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Digital health: a path to validation

Companies could be successful if a clear Digital Health Scorecard guided them with product development. The Scorecard itself could present an opportunity for a multi-stakeholder consultation to first generate and then periodically update, as refinements emerge with time and experience.

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If independent outside assessment of digital health products is to be realized, scaling up assessment to meet the demand of many new products would require a large organization, certification network, and substantial resources. The latter could be accomplished by identifying or building a network of independent, objective organizations that could complete the different domain assessments, while following universal requirements from the Scorecard.

The road to validating digital health will take resources, collaboration, and time.

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Even if successful, the first iteration of the Digital Health Scorecard will be different than latter versions as the healthcare environment evolves. The first Scorecard version, however, if transparent, rigorous, and pragmatic, would be an important step toward impact-driven digital health products that function in real healthcare settings. We are presently pursuing a small-scale pilot study implementing this approach in granular detail, the results of which will be published upon completion.

We believe there are two non-mutually exclusive initial approaches to the Digital Health Scorecard model.


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First, governmental regulatory bodies should partner with clinical stakeholders to create a standard set of requirements using the categorical concepts proposed here. This collaboration could produce certifications and ratings, but most importantly, requirements sets that promote the development of digital health products poised to be efficacious for the target patient population and function in a healthcare system with varied stakeholders.

We do not expect one regulatory body to have the bandwidth, resources, or expertise to take this on alone. Second, a provider healthcare or hospital system or collection of systems could lead to the development and adoption of a Digital Health Scorecard. Our preference is for a hybrid approach in which leading hospital systems partners with one or more of the aforementioned regulatory bodies, including the FDA, to lead a requirements-driven Scorecard approach. This system would not only lay out the requirements for digital health products that enter it, but only accept products that achieved high marks for each category of assessment.

An existing healthcare system with enough patient volume could have ample market clout to influence the development of digital health products. Further, healthcare systems could collaborate to create an even more influential Scorecard model of care that drives requirements and product development across larger geographic regions and patient populations. Although many large healthcare systems have sufficient market influence to drive this change, most are not nimble enough to do so.

For example, many leading healthcare systems remain tied to electronic health record technologies, nearly universally disparaged by end-user practitioners and healthcare leaders. The healthcare environment is evolving and converging with the entrance of non-traditional healthcare players, such as the CVS-Aetna partnership 43 and the nascent Amazon—JP Morgan Chase—Berkshire Hathaway collaboration.

As digital health companies have become more prolific and the number and diversity of digital health products has multiplied, the need for requirement-driven product realization and systematic validation has become increasingly important. Patients and providers will benefit from and demand the ability to discriminate clinically meaningful solutions.

Payers and investors will need to identify high-value opportunities that ultimately guide reimbursement, investment decisions, and impact-focused care. Given the growing pull from non-industry stakeholders to demand impact-focused, interoperable digital health products, industry will also find utility in demonstrating product quality over product claims. We provide a framework to guide the evolution and successful delivery of validated digital health solutions. Frank, S. Digital health care—the convergence of health care and the Internet.

Rock Health. World Health Organization. Classification of digital health interventions v1. World Health Organization Schoenfeld, A. The challenges of mobile health regulation. Lewis, T. Internet Res. Quinn, C. Diabetes Technol. Svendsen, M. A smartphone application supporting patients with psoriasis improves adherence to topical treatment: a randomized controlled trial.

Plante, T. Validation of the instant blood pressure smartphone app. JAMA Intern. Veazie, S. Mobile Applications for Self-Management of Diabetes. Technical Brief No. Smith, C. Origin and uses of primum non nocere—above all, do no harm! Shuren, J. FDA regulation of mobile medical apps. JAMA , — Federal Trade Commission.

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International Consortium for Health Outcomes Measurement. Postmarket Requirements Devices. User experience of instant blood pressure: exploring reasons for the popularity of an inaccurate mobile health app. World Wide Web Consortium. Notes on User Centered Design Process. International Organization for Standardization. ISO Ergonomics of human-system interaction — Part Human-centred design for interactive systems. UX Evaluation Criteria. Nielsen Norman Group. Smelcer, J. Usability of Electronic Medical Records.

Usability Stud. Iribarren, S. What is the economic evidence for mHealth? A systematic review of economic evaluations of mHealth solutions. Credit Scores Vs. Kellermann, A. What it will take to achieve the as-yet-unfulfilled promises of health information technology. Health Aff. Social networks and forums will add more confirmation and offer support, as well as offer examples of new tics and symptoms that you may not have realised were part of your problem.

Armed with false certainty and more than a spoonful of paranoia, you march to your medical practitioner and demand treatment. As this new medical infomatics trend began bubbling in the early days of the web, sociologists and medical professionals predicted that a new relationship between patient and practitioner would develop.

The paternalistic approach taken by doctors — you have X ailment and you can only fix it if you follow my advice — would evolve into a partnership in which they would facilitate a patient's recovery rather than proscribe it. This puts docs in a funny new situation: they must now incorporate persuasive techniques to convince patients that they offer the best counsel.

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In the past, we'd have simply swallowed any pill, however bitter. The health and wellbeing industry has evolved to address this relationship. And for patients and their families who want more information on treatments they've been prescribed, information from credible sources provides peace of mind as an illness progresses. However, we can pay a serious price for our newfound medical insight: websites will help identify what's wrong and give you a treatment schedule if you submit details about your age, gender, blood pressure, exercise regime, family history and dietary habits.

How should we maintain our autonomy over the often very sensitive information that we put into diagnostic sites? It's stored somewhere and used somehow, and we have no idea what will happen to that information in the future. There is no doubt that the wealth of health information online has contributed to a more informed public, but this is an area in which I believe the expertise of the professional should not be undermined by the levelling power of the web. As Dad says, a doctor who treats themself is a fool.

But even if that doctor isn't infallible, they have a hell of a lot more experience in saving lives than you or I. There's a joke that we tell in my family to irritate my physician father. Arch Dis Child Apr 6.

More patients are turning to the Internet for medical advice. To determine the accuracy of online medical information, researchers in the U. The first websites listed in the results for each search were evaluated. Thirty-nine percent of the websites gave accurate information consistent with current U. All government sites were accurate. Online medical information is highly variable and often inaccurate. Learn the best sources of information for your patients, and recommend government-sponsored sites when available. Scullard P et al.

Googling children's health: Reliability of medical advice on the internet.