Transparency is a concept that is becoming increasingly lauded as a solution to a host of problems in the American health care system. Transparency initiatives show great promise, including empowering patients and other stakeholders to make more efficient decisions, improve resource allocation, and better regulate the health care industry.
Nevertheless, transparency is not a cure-all for the problems facing the modern health care system. The authors of this volume present a nuanced view of transparency, exploring ways in which transparency has succeeded and ways in which transparency initiatives have room for improvement. Read More
Spring of 2019 brought flowers, showers…and many updates on the “fertility fraud” front.
Perhaps the biggest developments are on the legislative front. On May 5, Indiana Governor Eric Holcomb signed Senate Bill 174 into law, creating civil and criminal causes of action for fertility fraud for former patients and their offspring (and donors whose gametes were used in an unconsented-to manner).
Plaintiffs who sue in tort can be reimbursed for the costs of the fertility procedure and $10,000 in damages. The act makes it a level 6 felony to make a misrepresentation involving human reproductive material and a medical procedure, medical device, or drug. Read More
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
Direct-to-consumer (DTC) genetic testing has entered our world with a big splash and opened the flood gates of genetic information. For over a decade, we have been out talking with people from all walks of life and listening to their stories. Whether we are speaking with scientists or non-scientists, we hear excitement, concerns, ambivalence – sometimes all three at the same time –and not surprisingly, many many questions as people try to make sense of it all.
Susan Domchek, executive director of the Basser Center for BRCA,recallscounseling a patient with a family history of breast, ovarian, and colon cancer. This patient had taken a DTC genetic testthat looked at her BRCA genes, and the results led her to conclude that she was not at risk for the cancers that had burdened her family. However, the patient did not realize that the test onlylooked at 3 of the over 1,000 BRCA variants linked to an increased cancer risk. And because the test did not look at other genes implicated in cancer, the physicianrecognized that it may have underestimated her patient’s risk.What if the patient had seen a doctor who did not understand the limitations of the test? Might she have avoided taking potentially life-saving precautions?Read More
Do you say “thank you” to Alexa (or your preferred AI assistant)?
A rapid polling among my social media revealed that out of 76 participants, 51 percent thank their artificial intelligence (AI) assistant some or every time. When asked why/why not people express thanks, a myriad of interesting—albeit, entertaining—responses were received. There were common themes: saying thanks because it’s polite or it’s a habit, not saying thanks because “it’s just a database and not a human,” and the ever-present paranoia of a robot apocalypse.
But do you owe Alexa your politeness? Do you owe any moral consideration whatsoever? Read More
During the case’s first hearing in January 2018, Judge Dan Aaron Polster told lawyers that he expected to see a settlement that would reduce the adverse public health impact of the opioid crisis, instead of just “moving money around.” The amicus brief submitted by PHLW et al. proposes just that: a settlement that includes a framework for addressing the opioid crisis and has a meaningful positive impact on public health.
Specifically, the brief proposes the creation of a nonprofit foundation to monitor the settlement’s implementation, participate in development and implementation of evidence-based programmatic initiatives, and administer funding for local treatment and prevention resources.
The health care industry and the white-collar defense bar have eagerly awaited guidance from the Department of Justice regarding the impact of corporate cooperation and self-disclosure on 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.
Statements from DOJ officials raised anticipation over the past several months that guidance would be forthcoming. The guidance arrived on May 7, 2019, and focuses on answering the question of what conduct will constitute cooperation in the eyes of DOJ.
Unfortunately, the announcement fails to answer the question industry and the defense bar have been asking: how much credit will be given for cooperation and self-disclosure? Read More
For more than a century, US law has held that data – objective information and facts – cannot be owned as property. Nevertheless, in recent years there have been increasing calls to recognize property interests in individual health information. Inspired by high profile data breaches and skullduggery by Facebook and others, as well as ever more frequent stories of academic research misconduct and pharmaceutical industry profiteering, many bioethicists and patient advocates, seeking to bolster personal privacy and autonomy, have argued that property rights should be recognized in health data. In addition, a new crop of would-be data intermediaries (e.g., Nebula Genomics, Genos, Invitae, LunaDNA and Hu.manity.org) has made further calls to propertize health data, presumably to profit from acting as the go-betweens in what has been estimated to be a $60-$100 billion global market in health data. Read More
With the advent of CRISPR and the first babies born with edited genomes, gene editing technology is now cheaper and more accurate than it has been. And there is now a verifiable occurrence of heritable genome modification using CRISPR.
As such, human genome editing is naturally (and quite rightly) receiving world-wide attention. Scientists, bioethicists, lawyers, and policy makers are questioning what is the best course of action in the face of this new technology that promises great medicinal benefits, but also poses great and unknown risks. Read More
Dean John F. Manning honored Prof. I. Glenn Cohen, faculty director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, on the occasion of his appointment as the James A. Attwood and Leslie Williams professor of law.
Cohen, who is one of the world’s leading experts on the intersection of bioethics and the law, delivered a talk titled “The Second Reproductive Revolution,” focusing on how technology is changing reproduction from gene editing, to uterus transplants, to embryos derived from our skin. Read More