Category: Direct-to-Consumer Health Apps: Ethical, Legal, and Regulatory Concerns

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

Should We Regulate Direct-to-Consumer Health Apps?

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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.

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Mitigating Bias in Direct-to-Consumer Health Apps

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By Sara Gerke and Chloe Reichel

Recently, Google announced a new direct-to-consumer (DTC) health app powered by artificial intelligence (AI) to diagnose skin conditions.

The company met criticism for the app, because the AI was primarily trained on images from people with darker white skin, light brown skin, and fair skin. This means the app may end up over-or under-diagnosing conditions for people with darker skin tones.

This prompts the questions: How can we mitigate biases in AI-based health care? And how can we ensure that AI improves health care, rather than augmenting existing health disparities?

That’s what we asked of our respondents to our In Focus Series on Direct-to-Consumer Health Apps. Read their answers below, and check out their responses to the other questions in the series.

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Who Owns the Data Collected by Direct-to-Consumer Health Apps?

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By Sara Gerke and Chloe Reichel

Who owns the data that are collected via direct-to-consumer (DTC) health apps? Who should own that data?

We asked our respondents to answer these questions in the third installment of our In Focus Series on Direct-to-Consumer Health Apps. Learn about the respondents and their views on data privacy concerns in the first installment of this series, and read their thoughts on consumer access to DTC health app data in the second installment.

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Should Users Have Access to Data Collected by Direct-to-Consumer Health Apps?

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By Sara Gerke and Chloe Reichel

Should consumers have access to the data (including the raw data) that are collected via direct-to-consumer (DTC) health apps? What real-world challenges might access to this data introduce, and how might they be addressed?

In this second installment of our In Focus Series on Direct-to-Consumer Health Apps, that’s what we asked our respondents. Learn about the respondents and their views on data privacy concerns in the first installment of this series. Read on for their thoughts on whether and how consumers should gain access to the data that direct-to-consumer health apps collect.

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Perspectives on Data Privacy for Direct-to-Consumer Health Apps

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By Sara Gerke and Chloe Reichel

Direct-to-consumer (DTC) health apps, such as apps that manage our diet, fitness, and sleep, are becoming ubiquitous in our digital world.

These apps provide a window into some of the key issues in the world of digital health — including data privacy, data access, data ownership, bias, and the regulation of health technology.

To better understand these issues, and ways forward, we contacted key stakeholders representing a range of perspectives in the field of digital health for their brief answers to five questions about DTC health apps.

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