Eighth Annual Health Law Year in P/Review: Looking Back & Reaching Ahead

This post is part of our Eighth Annual Health Law Year in P/Review symposium. You can read all of the posts in the series here. Review the conference’s full agenda and register for the event on the Petrie-Flom Center’s website.

By Prof. I. Glenn Cohen and Kaitlyn Dowling

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is excited to host the Eighth Annual Health Law Year in P/Review to be held at Harvard Law School December 6, 2019. This one-day conference is free and open to the public and will convene leading experts across health law policy, health sciences, technology, and ethics to discuss major developments in the field over the past year and invites them to contemplate what 2020 may hold. This year’s event will focus on developments in health information technology, the challenge of increasing health care coverage, immigration, the 2020 election, gene editing, and drug pricing, among other topic areas.

As we come to the end of another year in health law, the event will give us both a post-mortem on the biggest trends in 2019 and also some predictions on what’s to come in 2020.

Among the topics we will discuss: Read More

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Measuring Health Privacy – Part I

This piece was part of a symposium featuring commentary from participants in the Center for Health Policy and Law’s annual conference, Promises and Perils of Emerging Health Innovations, held on April 11-12, 2019 at Northeastern University School of Law. The symposium was originally posted through the Northeastern University Law Review Online Forum.

Promises and Perils of Emerging Health Innovations Blog Symposium

We are pleased to present this symposium featuring commentary from participants in the Center for Health Policy and Law’s annual conference, Promises and Perils of Emerging Health Innovations, held on April 11-12, 2019 at Northeastern University School of Law. As a note, additional detailed analyses of issues discussed during the conference will be published in the 2021 Winter Issue of the Northeastern University Law Review.

Throughout the two-day conference, speakers and attendees discussed how innovations, including artificial intelligence, robotics, mobile technology, gene therapies, pharmaceuticals, big data analytics, tele- and virtual health care delivery, and new models of delivery, such as accountable care organizations (ACOs), retail clinics, and medical-legal partnerships (MLPs), have entered and changed the healthcare market. More dramatic innovations and market disruptions are likely in the years to come. These new technologies and market disruptions offer immense promise to advance health care quality and efficiency, and improve provider and patient engagement. Success will depend, however, on careful consideration of potential perils and well-planned interventions to ensure new methods ultimately further, rather than diminish, the health of patients, especially those who are the most vulnerable.

In this two-part post for the Promises and Perils of Emerging Health Innovations blog symposium, Ignacio Cofone engages in a discussion centered on the importance of addressing patients’ concerns when introducing new health technologies. While privacy risks may not always be avoided altogether, Cofone posits that privacy risks (and their potential costs) should be weighed against all health benefits innovative technology and treatments may have. To do so, Cofone introduces the concept of using health economics and a Quality-Adjusted Life Year (QALY) framework to evaluate the weight and significance of the costs and benefits related to health technologies that may raise patient privacy concerns.

Measuring Health Privacy – Part I

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Doctor types on a laptop

A Delicate Balance: Proposed Regulations May Upset the Tension between Accessibility and Privacy of Health Information

This piece was part of a symposium featuring commentary from participants in the Center for Health Policy and Law’s annual conference, Promises and Perils of Emerging Health Innovations, held on April 11-12, 2019 at Northeastern University School of Law. The symposium was originally posted through the Northeastern University Law Review Online Forum.

Promises and Perils of Emerging Health Innovations Blog Symposium

We are pleased to present this symposium featuring commentary from participants in the Center for Health Policy and Law’s annual conference, Promises and Perils of Emerging Health Innovations, held on April 11-12, 2019 at Northeastern University School of Law. Throughout the two-day conference, speakers and attendees discussed how innovations, including artificial intelligence, robotics, mobile technology, gene therapies, pharmaceuticals, big data analytics, tele- and virtual health care delivery, and new models of delivery, such as accountable care organizations (ACOs), retail clinics, and medical-legal partnerships (MLPs), have entered and changed the healthcare market. More dramatic innovations and market disruptions are likely in the years to come. These new technologies and market disruptions offer immense promise to advance health care quality and efficiency, and improve provider and patient engagement. Success will depend, however, on careful consideration of potential perils and well-planned interventions to ensure new methods ultimately further, rather than diminish, the health of patients, especially those who are the most vulnerable.

In his piece for the Promises and Perils of Emerging Health Innovations blog symposium, Oliver Kim emphasizes the important role trust plays in the provider-patient relationship. Kim unpacks the challenges that come with the introduction and incorporation of new health technology, and further cautions against the potential for erosion of trust when introducing third-parties into the relationship.

A Delicate Balance: Proposed Regulations May Upset the Tension between Accessibility and Privacy of Health Information

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Reviewing Health Announcements at Google, Facebook, and Apple

By Adriana Krasniansky

Over the past several days, technology players Google, Apple, and Facebook have each reported health-related business news. In this blog post, we examine their announcements and identify emerging ethical questions in the digital health space.

On Nov. 1, Google announced plans to acquire smartwatch maker Fitbit for $2.1 billion in 2020, subject to regulatory approval. The purchase is expected to jumpstart the production of Google’s own health wearables; the company has already invested at least $40 million in wearable research, absorbing watchmaker Fossil’s R&D technology in January 2019.

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Understanding Racial Bias in Medical AI Training Data

By Adriana Krasniansky

Interest in artificially intelligent (AI) health care has grown at an astounding pace: the global AI health care market is expected to reach $17.8 billion by 2025 and AI-powered systems are being designed to support medical activities ranging from patient diagnosis and triaging to drug pricing. 

Yet, as researchers across technology and medical fields agree, “AI systems are only as good as the data we put into them.” When AI systems are trained on patient datasets that are incomplete or under/misrepresentative of certain populations, they stand to develop discriminatory biases in their outcomes. In this article, we present three examples that demonstrate the potential for racial bias in medical AI based on training data. Read More

Diverse crowd of adults on a bus, all using smartphones

ACCESS Act Points the Way to a Post-HIPAA World

By Adrian Gropper

The October 22 announcement starts with: “U.S. Sens. Mark R. Warner (D-VA), Josh Hawley (R-MO) and Richard Blumenthal (D-CT) will introduce the Augmenting Compatibility and Competition by Enabling Service Switching (ACCESS) Act, bipartisan legislation that will encourage market-based competition to dominant social media platforms by requiring the largest companies to make user data portable – and their services interoperable – with other platforms, and to allow users to designate a trusted third-party service to manage their privacy and account settings, if they so choose.”

Although the scope of this bill is limited to the largest of the data brokers (messaging, multimedia sharing, and social networking) that currently mediate between us as individuals, it contains groundbreaking provisions for delegation by users that is a road map to privacy regulations in general for the 21st century.

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Photograph from above of a health care provider taking a patient's blood pressure.

Diving Deeper into Amazon Alexa’s HIPAA Compliance

By Adriana Krasniansky

Earlier this year, consumer technology company Amazon made waves in health care when it announced that its Alexa Skills Kit, a suite of tools for building voice programs, would be HIPAA compliant. Using the Alexa Skills Kit, companies could build voice experiences for Amazon Echo devices that communicate personal health information with patients. 

Amazon initially limited access to its HIPAA-updated voice platform to six health care companies, ranging from pharmacy benefit managers (PBMs) to hospitals. However, Amazon plans to expand access and has identified health care as a top focus area. Given Thursday’s announcement of new Alexa-enabled wearables (earbuds, glasses, a biometric ring)—likely indicators of upcoming personal health applications—let’s dive deeper into Alexa’s HIPAA compliance and its implications for the health care industry.
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Photograph of a doctor holding a headset sitting in front of a laptop

Navigating Sensitive Hospital Conversations in the Age of Telemedicine

By Adriana Krasniansky

On March 5, 2019, a terminally ill patient from Fremont, California, learned that he was expected to die within several days. The doctor who delivered the news did so via a robotic video teleconferencing device. 

Ernest Quintana, a 79-year-old patient with a previously-diagnosed terminal lung condition, was taken to the Kaiser Permanente Fremont Medical Center emergency room after reporting shortness of breath. His 16-year-old granddaughter, Annalisia Wilharm, was with him when a nurse stopped by and said that a doctor would visit shortly to deliver Mr. Quintana’s results. 

The video below, recorded by Ms. Wilharm, shows Mr. Quintana’s consultation with a critical care doctor through an Ava Robotics telepresence device—in which the doctor explains Mr. Quintana’s rapidly worsening condition and suggests transitioning to comfort care. Ms. Wilharm and her family chose to share the video with local media and on Facebook, inciting a debate around the legal and ethical challenges of using telemedicine in critical care conversations. 

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Illustration of a pill with a sensor embedded

Ethical and legal issues of ingestible electronic sensors

This post originally appeared in Device and Materials Engineering. You can read it here.

By Sara Gerke & I. Glenn Cohen

In our new paper, we discuss the ethical challenges of ingestible electronics sensors (IESs; also called “smart pills”) and examine the legal regulation of such sensors in the United States and Europe.

IESs are increasingly being developed for improving health outcomes. One such use could facilitate monitoring and promoting medication adherence. Once swallowed, an IES connects with a wearable sensor that can detect and record valuable data, including behavioral and physiological metrics or the time of drug intake. The wearable sensor subsequently sends the collected data to a computing device (e.g., a smartphone) that processes and displays the information. There is also the option to link the display function with a cloud database for data sharing with the patient’s doctor or family.

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People in a yoga class posing together

Are Wellness-Based Insurance Products Really a Win For Everyone?

By Anya Prince 

Insurers have long been in the business of selling a variety of life insurance products to their customers, but a new trend has them promoting wellness and encouraging customers to make healthy lifestyle choices through benefits programs. John Hancock’s Vitality program, for example, offers customers a free Fitbit, savings on annual life insurance premiums, and other discounts and perks for meeting fitness goals.

Other insurers are joining in this wellness game, offering their own versions of incentives and access to wearables in exchange for fitness goals. At first blush, these programs are a classic win-win situation similar to that behind workplace wellness programs. Customers/employees get free wearables. Win! Customers/employees (ideally) live longer due to healthy lifestyle choices. Win! Life insurers/employers have customers that pay premiums for more years before they die and a claim is paid out. Win!  Read More