partnering with FDA to lead development of a scorecard, resulting in a system that has the input of regulators and can be applied across a healthcare system with enough patients to influence product development.