Gavel And Medical Stethoscope

Does DOJ Actually Reward Cooperation by Health Care Organizations? New Data Raises Questions

By Jacob Elberg

For decades, even as the Department of Justice has pressed for corporate cooperation and self-disclosure, the health care industry and the white-collar defense bar have expressed skepticism regarding the actual impact of engaging in those behaviors. When it comes to the resolution of civil False Claims Act (FCA) cases – the primary tool for government action in response to corporate misconduct in the health care industry, through which the Department of Justice generates more than $2 billion annually – DOJ’s response has been a series of public statements amounting to, “trust us, we reward those things.”

Until now, the health care industry has been without any mechanism to test those assurances. Read More

Dov Fox on BYU Radio

dov fox headshotBill of Health contributor Dov Fox joined BYU radio’s Top of Mind with Julie Rose to discuss his new book, “Birth Rights and Wrongs: How Medicine and Technology are Remaking Reproduction and the Law,” and the implications of the largely unregulated U.S. fertility industry.

Across the country, more and more Americans choose to put off starting families, with many relying on the lucrative U.S. fertility industry for family planning when the time comes. Though a booming enterprise, the industry remains distinct from other medical practices: it offers patients little recourse for medical mistakes and misconduct. Read More

What We Lost When We Lost Google ATEAC

By Joanna Bryson

In a few weeks, the Advanced Technology External Advisory Council (ATEAC) was scheduled to come together for its first meeting. At that meeting, we were expected to “stress test” a proposed face recognition technology policy. “We were going to dedicate an entire day to it” (at least 1/4 the time they expected to get out of us.) The people I talked to at Google seemed profoundly disturbed by what “face recognition” could do. It’s not the first time I’ve heard that kind of deep concern – I’ve also heard it in completely unrelated one-on-one settings from a very diverse set of academics whose only commonality was working at the interface of machine learning and human computer interaction  (HCI). It isn’t just face recognition. It’s body posture, acoustics of speech and laughter, the way a pen is used on a tablet, and (famously) text. Privacy isn’t over, but it will never again be present in society without serious, deliberate, coordinated defense. Read More

What Should Happen to our Medical Records When We Die?

By Jon Cornwall

In the next 200 years, at least 20 billion people will die. A good proportion of these people are going to have electronic medical records, and that begs the question: what are we going to do with all this posthumous medical data? Despite the seemingly logical and inevitable application of medical data from deceased persons for research and healthcare both now and in the future, the issue of how best to manage posthumous medical records is currently unclear.

Presently, large medical data sets do exist and have their own uses, though largely these are data sets containing ‘anonymous’ data. In the future, if medicine is to deliver on the promise of truly ‘personalized’ medicine, then electronic medical records will potentially have increasing value and relevance for our generations of descendants. This will, however, entail the public having to consider how much privacy and anonymity they are willing to part with in regard to information arising from their medical records. After all, enabling our medical records with the power to influence personalized medicine for our descendants cannot happen without knowing who we, or our descendants, actually are.  Read More

Petrie-Flom Center Welcomes Fellow-In-Residence Jacob Sherkow

Along with our partners at the Edmond J. Safra Center for Ethics at Harvard University, the Petrie-Flom Center is thrilled to announce our new jointly hosted Fellow-in-Residence, Jacob Sherkow!

Sherkow is a Professor of Law at the Innovation Center for Law and Technology at New York Law School, where he teaches a variety of courses related to intellectual property and the life sciences. His research focuses on how scientific developments, especially in the biosciences, affect patent law, regulation, and bioethics.

He is the author of over 40 articles on these topics in both scientific journals and traditional law reviews, including ScienceNature, the Yale Law Journal, and the Stanford Law Review, for which he has won multiple prizes. In 2018, he was appointed to the National Academy of Medicine as an Emerging Leader in Health and Medicine. Sherkow  is a graduate of the University of Michigan Law School as well as Columbia and McGill Universities.

You can learn more about Jake Sherkow on the Petrie-Flom website, follow him on Twitter, and catch up on his latest scholarship on SSRN.

 

 

World map where continents are in blue pixels

Jennifer Prah Ruger: The World Needs a New Global Health Architecture

In a world beset by serious and unconscionable health disparities, by dangerous contagions that can circle our globalized planet in hours, and by a bewildering confusion of health actors and systems, humankind needs a new vision, a new architecture, new coordination among renewed systems to ensure central health capabilities for all. In her new book, “Global Health Justice and Governance,” Dr. Prah Ruger lays out the critical problems facing the world today and offers a new theory of justice and governance as a way to resolve these seemingly intractable issues.  Read More

ONC’s Proposed Rule is a Breakthrough in Patient Empowerment

By Adrian Gropper

Imagine solving wicked problems of patient matching, consent, and a patient-centered longitudinal health record while also enabling a world of new healthcare services for patients and physicians to use. The long-awaited Notice of Proposed Rulemaking (NPRM) on information blocking from the Office of the National Coordinator for Health Information Technology (ONC) promises nothing less. 

Having data automatically follow the patient is a laudable goal but difficult for reasons of privacy, security, and institutional workflow. The privacy issues are clear if you use surveillance as the mechanism to follow the patient. Do patients know they’re under surveillance? By whom? Is there one surveillance agency or are there dozens in real-world practice? Can a patient choose who does the surveillance and which health encounters, including behavioral health, social relationships, location, and finance are excluded from the surveillance? Read More

Privacy as a concept: shadowy opaque faces overlaid with 1s and 0s

HIPAA RFI Comments: Patient Privacy Rights

By Adrian Gropper and Deborah C. Peel

Among other rich nations, US healthcare stands out as both exceptionally privatized and exceptionally expensive. And taken overall, we have the worst health outcomes among the Western Democracies.

On one hand, regulators are reluctant to limit private corporate action lest we reduce innovation and patient choice and promote moral hazards. On the other hand, a privatized marketplace for services requires transparency of costs and quality and a minimum of economic externalities that privatize profit and socialize costs.

For over two decades, the HIPAA law and regulations have dominated the way personal health data is used and abused to manipulate physician practice and increase costs. During these decades, digital technology has brought marvels of innovation and competition to markets as diverse as travel and publishing while healthcare technology is burning out physicians and driving patients to bankruptcy.

Read More

Black-Box Medicine: Legal and Ethical Issues

Join us on Friday for Health Policy Biothics Consortium!

Black-box medicine—the use of opaque computational models to make care decisions—has the potential to shape health care by improving and aiding many medical tasks. For example, IBM Watson for Oncology is a machine-learning system that intends to help clinicians quickly identify essential information in patients’ medical records and explore treatment options for 13 cancers. However, it has only recently emerged that the recommendations Watson for Oncology gave for cancer treatments were “often incorrect” and that IBM kept this defect secret for over a year. What are the ethical and legal issues of black-box medicine? When do algorithms operate like a “black box“? How can we ensure that artificial intelligence technologies deliver what they promise? Read More

child pictured from the back holding both parents' hands.

Baby Not on Board: Must Children Born Through Illicit Insemination Be Barred From Recovery?

By Jody Lyneé Madeira

A new reproductive technology case type is forcing state and federal courts to answer a difficult question: can a fertility doctor be sued for medical malpractice by a biological child whom he conceives in secret through artificial insemination, substituting his sperm for an anonymous donor’s without consent?

Shockingly, one court has now answered this question in the negative, finding that the donor-conceived child couldn’t have been the physician’s “patient” prior to conception.

This gravely unjust ruling allows doctors to deny responsibilities to the very children they were paid to help create. But there are ways to avoid these outcomes, both in existing case law and legislative remedies. Read More