New Health Affairs Study: Effectiveness of Digital Health Solutions Remains Unproven
How effective are new digital health solutions—both consumer-facing and provider-facing—including “health care, health diagnostics, hospital, personal health, health insurance, analytics, big data, mobile apps, wearables, cloud data services, wellness, predictive analytics, mobile devices, data mining, biometrics, [and] home healthcare”—proving to be, in impacting health status? The reality is that even the serious study of such solutions remains in its infancy.
In that context, a group of healthcare policy researchers has just published an article in the January issue of Health Affairs. The researchers—Kyan Safavi, Simon C. Mathews, David W. Bates, E. Ray Dorsey, and Adam B. Cohen, have authored an article entitled “Top-Funded Digital health Companies And Their Impact On High-Burden, High-Cost Conditions,” in which they look at the extent to which other researchers have studied the effectiveness of all these solutions.
There is real collective potential in these solutions. As the authors point out, “Digital health companies hold promise to address major health care challenges, though little has been published on their impact. We identified the twenty top-funded private US-based digital health companies to analyze their products and services, related peer-reviewed evidence, and the potential for impact on patients with high-burden conditions. Data analytics (including artificial intelligence and big data) was the most common company type. Companies producing biosensors had the greatest funding. Publications were concentrated among a small number of companies. Healthy volunteers were most commonly studied. Few studies enrolled high-burden populations, and few measured their impact in terms of outcomes, cost, or access to care. These data suggest that leading digital health companies have not yet demonstrated substantial impact on disease burden or cost in the US health care system. Our findings indicate the importance of fostering an environment, with regard to policy and the consumer market, that encourages the development of evidence-based, high-impact products.”
What’s more, the authors note, “The necessary ingredients for the meaningful and widespread adoption of digital health technologies by patients and providers are falling into place: 70 percent of physicians report using mobile or smart devices as a part of their practice, and 80 percent of the US population has used at least one digital health application or technology.”
On the other hand, the task of analyzing the effectiveness of these digital solutions is a gargantuan one. As the authors point out, “[T]he digital health industry has become more crowded and diverse, as well as better funded. A 2016 study reported that 259,000 digital health apps were available for consumers. Global consumers are expected to spend $49 billion by 2020 on digital health solutions. A record number (296) of private digital health companies received venture funding in 2016, funding that totaled more than $4.2 billion that year and approached $6 billion the following year. As digital health companies have grown, digital technologies have attracted interest from US governmental bodies—as demonstrated by the Precision Medicine Initiative of the administration of President Barack Obama and the Digital Health Program of the Food and Drug Administration (FDA).”
So what have these researchers learned? While “Digital health products have the potential to help manage high-burden populations that account for the most morbidity, mortality, and cost in the US health care system,” they state bluntly that, “[A]mong a subset of leading private digital health companies in the U.S., we found relatively few studies published in the peer-reviewed literature. Most of those we found evaluated the product or service in healthy patients; high-burden populations were less commonly targeted. These results give reason to assume that digital health products and services from leading companies have had limited impact on disease burden and cost in the U.S. health care system in their current form and implementation.”
Indeed, the authors write, “We found no studies that evaluated effectiveness in terms of reducing cost or improving access to care. Furthermore, clinical effectiveness studies with a high level of evidence were uncommon (that is, there were few randomized controlled trials demonstrating clinical effectiveness). This may explain why the studies were largely published in lower-impact journals. Health care organizations attempting to identify which digital products to purchase might find such data essential,” they add.
As a result, they write, “We believe that the findings of this study indicate the importance of building an environment to encourage the digital health industry to build products and services that are impact focused and evidence based and that provide high value for patients and the health care system. Two areas that policy makers may address to foster such an environment are clarifying the regulatory requirements for such technologies and developing incentives that lead to a stronger customer market.”
Looking forward, the researchers note that, “To encourage innovation among companies aiming to solve critical challenges in the health care system, the FDA has created several guidance documents for app developers intended to clarify the scope of products requiring approval and the standards that these products must meet. FDA Commissioner Scott Gottlieb emphasized his hope that such clarity would help support the creation of digital technologies that, for example, empower patients to monitor and manage their chronic health conditions; enable better clinical decision making, diagnosis, and treatment; and help address public health crises.”
In addition, they note, “Another factor that may explain why the digital health companies in our study demonstrated little impact on key health care metrics or in high-burden patient populations might be the complex, challenging nature of the customer market for products with such characteristics. In contrast, wellness products that use direct-to-consumer approaches may present larger market opportunities.”
Ultimately, the authors write, “The value-based purchasing trend could encourage the market to produce more evidence-based, high-value digital health products. Value-based purchasing should incentivize providers to seek methods that improve outcomes and reduce costs. The Medicare Access and CHIP Reauthorization Act (MACRA) of 2015 represents the strongest recent federal legislation to encourage a shift to value-based care.32 If value-based purchasing becomes the dominant model, digital health tools that have evidence-based value will be in demand. However, to expect value-based purchasing to drive digital health companies might not yet be realistic, because fee-for-service models continue to dominate patient care reimbursement.” As a result, they state, “To incentivize the adoption of impact-focused products in the health care system, several approaches could serve as a bridge while value-based purchasing expands.”
Ultimately, the researchers conclude, “Digital health represents a new and expanding field with substantial promise to address major health care challenges in high-cost, high-burden patient populations. In this cross-sectional observational study of top-funded digital health companies, we found that few companies studied their products and services in high-cost, high-burden populations or measured their impact in terms of key health metrics such as outcomes, costs, or access. Most studies were of healthy patients, congruous with the direct-to-consumer approach that many digital health companies have taken to bring their products to market. These findings indicate the importance of building an environment to encourage the digital health industry to build products and services that are impact focused and evidence based and that provide value for high-cost, high-burden patients. Two areas in which policy makers could help foster such an environment are in clarifying the regulatory landscape around these products and incentivizing an impact-focused customer market.”
