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

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

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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Businessman crossing fingers behind his back.

Get Your Story Straight: Patent Office Cracks Down on Inconsistent Statements Made Before the FDA

By Matthew Chun

In an effort to “promote robust and reliable patents” and increase access to life-saving drugs, the United States Patent and Trademark Office (USPTO) recently issued a Federal Register Notice clarifying the responsibilities of individuals involved in the patent application process.

In the July 29, 2022 notice, the USPTO set forth its views on the “duty of disclosure” and “duty of reasonable inquiry,” emphasizing the importance of consistency between statements made to the USPTO, the FDA, and other governmental agencies. While the goals of the Federal Register Notice are certainly noble, its disruptive practical effects leave much to be desired.

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books

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

By Ameet SarpatwariBeatrice Brown, Alexander EgilmanAviva Wang, 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 August. The selections feature topics ranging from an overview on the evolution of medical device regulation in the United States, to an analysis of the impact of the disclosure of expanded access policies mandated by the 21st Century Cures Act, to an evaluation of how litigation has impacted the success of the Biologics Price Competition and Innovation Act.

A full posting of abstracts/summaries of these articles may be found on our website.

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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?

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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gavel.

Appeals Court Overturns FDA’s Partial Ban on Shock Devices: Analysis of Ruling

By David Orentlicher

In its regulation of medical devices, the U.S. Food and Drug Administration (FDA) may ban devices that pose “an unreasonable and substantial risk of illness or injury.” But earlier this month, the U.S. Court of Appeals for the D.C. Circuit decided that the FDA may not issue a partial ban of a medical device.

The case, Judge Rotenberg Educational Center v. FDA, addressed the use of electrical stimulation devices to treat self-injurious or aggressive behavior, as in patients with serious intellectual or developmental disabilities.

In March 2020, the FDA attempted to prohibit this use of electrical stimulation (or electrical shock) because of the risks it poses to patients. As the FDA observed, persons with self-injurious or aggressive behavior may have “difficulty communicating pain and other harms caused by” electrical stimulation, and consent to the use of electrical stimulation is typically made by a third party, limiting the patient’s control over use of the device.

In other settings, including smoking cessation treatment, or treatment of substance use disorder, the FDA permits the practice. Hence the partial, rather than total, ban of electrical stimulation devices.

But by a 2-1 vote, the Judge Rotenberg Educational Center court held that prohibiting electrical stimulation in some settings, but not others, runs afoul of a “practice of medicine” statutory provision. This provision precludes the FDA from limiting or interfering with a health care practitioner’s authority “to prescribe or administer any legally marketed device to a patient for any condition or disease.” In the majority’s view, once the FDA permits use of a medical device, it must defer to the states for regulation of decisions regarding which patients are appropriate candidates for the device.

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Home innovation technology concept illustration.

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

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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a pill in place of a model globe

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

By Ameet SarpatwariBeatrice 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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Code on computer.

Building Trust Through Transparency? FDA Regulation of AI/ML-Based Software

By Jenna Becker

To generate trust in artificial intelligence and machine learning (AI/ML)-based software used in health care, the U.S. Food and Drug Administration (FDA) intends to regulate this technology with an eye toward user transparency. 

But will transparency in health care AI actually build trust among users? Or will algorithm explanations go ignored? I argue that individual algorithm explanations will likely do little to build trust among health care AI users.

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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

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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