FI_EvidationHealthAccording to research firm Research2Guidance.com, an estimated 500 million smartphone users will download a healthcare app by 2015. This number is expected to grow to 1.7 billion by 2018. Evidation Health, formed in a partnership between Stanford Healthcare and GE Ventures, aims to provide the evaluation and validation necessary to help clinicians and patients alike figure out which apps do what they claim.

We are at a crossroads in medicine as it moves from a fee-for-service model to one based on quality, value, and outcomes. In that context, modern healthcare is seeing a digital health revolution, driven by a combination of changing policy and proliferation of connected, high tech consumer devices. These include activity trackers, wearable sensors, connected personal health monitoring devices, and a multitude of healthcare apps.

The FDA has specific guidelines as to what constitutes a mobile medical app and uses a risk-based approach to regulating health apps. FDA regulation for mobile health apps will focus on apps that “are intended to be used as an accessory to a regulated device” or “[intend] to transform a mobile platform into a regulated medical device.”

That leaves most mobile medical apps that pose “minimal medical risk” unregulated by the FDA. Additionally, the majority of research on mHealth applications focuses on patient preference and technical utility, factors that don’t necessarily drive the major hurdles to adoption, such as clinical outcomes, cost, and influence on the healthcare system. In a literature review by A.T. Kearney, only 13% of publications on mHealth used evidence-based research methodologies. As a result, physicians and other healthcare providers, patients, insurers, and hospitals are left to sort through thousands of mobile medical apps without any guidance on their quality and economic value.

Evidation Health was formed as a joint venture of Stanford Health Care and GE Ventures. The company will also join forces with The Activity Exchange, a company with experience in predictive analytics. Deborah Kilpatrick, PhD as its Chief Executive Officer will lead Evidation Health. In a statement upon the launch of Evidation Health, she highlights, “Our company has the core capabilities to make precision digital medicine a reality. We envision a digital health-enabled future where clinical interventions can be customized and concentrated in ways that maximize clinical and economic benefit for payors, providers and, most importantly, patients.”

DeborahEvidationI recently spoke with Dr. Kilpatrik about digital health and Evidation Health, starting with our agreement that most of the products in the market have no evidence supporting the marketing claims. She alluded to the fact that healthcare purchasers are inundated with digital technologies; with a lack of evidence-based data, they are not in the position to make the best choices on these products.

Dr. Kilpatrick and Evidation Health aim to tackle these issues by customizing patient management to maximize benefit and help partners determine how best and when best to apply and deploy technologies. Rather than focusing on a specific product or class of products, Evidation Health will fit each partner’s specific needs.

The business model of Evidation Health isn’t strictly a clinical research institute. They plan to partner with academic institutions for clinical expertise while also partnering with companies with existing data to help provide economic benefit.

To illustrate the role of Evidation Health, Dr. Kilpatrick provides a useful example, “imagine a startup company focusing on improving care of type II diabetics by providing patients with mobile-based tools to help them follow their provider’s prescribed medication and lifestyle plan, assuming that the tools have been developed according to society-accepted guidelines for management of diabetes and they have a growing volume of patients who are downloading and are using their tools. However, they lack real-world evidence showing that the use of those tools actually translates to better outcomes, either clinically or economically, in some set period of time. As a result, the start-up has not validated marketing claims regarding how their products can improve care.”

To fill that gap, Dr. Kilpatrick says, “Evidation Health can partner with that startup, design an appropriate clinical study plan to test whether the use of the company’s tools can lead to clinical and/or economic benefit, and execute that study plan with one or more of Evidation’s health care system partners. Given that our [Evidation Health] approach to validating health outcomes involves leveraging predictive analytics at the intersection of clinical endpoints, economic endpoints, and patient behaviors, we are able to help that startup validate its evidence-based marketing claims to help drive product adoption by providers and payers.”

At their core, Evidation Health attempts to defragment the digital healthcare landscape by “partnering across the healthcare ecosystem,” “demonstrate digital health product value,” and “deploy precision digital medicine” (Evidation.com).

The 5 steps of Evidence Based Practice were published a decade ago and, given the topic, warrant review: “1) translation of uncertainty to an answerable question; 2) systematic retrieval of best evidence available; 3) critical appraisal of evidence for validity, clinical relevance, and applicability; 4) application of results in practice; 5) evaluation of performance.” However, the majority of mobile medical apps have not been clinically validated, thus resulting in a fragmented digital health ecosystem without proven or documented quality and value for patients, physicians, and hospitals.

As more doctors are recommending and prescribing medical apps, and patients are using them, it is imperative that use is driven by clinical research supporting the efficacy and quality of these apps. Evidence-based medicine has led to improved outcomes and quality in medicine, so why would we consider adoption of mobile health devices and apps without evidence supporting them? Although the pace of innovation and development of digital health technologies is speeding forward, we need to have our foot on the breaks prior to widespread use.

To quote the summary on evidence-based medicine: “All health care professionals need to understand the principles of [evidence-based practice] EBP, recognize EBP in action, implement evidence-based policies, and have a critical attitude to their own practice and to evidence. Without these skills, professionals and organizations will find it difficult to provide ‘best practice’. ” Evidation Health has entered into the digital health world to provide some structure to our fragmented reality, with the goal of validating, connecting, and optimizing digital healthcare. These efforts by Evidation Health and the work of many others will shape the future of digital medicine.