Category: Mobile Health

AI-generated image of robot doctor with surgical mask on.

Who’s Liable for Bad Medical Advice in the Age of ChatGPT?

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By Matthew Chun

By now, everyone’s heard of ChatGPT — an artificial intelligence (AI) system by OpenAI that has captivated the world with its ability to process and generate humanlike text in various domains. In the field of medicine, ChatGPT already has been reported to ace the U.S. medical licensing exam, diagnose illnesses, and even outshine human doctors on measures of perceived empathy, raising many questions about how AI will reshape health care as we know it.

But what happens when AI gets things wrong? What are the risks of using generative AI systems like ChatGPT in medical practice, and who is ultimately held responsible for patient harm? This blog post will examine the liability risks for health care providers and AI providers alike as ChatGPT and similar AI models increasingly are used for medical applications.

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Medicine doctor and stethoscope in hand touching icon medical network connection with modern virtual screen interface, medical technology network concept

Governing Health Data for Research, Development, and Innovation: The Missteps of the European Health Data Space Proposal

The Petrie-Flom Center Staff Leave a comment

By Enrique Santamaría

Together with the Data Governance Act (DGA) and the General Data Protection Regulation (GDPR), the proposal for a Regulation on the European Health Data Space (EHDS) will most likely form the new regulatory and governance framework for the use of health data in the European Union. Although well intentioned and thoroughly needed, there are aspects of the EHDS that require further debate, reconsiderations, and amendments. Clarity about what constitutes scientific research is particularly needed.

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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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Hand holding smartphone with colorful app icons concept.

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

Sara Gerke Leave a comment

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?

Sara Gerke Leave a comment

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

Sara Gerke Leave a comment

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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Washington, DC, USA - Closeup view of December, 23, 2020: COVID-19 Vaccination Record Card by CDC on blurred documents background.

Key Considerations for the Ethical Design of COVID-19 Vaccine Passports

Chloe Reichel Leave a comment

By Chloe Reichel

States, employers, retailers, and other industries are now grappling with how to update mask policies in light of recent CDC guidance, which suggests vaccinated individuals may remove their face coverings indoors. 

But without a system in place to discern who has been vaccinated, the guidance poses a major risk: unvaccinated individuals, who can still contract and spread the virus, may also opt to go maskless. 

COVID-19 digital health passes, often called vaccine passports, may prove useful as a tool to relax mask policies. Vaccine passports can help to verify whether individuals may safely enter a space without a face covering.

Their ethical implementation, however, is contingent upon a number of factors: first and foremost, equitable access to vaccines. Other considerations include minimizing distrust, accessibility, risks of discrimination, and privacy protections.

For policy makers considering the implementation of COVID-19 vaccine credentialing programs, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Edmond J. Safra Center for Ethics at Harvard University have developed a road map highlighting key considerations for their ethical design.

This post provides a summary of key considerations and responsive policy recommendations presented in the paper to guide more equitable implementation of vaccine passports and to minimize distrust.

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Cartoon of contact tracing for COVID-19.

A Critical Analysis of the Eurocentric Response to COVID-19: Data Colonialism

The Petrie-Flom Center Staff Leave a comment

By Hayley Evans

The international response to COVID-19 has paid insufficient attention to realities in the Global South, making the response Eurocentric in several ways.

This series of blog posts looks at three aspects of the COVID-19 response that underscore this Eurocentrism. The first post in this series will scrutinize the digital aspect of the international response to COVID-19. In creating and promoting technological solutions that are impractical and ineffective in the Global South, this digital focus has afforded asymmetric protection to those located in the Global North.

This series draws on primary research conducted remotely with diverse actors on the ground in Colombia, Nigeria, and the United Kingdom, as well as secondary research gathered through periodicals, webinars, an online course in contact tracing, and membership in the Ecological Rights Working Group of the Global Pandemic Network. I have written about previous findings from this work here.

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

The Petrie-Flom Center Staff Leave a comment

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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