the NHS logo on the side of a building

Why Patients Make Claims for Clinical Negligence

The NHS (National Health Service) in England is in very deep water when it comes to the increasing costs of clinical negligence claims made against it. NHS litigation compensation damage awards and costs over  recent years have shot upwards to reach record heights threatening some would argue the very sustainability and fabric of the NHS. The increase in litigation against the NHS is well documented in terms of levels and trends over time. However, what is less clear is the motivation behind patients suing. Read More

health secretary matt hancock leaves 10 downing street

No room for complacency in patient safety in the NHS

Matt Hancock, the recently appointed Government, Health and Social Care Secretary, made a keynote speech on patient safety in London recently. The speech spelled out the future direction of NHS (National Health Service) patient safety policy development in England and also contained some very useful observations and policy which have relevance to patient safety policy developers globally, as well as in England.

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Cottage Food and Food Freedom Laws – New LawAtlas data

The newest map on LawAtlas.org analyzes state laws governing the production, sale, and regulation of cottage food operations.

Typically, commercial food production is required to take place in certified commercial kitchens that are heavily regulated. Cottage foods laws regulate the production and sale of certain foods (foods less likely to cause foodborne illness, such as jams and baked goods) made in home kitchens, rather than a licensed commercial kitchen, and a person’s ability sell them in venues like farm stands or retail stores. Similar state laws, called “food freedom laws,” expand upon cottage food laws to include potentially hazardous products like meat and poultry.

These laws are quickly becoming an increasing area of debate at the state level.  Part of this debate centers on the economic rights of “small-batch” home bakers and cooks versus public health and safety concerns. These private bakers, canners, and cooks want the liberty to sell their products to consumers free from the onerous licensing requirements required of their larger commercial counterparts, restaurants and food processing plants, are subject to.  At the same time, there is concern that this individual economic interest is riding roughshod over existing regulations designed to protect consumers from foodborne illnesses that can be caused by improperly prepared foods.

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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

A data set that looks like America

By Oliver Kim

May marks the annual Asian American and Pacific Islander Heritage Month, which recognizes the history and contributions of this diverse population in the United States. Accounting for that diversity though is one of the challenges facing the Asian American-Pacific Islander (AAPI) community: for example, the Library of Congress commemorative website recognizes that AAPI is a “rather broad term” that can include

all of the Asian continent and the Pacific islands of Melanesia (New Guinea, New Caledonia, Vanuatu, Fiji and the Solomon Islands), Micronesia (Marianas, Guam, Wake Island, Palau, Marshall Islands, Kiribati, Nauru and the Federated States of Micronesia) and Polynesia (New Zealand, Hawaiian Islands, Rotuma, Midway Islands, Samoa, American Samoa, Tonga, Tuvalu, Cook Islands, French Polynesia and Easter Island).

Understanding that diversity has huge policy and political implications, particularly in health policy. 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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New Article Examines the Possibility of Applying Workplace Safety Rules to the NFL

Part of the Law and Ethics Initiative of the Football Players Health Study at Harvard University: Article authored by Adam M. Finkel, Chris Deubert, Orly Lobel, I. Glenn Cohen (Faculty Director), and Holly Fernandez Lynch (Former Executive Director

Could occupational health and safety laws be applied to better protect NFL players? A new analysis, published on April 17 in the Arizona Law Review, explores this very possibility.

The article, written by the Law and Ethics Initiative of the Football Players Health Study at Harvard University, examines whether the U.S. Occupational Safety and Health Administration (OSHA) should take an active role in improving health and safety in the NFL workplace.

The article concludes that while OSHA clearly has the authority to regulate the NFL, there is little to no precedent or guidance for OSHA to insert itself into the on-the-field aspects of professional sports. The small body of case law that bears on OSHA’s authority in entertainment and sports opens some doors for OSHA to issue standards for the NFL but also sets some limits on its ability to alter the nature of the game. Adding a public institution like OSHA as a party to existing labor-management discussions concerning health and safety may be the best natural evolution of the issue, the report says, mapping a pathway for OSHA to step up to this challenge. Read More

The Health Service Ombudsman: NHS Failing Patients with Mental Health Problems

By John Tingle

Failings in National Health Service (NHS) care for patients with mental health problems is a worryingly persistent story in the English media. Many reports show harrowing and dramatic failings in NHS care provision for the mentally ill some of which result in avoidable deaths.The Health Service Ombudsman  (HSO) represents the final stage in the NHS complaints procedure and is an independent  office reporting  directly  to Parliament.The HSO carry’s out investigations into complaints  and makes the final decisions on those that have not been resolved by the NHS in England.In a recently published report the HSO reveals reveals unjust, shocking and tragic failings  in NHS care provision for patients with mental health problems.Some mental health care complaints figures are given in the report.In 2016-2017 there were 14,106 complaints made to NHS mental health trusts (hospitals) with ,65% being upheld or partly upheld by the local organisation.Case work data between 2014-15 and 2017-18 was analysed and five key themes showing persistent failings that the HSO see in complaints being made emerged from this exercise:

  • Diagnosis and failure to treat.
  • Risk assessment and safety
  • Dignity and human rights.
  • Communication.
  •  Inappropriate discharge and provision of aftercare.

The HSO also points out in the report that the other common factor in the cases examined is too frequent substandard complaint handling by the NHS organisation. This adds insult to injury, compounding the impact of failings. Read More

Systemic Oversight: a new approach for precision medicine and digital health

By Alessandro Blasimme and Effy Vayena

Imagine a clinical research protocol to test the efficacy of a nutritional regime on the aging trajectory of the participants. Such a study would need to be highly powered and include thousands of people in order to observe a credible effect size. Participants would remain enrolled in the study for many years, maybe decades. Endpoints would include novel measures of healthy aging such as functioning (the capacity to perform certain activities) and the quality of social life. Participants would thus be asked to provide enormous amounts of personal data covering at the same time their health state, their habits and their social activities – most likely with the help of smart appliances, sensor-equipped wearables, mobile phones and electronic records.

In a different scenario a research team aims to develop clinical protocols for cancer treatment according to the unique genomic signature of their tumor. They will need patients, willing to undergo whole genome germline and tumor sequencing right at the moment of diagnosis and be included in a basket trial. Therapy would then be targeted to the specific genetic alterations of each individual in the hope that a combination of targeted drugs would generate better medical outcomes than the current standard of care.

These two scenarios correspond to the prototypical form of, respectively, precision medicine and precision oncology studies. The first is likely to require large (very large) longitudinal cohorts of extensively characterized individuals – like the All of Us Research Program. The second will require sustained sharing of genomic data, information on patients’ clinical history and response to treatment, and possibly a unique repository in which such information would flow to – something akin the NCI’s Genomic Data Common.

This kind of data-intense research, in particular, introduces game changing features: increased uncertainty about foreseeable data uses, expanded temporal span of research activities due to virtually unlimited data lifecycles, and finally, the relational nature of data. This last feature refers both to the fact that, for instance, zip codes contain other types of sensitive information like information about ethnic background (redundant encoding); and to the fact that data about one person contain information about others– as is the case, for instance, with genetic data among family members. Read More