Close up of a computer screen displaying code

What Google Isn’t Saying About Your Health Records

By Adrian Gropper

Google’s semi-secret deal with Ascension is testing the limits of HIPAA as society grapples with the future impact of machine learning and artificial intelligence.

I. Glenn Cohen points out that HIPAA may not be keeping up with our methods of consent by patients and society on the ways personal data is used. Is prior consent, particularly consent from vulnerable patients seeking care, a good way to regulate secret commercial deals with their caregivers? The answer to a question is strongly influenced by how you ask the questions.

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Couple sitting on a couch, leaning forward to have a serious conversation with a doctor or counselor

Genetic Testing: Is There a “Duty to Warn” At-Risk Family Members?

By Shelly Simana

Genetic information is quite distinguishable from much medical information due its familial nature and its unique ability to predict future health. The fact that genetic testing supplies comprehensive information about the genetic make-up of patients and their family members underlies the ethical and legal challenges faced by physicians and patients when deciding whether to disclose genetic information to family members. Failure to disclose information may “lead to harm, particularly when knowledge could result in avoidance, treatment, or prevention of a genetic condition or in significant changes to reproductive choices or lifestyle.” Due to the potential harm, one may ask herself if there is a legal “duty to warn” family members about the presence of defective genes, and if so, upon whom should it be imposed.

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Photograph of Purdue Pharma headquarters

The Role of Attorneys General in the Opioid Litigation

By Daniel Aaron

People following the opioid lawsuits might have noticed some strange headlines as of late. Virtually every state’s attorney general (AG) is suing Purdue Pharmaceuticals, maker of the blockbuster drug OxyContin. Purdue filed for bankruptcy and is hoping to settle for “$10 billion.” However, the deal only includes $4.4 billion in cash, which is less than the Sackler family, owners of Purdue, transferred to personal accounts over the past decade. In other words, the amount of money the Sacklers made from the opioid epidemic is more than what they will pay more than forty states to help abate the crisis. Is anyone supporting this deal?

Yes, in fact, and this is where the plot thickens. With several exceptions, support for the deal falls along party lines: Republican AGs support the deal, and Democratic AGs oppose it. Why does a decision about settling with an opioid company appear to be political? What is the role of an attorney general? And are they supposed to defend public health?

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Picture of doctor neck down using an ipad with digital health graphics superimposed

Is Data Sharing Caring Enough About Patient Privacy? Part II: Potential Impact on US Data Sharing Regulations

A recent US lawsuit highlights crucial challenges at the interface of data utility, patient privacy & data misuse

By Timo Minssen (CeBIL, UCPH), Sara Gerke & Carmel Shachar

Earlier, we discussed the new suit filed against Google, the University of Chicago (UC), and UChicago Medicine, focusing on the disclosure of patient data from UC to Google. This piece goes beyond the background to consider the potential impact of this lawsuit, in the U.S., as well as placing the lawsuit in the context of other trends in data privacy and security.

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Image of binary and dna

Is Data Sharing Caring Enough About Patient Privacy? Part I: The Background

By Timo Minssen (CeBIL, UCPH), Sara Gerke & Carmel Shachar

A recent US lawsuit highlights crucial challenges at the interface of data utility, patient privacy & data misuse

The huge prospects of artificial intelligence and machine learning (ML), as well as the increasing trend toward public-private partnerships in biomedical innovation, stress the importance of an effective governance and regulation of data sharing in the health and life sciences. Cutting-edge biomedical research strongly demands high-quality data to ensure safe and effective health products. It is often argued that greater access to individual patient data collections stored in hospitals’ medical records systems may considerably advance medical science and improve patient care. However, as public and private actors attempt to gain access to such high-quality data to train their advanced algorithms, a number of sensitive ethical and legal aspects also need to be carefully considered. Besides giving rise to safety, antitrust, trade secrets, and intellectual property issues, such practices have resulted in serious concerns with regard to patient privacy, confidentiality, and the commitments made to patients via appropriate informed consent processes.

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José Baselga, MD, PhD

Memorial Sloan Kettering Stops Executives From Corporate Engagements: Is it Enough?

After a high profile set of scandals, the prominent cancer research hospital, New York’s Memorial Sloan Kettering made an unprecedented move to limit their executives capacity to engage with private industry while employed with Sloan Kettering. Part of a larger set of reforms, Sloan Kettering now has policies that curb or limit serving on corporate boards while employed at Sloan or from accepting certain forms of compensation such as stock or equity. These reforms were bold statements from a preeminent academic medical center about the need to ensure that financial conflicts aren’t compromising patient care or the work of the institution.

Yet, are these laudable reforms enough? Read More

Social media concept: students sit at a table with social media notification bubbles floating above them.

Is Your Cellphone Destroying Your Morals? Devices, Distraction and the Impossible Ethics of Modern Life

It isn’t that texting and driving is dangerous per se. If we were perfectly capable of doing both flawlessly, this danger would instantly disappear. Yet, we know that the danger of texting and driving exists precisely because of the fragility of our attention. The consequences of distracted driving loom large: According to one source, “Text messaging creates a crash risk 23 times worse than driving while not distracted.”

The reasons for this lay in the recesses of a brain stunningly ill-suited to multitasking. Yet, what is useful about this example is that it highlights with searing severity the moral risks and costs of an increasingly distracted mind.

As multitasking now defines modern life, a hugely important question emerges: What will an increasingly distracted brain mean for ethics? Read More

DNA Donors Must Demand Stronger Privacy Protection

By Mason Marks and Tiffany Li

An earlier version of this article was published in STAT.

The National Institutes of Health wants your DNA, and the DNA of one million other Americans, for an ambitious project called All of Us. Its goal — to “uncover paths toward delivering precision medicine” — is a good one. But until it can safeguard participants’ sensitive genetic information, you should decline the invitation to join unless you fully understand and accept the risks.

DNA databases like All of Us could provide valuable medical breakthroughs such as identifying new disease risk factors and potential drug targets. But these benefits could come with a high price: increased risk to individuals’ genetic data privacy, something that current U.S. laws do not adequately protect. Read More

Facebook Should ‘First Do No Harm’ When Collecting Health Data

By Mason Marks

Following the Cambridge Analytica scandal, it was reported that Facebook planned to partner with medical organizations to obtain health records on thousands of users. The plans were put on hold when news of the scandal broke. But Facebook doesn’t need medical records to derive health data from its users. It can use artificial intelligence tools, such as machine learning, to infer sensitive medical information from its users’ behavior. I call this process mining for emergent medical data (EMD), and companies use it to sort consumers into health-related categories and serve them targeted advertisements. I will explain how mining for EMD is analogous to the process of medical diagnosis performed by physicians, and companies that engage in this activity may be practicing medicine without a license.

Last week, Facebook CEO Mark Zuckerberg testified before Congress about his company’s data collection practices. Many lawmakers that questioned him understood that Facebook collects consumer data and uses it to drive targeted ads. However, few Members of Congress seemed to understand that the value of data often lies not in the information itself, but in the inferences that can be drawn from it. There are numerous examples that illustrate how health information is inferred from the behavior of social media users: Last year Facebook announced its reliance on artificial intelligence to predict which users are at high risk for suicide; a leaked document revealed that Facebook identified teens feeling “anxious” and “hopeless;” and data scientists used Facebook messages and “likes” to predict whether users had substance use disorders. In 2016, researchers analyzed Instagram posts to predict whether users were depressed. In each of these examples, user data was analyzed to sort people into health-related categories.

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Webinar, 6/28: Procedural Aspects of Compulsory Licensing under TRIPS

Join us at yet another webinar with J. Wested at the University of Copenhagen. This time we will debate procedural issues in compulsory licensing with H. Grosse Ruse-Kahn (University of Cambridge) & M. Desai (Eli Lilly). Further information on our webinar series is available at here, here, and below:

Procedural Aspects of Compulsory Licensing under Trade-Related Aspects of Intellectual Property Rights (TRIPS)

Wednesday 28. June 2017
4-6 p.m (CEST)
Sign-up & questions: Jakob.blak.wested@jur.ku.dk

This webinar on “TRIPS and the life sciences” will approach the question of compulsory licensing by looking at the technical and procedural requirements applied by courts when evaluating a petition for a compulsory license.  

The balancing of the instrumental application of patent rights as a stimulator of innovation and the public interest in having access to these innovations form a controversial trajectory of discourse, which is as old as patent law. Compulsory licenses are one of the means that have been applied throughout the history of patent law, to condition this complex intersection of interests. The TRIPS agreement is no exception and art 31 contains the provision for member states to grant CL. In 2013, the Indian authorities granted a compulsory license to NATCO Pharmaceuticals for Bayers patented pharmaceutical product Carboxy Substituted Diphenyl Ureas, useful for the treatment of liver and kidney cancer. This decision raised several issues regarding the procedures and requirements to be met in order to grant a compulsory license. Furthermore, in January 2017 an amendment to TRIPS agreement entered into force allowing compulsory licensors to export their generic pharmaceuticals to least developed countries, further recalibrating the intersection of the monopoly power of the patent and public interest. Read More