The Regulation of Health Apps and Why It Matters

A huge array of digital health applications (apps) is available in the medical marketplace, but most of them get relatively little use.  The sheer number of apps available makes things confusing for both patients and healthcare providers.

 Although it has been estimated that several hundred thousand apps can be purchased, they have not yet achieved their potential to meaningfully transform health care delivery. One could imagine, for instance that nearly every patient with a chronic condition like diabetes or hypertension would have an app that they could use to help manage their health on a regular basis, that these apps could be prescribed and covered by insurance, and that this would result in improved care in the form of more patient-focused tools and better health outcomes.  Yet, this is still far from the reality of care that patients and clinicians experience, and – as we discuss in our recent publication in nature digital medicine the fragmented policies around the regulation of apps represent key variables in this equation.

More specifically, the uncertainty regarding what criteria to use for evaluating the quality of health apps makes it difficult for purchasers, health professionals, and patients to distinguish high-quality, high-performing from low-quality, low-performing (or even non-performing) apps.  Further, the regulation of apps varies a great deal from country to country, and this poses a major barrier to app developers, who, as a result need to devote significant attention and resources to understanding and surmounting regulatory and market access barriers in individual countries.  As a corollary, if there were more standardization of app evaluation, it would be easier for app developers, patients, and providers to understand product quality and functionality.

In our article, we explored national policies for evaluating health apps across nine countries: Sweden, Norway, Denmark, Netherlands, Belgium, Germany, England, the United States, and Singapore.

We selected countries that have implmented innovative policy approaches from a diversity of regions.  Germany has adopted one of the most innovative approaches, by setting up a process called the Fast-Track that requires developers to show that their application improves care in one or more pre-defined ways; if an app makes it through that process, then reimbursement is guaranteed by Germany’s statutory health insurers.  This both encourages app developers to routinely collect data to assess whether their application is working, and simultaneously offers a benefit to the app community because it establishes a clear pathway to third-party payment for applications by health insurers. Belgium and England have also come relatively far in operationalizing a national framework for approving apps for market access and reimbursement.

Overall, we found considerable variability in how apps were regulated.  In European countries, there are some cross-cutting requirements such as compliance with the GPDR but these do not apply in the U.S. or in Singapore.  For app developers, more consistency around approaches and requirements would be very helpful.  It might be especially helpful if approval by one regulatory entity applied across a variety of countries such as the European Union, but currently such evaluation is done on a country-by-country basis.  Language represents one important problem.  Especially for languages that are not spoken among large populations, this may be a barrier for entering new markets because of limitations in market size.

We identified key challenges for app regulation in the categories of reimbursement, safety, and privacy, and suggest that more regulatory work is needed around operationalization, implementation, and international transferability of approvals. 

Our view is that in the future, the process might look something like the following.  Countries might identify a small set of apps which are “preferred” by condition—generally for chronic conditions.  They could identify these by using a rating approach and having an independent entity to evaluate and select specific app(s).  Providers could then prescribe these apps to individual patients, based on the patients’ characteristics.  Patients could also pick apps on their own.  To the extent possible, these apps should communicate with the electronic health record unless the patient does not want to share their data for some reason.  Today, this rarely occurs, but much of the potential value of digital data capture for care management and coordination is lost if this is not in place.  Tools will also be needed on the electronic health record side to sift through new sources of information and identify issues that are worrisome and that should be brought to the care team’s attention—for example when a patient is experiencing low blood sugar or is actively suicidal.  It should be noted that for many important chronic conditions, there are few or no high-quality apps available today, whereas for others, such as diabetes, there are a (potentially daunting) number to choose from.

This article defines what we believe are the key domains that regulations still need to address and describes the regulatory status across nine nations which have been leaders in this important area.  From the regulatory perspective, app manufacturers would welcome more international cooperation to enable streamlining of regulatory requirements and harmonization of regulations and policies for market access across countries.  Europe is particularly well suited to lead in this regard because some collaborations are already underway; however much more could still be done and other countries and regions would also benefit.  Yet, centralized approaches tend to create new bottlenecks, with long throughput times. Evaluations of innovative regulatory strategies such as those being implemented in Germany, Belgium, and England are also needed.  These countries have developed approaches that address several key issues: they require companies to collect data to demonstrate that their app improves care, which is helpful to healthcare providers and consumers, while at the same time offering companies a clear financial incentive: an app will be eligible for reimbursement if its manufacturer can demonstrate benefit.  We believe that an evidence-based regulatory and reimbursement approach will set a strong precedent going forward and we hope that other researchers will build on this work in studying the potential requirements and benefits of national and international efforts to evaluate and regulate apps going forward.

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  • npj Digital Medicine npj Digital Medicine

    An online open-access journal dedicated to publishing research in all aspects of digital medicine, including the clinical application and implementation of digital and mobile technologies, virtual healthcare, and novel applications of artificial intelligence and informatics.

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