Category: Medical devices

a pill in place of a model globe

Monthly Round-Up of What to Read on Pharma Law and Policy 

Ameet Sarpatwari Leave a comment

By Ameet Sarpatwari, Beatrice Brown, Neeraj Patel, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on pharmaceutical policy.

Below are the citations for papers identified from the month of March. The selections feature topics ranging from a commentary on the evidence base for the Alzheimer’s drug aducanumab (which is currently under FDA review), to a comparative study of drug pricing in the U.S. and France, to a study of the demographic characteristics of participants in vaccine trials leading to FDA approval. A full posting of abstracts/summaries of these articles may be found on our website.

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U.S. Supreme Court

The Patent Trial and Appeal Board Returns to the Supreme Court  

The Petrie-Flom Center Staff Leave a comment

By Gregory Curfman

For the second time in the span of just three years, the Patent Trial and Appeal Board (PTAB) within the U.S. Patent and Trademark Office (USPTO) is under scrutiny by the Supreme Court.

How the Supreme Court decides this latest PTAB case, United States v. Arthrex, will have important implications for patent law and for administrative law more generally.

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green, red, and yellow qr codes on phones.

The Promise and Pitfalls of China’s QR Codes as Health Certificates

The Petrie-Flom Center Staff Leave a comment

This article is adapted from a longer paper published in the Harvard Journal of Law and Technology (JOLT)’s Digest section. To access the original paper, please visit JOLT.

By April Xiaoyi Xu

At this point in the COVID-19 pandemic, China has successfully managed to contain the spread of the virus, due in large part to its technological strategy, which uses QR codes as a kind of health certificate.

These color-coded QR codes are automatically generated using cell phone data. Green indicates that an individual is healthy and can move freely, yellow signals that the user must quarantine for up to seven days, and red for fourteen days. The basis for these determinations, as well as the extent of the data collected in order to make them, remains opaque.

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Apple watch and fit bit.

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

Vrushab Gowda Leave a comment

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

Vrushab Gowda Leave a comment

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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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.

Weaknesses in Medical Device Regulation Worsened by Trump Administration

The Petrie-Flom Center Staff Leave a comment

By Jacob Howard

In the waning days of the Trump administration, a final push was made to fundamentally weaken regulation of medical devices.

Lambasted as a “full frontal assault on public health” by U.S. Food and Drug Administration (FDA) officials, key policy changes include proposed emergency exemptions to bring a multitude of devices to market without the necessary scientific backing. Justified as a strategy to expedite the delivery of life-saving products, this speed comes at a risk to millions of patients.

As the third most prevalent cause of death in the U.S., medical error continues to be a critical issue that is exacerbated by weakening integrity of the regulatory process. This issue is further compounded by the fact that past regulatory failures in the medical device sphere have not been adequately addressed. The surgical stapler offers an illustrative example.

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Person typing on computer.

Lessons Learned from Deep Phenotyping Patients with Rare Psychiatric Disorders

The Petrie-Flom Center Staff Leave a comment

By Catherine A Brownstein and Joseph Gonzalez-Heydrich

Given the potential sensitivities associated with describing (i.e., phenotyping) patients with potentially stigmatizing psychiatric diagnoses, it is important to acknowledge and respect the wishes of the various parties involved.

The phenotypic description and depiction of a patient in the literature, although deidentified, may still be of great impact to a family.

By way of example, a novel genetic variant was identified as a likely explanation for the clinical presentation of a patient in a large cohort of individuals with neurodevelopmental and/or psychiatric phenotypes, a finding of great medical interest. The research team elected to further study this candidate and collected samples for functional evaluation of the gene variant and preparation of a case report.

Because the patient had a complicated phenotype, several physicians from various specialties were involved in the patient’s care. The paper draft was circulated amongst the collaborating clinicians and researchers and ultimately shared with the patient’s family by one of their involved caregivers. This is typically not a requirement of such studies, as the informed consent process includes the subjects’ understanding and consent for dissemination of deidentified results in the scientific literature. But as a general practice, families are informed about manuscripts in process, and in this case the family had requested to be kept abreast of ongoing developments.

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A calculator, a stethoscope, and a stack of money rest on a table.

In Defense of Medicare Coverage of Innovative Technologies

Abe Sutton Leave a comment

By Abe Sutton

On January 12th, the Centers for Medicare & Medicaid Services (CMS) finalized a prior proposal to establish Medicare coverage for breakthrough medical devices approved by the U.S. Food and Drug Administration (FDA).

While some have expressed concerns about the proposal, I believe it is a balanced attempt to encourage innovation and CMS was right to finalize it.

In this post, I give an overview of the general regulatory standards, walk through what the Medicare Coverage of Innovative Technologies (MCIT) proposal does, and lay out a case for why it deserved to be finalized.

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Code on computer.

How to Secure Our Digital Health Infrastructure Against Cyber Attacks

Vrushab Gowda Leave a comment

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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Photograph of a stack of magazines on a chair

Monthly Round-Up of What to Read on Pharma Law and Policy

Ameet Sarpatwari Leave a comment

By Ameet Sarpatwari, Beatrice Brown, Neeraj Patel, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of December. The selections feature topics ranging from an analysis of potential approaches for evaluating novel SARS-CoV-2 vaccine candidates after other vaccines have already been authorized; to an examination of social, cultural, and economic aspects of microbial resistance; to a study on clinical evidence supporting FDA clearance of novel therapeutics devices via the de novo pathway. A full posting of abstracts/summaries of these articles may be found on our website.

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