Authors

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.

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

Should We Regulate Direct-to-Consumer Health Apps?

September 1, 2021September 1, 2021 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.

Close up of a computer screen displaying code

Mitigating Bias in Direct-to-Consumer Health Apps

August 30, 2021August 27, 2021 Sara Gerke Leave a comment

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.

Hand holding smartphone with colorful app icons concept.

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

August 27, 2021August 26, 2021 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.

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?

August 19, 2021August 18, 2021 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.

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

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

August 18, 2021August 18, 2021 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.

Germany’s Response to the COVID-19 Pandemic

May 18, 2020May 18, 2020 Sara Gerke Leave a comment

By Sara Gerke

Many countries are looking these days to Germany’s approach to combating COVID-19. Although Germany initially experienced a high case rate, the country has been able to slow the spread of the virus and appears to have the situation better “under control” than other countries.

There may be various reasons for Germany’s successful handling of the pandemic so far, ranging from early testing for COVID-19 to high public outreach and transparency to increasing the number of ICU beds and ventilators.

Graphic of a brain with a circuitry design within it

A User-Focused Transdisciplinary Research Agenda for AI-Enabled Health Tech Governance

February 6, 2019February 27, 2019 Sara Gerke Leave a comment

By David Arney, Max Senges, Sara Gerke, Cansu Canca, Laura Haaber Ihle, Nathan Kaiser, Sujay Kakarmath, Annabel Kupke, Ashveena Gajeele, Stephen Lynch, Luis Melendez

A new working paper from participants in the AI-Health Working Group out of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Berkman Klein Center for Internet & Society at Harvard University sets forth a research agenda for stakeholders (researchers, practitioners, entrepreneurs, policy makers, etc.) to proactively collaborate and design AI technologies that work with users to improve their health and wellbeing.

Along with sections on Technology and a Healthy Good Life as well as Data, the authors focus a section on Nudging, a concept that “alters people’s behavior in a predictable way without forbidding any options,“ and tie nudging into AI technology in the healthcare context. Read More

Graphic of sheets with algorithms shaped into a neuron

The Tricky Task of Defining AI in the Law

November 30, 2018January 7, 2019 Sara Gerke Leave a comment

By Sara Gerke and Joshua Feldman

Walking her bike across an Arizona road, a woman stares into the headlights of an autonomous vehicle as it mistakenly speeds towards her. In a nearby health center, a computer program analyzes images of a diabetic man’s retina to detect damaged blood vessels and suggests that he be referred to a specialist for further evaluation – his clinician did not need to interpret the images. Meanwhile, an unmanned drone zips through Rwandan forests, delivering life-saving vaccines to an undersupplied hospital in a rural village.

From public safety to diagnostics to the global medical supply chain, artificial intelligence (AI) systems are increasingly making decisions about our health. Legislative action will be required to address these innovations and ensure they improve wellbeing safely and fairly.

In order to draft new national laws and international guidelines, we will first need a definition of what constitutes artificial intelligence. While the examples above underscore the need of such a definition, they also illustrate the difficulty of this task: What is uniquely common between self-driving cars, diagnostic tools, and drones? Read More

The German Stem Cell Network Has Compiled a Sample Text for Informed Consent

June 8, 2018December 14, 2018 Sara Gerke Leave a comment

By Sara Gerke

Sara Gerke speaking — GSCN Conference in Jena in September, 2017

At the General Meeting of the German Stem Cell Network (GSCN) in Jena in September 2017, Tobias Cantz and I proposed the establishment of a new GSCN strategic working group.

This new working group, known as ELSA, focuses on the ethical, legal and social aspects of the modern life sciences. ELSA aims to serve as a country-wide interdisciplinary platform for the exchange of information and for the analysis and discussion of challenges facing basic and applied stem cell research in Germany.

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