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.

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Close up of a computer screen displaying code

Mitigating Bias in Direct-to-Consumer Health Apps

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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Hand holding smartphone with colorful app icons concept.

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

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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Illustration of multicolored profiles. An overlay of strings of ones and zeroes is visible

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

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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hands hold phone with app heart and activity on screen over table in office

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

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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Illustration of multicolored profiles. An overlay of strings of ones and zeroes is visible

We Need to Do More with Hospitals’ Data, But There Are Better Ways

By Wendy Netter Epstein and Charlotte Tschider

This May, Google announced a new partnership with national hospital chain HCA Healthcare to consolidate HCA’s digital health data from electronic medical records and medical devices and store it in Google Cloud.

This move is the just the latest of a growing trend — in the first half of this year alone, there have been at least 38 partnerships announced between providers and big tech. Health systems are hoping to leverage the know-how of tech titans to unlock the potential of their treasure troves of data.

Health systems have faltered in achieving this on their own, facing, on the one hand, technical and practical challenges, and, on the other, political and ethical concerns.

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Home innovation technology concept illustration.

Call for Abstracts — 2022 Petrie-Flom Center Annual Conference: Diagnosing in the Home

Contribute to the 2022 Petrie-Flom Center Annual Conference and subsequent book project!

Through October 14, 2021, the Petrie-Flom Center is accepting abstracts for its annual conference. The 2022 annual conference will focus on ethical, legal, and regulatory challenges and opportunities around at home digital health technology.

This conference will engage with the vision for a 21st century health care system that embraces the potential of at home digital products to support diagnoses, improve care, encourage caregivers, maximize pandemic resilience, and allow individuals to stay within the home when preferable. The goals of this conference and subsequent book project are to consider the ethical, sociological, regulatory, and legal challenges and opportunities presented by the implementation of digital products that support clinical diagnosis and/or treatment in patients’ homes over the next decade.

Interested in submitting an abstract, but want to know more about what we’re looking for? Read through the following frequently asked questions.

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Top Health Considerations in the European Commission’s ‘Harmonised Rules on Artificial Intelligence’

By Rachele Hendricks-Sturrup

On April 21, 2021, the European Commission released a “first-ever” legal framework on artificial intelligence (AI) in an attempt to address societal risks associated with AI implementation.

The EU has now effectively set a global stage for AI regulation, being the first nation of member states to create a legal framework with specific intent to address or mitigate potentially harmful effects of broad AI implementation.

Within the proposed framework, the Commission touched on a variety of considerations and  “high-risk” AI system scenarios. The Commission defined high-risk AI systems as those that pose significant (material or immaterial) risks to the health and safety or fundamental rights of persons.

This post outlines four key considerations in the proposal with regard to health: 1) prioritizing emergency health care; 2) law enforcement profiling as a social determinant of health; 3) immigrant health risk screening; and 4) AI regulatory sandboxes and a health data space to support AI product commercialization and public health innovation.

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Fake Vaccine Cards and the Challenges of Decentralized Health Data

By Carmel Shachar and Chloe Reichel

Soon the U.S. will have vaccinated all adults who are not vaccine hesitant. Our next key challenges will be reopening workplaces, restaurants, schools, and other public areas, as well as encouraging vaccine uptake among those who are hesitant or resistant to the vaccine.

Vaccine passports or certifications could be a tool used to address both of those challenges.

But our approach to health care data management may undermine this next stage of the pandemic response.

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