Category: In Focus Series

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

Should We Regulate Direct-to-Consumer Health Apps?

Sara Gerke Leave a comment

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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Hand holding smartphone with colorful app icons concept.

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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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?

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

Reforming How Medicare Pays for Digital Health

The Petrie-Flom Center Staff Leave a comment

By Robert Horne and Lucia Savage

The Fourth Industrial Revolution, also known as the digital revolution, leverages technology to blur the lines between products and services. In the health insurance sector, this revolution offers policymakers unique opportunities to improve coverage and payment efficiencies while providing meaningful benefits to beneficiaries.

Medicare could lead this charge. Congress has an opportunity to reform Medicare in 2024, when the Trust Fund will become insolvent. Policymakers expect Congress to address this problem legislatively to prevent interruptions in coverage for seniors.

If past behavior is any indication, the legislation will also include reforms to improve how the program operates and spends money. Reforms to Medicare’s traditional coverage and reimbursement approaches that harness the digital revolution can help the program secure additional value. We know this because other sectors of the U.S. economy that have fully embraced this revolution have realized additional value.

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Doctor working with modern computer interface.

To Set the Price Tag for Telehealth, First Understand Its Value

The Petrie-Flom Center Staff Leave a comment

By Mary Witkowski, Susanna Gallani, and David N. Bernstein

As the economy reopens, a debate has emerged about whether to continue supporting telehealth and digital practices, or whether to return to pre-pandemic practices, practically relegating telehealth solutions and digital interactions to lower-value exceptions to traditional medical care.

The next set of regulatory and payment policies will likely set the trajectory for how digital health is integrated into the overall care model. We suggest that rather than making these policy decisions based on incremental thinking relative to historical pricing of in-person care, they ought to be based on an assessment of how they generate value for patients.

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Burgess Hill, West Sussex – 12 January, 2021 Covid-19 home PCR self-test kit.

Pandemic Diagnostics: Present and Future Implications of Self-Testing Reimbursement

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By David A. Simon

The process of diagnosing a disease or condition, including detection of SARS-CoV-2 infection, is changing.

Consumers now can not only collect their specimen from their living room couch, but they can test it while watching Netflix. Sampling, testing, and obtaining results all can be done in a patient’s home.

For communicable diseases like COVID-19, the disease caused by SARS-CoV-2 infection, at-home testing has considerable public health benefits. In addition to being more convenient than traditional diagnostics, self-testing can substantially reduce or eliminate the risk that infected individuals will spread the virus en route to a testing site.

This innovation has been spurred, in part, by a powerful incentive: the federal government has all-but guaranteed reimbursement for these tests.

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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

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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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