illustration of person tracking his health condition with smart bracelet, mobile application and cloud services.

Should We Regulate Direct-to-Consumer Health Apps?

By Sara Gerke and Chloe Reichel

According to one estimate, over 318,000 health apps are available in app stores, and over 200 health apps are added each day. Of these, only a fraction are regulated by the U.S. Food and Drug Administration (FDA); those classified as “medical devices,” which typically pose a moderate to high risk to user safety.

In this final installment of our In Focus Series on Direct-to-Consumer Health Apps, we asked our respondents to reflect on this largely unregulated space in health tech.

Specifically, we asked: How can/should regulators deal with the assessment of health apps? For apps not currently regulated by the FDA, should they undergo any kind of review, such as whether they are helpful for consumers?

Read their answers below, and explore the following links for their responses to other questions in the series.

Ariel Stern:

This is an area where tools like “nutrition labels” for digital health products (mentioned before) may have a lot of promise. Indeed, there are some nice analogies with food products, where formal regulatory review is not a marketing requirement, but where producers/manufacturers need to include product information on standardized labels. If standards could be agreed upon for the content of such labels, the App/Play stores could mandate (or be required to mandate) their inclusion. At a minimum, this would give consumers an additional tool for making more informed decisions regarding product content and quality. There are already some nice examples out there — e.g., Coravos et al. have published what such a label might look like for connected sensors.

Deborah DiSanzo:

If health apps make a medical claim, they must be cleared by the FDA. However, how can we be assured that the 318,000 apps have followed FDA regulations? One idea could be to use natural language processing to “read” the health apps’ claims. If a medical claim is found, search can help determine if the app received FDA clearance. If no evidence is found, the app can be tagged with a note indicating that it has not received FDA clearance. Maybe this simple tag could alert consumers, educate app developers, and ensure that fewer medical claims are made on apps that have not gone through FDA clearance.

Peter Chai:

I think it would be difficult to regulate consumer facing apps developed by for-profit businesses. Those that have not been submitted to the FDA may certainly contain flawed data, but it does not seem fair to regulate all apps that are meant to be health-facing. There are already-existing consumer sites that conduct reviews of digital health apps. Clinicians who want to recommend apps to their patients may also consider reviewing or trying specific apps. There should ultimately be a line drawn surrounding digital health apps for wellness, compared to those that are intended to address a specific disease as a therapeutic.

Sara Gerke:

The sheer amount of health apps available to consumers certainly raises problems. For example, it would be desirable for consumers to know whether these apps work as promised and whether their privacy is adequately protected. Some kind of review would definitely be welcomed. However, the FDA has limited resources, and the review of all health apps is unlikely to be feasible. This is why the FDA is focusing on a risk-based approach. Nevertheless, it may be helpful to look at what other countries are doing. Germany, for example, adopted a new Digital Healthcare Act that entitles insured persons to coverage benefits for particular digital health apps that meet specific criteria, including safety, quality, functionality, data protection and security, and positive effects on care. This Act may give AI developers an incentive to develop better products to make sure that insurers will reimburse them.

Sara Gerke

Sara Gerke joined the Petrie-Flom Center's Project on Precision Medicine, Artificial Intelligence, and the Law (PMAIL) in August 2018. As Research Fellow, Medicine, Artificial Intelligence, and Law, Sara oversees the day-to-day work of the Center’s component of this collaborative project, including conducting law, policy, and ethics research; drafting reports and recommendations; and coordinating the Center's efforts with collaborators at the Center for Advanced Studies in Biomedical Innovation Law (CeBIL) at the University of Copenhagen as well as other partners.

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