C-TAC and Petrie-Flom Center Convene Leaders to Explore New Approaches for Serious Illness Care

By Stephen Waldron

Health care leaders gathered at Harvard Law School on April 26 to discuss opportunities to redesign care delivery for people with serious illness. These efforts are informed by the shift to value-based care, which has been championed by innovators in the advanced care movement.

The event was part of the Project for Advanced Care and Health Policy, a collaboration between the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Coalition to Transform Advanced Care (C-TAC). Read More

The Funding Effect: How Drug Manufacturers Design Clinical Trials to Produce Favorable Results

By Ryan J. Duplechin

Many consumers are unaware that the U.S. Food and Drug Administration (“FDA”) does not test drugs in the approval process. Instead, drug manufacturers test their drugs and submit their own results to the FDA for review. Hoping to convince the FDA and investors of the safety and effectiveness of their new drug, manufacturers go to great lengths to report positive results in clinical trials. Read More

Who are the Healthcare Providers Approving Consumer-Driven Genetic Test Orders?

By Emily Qian, Magalie Leduc, and Birgit Funke

Consumer driven genetic testing has rapidly expanded, to the point where some genetic testing companies have reached 10 million customers. These tests are being advertised in commercials and in ads on social media. Genetic testing can reveal a variety of information ranging from ancestry to predisposition for disease. While ancestry, fitness regimens, and food preferences may seem all fun and games, the potential of learning about a predisposition for a serious disease should not be treated lightly.

While a DNA-based ancestry report may not require scientific expertise to understand the results, the genetics of human disease are highly complex. Thus specialized training is necessary to accurately interpret genetic information in this context. However, with the development of specialized medicine, the growing variety of health care providers, and the growing number of available un-credentialed educational courses online and degrees in various scientific areas, it is difficult for consumers to determine who may be the best provider with the right credentials to help them understand their genetic results. Read More

Faculty Director I. Glenn Cohen Appointed James A. Attwood and Leslie Williams Professor of Law

Harvard Law School Dean John F. Manning honored Petrie-Flom Center Faculty Director I. Glenn Cohen  on the occasion of his appointment as the James A. Attwood and Leslie Williams Professor of Law at a lecture and reception yesterday evening.

Prof. Cohen presented his work, “The Second Reproductive Revolution: From Gene Editing, to Uterus Transplants, to Embryos Derived from Our Skin – How Technology Is Changing Reproduction,” which will be the subject of a forthcoming book.

Cohen, a popular professor at Harvard and a first generation college graduate, was the youngest professor on the faculty at Harvard Law School (tenured or untenured) both when he joined the faculty in 2008 (at age 29) and when he was tenured as a full professor in 2013 (at age 34).

Glenn’s current projects relate to health information technologies, mobile health, reproduction/reproductive technology, research ethics, rationing in law and medicine, health policy, FDA law and to medical tourism – the travel of patients who are residents of one country, the “home country,” to another country, the “destination country,” for medical treatment. His past work has included projects on end of life decision-making, FDA regulation and commodification. He is the founding editor of this blog.

The Bill of Health community wishes him a heartfelt congratulations!

Petrie-Flom Student Fellowship Now Accepting Applications

What do a MacArthur Genius award winner, several health law professors at top schools, executive directors of leading health law centers, an associate chief counsel of the FDA, and partners and associates at top health care law firms all have in common? The Petrie-Flom Center Student Fellowship!

The Petrie-Flom Center Student Fellowship is a competitive one-year program designed to support Harvard graduate students interested in pursuing independent scholarly projects related to health law policy, biotechnology, and bioethics. With intensive mentorship from Petrie-Flom Center affiliates, student fellows are expected to produce a piece of publishable scholarship by the end of the academic year, at which point they may choose to be awarded a modest stipend and/or academic credit. Student fellows also blog regularly at Bill of Health, the Center’s blog, where their work receives substantial public exposure. Student fellows will receive training for online scholarly publishing; participate in and organize Center events; and enroll in the Health Law, Policy, Bioethics, and Biotechnology Workshop, which provides the opportunity to interact with leading scholars in the field.

 

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Three eggs in a carton with sad faces drawn on.

Can Ethical Labelling Make Food Systems Healthy, Sustainable, and Just?

By Christine Parker

Consumers are often encouraged to “vote with their fork” and “say no” to unhealthy, unsustainable and unfair food. Food packaging is typically littered with claims about the nutrition, ethics and social goods associated with the product inside. Claims like “organic”, “GMO free”, “fair trade”, and “anti-biotic free” are common. But can consumer preference base labelling make a difference to the health, sustainability and ethics challenges facing the food system?

Governments, civil society groups and industry all act as if label claims make a big impact on consumers and food businesses. Governments mandate that certain safety and nutritional information should be displayed on food labels. Public health advocates campaign for mandatory disclosure of more information (like added sugars) hoping  it will nudge both consumers and businesses towards healthier options. Businesses use label claims to promote themselves as ethical and environmentally responsible. A plethora of other groups have put forward their own independent certifications and trademarks from dolphin friendly tuna to sustainably farmed coffee. Read More

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