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

Reforming How Medicare Pays for Digital Health

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

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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Cartoon of contact tracing for COVID-19.

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

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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Wade Ackerman.

Meet Wade Ackerman, Petrie-Flom Center Advisory Board Member

The Petrie-Flom Center is excited to welcome Wade Ackerman to our Advisory Board!

Ackerman is a partner in Covington’s FDA Regulatory group, where he advises companies and trade associations on complex Food and Drug Administration (FDA) issues. He also co-leads Covington’s multidisciplinary Digital Health Initiative, which advises clients who are using information technology and data to innovate and improve health.

To learn more about the expertise that Ackerman will bring to the Advisory Board, we asked him a few questions about his background and current areas of practice. The conversation touches on a range of topics, from misconceptions about the FDA’s Emergency Use Authorization, to the promise that digital technologies hold in promoting health and wellness. The interview, which has been edited and condensed, follows.

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Emergency room.

Worsening Health Inequity During Pandemic for People Experiencing Homelessness

This piece was adapted from a post that originally ran at On the Flying Bridge on March 28, 2021.

By Michael Greeley

With great fanfare last week, DoorDash announced an initiative to provide same-day home delivery of approved COVID-19 test collection kits.

Much of the business model innovation in health care today is to move as much care as is feasible to the home. But what does that mean for the homeless?

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Apple watch and fit bit.

Beyond HIPAA: A Proposed Self-Policing Framework for Digital Health Products

By Vrushab Gowda

As digital health products proliferate, app developers, hardware manufacturers, and other entities that fall outside Health Insurance Portability and Accountability Act (HIPAA) regulation are collecting vast amounts of biometric information. This burgeoning market has spurred patient privacy and data stewardship concerns.

To this end, two policy nonprofits – the Center for Democracy and Technology (CDT) and the eHealth Initiative (eHI) – earlier this month jointly published a document detailing self-regulatory guidelines for industry. The following piece traces the development of the “Proposed Consumer Privacy Framework for Health Data,” provides an overview of its provisions, and offers critical analysis.

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AI concept art.

A Closer Look at FDA’s Newly Released AI/ML Action Plan

By Vrushab Gowda

The U.S. Food and Drug Administration (FDA or “the Agency”) recently issued its long awaited AI/ML (Artificial Intelligence/Machine Learning) Action Plan.

Announced amid the closing days of Stephen Hahn’s term as Commissioner, it takes steps toward establishing a dedicated regulatory strategy for AI products intended as software as a medical device (SaMD), versus those embedded within physical hardware. The FDA has already approved a number of such products for clinical use; however, AI algorithms’ self-learning capabilities expose the limitations of traditional regulatory pathways.

The Action Plan further outlines the first major objectives of the Digital Health Center of Excellence (DHCoE), which was established to much fanfare but whose early moves have remained somewhat unclear. This document presents a policy roadmap for its years ahead.

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lady justice.

Computational Psychiatry for Precision Sentencing in Criminal Law

By Francis X. Shen

A core failing of the criminal justice system is its inability to individualize criminal sentences and tailor probation and parole to meet the unique profile of each offender.

As legal scholar, and now federal judge Stephanos Bibas has observed, “All too often … sentencing guidelines and statutes act as sledgehammers rather than scalpels.”

As a result, dangerous offenders may be released, while offenders who pose little risk to society are left behind bars. And recidivism is common — the U.S. has an astounding recidivism rate of 80% — in part because the current criminal justice system largely fails to address mental health challenges, which are heavily over-represented in the justice system.

Advances in computational psychiatry, such as the deep phenotyping methods explored in this symposium, offer clinicians newfound abilities to practice precision psychiatry. The idea behind precision psychiatry is both simple and elusive: treat individuals as individuals. Yet advancing such a program in practice is “very ambitious” because no two individual brains — and the experiences those brains have had over a lifetime — are the same.

Deep phenotyping offers the criminal justice system the tools to improve public safety, identify low-risk offenders, and modify decision-making to reduce recidivism. Computational psychiatry can lead to what can be described as precision sentencing.

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phone camera

Deep Phenotyping Could Help Solve the Mental Health Care Crisis

By Justin T. Baker

The United States faces a growing mental health crisis and offers insufficient means for individuals to access care.

Digital technologies — the phone in your pocket, the camera-enabled display on your desk, the “smart” watch on your wrist, and the smart speakers in your home — might offer a path forward.

Deploying technology ethically, while understanding the risks of moving too fast (or too slow) with it, could radically extend our limited toolkit for providing access to high-quality care for the many individuals affected by mental health issues for whom the current mental health system is either out of reach or otherwise failing to meet their need.

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