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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Petrie-Flom Center logo.

Call for Applications: Research Fellow for Diagnostic Digital Home Health

Overview

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is hiring a full-time post-doctoral fellow to support its newly launched Diagnostic Digital Home Health initiative. This position will likely be a three year commitment.

This sponsored research project examines the ethical, social, and legal challenges of digital home health products, with a focus on home diagnosis of infectious and chronic conditions. This project will develop scholarship, guidelines, and proposed regulations for the ethical implementation of these products, using focus groups, virtual workshops, and interdisciplinary scholarship, with a focus on considerations of access and equity, social interconnectedness, and patient privacy.

Previous Petrie-Flom Center post-doctoral fellows have used their positions as successful launching pads for tenure-track legal, health policy, and bioethics academic careers. Our most recent post-doctoral fellow has published in leading journals such as JAMA, Science, and the Journal of Law and the Biosciences. She has been interviewed as an expert in biomedical regulation by media outlets such as Forbes and Lancet Digital Health and presented to regulators at the U.S. Department of Health and Human Services.
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Unique Challenges to Informed Consent in Deep Phenotyping Research

By Benjamin C. Silverman

Deep phenotyping research procedures pose unique challenges to the informed consent process, particularly because of the passive and boundless nature of the data being collected and how this data collection overlaps with our everyday use of technology.

As detailed elsewhere in this symposium, deep phenotyping in research involves the collection and analysis of multiple streams of behavioral (e.g., location, movement, communications, etc.) and biological (e.g., imaging, clinical assessments, etc.) data with the goal to better characterize, and eventually predict or intervene upon, a number of clinical conditions.

Obtaining voluntary competent informed consent is a critical aspect to conducting ethical deep phenotyping research. We will address here several challenges to obtaining informed consent in deep phenotyping research, and describe some best practices and relevant questions to consider.

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Telemedicine or telehealth virtual visit / video visit between doctor and patient on laptop computer and mobile phone device.

The Petrie-Flom Center Launches New Project: Diagnosing in the Home

Diagnosing in the Home will seek to examine the ethical, social, and legal challenges of digital home health products, with a focus on home diagnosis of infectious and chronic conditions.

January 27, 2021 – The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School today announced a new research initiative, Diagnosing in the Home: The Ethical, Legal, and Regulatory Challenges and Opportunities of Digital Home Health. This three-year project will seek to promote the translation of diagnostic medical services into home health care through regulatory and ethical frameworks. This initiative is generously supported by a grant from the Gordon and Betty Moore Foundation.

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Code on computer.

How to Secure Our Digital Health Infrastructure Against Cyber Attacks

By Vrushab Gowda

Our health information infrastructure is highly susceptible to cyber attacks. At the time of writing, the Department of Health and Human Services (HHS) is actively investigating over 700 major breaches over the past 24 months alone.

It is incumbent upon our institutions to proactively guard against these threats, with our federal government leading the charge.

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computer and stethoscope

How Telehealth Could Improve — or Worsen — Racial Disparities

By Craig Konnoth, JD, M.Phil., Wendy Netter Epstein, JD, and Max Helveston, JD

Despite upping the stakes of America’s partisan divide, the pandemic has prompted bipartisan support for at least one cause — the rapid rollout of telehealth, which allows people to see their doctors by videoconference or telephone.

In last week’s executive order, the Trump Administration reaffirmed its commitment to the use of telehealth. While telehealth may be, in many ways, a panacea for access to healthcare, particularly in COVID times, we should be concerned that patients of color may be left behind.

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Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

A New Step for the FDA in Regulating Digital Health Products

By Vrushab Gowda

On September 22, the U.S. Food and Drug Administration (FDA) announced the establishment of a new initiative to regulate digital health products – the Digital Health Center of Excellence (DHCoE).

In some ways, the announcement does not come as a surprise; FDA Commissioner Stephen Hahn’s predecessor, Scott Gottlieb, outlined the DHCoE in a press release two years ago. What does remain to be seen is whether DHCoE represents a true paradigm shift in FDA’s approach to regulating digital health products.

According to Hahn, the DHCoE aims to (1) build partnerships, (2) share knowledge across FDA and with stakeholders, and (3) innovate regulatory approaches. It will be led by the current Director of CDRH’s Division of Digital Health, Bakul Patel.

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